Nick McGlashan, known as a deck boss on Discovery’s “Deadliest Catch,” has died. He was 33 years old.
— FOX News
Author: Michelle Dryden
Marketing Authorization Application is supported by positive results from the pivotal Phase 3 True North study evaluating oral Zeposia (ozanimod) in adults with moderately to severely active ulcerative colitis
If approved, Zeposia would be the first oral sphingosine-1-phosphate (S1P) receptor modulator for the treatment of ulcerative colitis
PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #BMS—Bristol Myers Squibb (NYSE:BMY) today announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for Zeposia (ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis (UC). Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.
The MAA submitted to the EMA is based on results from True North, a pivotal, placebo-controlled Phase 3 trial evaluating Zeposia as an induction and maintenance therapy in adults with moderately to severely active UC. True North met both primary endpoints, demonstrating highly statistically significant and clinically meaningful results for clinical remission compared to placebo at induction at Week 10 and in maintenance at Week 52. The overall safety observed in True North was consistent with the known safety profile for Zeposia in approved labeling.
“Ulcerative colitis is an unpredictable and potentially debilitating disease, and many patients cycle through different therapies as they try to manage their disease,” said Mary Beth Harler, M.D., head of Immunology and Fibrosis Development, Bristol Myers Squibb. “This validation is an important step toward making Zeposia available to eligible patients in the European Union, who are in need of new treatment options offering proven efficacy and safety, as well as oral administration.”
About True North
True North is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of Zeposia 1mg in patients with moderately to severely active ulcerative colitis who did not adequately respond to prior treatment. In the induction phase, a total of 645 patients were randomized to receive Zeposia (n=429) or placebo (n=216), of whom 94% and 89%, respectively, completed the induction period. At study entry, mean age was 42 years, 60% were male and mean disease duration was 7 years; patient characteristics were well-balanced across treatment groups. Cohort 1 patients were randomized 2:1 to Zeposia or placebo and treated once daily for 10 weeks. Cohort 2 (n=367) was an open-label arm, and included to allow adequate patient numbers for the maintenance phase of the trial. Cohort 2 patients were treated once daily with Zeposia for 10 weeks.
For the maintenance phase, 457 patients were re-randomized to maintenance treatment with either Zeposia (n=230) or placebo (n=227). Of these, 80% and 54.6% of patients who received Zeposia and placebo, respectively, completed the study; disease relapse (13.5% Zeposia, 33.9% placebo) was the most common reason for discontinuation. Patients on Zeposia from either Cohort 1 or 2 who achieved clinical response in the induction phase at Week 10 were re-randomized 1:1 to Zeposia or placebo through Week 52. Patients on placebo who achieved clinical response in the induction phase at Week 10 remained on placebo during this blinded maintenance phase.
In Cohort 1 of the induction phase and in the re-randomized patient group in the maintenance phase, 30% of patients had prior TNF-inhibitor exposure.
All eligible patients were rolled into an open-label extension trial, which is ongoing and designed to assess the longer-term profile of Zeposia for the treatment of moderately to severely active ulcerative colitis.
The primary endpoints in True North are the proportion of patients in clinical remission based on a composite clinical and endoscopic score (3-component Mayo Score) at Week 10 in the induction phase, and at Week 52 for the maintenance phase. Secondary endpoints include the proportion of patients achieving clinical response at Week 10 and Week 52, the proportion of patients with endoscopic improvement (endoscopy score ≤1) at Week 10 and Week 52, the proportion of patients with mucosal healing at Week 10 and Week 52, and clinical remission at Week 52 in patients that were in remission at Week 10. In this study, mucosal healing is defined as endoscopic improvement with histologic remission. More information can be found on www.clinicaltrials.gov, NCT02435992.
About Ulcerative Colitis
Ulcerative colitis, a chronic inflammatory bowel disease (IBD), is characterized by an abnormal, prolonged immune response that creates long-lasting inflammation and ulcers (sores) in the mucosa (lining) of the large intestine (colon) or rectum. Symptoms, including bloody stools, severe diarrhea and frequent abdominal pain, usually develop over time rather than suddenly. Ulcerative colitis has a major impact on patients’ health-related quality of life, including physical functioning, social and emotional well-being and ability to work. Many patients have an inadequate response or do not respond at all to currently available therapies. It is estimated that approximately 12.6 million people worldwide have IBD.
