Category: Science

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Energy Government International & World Regulations & Security Science Technology

EMP expert shares message of hope, advises about impact of strikes and attacks

For nearly two decades, William R. Forstchen, Ph.D., a military historian and renowned expert on nuclear energy (electromagnetic pulse) EMP strikes, has been spreading the word about the importance of updating America’s aging power grid to not only protect our population in the event of an EMP attack, but to also make our opponents think twice about launching one in the first place. Dr. Forstchen is also a New York Times bestselling author who has written extensively about EMP weapons.

 

EMP expert shares message of hope, and says working together as a community is key

 

BLACK MOUNTAIN, N.C. — Military historian William R. Forstchen, Ph.D., considers himself an optimist by nature, even though he has written extensively about the catastrophic impact of an EMP strike and has spent nearly two decades urging national and local governments to heed his warnings.

 

“In the first hours, people will be relatively civil to each other … but at what point does that start changing?” he said in a recent interview. “Within about 24 hours, it’s going to start to get squirrely, and the big factor right at the start is water.”

 

Widely considered one of the foremost experts on EMP attacks, Forstchen is the New York Times bestselling author of the One Second After series, a fictional exploration rooted in the cold, solid facts of how an EMP strike above U.S. soil would impact society. There are now four books in the series, which should give people hope that survival is possible, with the right measures and mindset in place.

 

“The component of my [first] book that was so important … is the realization that the only way we’re going to get through this as a community is by working together as a community, helping those who need help … and then planning realistically for how we’re going to get through the next six months, the next year, and still have food on hand, water supply, medication, etc.,” Forstchen added.

 

The latest book in the series, Five Years After, follows protagonist John Matherson as he contends with new threats to the fragile civilization that he helped rebuild.

 

In Five Years After, the Republic of New America has all but collapsed into regional powers, and the world at large is struggling to remain stable as regional conflicts ravage the post-EMP landscape. After several years attempting to lead a quiet life, John receives word that the President is terminal with cancer, and John is asked to take over the reins of government.

 

Pulled back into the fray, John struggles to hold the tottering Republic together. Facing threats on multiple fronts, he races against time to stop another EMP attack on the former United States and China, putting years of progress at risk. With so much of his work under threat, John must find the strength within to start over, so that he can save the country and the people that he holds dear from even greater calamity.

 

Forstchen’s depiction of a post-EMP society throughout his One Second After series is rooted in years of extensive research, and he has long been advocating for greater awareness and preparation against an EMP strike, which he considers a very real threat. His goal is not to alarm, but to prompt proactive measures to protect the American public.

 

“We’ve got to live our lives; we’ve got to enjoy ourselves … don’t make this the obsession,” Forstchen said of the topic of EMPs. “But it should be out there. You should be thinking about this and doing some basic planning.”

 

About the Author

William R. Forstchen is a New York Times bestselling author and a Professor of History at Montreat College, in Montreat, North Carolina. He holds a doctoral degree from Purdue University with a specialization in military history and technology. He is the author of more than 50 books, including the One Second After series that details the realistic effects of an EMP strike.

 

He is a noted expert historian and public speaker and has been interviewed on FOX News, C-SPAN and many others on topics ranging from history to technology and cultural issues, to space technology development, to security threats.

 

For more information about the One Second After series, please visit https://www.onesecondafter.com/.

Amazon link: https://www.amazon.com/Five-Years-After-Matherson-Novel/dp/1250854563/

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Culture Environment Government Healthcare Lifestyle Local News Programs & Events Science

Who you gonna call? Mercer Mosquito Control

Summer’s most unwelcome guest, the mosquito, is here, and even though Mercer County runs a highly sophisticated Mosquito Control program to safeguard the health of residents, mosquitoes remain a reality throughout the warmer months.

PHOTO: Mercer County Mosquito Control staff with Gen. Supervisor Nick Indelicato, kneeling, right.

“While our crews can help mitigate the nuisance, mosquitoes are a backyard problem, and community involvement is crucial for success in controlling them,” said Mercer County Executive Brian M. Hughes.

“I urge our residents to take some simple measures, such as eliminating standing water in and around their homes, to protect themselves and their families from mosquitoes.”

Female mosquitoes lay eggs on the walls of water-filled containers. To keep those eggs from hatching and becoming adult mosquitoes, residents should do the following:

• Empty out water from containers in your yard such as buckets, recycle bins and potted-plant saucers.
• Store tires indoors or away from rain. Check for tire recycling programs in your area.
• Empty and replace water in bird baths at least once a week. Remember: water plus seven days equals mosquitoes.
• Make sure drain pipes slope downward. These drain pipes are dominated by Asian tiger mosquito immatures, and this species is an aggressive day biter.
• Maintain your pool. Remove water from tarps and pool covers.

 

Other steps residents can take include keeping mosquitoes out of the home by installing or repairing window screens and using air conditioning when available; and preventing mosquito bites by using an Environmental Protection Agency-registered insect repellent with an active ingredient such as DEET, Picaridin, IR3535, Oil of lemon eucalyptus (OLE) or para-menthane-diol (PMD).

 

If you’ve done all you can to control the mosquito populations by removing water sources and believe you need further help, you can fill out an inspection request and a member of our team will assist.

 

For more information about protecting your family from mosquitoes all summer long, as well as up-to-date information about mosquito-borne diseases, visit the Mercer County Mosquito Control website or watch our video, Mercer County Mosquito Control in the field – YouTube.

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Lifestyle Science Special/Sponsored Content

Introducing: Manta NAP Arc, a must for getting the power nap you deserve at work

We are so excited to announce that Manta Sleep, renowned for their world-class sleep masks, recently launched their much-anticipated new wellness essential for those who work in an office: the Manta NAP Arc. This napping essential will help you reclaim your right to rest, as it is crafted for easy, comfy power naps at your desk.

