| Today’s Big NewsDec 20, 2023 |
| By Gabrielle Masson Just six days after CRISPR Therapeutics secured a landmark FDA approval for its Vertex-partnered gene therapy Casgevy, the biotech's Chief Medical Officer Phuong Khanh Morrow, M.D., resigned. |
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By Zoey Becker After a swing and miss in a rare blood disorder last month, argenx's Vyvgart Hytrulo missed its primary and secondary endpoints in a phase 3 in patients with two types of pemphigus. With the result, argenx will abandon its ambitions in the disease. |
By Conor Hale A recall of lung scopes from Olympus has been rated as Class I by the FDA, the agency’s most serious classification, after reports of fires and burns when being used with electrosurgery equipment. |
By James Waldron The antibody-drug conjugate (ADC) fever of recent months still shows no signs of abating, with GSK heading back to Hansoh Pharmaceutical to pick up another candidate for $185 million upfront. |
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Tuesday, January 23, 2024 | 11am ET / 8am PT Join a cutting-edge conversation on January 23, 2024 with Real Chemistry and Quid as they explore how their partnership has forged a deeper understanding of patient insights. Register now. 
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By Andrea Park Once again, Medtronic has issued a product correction for its surgical navigation software, earning the StealthStation platform its fifth Class I recall categorization from the FDA in as many years. |
By Kevin Dunleavy Seven months after Krystal Biotech became the first company to gain FDA approval to treat the rare, devastating skin disease epidermolysis bullosa (EB), Chiesi Farmaceutici has followed suit. On Tuesday, the U.S. regulator gave a thumbs up to Chiesi’s Filsuvez (birch triterpenes) to treat both junctional epidermolysis bullosa (JEB) and dystrophic epidermolysis bullosa (DEB) in patients 6 months and older. |
By Conor Hale We're looking for the fiercest and most innovative private medtech companies and startups, from around the globe and in every healthcare area, for our annual list of the Fierce 15. |
By Gabrielle Masson After sending 26% of staff and two C-suite execs packing this summer, Passage Bio once again wants to lighten its load. The gene therapy biotech is looking for a partner to pick up three of its clinical-stage pediatric candidates, including a lead program. |
By Fraiser Kansteiner In a deal worth around $116 million, Novartis is handing over a portfolio of “select ophthalmology brands” to Mumbai’s J.B. Chemicals & Pharmaceuticals. The sale is expected to go into effect in January 2027. Until then, J.B. plans to distribute and market the medicines in India. |
By Gabrielle Masson With Sanofi Ventures in tow, Sudo Biosciences has secured $116 million to advance programs in multiple sclerosis and psoriasis into the clinic. |
By Andrea Park It’s a baby (monitor) boom! Shortly after Owlet secured a long-awaited FDA clearance for its baby-monitoring “sock” equipped with pulse oximetry technology, Masimo has followed suit. |
By Kevin Dunleavy In 2020, Palatin paid $12 million to regain the rights in North America to its struggling female libido drug Vyleesi. Three years later, the New Jersey company has sold the treatment for the same up-front figure—$12 million—in a deal that indicates the medicine is unlikely to ever make a significant impact in the market. |
Fierce podcasts Don’t miss an episode |
| This week on "Podnosis," Dr. Nigam Shah, Chief Data Scientist at Stanford Health Care, shares insights into the direction of the industry and anticipated developments as AI adoption gains momentum. |
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