In the aftermath of devastating wildfires on Maui, Bayer is standing up as one of the first pharmaceutical companies to offer relief. The German conglomerate is providing a cash donation of $250,000 to the island, plus a donation of essential healthcare products also worth $250,000. Bayer has operated in Maui for more than half a century, the company said in a Wednesday release. The company said it “stands in solidarity with those impacted and offers heartfelt condolences for the losses endured.” The fire in Lahaina, Hawaii, is now the deadliest in more than a century, according to the U.S. Fire Administration and CNN. To date, some 2,200 structures have been destroyed or damaged, 86% of which are residential, the state’s governor, Josh Green, has said. The death toll was 110 as of Wednesday. Of Bayer’s cash donation, $150,000 will go to the Hawaii Community Foundation’s Maui Strong program, which is ...
As companies have flocked to compete in the new respiratory syncytial virus (RSV) vaccine market, GSK has had the best timing. In May, the U.K. company was first to secure FDA approval for its shot Arexvy for adults 60 and older, beating out rivals from Pfizer and Moderna. And now—well in advance of the fall and winter RSV season—Arexvy is available in major U.S. retail pharmacies, GSK said Thursday. Under the Inflation Reduction Act, Medicare Part D patients will pay no out-of-pocket expenses for the shot, GSK said. Additionally, under the Affordable Care Act, patients with commercial insurance may be covered when Arexvy is administered in-network, GSK said. In June, the Advisory Committee on Immunization Practices (ACIP) recommended that people 60 and older decide in consultation with their healthcare provider whether to receive the RSV vaccine. As people age, their immune systems can become compromised, making them more vulnerable to ...
Speculation that Stada Arzneimittel may be looking for a buyout has largely been confirmed after the company’s CEO said as much in a recent German-language news story. Responding to recent acquisition rumors, Stada CEO Peter Goldschmidt told the German Press Agency, “Whether and when STADA might be sold is solely the decision of our owners; Bain Capital and Cinven.” From the company’s view, Goldschmidt said, “our owners are in an orientation phase in which initial exploratory talks are taking place.” A Stada press representative emailed a translated version of the remarks early Tuesday along with the company’s second-quarter results. Goldschmidt added that he doesn’t expect a decision before 2024. Additionally, the company’s investors “have no pressure to sell,” the CEO pointed out. “What speaks in favor of a sale process is that it is common for financial investors to exit after five to six years,” Goldschmidt opined. Early this month, ...
Novartis has shared positive top-line results from two late-stage studies evaluating its Bruton’s tyrosine kinase (BTK) inhibitor, remibrutinib, in patients with chronic spontaneous urticaria (CSU) whose symptoms are inadequately controlled by H1-antihistamines. Affecting 40 million people worldwide, CSU is a debilitating and unpredictable condition characterised by the occurrence of itchy hives and/or deep tissue swelling that lasts for six weeks or longer. H1-antihistamines are the first-line treatment for the condition; however, approximately 60% of patients are inadequately controlled by these alone and continue to live with the distressing symptoms of CSU. Novartis’ remibrutinib works by blocking the cascade of BTK, an enzyme central to the release of histamine and, when spontaneously activated, plays a critical role in the symptoms associated with CSU. The ongoing phase 3 REMIX-1 and REMIX-2 trials met their primary endpoint of absolute change from baseline in weekly urticaria activity score (UAS7) at week 12, demonstrating clinically ...
The Scleroderma Research Foundation (SRF) has announced the launch of a new clinical trial platform aimed at advancing treatments for the rare autoimmune disease of the skin and organs. Using a model created over a decade ago to accelerate oncology drug development but not previously used for autoimmune disorders, the CONQUEST platform is designed to identify agents that are ready to progress from phase 2b to phase 3 clinical trials. The initiative, conceived and led by the SRF, will initially focus on interstitial lung disease secondary to scleroderma but will be expanded in the future to address other manifestations of the disease. The first iteration, which is expected to begin in the fourth quarter of this year, will include approximately 400 patients and will test two drugs, including one from Sanofi. The trial will measure forced vital capacity, the total volume of air that can be exhaled during a maximal ...