About Zeposia (ozanimod)
Zeposia (ozanimod) is an oral, sphingosine-1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. Zeposia reduces the capacity of lymphocytes to exit from lymph nodes, reducing the number of circulating lymphocytes in peripheral blood. The mechanism by which Zeposia exerts therapeutic effects in ulcerative colitis is unknown but may involve the reduction of lymphocyte migration into the inflamed intestinal mucosa.
Bristol Myers Squibb is continuing to evaluate Zeposia in an open-label extension trial, which is ongoing and designed to assess the longer-term profile of Zeposia for the treatment of moderately to severely active ulcerative colitis. The company is also investigating Zeposia for the treatment of moderately to severely active Crohn’s disease in the ongoing Phase 3 YELLOWSTONE clinical trial program.
Zeposia was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with relapsing forms of multiple sclerosis (RMS) in March 2020. The European Commission approved Zeposia for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features in May 2020. Zeposia is not approved for the treatment of ulcerative colitis in any country.
U.S. FDA-APPROVED INDICATION FOR ZEPOSIA
ZEPOSIA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
IMPORTANT SAFETY INFORMATION
Contraindications:
- Patients who in the last 6 months, experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III/IV heart failure or have a presence of Mobitz type II second or third-degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial, unless the patient has a functioning pacemaker
- Patients with severe untreated sleep apnea
- Patients taking a monoamine oxidase (MAO) inhibitor
Infections: ZEPOSIA may increase the susceptibility to infections. Life-threatening and rare fatal infections have occurred in patients receiving ZEPOSIA. Obtain a recent (i.e., within 6 months or after discontinuation of prior MS therapy) complete blood count (CBC) including lymphocyte count before initiation of ZEPOSIA. Delay initiation of ZEPOSIA in patients with an active infection until the infection is resolved. Consider interruption of treatment with ZEPOSIA if a patient develops a serious infection. Continue monitoring for infections up to 3 months after discontinuing ZEPOSIA
- Herpes zoster was reported as an adverse reaction in ZEPOSIA -treated patients. Herpes simplex encephalitis and varicella zoster meningitis have been reported with sphingosine 1-phosphate (S1P) receptor modulators. Patients without a healthcare professional-confirmed history of varicella (chickenpox), or without documentation of a full course of vaccination against varicella zoster virus (VZV), should be tested for antibodies to VZV before initiating ZEPOSIA. A full course of vaccination for antibody-negative patients with varicella vaccine is recommended prior to commencing treatment with ZEPOSIA
- Cases of fatal cryptococcal meningitis (CM) were reported in patients treated with another S1P receptor modulator. If CM is suspected, ZEPOSIA should be suspended until cryptococcal infection has been excluded. If CM is diagnosed, appropriate treatment should be initiated.
