biologic drugs
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Senate Bill Proposes Slashing ‘Red Tape’ Around Biosimilar Interchangeability
Legislation introduced by Utah Senator Mike Lee would eliminate testing to show a biosimilar can be substituted for a reference biologic product. Lee contends the current testing requirement adds costs and delays market access for these lower-cost biological medicines.
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Blood Biotech Grifols Cuts Deep in the U.S. to Find €400M in Savings
Grifols said the layoffs sparked by its restructuring represent just 8% of its workforce. But the cuts will happen mainly in the Barcelona-based company’s U.S. plasma operations, source of most of the plasma that is the basis for its biologic medicines.
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Payer’s Place: Dawn Maroney
Dawn Maroney, President, Markets of Alignment Health and CEO of Alignment Health Plan, to discuss how they are using technology to provide better service and care to consumers.
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With Secreted Proteins Map, Juvena Finds Path to $41M for New Regenerative Meds
Juvena Therapeutics is developing secreted protein drugs built on new knowledge gleaned from proprietary technology that maps these proteins and the tissues in the body where they offer a regenerative effect. The startup’s lead program is in development for the muscle disorder myotonic dystrophy type 1.
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Sanofi’s hemophilia A data set stage for regulatory filings, matchup with Roche
An experimental hemophilia A therapy from Sanofi and partner Sobi has met the goals of a pivotal study, and the pharmaceutical giant is now planning global regulatory submissions for later this year. The drug could compete against a blockbuster hemophilia A treatment marketed by Roche.
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Biocon expands portfolio & market reach with $3.3B buyout of Viatris biosimilars
Biocon Biologics is acquiring the biosimilars business of its longtime partner, Viatris. The deal gives Biocon a biosimilars presence in both emerging and developed markets, while Viatris sheds non-core assets as part of a broader strategic review.
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Pfizer’s growth hormone deficiency drug comes up short at the FDA
The FDA has rejected Pfizer’s somatrogon, a long-acting form of human growth hormone designed for once-weekly dosing. The setback delays Pfizer and partner Opko Health from competing against a newly approved human growth hormone drug from Ascendis Pharma that is also designed for once-weekly dosing.
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Sanofi’s $1B Amunix acquisition aims for targeted, safer T cell engagers for cancer
In acquiring Amunix, Sanofi becomes the latest big pharmaceutical company to strike a deal to gain access to technology that improves the safety and efficacy of T cell engager cancer therapies. Sanofi agreed to pay $1 billion up front to buy preclinical Amunix.
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Biologics manufacturing drives Evotec’s $435M U.S. stock market debut
Evotec is an old player in the life sciences, but in offering new shares on the Nasdaq, the Germany-based company plans to bolster its new biologics manufacturing capabilities in the U.S and Europe. In other stock market debuts, IO Biotech’s IPO raised $100 million as it prepares a pivotal test of its lead cancer immunotherapy.
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Artificial Intelligence, BioPharma
Synbio startup GRObio gets $25M to work with new building blocks for protein drugs
Harvard University spinout GRO Biosciences has technology offering the potential for protein therapies that are safer and more effective than currently available biologic drugs. The startup’s research is now backed by $25 million, a Series A financing round whose investors include the venture arm of Bayer.
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Applying Remote Patient Monitoring to Surgery Prep and Recovery, Oncology and Women’s Health
Join us to learn about the latest trends in remote monitoring and how to extend its benefits beyond chronic conditions to more patients – all while using fewer staff resources.
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Resilience turns to Harvard for biologics manufacturing tech, inks 5-year R&D pact
Biomanufacturing technologies company Resilience is partnering with Harvard in a deal that could see innovations from the university’s labs commercialized under new businesses. Resilience has committed $30 million in funding to support Harvard biomanufacturing research.
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Repligen sees $150M Avitide acquisition as key to reaching gene therapy goals
Bioprocessing technologies company Repligen is acquiring Avitide, and its biologics purifying technology, in a $150 million cash and stock deal. Repligen said Avitide will help it meet growing demand for gene therapy solutions.
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Payer’s Place: Dr. Anil Singh
Dr. Anil Singh shares his insights into the strategies employed by the organization to identify the most effective digital solutions for their members.
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Discover the Next-Gen Platform for Integrated Collaborative Care
Beyond EHRs and digital front doors, reducing the gaps in patient care journeys.
