Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) and Pfizer Inc. (NYSE: PFE), today announced positive top-line results from an Asia-Pacific, Phase 3 clinical trial of rimegepant in 1,431 adults for the acute treatment of migraine. Led by BioShin Limited, a subsidiary of Biohaven in China and South Korea, the randomized, regional, multi-center study met the co-primary endpoints evaluating the efficacy and safety of the orally dissolving tablet (ODT) formulation of rimegepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist.
This is the fourth positive Phase 3 study of rimegepant for the acute treatment of migraine and the first to be conducted in Asia Pacific. The study met its co-primary endpoints of freedom from pain (p<0.0001) and freedom from most bothersome migraine‐associated symptom (MBS) including nausea, phonophobia or photophobia (p<0.0001) at 2-hours following a single oral dose of rimegepant. In the study, a single oral dose of rimegepant 75 mg provided significant relief of migraine symptoms and return to normal function at 2 hours and delivered sustained efficacy that lasted up to 48 hours for many patients. Rimegepant showed a favorable safety and tolerability profile among study participants that was consistent with prior clinical trial results in the United States. Detailed data from the study will be presented at future medical meetings to help inform ongoing and future research.
Under the terms of the collaboration agreement between Biohaven and Pfizer, Pfizer has commercialization rights to rimegepant in markets outside of the U.S. Biohaven continues to lead research and development globally and retains the U.S. market. Rimegepant is commercialized as Nurtec® ODT in the U.S. and is the only oral CGRP receptor antagonist approved for both the acute and preventive treatment of migraine in adults. An application for the approval of rimegepant is currently under review by the European Medicines Agency with a decision expected in the first half of 2022. Rimegepant is approved for the acute treatment of migraine in Kuwait and the United Arab Emirates, and for the acute and preventive treatment of migraine in Israel.
Continued positive efficacy and durability with stable visual acuity (VA) and optical coherence tomography (OCT) through eight-month follow-up
- 41% of eyes remained rescue free up to nine months after a single dose of EYP-1901
- Positive safety data continued with no dose limiting toxicities, no ocular serious adverse events (SAEs) and no drug-related systemic SAEs observed
- Overall treatment burden reduced by 75% at eight months
- Phase 2 studies for EYP-1901 in wet AMD expected to initiate in Q3 2022 and in diabetic retinopathy in 2H 2022
EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a pharmaceutical company committed to developing and commercializing therapeutics to improve the lives of patients with serious eye disorders, today announced updated interim data from the "Durasert® and Vorolanib in Ophthalmology" (DAVIO) Phase 1 clinical trial of EYP-1901, a bioerodible sustained delivery intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatment targeting wet age-related macular degeneration (wet AMD). These data are being presented today at the Angiogenesis, Exudation, and Degeneration 2022 virtual meeting by Jay S. Duker, M.D., Chief Operating Officer, EyePoint Pharmaceuticals.
The Monday morning decision by the Court of Arbitration for Sport allows the Russian Olympic Committee to keep her gold medal in last week’s team event. The 15-year-old phenom led the team to victory after becoming the first woman to ever land a quadruple jump in the Olympics.
The decision also paves the way for the teen skater and the ROC to claim another gold in her next scheduled Olympic event in less than 24 hours — the women’s individual competition — in which she is the heavy favorite, followed by her two Russian teammates.
Three judges with the Court of Arbitration for Sport heard testimony directly from the skater during her testimony regarding the doping scandal on Sunday.
The 15-year-old figure skater appealed her ban after she tested positive for a banned substance.REUTERSValieva will be allowed to keep her gold medal in the team event.Photo by WANG ZHAO/AFP via Getty Images
Valieva tested positive for banned heart medication, trimetazidine, which was flagged last Monday by a Swedish laboratory, six weeks after the sample was taken in St. Petersburg, Russia in December.
Valieva had helped lead her team to the gold medal a day before news of the lab results broke.