 

At home, your self-care game is solid. But at the office, you’re imprisoned by endless “quick” meetings and the constant subtle pressure to hustle and grind through your need for rest. That’s why we made NAP Arc: the ergonomic power nap pillow designed for your desk, so you can take a well-deserved break no matter where you’re working. Now, self-care goes where you go — as it should. This is our new normal.

 

Nap Arc is designed for quick setup, easy adjustability and ergonomic support. So you’re always only a few seconds away from a comfy power nap — right at your desk. Its intelligent arc design also means you waste zero time finding the right position for the quick, easy rest you deserve.

 

NAP Arc has an ultra-soft, stable structure that optimally supports your head and neck — so you wake up with zero neck strain. It’s crafted for comfort, so you get the same TLC at the office that you do at home — exactly as you should.

 

NAP Arc’s easy adjustability makes it the perfect fit for anyone who needs a good rest at the office just as they do at home. And adjusting the height is easy: pull the strap to increase it, tug at the G-hook to decrease it. It’s quick and effortless. It also features premium, high-quality materials and a reversible cover — so you can always switch to the cool side of the pillow, just like at home. The cover is also machine washable, so you can easily slide it off and throw it in the washing machine when needed.

 

Manta Sleep’s mission is to empower light sleepers to sleep better so they can do more. Manta Sleep believes great sleep is the non-negotiable foundation you need to create your best life. That it’s impossible to unlock your full potential if you’re not getting an afternoon nap every day. And that naps beat coffee hands down. Everything Manta Sleep creates is fueled by their drive to enable better lives through better sleep and regular naps.

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Culture Education Healthcare Lifestyle Science Technology

Parenting tips to uphold kids’ mental health in the digital age

There has been much critical discourse about the escalating children’s mental health crisis relative to how benchmarks like stress, anxiety and loneliness are driving depression and other serious psychological conditions amongst youth populations like never before.

 

Of course, children are not the only ones suffering, as parents and caregivers struggle to prevent, address and treat concerns in order to uphold kids’ emotional well-being.  In this process, the adults themselves are suffering in kind—often exacerbating their own mental and emotional struggles amid the copious complexities of modern life. This, of course, has a litany of macro-economic implications.

 

As one case in point, a Morgan Stanley Alliance for Children’s Mental Health research report cited that six in ten of those who are concerned say their children’s mental health has impacted them negatively, with nearly half of those indicating it has affected their productivity at work.

 

The report goes on to reveal that fully 48% of working parents who reported concern said their children’s mental health has impacted their performance at work in some way—including having to deal with disruptions and an inability to concentrate on the job. Some concerned working parents have considered reducing their working hours to support their child(ren) while others have even considered quitting their jobs altogether.

 

Relative to the role Internet use, specifically, plays into the children’s mental health crisis, other reported research from the Child Mind Institute found approximately half of parents polled expressed concern over the impact of internet use on cognitive, social and emotional development.

 

“In today’s digital age, parents are tasked with navigating an ever-evolving technology landscape to address and safeguard their kids’ mental health while also balancing work and parenting—an endeavor that has become a daunting—often seemingly impossible—task that’s ushered in an era of pressure-driven parenting,” says Neuropsychologist, American Mothers New York State.

 

“Mother of the Year” award recipient and Brilliant Minds Unite Founder Dr. Jatali Bellanton—author of Kidpreneurs and founder of the Kids Who Bank financial literacy program, deployed in, hundreds of elementary schools across the United States.

 

“It is certainly possible for kids to thrive and deeply benefit from technological advancements. But, parents and caregivers must wholeheartedly commit to not just monitor such usage and activities, but also achieve and sustain healthy boundaries away from screens and buttons—both the kids and the adults. The key is to fill that tech downtime with activities that foster connectivity to, and a reverence for, ‘real world’ experiences.

 

And, when technology is in use, to remain hyper observant and aware ensure it’s not impeding the child’s mental health in any way whether before, during or after. If red flags present, however minor, it’s imperative to address them immediately.”

 

Social media has long been a culprit of compromising kids’ mental health. A new American Psychological Association health advisory on social media use in adolescence offers the following scientific evidence-based recommendations:

 

1. Youth using social media should be encouraged to use functions that create opportunities for social support, online companionship, and emotional intimacy that can promote healthy socialization.

2. Social media use, functionality, and permissions/consenting should be tailored to youths’ developmental capabilities; designs created for adults may not be appropriate for children.

3. In early adolescence (i.e., typically 10–14 years), adult monitoring (i.e., ongoing review, discussion, and coaching around social media content) is advised for most youths’ social media use; autonomy may increase gradually as kids age and if they gain digital literacy skills. However, monitoring should be balanced with youths’ appropriate needs for privacy.

4. To reduce the risks of psychological harm, adolescents’ exposure to content on social media that depicts illegal or psychologically maladaptive behavior, including content that instructs or encourages youth to engage in health-risk behaviors, such as self-harm (e.g., cutting, suicide), harm to others, or those that encourage eating-disordered behavior (e.g., restrictive eating, purging, excessive exercise) should be minimized, reported, and removed;  moreover, technology should not drive users to this content.

5. To minimize psychological harm, adolescents’ exposure to “cyberhate” including online discrimination, prejudice, hate, or cyberbullying especially directed toward a marginalized group (e.g., racial, ethnic, gender, sexual, religious, ability status), or toward an individual because of their identity or allyship with a marginalized group should be minimized.

6. Adolescents should be routinely screened for signs of “problematic social media use” that can impair their ability to engage in daily roles and routines, and may present risk for more serious psychological harms over time.

7. The use of social media should be limited so as to not interfere with adolescents’ sleep and physical activity.

8. Adolescents should limit use of social media for social comparison, particularly around beauty- or appearance-related content.

9. Adolescents’ social media use should be preceded by training in social media literacy to ensure that users have developed psychologically-informed competencies and skills that will maximize the chances for balanced, safe, and meaningful social media use.

