| Today's Big NewsMay 16, 2023 |
| By Angus Liu The FTC has filed a lawsuit to block Amgen’s proposed $27.8 billion acquisition of Horizon Therapeutics, raising an argument that serves as an alarming sign for M&A scrutiny to come. The move comes just as biopharma's dealmaking prospects seemed to be improving. |
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By Nick Paul Taylor Viking Therapeutics’ non-alcoholic steatohepatitis has sailed past another clinical test, this time a phase 2b that linked VK2809 to mean relative changes in liver fat of up to 51.7% without causing widespread gastrointestinal side effects. |
By Fraiser Kansteiner Johnson & Johnson's COVID-19 vaccine is “no longer available in the U.S.,” the Centers for Disease Control and Prevention (CDC) said. The last remaining doses in the U.S. stockpile expired on May 7, 2023, with the CDC now giving instructions to “[d]ispose of any remaining Janssen COVID-19 vaccine in accordance with local, state and federal regulations.” |
By Andrea Park Almost two full years into its Class I recall of more than 5 million respiratory devices, Philips has wrapped up safety tests covering nearly all of the affected models—and is reiterating its previous conclusion that the disintegrating foam at the heart of the recall carries a low risk of harm to users’ health. |
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Tuesday, May 23, 2023 | 12pm ET / 9am PT Join us for this insightful webinar to explore why analytical development is often underestimated, and should go hand-in-hand with process development when addressing clinical and commercial manufacturing requirements, advantages of using integrated analytical services within the areas of process development and technology transfer, and more. Register now.
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By Gabrielle Masson Eli Lilly’s Prevail Therapeutics is jotting down up to $1.5 billion for Scribe Therapeutics in hopes of writing some new CRISPR-based genetic medicines for neurological and neuromuscular diseases into history. |
By Zoey Becker After AbbVie and Teva scratched their memberships with the influential trade group, AstraZeneca is now the latest to ditch PhRMA. |
By Max Bayer The Foundation for the National Institutes has tacked on eight new rare diseases to its Bespoke Gene Therapy Consortium, partnering with research institutions to advance novel therapies. The foundation's near-term goal is funding development of the trials through phase 1/2 studies. |
By Annalee Armstrong The COVID pandemic was a make or break moment for many a biotech. For Mammoth Biosciences, it may have been both. For Janice Chen, chief technology officer and co-founder, the whole journey has been wild. |
By Kevin Dunleavy Dermavant has released data from a phase 3 trial that show Vtama’s effectiveness in adults and children ages 2 and older with eczema. The results from this trial, dubbed ADORING 1, back up and amplify those from ADORING 2, which were released two months ago. |
By Andrea Park Abbott is putting the old adage that “good things come in threes” to the test, with its fourth FDA approval in less than a year for its spinal cord stimulation systems. |
By Helen Floersh The world’s second-ever private astronaut mission to the International Space Station will ferry a first-of-its-kind experiment that will test whether scientists can create induced pluripotent stem cells in microgravity. |
Fierce podcastsDon't miss an episode |
| | This week on "The Top Line," we're concluding our miniseries on Narcan the nasal spray. It is the first naloxone product to be approved for use without a prescription. |
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Thursday, May 25, 2023 | 10:00am ET / 7:00am PT Join the webinar and discover our MVA technology platform and explore the advantages for development and manufacturing of multiple vaccines and cell and gene therapeutics. Register now.
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