Following the results, The Russian Anti-Doping Agency immediately imposed an interim ban against the skater, but later lifted it on appeal so she can compete in her main event – a decision that was challenged by The International Olympic Committee, World Anti-Doping Agency and International Skating Union, prompting Sunday’s hearing.
Valieva tested positive for the heart medication trimetazidine before the games began.AP Photo/David J. Phillip
Valieva has yet to miss a scheduled practice since her positive drug test was revealed.
The ROC claimed that Valieva had “repeatedly passed doping tests” prior to the positive result on Dec. 25.
Ahead of her hearing, ROC coach Eteri Tutberidze told Russian state media “We are absolutely sure that Kamila is innocent and clean.”Russian figure skater Kamila Valievahas been cleared to continue competing in the Beijing Winter Olympics following an appeal on the teen star’s interim ban after she failed a pre-Olympics doping test.
The Monday morning decision by the Court of Arbitration for Sport allows the Russian Olympic Committee to keep her gold medal in last week’s team event. The 15-year-old phenom led the team to victory after becoming the first woman to ever land a quadruple jump in the Olympics.
The decision also paves the way for the teen skater and the ROC to claim another gold in her next scheduled Olympic event in less than 24 hours — the women’s individual competition — in which she is the heavy favorite, followed by her two Russian teammates.
Three judges with the Court of Arbitration for Sport heard testimony directly from the skater during her testimony regarding the doping scandal on Sunday.
The 15-year-old figure skater appealed her ban after she tested positive for a banned substance.REUTERSValieva will be allowed to keep her gold medal in the team event.Photo by WANG ZHAO/AFP via Getty Images
Valieva tested positive for banned heart medication, trimetazidine, which was flagged last Monday by a Swedish laboratory, six weeks after the sample was taken in St. Petersburg, Russia in December.
Valieva had helped lead her team to the gold medal a day before news of the lab results broke.
Following the results, The Russian Anti-Doping Agency immediately imposed an interim ban against the skater, but later lifted it on appeal so she can compete in her main event – a decision that was challenged by The International Olympic Committee, World Anti-Doping Agency and International Skating Union, prompting Sunday’s hearing.
Valieva tested positive for the heart medication trimetazidine before the games began.AP Photo/David J. Phillip
Valieva has yet to miss a scheduled practice since her positive drug test was revealed.
The ROC claimed that Valieva had “repeatedly passed doping tests” prior to the positive result on Dec. 25.
Ahead of her hearing, ROC coach Eteri Tutberidze told Russian state media “We are absolutely sure that Kamila is innocent and clean.”
The healthcare insurer that the city recently chose to provide medical coverage for 275,000 retired workersis being sued by the US Justice Department for overcharging Medicare by millions of dollars.
The Manhattan US Attorney’s Office brought the civil-fraud suit against Anthem in March 2020, and the case is still pending.
But that didn’t stop former Mayor Bill de Blasio from selecting Anthem for local-government retiree coverage this past fall — or now-Mayor Eric Adams from signing off on the deal last week.
The fraud suit against Anthem alleges that the company did not clean up faulty data rendered by hospitals and other medical providers in its reimbursement claims submitted to the federal Centers for Medicare and Medicaid Services.
“By ignoring its duty to delete thousands of inaccurate diagnoses, Anthem unlawfully obtained and retained from CMS [Center for Medicare Services] millions of dollars in payments under the risk adjustment payment system for Medicare Part C,” a press release accompanying the suit said.
Mayor Eric Adams recently praised Anthem/Blue Cross Shield, saying it provides the best deal for city retirees.Getty Images for NYFW: The Shows
In Mayor Adams’ statement last week supporting the selection of the Anthem/Blue Cross Shield and Emblem Health Alliance to run the city’s Medicare Advantage Plus program, he called the deal “in the best interest of retirees and city taxpayers.”
Adams was signing off on an agreement reached by de Blasio and the Municipal Labor Council, the coalition of unions representing retired government workers.