10. Substantial resources should be provided for continued scientific examination of the positive and negative effects of social media on adolescent development.

 

 

Dr. Bellanton, also a technology futurist and leading Metaverse influencer, has some additional valuable insights into how parents can navigate this tricky, ever-changing terrain—especially for younger elementary-age children.

 

1. Ditch rigid schedules. While it’s essential to have some structure in your child’s daily routine, it’s equally important to provide flexibility. Instead of imposing a strict, timed schedule on your child’s educational or other activities, Dr. Bellanton recommends creating a more relaxed and flexible approach that fits around the parents’ work schedule.

2. Create safe folders for YouTube videos and shows that your child is allowed to watch. With the abundance of inappropriate content available on the internet, it can be challenging to monitor what your child is watching. However, by creating special YouTube folders and streaming media playlists on Netflix and the like, parents can control the content their children consume and avoid unnecessary worry.

3.  Introduce your children to hobbies that require the use of different parts of the brain. Whether it’s sculpting, painting, or physical activities that teach children how to utilize new tools, engaging in a hobby at least once every other day can help children develop new skills and foster creativity.

4. Create a star chart system is another effective way to incentivize and reward children for doing things that do not involve digital devices. For instance, parents can reward their children for cleaning, reading, or playing outside, instead of spending time on screens.

5. Parents can also take advantage of the metaverse by teaching their children how to build and make money through playing video games. Children can be introduced to games that allow them to learn how to make money and build skills while playing.

7. Have conversations with children about online predators and to teach them to be cautious when playing games like Roblox. Parents should also pay attention to the music played in games, as some songs may contain inappropriate lyrics.

8. Put timers on devices to limit screen time. Parents can set a specific amount of time for their children to watch videos or play games on their devices, ensuring they have a healthy balance of screen time and other activities.

Parenting in the digital age is a challenge that requires a multifaceted and highly concerted approach with tactical strategies that must be employed with intention and upheld with consistency. Doing so will allow families to embrace the litany of benefits the digital age affords and use them to derive emotional and lifestyle advantages versus impairments.

 

 

About the expert

After 9.5 years in investment banking, and 4.5 years in forensic accounting, Jatali decided to leave the corporate world in order to share her years of financial experience to help the young and ambitious gain business knowledge to build successful careers from doing what they love which has formed into 6 years of her teaching youth in various systems worldwide, including in Ghana, Kenya, etc.

 

Among her corporate business accomplishments, Jatali restructured and managed accounting departments towards multi-million-dollar profits and clientele growth while lowering costs. She helped companies survive global shifts towards online business by implementing new software programs to replace outdated communication. As a financial consultant for a medical practice, she increased profit margins by 42% in just one year.

 

In March 2015, Jatali gave birth to her first child, which, little did she know, would lead her to create a youth financial literacy initiative by the name Kids Who Bank. The limited offerings of financial literacy books for children, when in search for her son, inspired her to write a story formatted finance book for youth, and also create a finance curriculum, thus starting her journey of becoming an entrepreneur.

 

In Kids Who Bank, Jatali strives to inspire children to continue following their dreams. She is passionate about combining her business expertise with her desire to give all children a fair chance to succeed in life.

 

Jatali has donated over $40,000 to schools worldwide to help students pay for their education, school supplies, backpacks, and books. She is committed to incorporating financial and business education into school curricula.

 

Also notable, she was awarded the 2019 New York State Mother Of The Year award. Jatali coordinated the “2nd Annual Kidpreneur Awards Gala” on April 7th, 2019, recognizing the entrepreneurial and philanthropic pursuits of bright minds across the nation.

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Healthcare Lifestyle Perks Science Technology

Next evolution of wearables: Med-tech expert brings 1st medical-grade smart ring to market

After spending over 30 years in the medical device industry, John Mastrototaro has set out to change what consumers expect from their wearables.

 

Consumers are looking for more than just an activity or sleep tracker, they are looking for a more accurate wearable that gives them a holistic view of their health.

 

Tapping into his experiences at Medtronic and MiniMed where he was instrumental in introducing the ambulatory continuous glucose monitoring system and the sensor augmented insulin pump, Mastrototaro has flipped the script on traditional wearables, building Movano Health as a medical device company rather than a consumer wellness or fitness device company, to give consumers and medical professionals the data they need and want.

 

The Evie Ring, available this September, is a medical-grade health smart ring measures a comprehensive set of health metrics including heart rate, heart rate variability, SPO2, respiration rate, temperature, steps, activity, calories, sleep, menstrual cycle, and more. The Evie Ring has also met FDA benchmarks for HR & SpO2 accuracy and is preparing to file for FDA clearance.

 

Beyond pursuing FDA clearance, Movano Health is focusing the Evie Ring on those who have been underserved in the wearables market: women. From bulky designs, to inaccuracies, to unintuitive and unhelpful data, current wearables don’t give women what they are looking for, especially as they enter menopause.

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Business Healthcare Lifestyle Science

Blue Earth Diagnostics announces results of post-hoc analysis assessing impact of urinary activity on interpretation of POSLUMA® (Flotufolastat F 18) injection PET/CT in prostate cancer

− Based on data from prospective Phase 3 LIGHTHOUSE and SPOTLIGHT studies in newly diagnosed and recurrent prostate cancer –

 

MONROE TOWNSHIP, N.J. & OXFORD, England — (BUSINESS WIRE) — Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced results of a post-hoc analysis assessing the impact of urinary activity on the interpretation of POSLUMA® (flotufolastat F 18) injection (formerly known as 18F-rhPSMA-7.3) PET/CT in prostate cancer.

