| Today's Big NewsMay 15, 2023 |
| By Max Bayer FDA advisers have narrowly voted in favor of Sarepta’s gene therapy for patients with Duchenne muscular dystrophy, a stunning decision that runs counter to regulators who expressed skepticism heading into the meeting. |
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By Angus Liu Pfizer's $43 billion Seagen deal is now up for its high-stakes review at the FTC. The review comes after the agency said it would take a tougher stance toward biopharma megamergers. |
By Max Bayer Sarepta was handsomely rewarded by investors early Monday after FDA advisers surprisingly voted in favor of the accelerated approval path for the company’s Duchenne muscular dystrophy gene therapy on Friday evening. |
By Andrea Park For the second time in a decade, Philips has agreed to settle with the U.S. Securities and Exchange Commission over alleged misconduct in its international operations. |
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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 Zoey Becker Months after the U.S. and European approvals of its CSL-partnered hemophilia A gene therapy, uniQure is selling some royalty rights for up to $400 million. |
By James Waldron Whether it’s returning to CAR-Ts, swooping in to pick up a Parkinson’s asset from a sinking biotech or setting up a spinout company to pursue its neuroscience ambitions, Janssen has been busy in recent months. |
By Andrea Park Embecta has teamed up with Tidepool to add an automated insulin delivery algorithm to its insulin patch pump to create a closed-loop diabetes management system for Type 2 users. |
By Fraiser Kansteiner The Supreme Court’s brief involvement in the "skinny label" feud between GSK and Teva Pharmaceuticals has ended in a rejection—even after the United States’ top lawyer urged the Justices to take up the case. |
By Phil Taylor A medical device that aims to make the administration of epidurals more reliable and safer has been cleared by the FDA, giving its developer Omeq Medical its first approved product. |
By Gabrielle Masson Nido Biosciences is exiting stealth mode with $109 million in hand to develop new precision medicines for neurological diseases, with a lead asset that takes aim at Kennedy’s disease, a rare degenerative disorder. |
By Zoey Becker The decision came nearly three months after the drug's original FDA decision date. |
By Phil Taylor Want to know what’s going on across the length of your gastrointestinal tract? Swallowing a smart capsule device developed by Envivo Bio could give you the answer, according to a new study. |
Fierce podcasts Don'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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| July 18-19, 2023 | Jersey City, NJ |
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