“The NYC Medicare Advantage Plus Plan unveiled last year — the product of many months of negotiations between the city and the Municipal Labor Committee, representing more than 100 unions — will continue to offer premium-free health coverage to retirees, along with new and enhanced benefits,” Adams said.
“That is why after a careful and thorough review by my administration, I am announcing my support for this plan. I believe the new program will be in the best interest of retirees and the city’s taxpayers, who stand to save $600 million annually.”
The civil fraud action states that Anthem “knowingly disregarded” its duty to ensure the accurate data that it submitted for hundreds of thousands of Medicare beneficiaries.Bloomberg via Getty Images
But a rival bidder, insurance giant Aetna, has sued the city alleging the selection process was fixed to favor Alliance, a consortium that includes Emblem Health and Anthem/Blue Cross Blue Shield and has strong ties to union leaders, to operate the new Medicare Advantage Plus program.
A group of retirees has filed a separate lawsuit to block the implementation of the new $34 billion, 11-year Medicare supplemental program, claiming they are being forced into a new plan that costs more for fewer benefits.
Retired city workers are eligible for Medicare, the federally run program that provides health insurance for people who reach 65 — but their union contract also calls for the Big Apple to pick up the cost of their monthly premiums for Medicare Part B, which covers outpatient care as well as other supplemental services not covered by Medicare.
Sarah Shapiro of the Cross-union Retirees Organizing Committee is hopeful that Comptroller Lander rejects this contract with Anthem.SOPA Images/LightRocket via Gett
Retirees who are critics of the deal with Anthem said the alleged fraud cited by the federal government needs to be looked at by the city.
“This is extremely troubling. I hope the City Council conducts an investigation into how a company that’s accused of defrauding the federal government of millions ended up with a huge contract with the city,” said Sarah Shapiro of the Cross-union Retirees Organizing Committee, a group of city workers who have been petitioning elected officials to try and get Mayor Adams to stop the plan.
“I also hope that Comptroller [Brad] Lander rejects this contract. We expected this level of incompetence from Mayor de Blasio, but it’s very disappointing that Mayor Adams is following his lead,” she said.
A group of retirees has previously filed a separate lawsuit to block the new $34 billion, 11-year Medicare supplemental program.Bloomberg via Getty Images
City Hall and Anthem had no immediate comment.
Harry Nespoli, head of the Municipal Labor Council who negotiated and defended the Anthem deal, said he was not familiar with the lawsuit.
Manitoba will eliminate capacity limits for many businesses and other venues starting Tuesday as the province aims to abolish all restrictions, including mask mandates, on March 15.
The province also intends to remove all proof of vaccination requirements on March 1, which means vaccination cards will no longer be needed.
All restrictions will end March 15, Premier Heather Stefanson said at a Friday morning news conference.
"Today we offer hope to those who have been waiting for a long time to see that light at the end of the tunnel," she said.
"The restrictions have placed many burdens on Manitobans, and now that we see the pressure of our hospital systems starting to ease, it's our responsibility of government to ease those restrictions on Manitobans."
Stefanson, who has stressed the importance of getting vaccinated, toned that message down on Friday. While she said she and her family are fully vaccinated, she added that "the choice to get vaccinated is yours."
"It's time for a new normal to begin in Manitoba," she said.
"We need to end the divisiveness between families, between communities. We need to move forward. It's time to bring Manitobans back together again."
On Tuesday, pandemic capacity limits will be dropped for restaurants, licensed premises, entertainment venues, indoor and outdoor sporting events and casinos and gatherings at private residences.
They will also be removed for outdoor public gatherings.
Indoor public gathering limits will be removed if proof of vaccination is required to enter. If not, the limit will be 50 people.
Anyone age 12 to 17 who is participating in indoor sports and recreation will no longer be required to provide proof of vaccination or recent testing.
There are no changes to retail and personal services until March.