 

The analysis was based on data from Blue Earth Diagnostics’ prospective Phase 3 LIGHTHOUSE and SPOTLIGHT studies that evaluated the diagnostic performance and safety of POSLUMA in newly diagnosed and recurrent prostate cancer. The majority read results from 3 blinded readers assessing 712 evaluable POSLUMA scans showed that urinary activity did not influence disease assessment for the majority (96%, 682/712) of patients and that halo artifacts, that can potentially inhibit image assessment, occurred very rarely (0.3%, 2/712). The results as reported expanded on the initial data from a single reader that were detailed in the abstract. Recently approved by the U.S. FDA, POSLUMA is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. The results were reported at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, held June 24 – 27, in Chicago, Ill.

 

“The ability to gather actionable information from PSMA PET scans is important for physicians to make informed decisions about patient management for men with prostate cancer,” Phillip Kuo, MD, Ph.D., Departments of Medical Imaging, Medicine, and Biomedical Engineering. “Activity in the urinary bladder area is a common feature of PSMA-PET radiopharmaceuticals. It can potentially obscure tumors and lymph nodes in the prostate region, which is the most common site of recurrence, and interfere with accurate image interpretation. The data presented here build on early clinical experience and suggest that, among this large dataset from two Phase 3 prospective trials, POSLUMA urinary activity is relatively low and rarely impacts disease assessment.”

 

“We are pleased to share these results about our new FDA-approved product, POSLUMA, with the imaging community at SNMMI,” said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. “POSLUMA represents a new class of PSMA-targeted PET radiopharmaceuticals based on novel radiohybrid technology. It is engineered to advance clinical decision-making by providing beneficial information for treatment planning in men with prostate cancer, which can lead to changes in patient management. In preclinical and Phase 1 studies, POSLUMA demonstrated a high binding affinity for PSMA, with low urinary bladder activity, thus providing the potential for enhanced image evaluation in the prostate and regions near the ureters for patients with prostate cancer. We conducted this post-hoc analysis of PET scans from the Phase 3 LIGHTHOUSE and SPOTLIGHT studies to further investigate these earlier findings. We believe that POSLUMA’s diagnostic performance, high-affinity PSMA binding and low urinary activity characteristics make it a valuable diagnostic tool that is radiolabeled with 18F for high image quality and readily available patient access.”

 

Results presented at SNMMI were based on 712 evaluable POSLUMA scans (348 newly diagnosed patients and 364 patients with recurrent prostate cancer from LIGHTHOUSE and SPOTLIGHT, respectively). Of the 718 eligible scans, 6 were excluded on the basis of cystectomy, renal failure or presence of a urinary catheter. Findings included quantitative analyses of activity in the urinary bladder, based on maximum and mean standardized uptake values (SUVmax and SUVmean, respectively). Qualitative analyses conducted by 3 blinded, independent PET readers examined the impact of any urinary activity on the ability to assess the prostate/prostate bed and pelvic/retroperitoneal lymph nodes using a 3-point scale.

 

The median bladder SUVmax and SUVmean for POSLUMA were 17.1 and 12.5, respectively. For the qualitative metrics, by majority read, it was possible to distinguish urinary activity from disease uptake in 96% (82/712) of patients. Halo artifacts impacting assessment around the ureters and bladder were only observed in 0.3% (2/712) of patients.

 

There were several limitations to the study, including that it was not designed as a head-to-head comparison with other PSMA-PET radiopharmaceuticals and that any comparisons with data from other radiopharmaceuticals reported in the literature should be made with caution. Another limitation was that reader agreement was not formally tested. It should also be noted that, per the Important Safety Information for POSLUMA, the interpretation of POSLUMA PET in patients with suspected prostate cancer recurrence may differ depending on imaging readers, particularly in the prostate/prostate bed region.

 

Results of the presentation, “Post-hoc analysis of the LIGHTHOUSE and SPOTLIGHT studies to assess the impact of urinary activity on interpretation of 18F-rhPSMA-7.3,” were presented at SNMMI on June 27, 2023, by Phillip Kuo, MD, Ph.D., Departments of Medical Imaging, Medicine, and Biomedical Engineering, University of Arizona, Tucson, Ariz. Full session details and the abstract are available in the SNMMI 2023 online program here.

 

Blue Earth Diagnostics’ LIGHTHOUSE Phase 3 clinical trial (NC04186819) was a prospective, Phase 3, multi-center, single-arm, imaging study conducted in the United States and Europe to evaluate the safety and diagnostic performance of POSLUMA PET in men with newly diagnosed prostate cancer. Results have been presented at the 23rd Annual Scientific Meeting in Urologic Oncology (SUO) in December 20221 and at ASCO GU in February 2023.2 The SPOTLIGHT trial (NCT04186845) was a Phase 3, multi-center, single-arm imaging study conducted in the United States and Europe to evaluate the safety and diagnostic performance of POSLUMA PET imaging in men with suspected prostate cancer recurrence based on elevated PSA following prior therapy. Results from the SPOTLIGHT study were published online on April 26, 2023 in the Journal of Urology: DOI: 10.1097/JU.0000000000003493.3

 

About POSLUMA® (flotufolastat F 18)

POSLUMA® (flotufolastat F 18) injection (formerly referred to as 18F-rhPSMA-7.3) is an optimized, targeted radiohybrid diagnostic imaging agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Precision PET imaging with POSLUMA can help identify the location and extent of prostate cancer, providing clinically valuable information to guide patient management. POSLUMA represents a new class of high-affinity PSMA-targeted PET radiopharmaceuticals based on novel radiohybrid technology and is labeled with the radioisotope 18F to provide readily available patient access and leverage the high image quality of 18F-labeled PSMA PET imaging to facilitate effective detection of disease. POSLUMA was approved by the U.S. Food and Drug Administration in May 2023.

 

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)

Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) compounds consist of a radiohybrid (“rh”) Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells, and they may be radiolabeled with imaging isotopes for PET imaging, or with therapeutic isotopes for therapeutic use – providing the potential for creating a true theranostic technology. Radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Blue Earth Diagnostics received U.S. Food and Drug Administration approval for its radiohybrid PET diagnostic imaging product for use in prostate cancer in 2023. rhPSMA compounds for potential therapeutic use are investigational and have not received regulatory approval.