- Progressive Multifocal Leukoencephalopathy (PML) is an opportunistic viral infection of the brain that typically occurs in patients who are immunocompromised, and that usually leads to death or severe disability. No cases of PML were identified in active-controlled MS clinical trials with ZEPOSIA. PML has been reported in patients treated with S1P receptor modulators and other MS therapies and has been associated with some risk factors. If PML is suspected, withhold ZEPOSIA and perform an appropriate diagnostic evaluation. If confirmed, treatment with ZEPOSIA should be discontinued
- In clinical studies, patients who received ZEPOSIA were not to receive concomitant treatment with antineoplastic, non-corticosteroid immunosuppressive, or immune-modulating therapies used for treatment of MS. Concomitant use of ZEPOSIA with any of these therapies would be expected to increase the risk of immunosuppression. When switching to ZEPOSIA from immunosuppressive medications, consider the duration of their effects and their mode of action to avoid unintended additive immunosuppressive effects
- Use of live attenuated vaccines should be avoided during and for 3 months after treatment with ZEPOSIA. If live attenuated vaccine immunizations are required, administer at least 1 month prior to initiation of ZEPOSIA
Bradyarrhythmia and Atrioventricular Conduction Delays: Since initiation of ZEPOSIA may result in a transient decrease in heart rate and atrioventricular conduction delays, dose titration is recommended to help reduce cardiac effects. Initiation of ZEPOSIA without dose escalation may result in greater decreases in heart rate. If treatment with ZEPOSIA is considered, advice from a cardiologist should be sought for those individuals:
- with significant QT prolongation
- with arrhythmias requiring treatment with Class 1a or III anti-arrhythmic drugs
- with ischemic heart disease, heart failure, history of cardiac arrest or myocardial infarction, cerebrovascular disease, and uncontrolled hypertension
- with a history of Mobitz type II second-degree or higher AV block, sick-sinus syndrome, or sinoatrial heart block
Liver Injury: Elevations of aminotransferases may occur in patients receiving ZEPOSIA. Obtain liver function tests, if not recently available (i.e., within 6 months), before initiation of ZEPOSIA. Patients who develop symptoms suggestive of hepatic dysfunction should have hepatic enzymes checked and ZEPOSIA should be discontinued if significant liver injury is confirmed. Caution should be exercised when using ZEPOSIA in patients with history of significant liver disease
Fetal Risk: There are no adequate and well-controlled studies in pregnant women. Based on animal studies, ZEPOSIA may cause fetal harm. Women of childbearing potential should use effective contraception to avoid pregnancy during treatment and for 3 months after stopping ZEPOSIA
Increased Blood Pressure: Increase in systolic pressure was observed after about 3 months of treatment and persisted throughout treatment. Blood pressure should be monitored during treatment and managed appropriately. Certain foods that may contain very high amounts of tyramine could cause severe hypertension in patients taking ZEPOSIA. Patients should be advised to avoid foods containing a very large amount of tyramine while taking ZEPOSIA
Respiratory Effects: ZEPOSIA may cause a decline in pulmonary function. Spirometric evaluation of respiratory function should be performed during therapy, if clinically indicated
Macular edema: S1P modulators have been associated with an increased risk of macular edema. Patients with a history of uveitis or diabetes mellitus are at increased risk. Patients with a history of these conditions should have an ophthalmic evaluation of the fundus, including the macula, prior to treatment initiation and regular follow-up examinations. An ophthalmic evaluation is recommended in all patients at any time if there is a change in vision. Continued use of ZEPOSIA in patients with macular edema has not been evaluated; potential benefits and risks for the individual patient should be considered if deciding whether ZEPOSIA should be discontinued
Posterior Reversible Encephalopathy Syndrome (PRES): Rare cases of PRES have been reported in patients receiving a S1P receptor modulator. If a ZEPOSIA-treated patient develops unexpected neurological or psychiatric symptoms or any symptom/sign suggestive of an increase in intracranial pressure, a complete physical and neurological examination should be conducted. Symptoms of PRES are usually reversible but may evolve into ischemic stroke or cerebral hemorrhage. Delay in diagnosis and treatment may lead to permanent neurological sequelae. If PRES is suspected, treatment with ZEPOSIA should be discontinued
Unintended Additive Immunosuppressive Effects from Prior Immunosuppressive or Immune-Modulating Drugs: When switching from drugs with prolonged immune effects, the half-life and mode of action of these drugs must be considered to avoid unintended additive immunosuppressive effects while at the same time minimizing risk of disease reactivation. Initiating treatment with ZEPOSIA after treatment with alemtuzumab is not recommended
Severe Increase in Disability After Stopping ZEPOSIA: Severe exacerbation of disease, including disease rebound, has been rarely reported after discontinuation of a S1P receptor modulator. The possibility of severe exacerbation of disease should be considered after stopping ZEPOSIA treatment so patients should be monitored upon discontinuation
Immune System Effects After Stopping ZEPOSIA: After discontinuing ZEPOSIA, the median time for lymphocyte counts to return to the normal range was 30 days with approximately 90% of patients in the normal range within 3 months. Use of immunosuppressants within this period may lead to an additive effect on the immune system, therefore caution should be applied when initiating other drugs 4 weeks after the last dose of ZEPOSIA
Most common Adverse Reactions (≥ 4%): upper respiratory infection, hepatic transaminase elevation, orthostatic hypotension, urinary tract infection, back pain, and hypertension.
