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A service for global professionals · Tuesday, October 15, 2024 · 751,969,808 Articles · 3+ Million Readers
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Sanofi FDA News Monitoring

  • Published on 07:10 GMT

    Regeneron and Sanofi’s Dupixent Tipped to Dominate COPD Biologics Market

    Regeneron and Sanofi won FDA approval for Dupixent in COPD in late September 2024. The approval of the antibody in a seventh indication marked the first time the regulator had authorized a biologic in COPD. The FDA approved Dupixent on the strength of …

    Source: BioSpace - Label Pending
  • Published on Oct 14, 2024

    Pfizer drug for hemophilia approved by FDA

    Dive Brief: The Food and Drug Administration on Friday approved a new kind of medicine for hemophilia, clearing Pfizer’s Hympavzi for people with either the “A” or “B” forms of the inherited bleeding condition. Adults and children 12 years of age or older …

    Source: BioPharma Dive - Label Pending
  • Published on Oct 14, 2024

    Pfizer rounds out haemophilia portfolio with FDA approval

    Pfizer’s anti-TFPI antibody marstacimab has been approved by the FDA to treat haemophilia, becoming the pharma group’s second new therapy for the blood disorder this year. Marstacimab will be launched as Hympavzi to treat haemophilia A without factor VIII …

    Source: pharmaphorum - Neutral
  • Published on Oct 11, 2024

    Thermo Fisher plant in North Carolina flagged for contamination, air bubble issues in FDA inspection

    Thermo Fisher Scientific is responsible for helping to produce some of the hottest drugs on the market, including Novo Nordisk’s obesity blockbuster Wegovy and Sanofi and AstraZeneca’s infant respiratory syncytial virus (RSV) antibody Beyfortus. But …

    Source: Fierce Pharma - Neutral
  • Published on Oct 11, 2024

    A setback for the Denali-Sanofi partnership

    This story first appeared in The Readout newsletter. Sign up for The Readout and receive STAT’s award-winning biotech news delivered straight to your inbox.  This newsletter was penned in the company of some mastodon fossils in New York. They say good …

    Source: STAT - Massachusetts - Neutral
  • Published on Oct 11, 2024

    FDA clears Roche breast cancer drug; Turnstone lays off 60% of staff

    Today, a brief rundown of news from Roche and Turnstone Biologics, as well as updates from Sanofi, Pfizer and Flagship Pioneering that you may have missed. Turnstone Biologics will lay off about 60% of its workforce and trim its pipeline in a bid to focus …

    Source: BioPharma Dive - Label Pending
  • Published on Oct 11, 2024

    US private equity firm set to win Sanofi's consumer health division

    The proposed offer from Clayton, Dubilier & Rice (CD&R) would mean the sale of a 50% stake in Opella, which makes over-the-counter medicine such as Doliprane and Allegra. The deal for the pharmaceutical giant is one of the biggest of its kind. It …

    Source: Euronews - Neutral
  • Published on 17:15 GMT

    Revolutionizing Pharma: The Power of AI and Chatbots in Clinical Trials and Beyond

    CHATBOT CORNER The pharmaceutical industry is in the midst of a transformative revolution driven by advancements in large language models (LLMs), generative artificial intelligence (AI), and chatbots. These technologies offer unprecedented opportunities to …

    Source: Psychiatric Times - New Jersey - Label Pending
  • Published on 17:10 GMT

    A Well-Written Analytical Procedure for Regulated HPLC Testing

    This paper describes the content of a well-written analytical procedure for regulated high-performance liquid chromatography (HPLC) testing. A stability-indicating HPLC assay for a drug product illustrates the required components for regulatory compliance, …

    Source: LCGC International - Label Pending
  • Published on 15:27 GMT

    Diabetes Dialogue: What to Know About the Eversense 365 CGM, with Brian Hansen

    On September 17, 2024, Ascensia Diabetes Care and Senseonics announced the US Food and Drug Administration's (FDA) clearance of the Eversense 365 system for people with type 1 and type 2 diabetes aged 18 years or older—the world’s first 1-year …

    Source: HCPLive - Label Pending
  • Published on 04:07 GMT

    It's Been a Bumpy Ride for the BTK Inhibitors for MS

    The race is on as several drugmakers get closer to the finish line in developing the first Bruton tyrosine kinase (BTK) inhibitor to treat multiple sclerosis (MS). BTK is a nonreceptor enzyme expressed in B cells and myeloid cells, both of which play a …

    Source: Managed Healthcare Executive - Neutral
  • Published on Oct 14, 2024

    Activism and Alpha: Himanshu Shah’s blueprint for long-term success at Shah Capital

    From Novavax to global equities, Raleigh, NC -based Shah Capital’s founder shares his investment philosophy and strategy Himanshu Shah’s journey into the world of finance started early. As a teenager in India, he made his first investment with a small …

    Source: The American Bazaar - Center-left
  • Published on Oct 14, 2024

    Stephanie Christenson, MD: An "Exciting" New Era in COPD Management

    After a pair of historic approvals in 2024, the pulmonology community heads into 2025 with a revamped armamentarium boasting new options for chronic obstructive pulmonary disease (COPD) management, including the first biologic therapy ever approved for the …

    Source: HCPLive - Label Pending
  • Published on Oct 13, 2024

    Discolored dose of flu shot found in Keelung: CDC

    A discolored dose of an Adimmune influenza vaccine was found in Keelung from a batch of 183,000 doses that have already been distributed to six cities and counties, the Centers for Disease Control (CDC) said on Saturday. The Keelung Health Bureau on …

    Source: Taipei Times - Neutral
  • Published on Oct 11, 2024

    Novel theories of harm spark legal uncertainty for pharmaceutical deal reviews

    Introduction As competition authorities’ review of pharmaceutical deals continues to expand, there is ongoing attention to whether the existing toolbox for identifying and remedying competition issues suffices. For example, in March 2021, several …

    Source: Global Competition Review - Label Pending
  • Published on Oct 11, 2024

    Early Parkinson Disease and the Potential Therapeutic Role of Lixisenatide

    Parkinson disease (PD) is a neurodegenerative disorder primarily affecting motor function, leading to movement difficulties, balance disorders, and memory deterioration.1 Emerging research suggests that the progression of PD may be linked to brain insulin …

    Source: Pharmacy Times - Neutral
  • Published on Oct 11, 2024

    Recordati to acquire global rights to Enjaymo

    Recordati has announced an agreement with Sanofi to acquire the global rights to Enjaymo (sutimlimab), a biologic which is the only approved targeted product for the treatment of cold agglutinin disease (CAD), a rare B-cell lymphoproliferative disorder. …

    Source: Pharma Business International - Neutral
  • Published on Oct 11, 2024

    Upstream Raises $255M IPO for Inflammatory Drugs; CAMP4 Nets $75M for RNA Work

    Two more companies jumped to the public markets to end the week, with inflammatory disease biotech Upstream Bio upsizing its offering for proceeds totaling $255 million while RNA outfit CAMP4 Therapeutics picked up $75 million. In the larger IPO, Upstream …

    Source: BioSpace - Label Pending
  • Published on Oct 11, 2024

    CPHI Europe: Overcoming the unique challenges with high-concentration mAbs

    There is an increasing number of high-concentration mAbs among approved therapeutics, with 76% of US Food and Drug Administration (FDA)-approved mAbs having high concentration formulations, says Antonio Pierno, senior manager, Scientific Laboratory …

    Source: Pharmaceutical Technology - Neutral

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