 

Indication and Important Safety Information About POSLUMA

INDICATION

POSLUMA® (flotufolastat F 18) injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer

  • with suspected metastasis who are candidates for initial definitive therapy
  • with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level

 

IMPORTANT SAFETY INFORMATION

  • Image interpretation errors can occur with POSLUMA PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended.
  • Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline.
  • POSLUMA use contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers.
  • The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain.
  • Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established.

 

To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

Full POSLUMA prescribing information is available at www.posluma.com/prescribing-information.pdf.

 

About Blue Earth Diagnostics

Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is a growing international molecular imaging company focused on delivering innovative, well-differentiated diagnostic solutions that inform patient care. Formed in 2014, the Company’s success is driven by its management expertise and supported by a demonstrated track record of rapid development and commercialization of positron emission tomography (PET) radiopharmaceuticals. Blue Earth Diagnostics’ expanding oncology portfolio encompasses a variety of disease states, including prostate cancer and neuro-oncology. Blue Earth Diagnostics is committed to the timely development and commercialization of precision radiopharmaceuticals for potential use in imaging and therapy. For more information, please visit: www.blueearthdiagnostics.com.

 

About Bracco Imaging

Bracco Imaging S.p.A., part of the Bracco Group, is a world-leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose-management software. In 2019 Bracco Imaging enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting-edge biotechnology vehicle to develop radiopharmaceutical therapies. Visit: www.braccoimaging.com.

 

References

1 Chapin BF, LIGHTHOUSE Study Group. 134: Diagnostic performance and safety of 18F-rhPSMA-7.3 PET in patients with newly diagnosed prostate cancer: Results from a phase 3, prospective, multicenter study (LIGHTHOUSE). SUO Annual Meeting. Orlando, FL: https://suo-abstracts.secure-platform.com/a/gallery/rounds/15/details/2390, 2022.

 

2 Chapin BF on behalf of Koontz B, LIGHTHOUSE Study Group. “Detection of true positive M1 lesions by 18F-rhPSMA-7.3 PET in newly diagnosed prostate cancer: Results from the phase 3 prospective LIGHTHOUSE study,” 2023 ASCO Genitourinary Cancers Symposium (ASCO GU), ASCO GU 2023. San Francisco, Calif.: https://meetings.asco.org/abstracts-presentations/217100, 2023.

 

3 Jani AB, Ravizzini GC, Gartrell BA, et al. Diagnostic Performance and Safety of 18F-rhPSMA-7.3 PET in Men with Suspected Prostate Cancer Recurrence: Results from a Phase 3, Prospective, Multicenter Study (SPOTLIGHT), The Journal of Urology® (2023), doi:10.1097/JU.0000000000003493.

Contacts

For Blue Earth Diagnostics (U.S.)

Priscilla Harlan

Vice President, Corporate Communications

(M) (781) 799-7917

priscilla.harlan@blueearthdx.com

For Blue Earth Diagnostics (UK)

Clare Gidley

Associate Director Marketing and Communications

Tel: +44 (0) 7917 536939

clare.gidley@blueearthdx.com

Media

Sam Brown Inc.

Mike Beyer

(M) (312) 961-2502

mikebeyer@sambrown.com

Categories
Business Lifestyle Science Technology

Corporate Governance calls out for AI-powered board

Corporate boards are struggling to cope with digital transformation to assess risks such as cybersecurity, and AI-driven software can provide real-time data and improve decision-making, ultimately leading to increased profitability.

 

Digital transformation remains the Achilles Heel for corporate boards:

 

Marion Lewis, Founder and CEO of Govenda, an innovative board management SaaS developer asserts that boards are finding rapid and constant digital transformation difficult, raising fears that they will not be able to pivot in response to needed change, putting the boards and organizations at risk.

 

Govenda recently launched their Artificial Board Intelligence Innovation called ‘Gabii’ to facilitate decision-making through a fast presentation of real-time data to ensure compliance from anywhere in the world, using customers’ data without compromising security:

  • Blockchain technology provides an additional layer of security for board materials.
  • Administrative tasks like creating meetings, managing committee members, and tracking RSVPs will help in reducing the need to perform tedious, repetitive tasks.
  • With faster access to relevant information, board professionals and directors can make more informed decisions.
  • ‘Gabii’ supports voice accessibility, by answering questions to help complete tasks.

 

Boards must evaluate their current software for digital transformation and sustainability.

 

“The sustainability of board governance is in jeopardy. The solution is to incorporate AI-driven board portal software into corporate board processes,” says Lewis.

 

Flawed judgment and a lack of proper decision-making often lead to business failures.

Lewis notes that U.S. board members face challenges without AI, including limited real-time information access and the inability to spot patterns in large data sets or automate decision-making.

 

Marion Lewis, Co-Founder and CEO of Govenda can speak on the following:

  • Why must organizations leverage the use of AI in the advancement of digital transformation?
  • How can AI integration in corporate governance ensure that disaster response and contingency planning are effective in the face of digital disruption?
  • Why has AI integration been missing in corporate governance systems till today?
  • What role can AI-driven board portal software play in improving corporate governance practices, decision-making, and managing risks associated with digital transformation?