For additional safety information, please see the full Prescribing Information and Medication Guide.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.
Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that Zeposia (ozanimod) may not receive regulatory approval for the additional indication described in this release and, if approved, whether such product candidate for such additional indication described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2019, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.
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Officials named a 63-year-old man as a person of interest in the Christmas morning explosion in downtown Nashville.
— NYT: Top Stories
Mr. Trump’s hesitation to signing the relief bill risks leaving million of Americans without crucial benefits such as unemployment checks, critical assistance for businesses and families, and even the possibility of a government shutdown Tuesday.
Also, the Democrats’ House losses in California signal the steep obstacles they will face in 2022. President-elect Joseph R. Biden Jr. expressed optimism that his brand of centrist deal making would help him move beyond the bitter partisanship of the past four years.
— NYT: Top Stories
Mr. Huber, who was known in the ring as Brodie Lee and Luke Harper, died from a “lung issue” unrelated to Covid-19, his wife said.
— NYT: Top Stories
People cast their votes for presidential and legislative elections, at the Lycee Boganda polling station in the capital Bangui, Central African Republic Sunday, Dec. 27, 2020. President Faustin-Archange Touadera and his party said the vote will go ahead after government forces clashed with rebels in recent days and some opposition candidates pulled out of the race amid growing insecurity. (AP Photo)
BANGUI, Central African Republic (AP) — Voters went to the polls for Central African Republic’s presidential and legislative elections after a campaign period marked by violence between rebels and government forces.
Despite calls from the opposition to delay the vote amid the insecurity, the Constitutional Court rejected a postponement.
President Faustin-Archange Touadera, seeking a second term, has tried to reassure candidates and voters that the voting will be secure. This is the central African country’s first election since a peace deal was signed between the government and 14 rebel groups in February 2019, although fighting continues.
“The vote is a right, a right for Central Africans. Each person has the power in the constitution of this country … each citizen has the right to freely choose its directors,” Touadera said after casting his ballot. “This is quite important for the Central African Republicans who are searching in these moments of crisis. They have the right to development, for their well-being, for our country, for our people.”
Three peacekeepers from Burundi were killed and two others wounded Friday by armed combatants. The U.N. Secretary-General Antonio Guterres condemned the attacks in the Dekoua and Bakouma areas ahead of the elections, calling for swift justice and saying they may constitute war crimes.
The U.N. retook the town of Bambari last week from rebels. Rebel groups have also seized several towns near the capital, Bangui.
Voters went to the polls in the capital Sunday.
“I am really pleased (to vote) and I ask the citizens, even those who are still at home, to come and vote massively so by tomorrow, peace returns to our country,” said Bangui resident Désiré Ngaibona after casting his vote.
Others in various parts of Central African Republic couldn’t make it to the polls.
Many residents of the town of Bangassou in the nation’s southeast were fleeing because of the fighting, residents said.
“I am in the town of Bangassou but my wife and children crossed to the other side of the bank towards Congo because of the violence,” said Christian Kombro a teacher from the town.
The government blames the unrest on former President Francois Bozize, who returned from exile a year ago and has been blocked from running in the election. He has been accused of joining up with armed groups to destabilize the country and launch a coup. He has denied it.
Rwanda and Russia have each sent hundreds of troops to the country to support the government.
Sixteen candidates are running for president, including three women. More than 1,500 candidates are running for 140 seats in the national assembly. More than 1.86 million voters are registered, but more than 598,000 refugees in neighboring countries will not be able to vote, according to the U.N.
Parties in the Democratic Opposition Coalition known as COD-2020 last week said seven of its candidates pulled out of the election, citing the violence. The parties had wanted the vote to be delayed, alleging poor preparations and an electoral body influenced by the president.
Experts warn of a strong chance of further violence if the opposition doesn’t accept the election results. “A contested outcome may lead to a post-electoral crisis that armed groups could use to further weaken the state,” the International Crisis Group noted.
The mineral-rich Central African Republic has faced deadly inter-religious and inter-communal fighting since 2013, when predominantly Muslim Seleka rebels seized power from Bozize after long claiming marginalization. Resistance to Seleka rule eventually led to Muslims being targeted en masse, with some beaten to death, mosques destroyed and tens of thousands forced from the capital in 2014.
