Search Results for “Sanofi” – Page 12 – media

BMS buys Karuna for US$ 14 billion; Astra-Ionis’ nerve damage drug bags FDA nod

By PharmaCompass BMS buys Karuna for US$ 14 billion; Astra-Ionis’ nerve damage drug bags FDA nod This week’s Phispers is a double bill with news from last week and the first days of the New Year. Bristol Myers Squibb (BMS) and AstraZeneca have been on year-end shopping sprees with the former picking up Karuna Therapeutics for a whopping US$ 14 billion and the latter expanding its already dominant presence in China through an acquisition and a deal. Novo Nordisk is investing over US$ 2 billion, this time in Ireland, to meet the skyrocketing demand for its blockbuster diabetes and weight-loss drugs, Ozempic and Wegovy. In drug approvals, AstraZeneca and Ionis Pharmaceuticals’ drug Wainua became the first self-administered treatment in the United States for a rare nerve damage disease. In trial news, a potential first-in-class small molecule that was on course to becoming the first new drug approved in 20 years ...
- Source: drugdu
- 123
- January 8, 2024
Beyfortus® Approved in China for the Prevention of Respiratory Syncytial Virus Infections in Infants

On January 2, 2024, AstraZeneca and Sanofi announced that the long-acting monoclonal antibody Beyfortus® (Nirsevimab/nisevizumab) has been officially approved for marketing by the State Drug Administration of China (SDA) for the prevention of Lower Respiratory Tract Infections (LRTIs) caused by Respiratory Syncytial Virus (RSV) in newborns and infants. The drug is indicated for newborns and infants who are entering or born during the first season of RSV infection. Nisevizumab is expected to be available in China during the 2024-2025 RSV infection season. Nisevizumab is the first and only* approved prophylaxis in China to protect the broader infant population against RSV infection, covering healthy term infants, preterm infants, and infants vulnerable to serious RSV infection due to specific health conditions. Nisevizumab was approved in China based on the results of three pivotal clinical trials and the Chinese clinical development program. For all clinical trial endpoints, a single injection of nisevizumab demonstrated ...
- Source: drugdu
- 127
- January 4, 2024
After a down year, FDA signs off on a bounty of new meds, including 7 from Pfizer

In 2022, fueled by its powerhouse COVID products, Pfizer became the first company in the history of the biopharma industry to top $100 billion in annual revenue. What would the New York drugmaker do for an encore? In 2023, Pfizer went from generating the most sales in the industry to gaining the most approvals. With seven FDA nods in 2023, Pfizer had more than double that of any other company. It’s also more than twice as many as every drugmaker over each of the last three years. You need to go back to 2019, when Novartis scored six approvals, to find a company that approached what Pfizer accomplished in 2023. Pfizer’s splurge included four approvals in a dizzying five weeks in May and June. And all but one of the seven products has been pegged by analysts as a potential blockbuster. Two of the newly approved Pfizer treatments were acquired ...
- Source: drugdu
- 223
- January 4, 2024
FDA Issues Alert to Mitigate Risks to a Widely Used Allergy, Nausea Drug

The FDA said promethazine hydrochloride, a generic drug used to manage allergies and motion sickness, should be administered by intramuscular injection. Intravenous injection can cause chemical irritation and tissue damage, an FDA alert states. By FRANK VINLUAN An old drug with a wide range of uses now has a new FDA alert that could spare patients from some severe reactions. The FDA communication covers promethazine hydrochloride, a medicine approved for managing allergic reactions, motion sickness, and post-operative nausea and vomiting. It’s also used as a sedative or as an adjunct to analgesics. While promethazine is available in oral formulations, the FDA alert issued Wednesday covers versions administered either as a deep intramuscular injection or as a slow intravenous injection. The agency now says it recommends administration by deep intramuscular injection to reduce the risk of severe chemical irritation and damage to tissues. If promethazine must be dosed intravenously, the FDA ...
- Source: drugdu
- 93
- December 30, 2023
Big Pharma reworks China strategy, and job cuts are part of it

Big Pharma companies have often talked about the major opportunities that await in China. But as price cuts play out and internal priorities shift, multinational companies are reworking their business models in the country. In the last few months of 2023, Pfizer, GSK, Sanofi and Biogen have each tapped local partners to help commercialize their products in China. With marketing responsibilities shifting to other firms, job cuts were expected at each of those large drugmakers. It’s not a new approach for foreign drugmakers to tap local partners in China, Justin Wang, head of L.E.K. Consulting’s China practice, pointed out in an email interview with Fierce Pharma. But these deals are on the rise lately, Wang explained, partly because “there is increasing pricing and competitive pressure in the market, especially for mature products, leaving reduced [return on investment] for in-house commercial resources.” Pfizer in November unveiled a deal with Keyuan Pharma, ...
- Source: drugdu
- 195
- December 27, 2023
AstraZeneca’s Icosavax M&A Deal Helps It Stand Out in Multivalent Vaccines Chase