 

About Govenda

Marion Lewis and Jeanette Thomas, two results-driven entrepreneurs, investors, philanthropists, and business community leaders co-founded Govenda. Govenda is reimagining how board of directors convene to provide intentional, strategic governance ─ by being the bridge between the boardroom and a company’s strategic goals. The board management software accelerates stakeholder governance as a force for good in the world and empowers organizations to create sustainable value by equipping stakeholders with innovative tools that transform practices. It was designed to magnify security and compliance as board tools to handle sensitive and confidential information crucial to compliance and control of proprietary data. Portability of access with enhanced collaboration is no longer a plus – it is essential. GABII, the Govenda product integrating its AI-driven portal tools with Microsoft 365 and enterprise resource planning (ERP) software streamlines workflows and improves efficiency. For more information on the most innovative platform in board governance visit www.Govenda.com

Categories
Business Culture Healthcare Lifestyle Regulations & Security Science

Members vote yes for first contract in UFCW Local 152’s cannabis division

EGG HARBOR TOWNSHIP, N.J. — (BUSINESS WIRE) — UFCW Local 152 members at The Botanist dispensaries in Egg Harbor and Atlantic City, N.J. voted overwhelmingly on June 21 to ratify a bargaining agreement with their employer, making it the first of its kind for cannabis workers at the local union.

 

The three-year agreement calls for raises as well as ratification bonuses and improved health benefits. The base salary for new hires is increased and all members at both Botanist locations have access to the grievance process through their union.

 

“This strong first contract is the culmination of months of hard bargaining on behalf of our members,” Local 152 President Brian String said. “The unity displayed by these workers was crucial to our success and sets a strong foundation for continued achievements.”

 

UFCW Local 152 represents more than 60 workers at The Botanist across the two locations. Members grow, harvest and process cannabis and sell it in several forms at their retail spaces. Customers can seek assistance from the experts at either location to find the products that meet their medical needs.

 

For more than a decade, Local 152 has been at the forefront of organizing the cannabis industry in New Jersey. Earlier this year, workers at another cannabis cultivation site owned by MPX NJ group voted to join the union and are in negotiations to determine their first contract.

 

“Our expertise in bargaining across many diverse, challenging industries makes Local 152 a powerful ally for cannabis workers,” String said.

 

“No one has to go it alone. With a union, we’re all in this together.”

Contacts

Brian String, President

UFCW Local 152

(609) 704-3900

Categories
Business Lifestyle Science Technology

AI sans human touch results in marketing disaster declares a tech expert

There are potential risks and drawbacks for relying solely on AI for marketing purposes, and so human involvement and collaboration are important in creating effective and high-quality messaging.

 

In marketing, AI is designed to work on HUMAN command.

 

Well-directed AI tools can mimic a brand’s identity but cannot be relied upon to generate or direct it. It lacks creativity, subjective thinking, and conscious thought, and relying too heavily on AI can lead to plagiarism, inaccuracies, and content that lacks emotional intelligence.

 

“Just because you CAN automate doesn’t mean you SHOULD. If a company makes its decisions purely on AI, it can lead to serious consequences,” says Derek Chew, CEO of Fullmoon Digital.

 

AI should augment human intelligence, not replace it.

By 2025, AI is projected to replace 85 million jobs globally. Chew, however, believes that although AI can help analyze and predict customer behavior, personalize content, and optimize advertising campaigns, without human direction and adjustment, the AI output lacks insight, humor, and structural diversity. Human sensibilities are required to ensure high-quality and clear messaging and easy readability.

 

“Businesses need to look for uniquely tailored marketing processes for each client emphasizing the importance of effective communication and consistent collaboration,” affirms Chew.

 

Derek Chew, CEO of Fullmoon Digital, can speak on the following:

  • Why is human creativity important for AI in marketing?
  • Why should marketers use personalized marketing strategies with AI?
  • How will AI advancement affect marketing jobs and how to prepare?
  • What businesses are harmed if AI is relied on too much without human intervention?
  • Why are businesses seeing a reduction in revenue with the use of AI?
  • How can digital marketers meet evolving customer needs to ensure their clients feel valued?

 

About Fullmoon Digital

Fullmoon Digital, founded by Derek Chew, a former early Yahoo! employee, is one of the few 100% independent digital marketing agencies in the United States. The firm is cross-functional, with deep experience in media planning and buying, digital consultancy, SEO, digital strategy, programmatic, analytics, performance marketing, paid media, social advertising, and creative. They push the envelope of what is possible in terms of marketing and technology, all the while providing best-in-class digital marketing service to their “pack” of clients. For more information, please visit www.fullmoondigital.com.

Categories
Business Government Healthcare International & World Lifestyle Science

FDA approves Bayer’s Ultravist® (iopromide) injection for contrast-enhanced mammography

  • Ultravist™-300, -370 is now the only contrast agent in the U.S. indicated to visualize known or suspected lesions of the breast in adults, as an adjunct to mammography and/or ultrasound
  • Contrast-enhanced mammography (CEM) is an emerging modality combining digital mammography with the administration of a contrast agent1
  • Strategically expands Bayer’s portfolio in breast imaging, including contrast agents and injectors

 

WHIPPANY, N.J. — (BUSINESS WIRE) — Bayer announced today that Ultravist® (iopromide)-300, -370, its iodine-based contrast agent, has been approved by the U.S. Food and Drug Administration (FDA) for contrast-enhanced mammography (CEM) – making it the only contrast agent approved for this indication. The product can be used to visualize known or suspected lesions of the breast in adults, as an adjunct to mammography and/or ultrasound. CEM is an emerging modality that combines digital mammography with the administration of a contrast agent, such as Ultravist, to help identify breast lesions.1

 

The new FDA approved indication aligns with the recent increased focus on supplemental imaging needs for women at a higher risk for breast cancer, which may include the 40-50% of U.S. women older than 40 with dense breasts.2

 

“The approval of Ultravist-300 and -370 in contrast-enhanced mammography gives physicians a new imaging option where conventional mammography might not be enough,” said Dr. Konstanze Diefenbach, Head of Radiology Research and Development, Bayer. “We are pleased to be able to offer additional options for breast imaging to healthcare professionals, as we aim to support them in their role of providing clear answers from diagnosis to care for patients.”