Despite a 2019 peace agreement between the government and 14 rebel groups, intermittent violence and human rights abuses have continued.
The most recent insecurity began after the Constitutional Court rejected the candidacy of Bozize, on the grounds that he did not satisfy the “good morality” requirement.
Bozize, who took power in a coup in 2003 and ruled until 2013, faces an international arrest warrant for “crimes against humanity and incitement of genocide.” He also faces U.N. sanctions for his alleged role in supporting the anti-Balaka groups that resisted the Seleka in 2013.
— Associated Press
Jennifer Aniston sparked a debate on social media after sharing a photo of a Christmas ornament that many thought made light of the coronavirus pandemic.
— FOX News
Three others were wounded in what the police said was most likely a random act.
— NYT: Top Stories
The effort to protect 450 million people in 27 nations started with vaccinations in nursing homes and hospitals. “Today Italy reawakens,” the prime minister said after a 29-year-old nurse received the country’s first shot.
— NYT: Top Stories
FILE – This Aug. 28, 2020, file photo shows the federal prison complex in Terre Haute, Ind. (AP Photo/Michael Conroy, File)A federal judge said the Justice Department unlawfully rescheduled the execution of the only woman on federal death row, potentially setting up the Trump administration to schedule the execution after president-elect Joe Biden takes office. U.S. District Court Judge Randolph Moss also vacated an order from the director of the Bureau of Prisons that had set Lisa Montgomery’s execution date for Jan. 12, 2021. (AP Photo/Michael Conroy)
WASHINGTON (AP) — A federal judge said the Justice Department unlawfully rescheduled the execution of the only woman on federal death row, potentially setting up the Trump administration to schedule the execution after president-elect Joe Biden takes office.
U.S. District Court Judge Randolph Moss also vacated an order from the director of the Bureau of Prisons that had set Lisa Montgomery’s execution date for Jan. 12. Montgomery had previously been scheduled to be put to death at the Federal Correctional Complex in Terre Haute, Indiana, this month, but Moss delayed the execution after her attorneys contracted coronavirus visiting their client and asked him to extend the amount of time to file a clemency petition.
Moss prohibited the Bureau of Prisons from carrying out Lisa Montgomery’s execution before the end of the year and officials rescheduled her execution date for Jan. 12. But Moss ruled on Wednesday that the agency was also prohibited from rescheduling the date while a stay was in place.
“The Court, accordingly, concludes that the Director’s order setting a new execution date while the Court’s stay was in effect was ‘not in accordance with law,’” Moss wrote.
A spokesperson for the Justice Department did not immediately respond to a request for comment.
Under the order, the Bureau of Prisons cannot reschedule Montgomery’s execution until at least Jan. 1. Generally, under Justice Department guidelines, a death-row inmate must be notified at least 20 days before the execution. Because of the judge’s order, if the Justice Department chooses to reschedule the date in January, it could mean that the execution would be scheduled after Biden’s inauguration on Jan. 20.
A spokesperson for Biden has told The Associated Press the president-elect “opposes the death penalty now and in the future” and would work as president to end its use in office. But Biden’s representatives have not said whether executions would be paused immediately once Biden takes office.
Montgomery was convicted of killing 23-year-old Bobbie Jo Stinnett in the northwest Missouri town of Skidmore in December 2004. She used a rope to strangle Stinnett, who was eight months pregnant, and then a kitchen knife to cut the baby girl from the womb, authorities said.
Prosecutors said Montgomery removed the baby from Stinnett’s body, took the child with her, and attempted to pass the girl off as her own. Montgomery’s legal team has argued that their client suffers from serious mental illnesses.
“Given the severity of Mrs. Montgomery’s mental illness, the sexual and physical torture she endured throughout her life, and the connection between her trauma and the facts of her crime, we appeal to President Trump to grant her mercy, and commute her sentence to life imprisonment,” one of Montgomery’s lawyers, Sandra Babcock, said in a statement.
Two other federal inmates are scheduled to be executed in January but have tested positive for coronavirus and their attorneys are also seeking delays to their executions.
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— Associated Press