AstraZeneca is acquiring Icosavax, which has technology well-suited for multivalent vaccines. Icosavax’s pipeline includes a Phase 3-ready program that protects against two pathogens that cause severe respiratory infections in older adults. By FRANK VINLUAN AstraZeneca is already in the respiratory syncytial virus market with two products, including the drug Beyfortus, approved earlier this year. An M&A deal will give AstraZeneca an RSV vaccine candidate based on technology that could help the company compete where new vaccines are going. AstraZeneca is acquiring clinical-stage Icosavax for $800 million up front, the pharmaceutical giant announced Tuesday. Under the deal terms, AstraZeneca will pay $15 for each Icosavax share, which is a nearly 43% premium to the stock’s closing price on Monday. AstraZeneca could pay an additional $5 per share depending on the progress of Icosavax’s vaccine candidates. That payout could bring the value of the deal to $1.1 billion. The vaccines of Seattle-based ...
- Source: drugdu
- 110
- December 14, 2023
National Resilience lines up 440 new jobs at former AstraZeneca plant in Ohio

After multiple expansion forays overseas this year, biomanufacturing outfit National Resilience is returning to its American roots with plans to beef up production and add hundreds of new jobs at a recently purchased plant in Ohio. Resilience is expanding operations at the West Chester, Ohio, facility it bought from AstraZeneca in January, the technology-focused contract manufacturer said Monday. In turn, the company expects to create some 440 new jobs with an associated annual payroll of nearly $29 million over the next three years. The project represents a partnership between Resilience, JobsOhio and Cincinnati’s Regional Economic Development Initiative (REDI), the company noted. All told, the plan is set to nearly double Resilience’s current presence in West Chester, according to JobsOhio president and CEO J.P. Nauseef. In the company’s press release, Resilience’s CEO Rahul Singhvi pointed out that the West Chester site serves as the CDMO’s global center of excellence for commercial ...
- Source: drugdu
- 104
- December 14, 2023
On Heels of ASH Data, Pfizer Eyes FDA Submission for New Hemophilia Drug

Pfizer already reported its experimental drug for hemophilia A and B met a pivotal study’s goals of reducing bleeding episodes. During the annual meeting of the American Society of Hematology, the company presented a full look at the results, which are expected to support regulatory submissions soon. By FRANK VINLUAN Patients with hemophilia A or B can manage the inherited bleeding disorders with regular infusions of the clotting proteins they lack. This treatment helps—until it doesn’t. One problem with these infused factor replacement therapies is patients can develop inhibitors, which are antibodies that render the clotting proteins ineffective. Experimental Pfizer drug marstacimab takes a different approach to both forms of hemophilia. Results from a pivotal study show the subcutaneously injected drug met the main goals of reducing bleeding episodes. The company also has some additional long-term data showing continuing improvement beyond the initial clinical trial evaluation period. The full Phase ...
- Source: drugdu
- 93
- December 12, 2023
IGM jettisons workforce and blood cancer programme to refocus pipeline

IGM Biosciences plans to axe 22% of its workforce, becoming the latest company to downsize in a bid to free cash resources. Amid the layoffs, the US-based biotechnology company will also reprioritise its pipeline, discontinuing operations for all haematologic oncology and targeted cytokine product development while doubling down on its efforts in the clinical development of T cell engagers for autoimmune diseases and a DR5 agonist for colorectal cancer. IGM expects the restructuring to extend the company’s cash runway into Q2 2026. The restructuring comes less than a month after the company said it anticipated an increase in headcount to support the research and development of its pipeline candidates, citing its intent to advance and expand its antibody product pipeline, in its 13 November 10-Q filing. In the same filing, the company acknowledged that it had significant net losses to date and that achieving profitability sufficient enough to offset the ...
- Source: drugdu
- 100
- December 8, 2023
GSK Pulls Ahead of Pfizer in RSV Vaccine Market as Arexvy Nears Blockbuster Status

By Tristan Manalac Pictured: GSK building in Poznan, Poland/iStock, Wirestock GSK CEO Emma Walmsley on Thursday touted the smooth launch of its respiratory syncytial virus vaccine Arexvy and its strong potential for growth in the coming years. In an interview with Reuters, Walmsley said the British biopharma is “delighted” with the progress it has made in the RSV vaccine race with Pfizer. “We are delighted with the start of our RSV vaccine,” Walmsley said, adding that the company expects Arexvy “will be more than £1 billion in its first year, (it) has lots of headroom for growth.” GSK is positioning Arexvy to be its next blockbuster asset. The U.S. launch of the vaccine has so far reached three million of the more than 80 million adults over 60 at risk from RSV, according to Walmsley. Arexvy became the first FDA-approved RSV shot in May 2023 and is authorized for use ...
- Source: drugdu
- 108
- December 5, 2023

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