 

The approval expands upon Bayer’s focus on breast imaging, with a portfolio that also includes Gadavist® (gadobutrol) injection, a gadolinium-based contrast agent approved for use with MRI (Magnetic Resonance Imaging) to assess the presence and extent of malignant breast disease in adult patients. In 2019, the MEDRAD® Stellant FLEX Computed Tomography (CT) Injection System with Certegra® Workstation was also cleared in the U.S. for use in CEM. Through the use of iodine-based x-ray contrast agents, CEM can allow for better visualization of abnormalities in breast tissue that may not be visible with standard mammography.3

 

About breast cancer and contrast-enhanced mammography

In 2020, there were 2.3 million women diagnosed with breast cancer globally, according to the World Health Organization (WHO).4 Contrast-enhanced mammography (CEM) has been demonstrated to help with visualization of lesions in breast tissue and is a relatively low-cost breast imaging examination. CEM is easy to perform in everyday clinical practice and can be used in various clinical settings, such as when routine imaging produces inconclusive findings. It can also be a helpful tool when breast MRI is unavailable or contraindicated.5

 

About Ultravist

INDICATIONS and IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

Intra‐arterial Procedures*: Ultravist® is indicated for: • Cerebral arteriography and peripheral arteriography in adults; • Coronary arteriography and left ventriculography, visceral angiography, and aortography in adults; • Radiographic evaluation of cardiac chambers and related arteries in pediatric patients aged 2 years and older.

 

Intravenous Procedures*: Ultravist® is indicated for: • Excretory urography in adults and pediatric patients aged 2 years and older; • Contrast Computed Tomography (CT) of the head and body (intrathoracic, intra-abdominal, and retroperitoneal regions) for the evaluation of neoplastic and non-neoplastic lesions in adults and pediatric patients aged 2 years and older; • Contrast mammography to visualize known or suspected lesions of the breast in adults, as an adjunct following mammography and/or ultrasound.

 

*Specific concentrations and presentations of Ultravist® are recommended for each type of imaging procedure [see Dosage and Administration (2.2, 2.3, 2.4)] in the Full Prescribing Information]

 

IMPORTANT SAFETY INFORMATION

WARNING: RISK ASSOCIATED WITH INTRATHECAL USE

Intrathecal administration, even if inadvertent, may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. ULTRAVIST is not approved for intrathecal use.

 

Risks Associated with Intrathecal Use: Intrathecal administration, even if inadvertent, can cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Ultravist® is for intra-arterial or intravenous use only. Ultravist® is not approved for intrathecal use.

 

Hypersensitivity Reactions: Ultravist® can cause life-threatening or fatal hypersensitivity reactions including anaphylaxis. Manifestations include respiratory arrest, laryngospasm, bronchospasm, angioedema, and shock. Most severe reactions develop shortly after the start of injection (e.g., within 1 to 3 minutes), but delayed reactions can also occur. There is increased risk of hypersensitivity reactions in patients with a history of previous reaction to a contrast agent and known allergic disorders, or other hypersensitivities. Premedication with antihistamines or corticosteroids does not prevent serious life-threatening reactions but may reduce both their incidence and severity. Obtain a history of allergy, hypersensitivity, or hypersensitivity reactions to iodinated contrast agents and have emergency resuscitation equipment and trained personnel available prior to Ultravist® administration. Monitor all patients for hypersensitivity reactions.

 

Acute Kidney Injury: Acute kidney injury, including renal failure, may occur after administration. Risk factors include: pre-existing renal insufficiency, dehydration, diabetes mellitus, congestive heart failure, advanced vascular disease, elderly age, concomitant use of nephrotoxic or diuretic medications, multiple myeloma or other paraproteinemia, and repetitive and/or large doses of Ultravist® . Use the lowest necessary dose of Ultravist® in patients with renal impairment. Hydrate patients prior to and following Ultravist® administration. Do not use laxatives, diuretics, or preparatory dehydration prior to Ultravist® administration.

 

Cardiovascular Adverse Reactions: In patients with cardiac and / or renal disease, hemodynamic disturbances including shock and cardiac arrest may occur during or shortly after administration of Ultravist®. Hypotensive collapse and shock have occurred. Cardiac decompensation, serious arrhythmias, and myocardial ischemia or infarction can occur during coronary arteriography and ventriculography. Use the lowest necessary dose of ULTRAVIST in patients with congestive heart failure. Always have emergency resuscitation equipment and trained personnel available. Monitor all patients for severe cardiovascular reactions.

 

Thromboembolic Events: Serious, in some cases fatal, thromboembolic events causing myocardial infarction and stroke can occur during angiography procedures. During these procedures, increased thrombosis and activation of the complement system can occur. Risk of thromboembolic events can be influenced by: length of procedure, catheter and syringe material, underlying disease state, and concomitant medications. To decrease thromboembolic events, use meticulous angiographic techniques and minimize the length of the procedure. Avoid blood remaining in contact with syringes containing iodinated contrast agents, which increases the risk of clotting. Avoid angiography in patients with homocystinuria because of the risk of inducing thrombosis and embolism.

 

Extravasation and Injection Site Reactions: Extravasation can occur, particularly in patients with severe arterial or venous disease. In addition, injection site reactions such as pain and swelling at the injection site can also occur. Ensure intravascular placement of catheters prior to injection. Monitor patients for extravasation and advise patients to seek medical care for progression of symptoms.

 

Thyroid Storm in Patients with Hyperthyroidism: Thyroid storm has occurred after the intravascular use of iodinated contrast agents in patients with hyperthyroidism or with an autonomously functioning thyroid nodule. Evaluate the risk in such patients before use of Ultravist®.

 

Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age: Thyroid dysfunction characterized by hypothyroidism or transient thyroid suppression has been reported after both single exposure and multiple exposures to iodinated contrast media (ICM) in pediatric patients 0 to 3 years of age. Younger age, very low birth weight, prematurity, underlying medical conditions affecting thyroid function, admission to neonatal or pediatric intensive care units, and congenital cardiac conditions are associated with an increased risk of hypothyroidism after ICM exposure. After exposure to ICM, individualize thyroid function monitoring based on underlying risk factors, especially in term and preterm neonates. The safety and effectiveness of Ultravist® in pediatric patients younger than 2 years of age have not been established, and Ultravist® is not approved for use in pediatric patients younger than 2 years of age.

