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How is your lab navigating complex NGS workflows? In this webinar, hear subject matter experts explore how a lab informatics solution with out-of-the-box NGS capabilities delivers real value. View Now.
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Today’s Big NewsSep 13, 2023 |
| By Max Bayer After tweaking the formula behind an mRNA flu vaccine, Moderna has finally met all the goals needed for a successful shot in a phase 3 trial. Now, CEO Stéphane Bancel is eyeing a launch as early as 2024. |
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By James Waldron Calidi Biotherapeutics has become the latest biotech to take the SPAC route to the public market, loading up with around $70 million in funding agreements to develop its allogeneic stem cells through to 2025. |
By Gabrielle Masson Just days after a CEO shake-up, Madrigal Pharmaceuticals has shared that the FDA has given its NASH drug priority review and that the agency doesn’t plan on holding an advisory committee meeting. |
Sponsored by IQVIA With IQVIA’s clinical trial solutions and flexible site support strategies, decentralized trial elementss are being leveraged to enhance patient- centered care as well as support sites through hands- on enablement and implementation of DCT platforms these services. |
By Annalee Armstrong Eiger BioPharmaceuticals is finally putting a pin in efforts to find a home for peginterferon lambda, a drug once tried in COVID-19 that has now failed in a study for chronic hepatitis delta. |
By Gabrielle Masson To build the "best pipeline in BioMarin history," the California biotech is looking to its already approved meds as a jumping-off point. |
By Nick Paul Taylor Rocket Pharmaceuticals has reached alignment with the FDA on the design of a pivotal phase 2 rare disease trial, positioning it to run a 12-patient study that could support accelerated approval of a gene therapy. |
By Gabrielle Masson,Max Bayer,Annalee Armstrong Alongside the new year, we've launched a new Fierce Biotech Fundraising Tracker to keep the pulse on the industry's financing. |
By Fraiser Kansteiner The companies included in the warning letter sweep are: Boiron, CVS Health, DR Vitamin Solutions, Natural Ophthalmics, OcluMed, Similasan, TRP Company and Walgreens Boots Alliance. |
By Conor Hale The spine and orthopedics company said that President and CEO Keith Valentine, Chief Financial Officer John Bostjancic and Chief Legal Officer Patrick Keran will be replaced, effective immediately. |
By Joseph Keenan Clinical development and analytics provider Phesi in partnership with Krystelis has launched a new service to recruit more diverse patients in clinical trials. |
By Angus Liu Moderna is speaking with its manufacturing partners to scale back production of its mRNA COVID vaccine to adapt to the endemic phase of the disease, Moderna’s president and R&D head, Stephen Hoge, said, Reuters reports. |
By Joseph Keenan CRO giant Icon has been tapped by the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority to conduct a clinical trial to evaluate next-generation vaccines for COVID-19. |
By Heather Landi Provider groups are urging the Biden administration to reconsider proposed cuts to physician payments in its annual fee schedule rule, arguing that the cuts could force service and staffing reductions as practices feel the financial pinch. |
Fierce podcastsDon’t miss an episode |
| | This week on "The Top Line," we discuss the trends seen at Cannes Lions, the top compensated CEOs in the industry, and the cancer drug shortage |
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