| Today's Big NewsApr 14, 2023 |
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July 18-19, 2023 | Jersey City, NJ Hear the latest industry trends from leaders in the field, and developed with input from our esteemed advisory board, to ensure you have a sound plan for your company, brands, and yourself. Save $500 when you Register Today!
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| By Angus Liu Following the surprise FDA rejection of Alzheimer’s disease candidate donanemab in January, another Eli Lilly biologic drug has been met with an FDA cold shoulder. This time, manufacturing is to blame. |
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By Andrea Park A year and a half into the repair-and-replace program for its far-reaching respiratory recall, Philips’ website states that 90% of the production of all needed replacement devices and repair kits has been completed, and that 2.46 million of the devices and kits have been “shipped in the U.S.”—but the FDA is taking issue with the latter figure. |
By Annalee Armstrong Exelixis is still feuding with Farallon Capital Management, but the biotech’s board likes at least some of the activist investor’s ideas—including two new recommended board members. |
By Fraiser Kansteiner Manufacturing deficits have triggered a second complete response letter in Teva and Alvotech’s quest for approval of AVT02, a high-concentration biosimilar candidate for Humira, the companies said Friday. The FDA flagged deficiencies after reinspecting Alvotech’s Reykjavik, Iceland, production plant. |
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Thursday, April 20, 2023 | 11am ET / 8am PT In this presentation, we highlight key study design challenges and considerations for rare disease CGT trials and discuss the potential for leveraging in silico approaches for generating synthetic control arms that enable a control-based comparative assessment of efficacy. Register now. 
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By Andrea Park Last month, Medtronic confirmed that it had quietly combined its surgical robotics and surgical innovations operating units into a single segment, effective Feb. 1. The unit is led by Mike Marinaro, a two-decade company veteran who was previously made head of the surgical robotics business in early 2022. |
By Nick Paul Taylor Acelyrin is about to find out whether a once well-trodden path is still open to biotechs that need big bucks to bankroll their plans. Having raised $408 million from private investors in recent years, the immune drug developer now wants public financiers to step up and help it deliver phase 2b/3 data in three indications. |
By Angus Liu Struggling to meet demand for CAR-T med Caryvkti, Johnson & Johnson and Legend Biotech have reached out to Novartis, a cell therapy expert, for help manufacture their multiple myeloma treatment. |
By Gabrielle Masson After the FDA denied approval for Soligenix’s rare cancer treatment in February, the agency has now said a second clinical trial with positive results will be required to accept another request for approval. |
By Andrea Park As it embarks on a widespread effort to remind users of the proper care and keeping of the handheld readers used with its FreeStyle Libre continuous glucose monitors, Abbott is further expanding the devices’ user pool. |
By James Waldron Following in the footsteps of Incyte’s Opzelura, Minghui Pharmaceutical has reported phase 2 results from its own JAK inhibitor that suggests the Chinese biotech's cream could also be effective against dermatitis. |
By Conor Hale The former Fierce Medtech Fierce 15 winner’s minimally invasive Revivent TC system is designed to help reshape the heart’s left ventricle as it recovers from the severe trauma of a heart attack. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we talk about biotech’s top money raisers in 2022. We also cover J&J's talc litigation, prison plans for Elizabeth Holmes and more of this week's top headlines. |
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Thursday, May 4, 2023 | 11am ET / 8am PT Join industry experts for this insightful webinar to learn more about enzyme inhibition studies. We’ll explore how these studies drive informed decisions for drug developers, frequently asked questions from sponsors, recommendations for achieving successful regulatory submission, and more. Register now. |
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| May 1-3, 2023 | Jersey City, NJ |
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