 

Hypertensive Crisis in Patients with Pheochromocytoma: Hypertensive crisis in patients with pheochromocytoma has occurred with iodinated contrast agents. Closely monitor patients when administering Ultravist® if pheochromocytoma or catecholamine-secreting paragangliomas are suspected. Inject the minimum amount of Ultravist® necessary and have measures for treatment of a hypertensive crisis readily available.

 

Sickle Cell Crisis in Patients with Sickle Cell Disease: Iodinated contrast agents may promote sickling in individuals who are homozygous for sickle cell disease. Hydrate patients prior to and following administration and use only if the necessary imaging information cannot be obtained with alternative imaging modalities.

Severe Cutaneous Adverse Reactions: Severe cutaneous adverse reactions (SCAR) may develop from 1 hour to several weeks after intravascular contrast agent administration. These reactions include Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS). Reaction severity may increase and time to onset may decrease with repeat administration of contrast agent; prophylactic medications may not prevent or mitigate severe cutaneous adverse reactions. Avoid administering Ultravist® to patients with a history of a severe cutaneous adverse reaction to Ultravist®.

 

Interference with Laboratory Tests: Ultravist® can interfere with protein-bound iodine test.

Common Adverse Reactions: Common adverse reactions (>1%) are headache, nausea, injection site and infusion site reactions, vasodilatation, vomiting, back pain, urinary urgency, chest pain, pain, dysgeusia, and abnormal vision.

 

Please see Full Prescribing Information for Ultravist®.

About Gadavist

INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS

Gadavist® (gadobutrol) injection is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI):

  • To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients including term neonates.
  • To assess the presence and extent of malignant breast disease in adult patients.
  • To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD).

 

Gadavist® is indicated for use in magnetic resonance angiography (MRA):

  • To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates.

 

IMPORTANT SAFETY INFORMATION

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)

Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.

  • The risk of NSF appears highest among patients with:
    • Chronic, severe kidney disease (GFR <30 mL/min/1.73m2), or
    • Acute kidney injury
  • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
  • For patients at highest risk for NSF, do not exceed the recommended GADAVIST dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.

 

Contraindication and Important Information about Hypersensitivity Reactions: Gadavist® is contraindicated in patients with history of severe hypersensitivity reactions to Gadavist®. Anaphylactic and other hypersensitivity reactions with cardiovascular, respiratory, or cutaneous manifestations, ranging from mild to severe, including death, have uncommonly occurred following Gadavist® administration. Before Gadavist® administration, assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders. These patients may have an increased risk for a hypersensitivity reaction to Gadavist®.

 

Gadolinium Retention: Gadolinium is retained for months or years in several organs. Linear GBCAs cause more retention than macrocyclic GBCAs. At equivalent doses, retention varies among the linear agents. Retention is lowest and similar among the macrocyclic GBCAs. Consequences of gadolinium retention in the brain have not been established, but they have been established in the skin and other organs in patients with impaired renal function. While clinical consequences of gadolinium retention have not been established in patients with normal renal function, certain patients might be at higher risk. These include patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions. Consider the retention characteristics of the agent and minimize repetitive GBCA studies, when possible.

 

Acute Kidney Injury: In patients with chronic renal impairment, acute kidney injury sometimes requiring dialysis has been observed with the use of GBCAs. Do not exceed the recommended dose; the risk of acute kidney injury may increase with higher than recommended doses.

 

Extravasation and Injection Site Reactions: Ensure catheter and venous patency before the injection of Gadavist®. Extravasation into tissues during Gadavist® administration may result in moderate irritation.

 

Overestimation of Extent of Malignant Disease in MRI of the Breast: Gadavist® MRI of the breast overestimated the histologically confirmed extent of malignancy in the diseased breast in up to 50% of the patients.

 

Low Sensitivity for Significant Arterial Stenosis: The performance of Gadavist® MRA for detecting arterial segments with significant stenosis (>50% renal, >70% supra-aortic) has not been shown to exceed 55%. Therefore, a negative MRA study alone should not be used to rule out significant stenosis.

 

Adverse Reactions: The most frequent (≥0.5%) adverse reactions associated with Gadavist® in clinical studies were headache (1.7%), nausea (1.2%) and dizziness (0.5%).

 

Please see Full Prescribing Information for Gadavist® (Vials and Syringes).
Please see Full Prescribing Information for Gadavist® (Imaging Bulk Package).

 

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com/
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Follow us on Twitter: @BayerPharma

 

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conformthem to future events or developments.

PP-ULT-US-0096-1 June 2023

______________________

1 Kimeya F. Ghaderi, Jordana Phillips, Hannah Perry, Parisa Lotfi, and Tejas S. Mehta. Contrast-enhanced Mammography: Current Applications and Future Directions. RadioGraphics 2019 39:7, 1907-1920.

2 Susan G. Koman. Breast Density on a Mammogram. Updated April 4, 2023. Retrieved June 12, 2023 from: https://www.komen.org/breast-cancer/risk-factor/breast-tissue-density/.

3 Contrast-enhanced Mammography: How Does It Work? William F. Sensakovic, et al. RadioGraphics 2021 41:3, 829-839.

4 World Health Organization. Breast Cancer Fact Sheet. Updated March 26, 2021. Retrieved May 26, 2023 from: https://www.who.int/news-room/fact-sheets/detail/breast-cancer.

5 Maxine S. Jochelson, Marc B. I. Lobbes. Contrast-enhanced Mammography: State of the Art. Radiology 2021; 299:36–48.

Contacts

Contact for media inquiries:
Jennifer May, 412-656-8192
Email: jennifer.may@bayer.com