The UK’s Medicines and Healthcare products Regulatory Agency said Wednesday that it is reviewing a class of drugs used for obesity and diabetes treatment after reports of self-injury and suicidal thoughts in patients. The probe by the MHRA comes shortly after the European Medicines Agency (EMA) expanded its own investigation into the GLP-1 receptor agonist class of drugs. This includes medications like Saxenda (liraglutide), Wegovy (semaglutide) and Ozempic (semaglutide) produced by Danish pharma company Novo Nordisk. According to reporting by Reuters, the MHRA also confirmed AstraZeneca’s Bydureon (exenatide), Sanofi’s lixisenatide, and Eli Lilly’s dulaglutide were also being included in the review. Novo Nordisk told Reuters that it had received a request from the MHRA about the investigation. “The review is ongoing and a response will be provided within the requested timelines,” Novo Nordisk said in a statement. The MHRA review kicked off July 12, though the agency could not specify when it would ...
In reporting its first-quarter earnings, Biogen said it would halt the development of at least four investigational drugs to allow the company to focus on more lucrative opportunities.On Tuesday, Biogen revealed what those opportunities—and its other cost-cutting measures—would entail, saying (PDF) it would reduce its headcount by 1,000 by 2025. With the company starting 2023 with 8,725 employees, that’s an 11.5% reduction of the workforce. At the start of 2022, Biogen employed (PDF) 9,610 people, according to an SEC filing. The numbers show that Biogen has already been working to downsize in the wake of the disastrous Aduhelm launch for Alzheimer’s disease. The latest measures will save Biogen $1 billion in operating expenses by 2025, the company estimates, with roughly $300 million of that earmarked for re-investment as Biogen launches key products, including newer Alzheimer’s disease drug Leqembi, which gained a full approval from the FDA earlier this month. Biogen’s shift comes ...
Pictured: Biogen/The Boston Globe via Getty, John Tlumacki With full FDA approval and CMS coverage for Leqembi in hand, Biogen is ramping up its launch efforts for the Alzheimer’s drug and executing a massive cost reduction program. The biotech company announced second-quarter earnings and its new cost-savings plan on Tuesday. The “Fit for Growth” program is expected to generate around $1 billion in operating expense savings by 2025, which includes a headcount reduction of approximately 1,000 jobs, or about 11% of Biogen’s workforce. Around $300 million will be reinvested into product launches and R&D programs for a net savings of $700 million. The staff reduction will be completed by 2025. The company had more than 8,700 employees in 2022, according to Statista. Biogen CFO Michael McDonnell told investors on Tuesday’s earnings call that a “substantial portion” of the $700 million in net operating expense savings are expected to come from cutting ...
Photo: Kiyoshi Ota/Bloomberg, via Getty Images Astellas Pharma is far from alone in viewing cancer as a major growth area, but the Japanese drugmaker has specifically identified a type of therapy called targeted protein degradation as one of the key areas for increasing revenue. It just struck its second deal in the past two months to help it execute on that strategy and perhaps stand apart from others pursuing the same type of drugs. Under a partnership announced Tuesday, Astellas will work with PeptiDream to discover new protein degraders using the technology of that company. Specific targets were not disclosed, but they will be selected by Astellas. The deal also grants Tokyo-based Astellas the option to select up to three additional targets for inclusion in the collaboration. Astellas will pay PeptiDream 3 billion yen (about $21 million) up front. PeptiDream, based in Kawasaki, Japan, is eligible to receive up to ...
The respiratory syncytial virus (RSV) vaccine arena lost a competitor on Saturday 21 July after Danish company Bavarian Nordic shelved its programme following missed endpoints in a Phase III trial. The candidate, named MVA-BN RSV, failed to meet the co-primary endpoint of severe lower respiratory tract disease (LRTD) based on at least three pre-defined symptoms, only demonstrating a 42.9% efficacy. The vaccine did, however, have a 59% efficacy in preventing at least two pre-defined LRTD symptoms. The randomised, double-blind Phase III trial (NCT05238025) involved 20,000 older adults across centres in the US and Germany. As a result of the programme termination, Bavarian Nordic has also ended its partnership with Nuance Pharma, a Chinese pharma company brought in to develop and launch the vaccine for Asian markets. Although Bavarian Nordic’s president and CEO Paul Chaplin said in a statement that the blow would impact short-term growth, ...
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