| Editor's Note: Fierce Life Sciences’ weekly digest will take a publishing break next week, December 29. Have a happy new year, and we’ll be back in your inboxes January 5, 2024. |
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| 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 Kevin Dunleavy Since Merck secured approval for kidney cancer pill and blockbuster hopeful Welireg (belzutifan) in August of 2021, sales have grown slowly but surely. With a second FDA nod for a much larger patient population, the company can anticipate a more pronounced upswing in revenue from the hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor. |
By Nick Paul Taylor Pfizer just swallowed a $43 billion ADC company and still isn’t full. Hours after Pfizer closed the Seagen buyout, Nona Biosciences put out news that the Big Pharma has committed $53 million in upfront and near-term payments for rights to its mesothelin-targeted ADC, dubbed HBM9033. |
By Andrea Park With only a week left in President Biden’s review of a proposed import ban on Apple Watches containing a pulse oximetry feature, Apple is preemptively complying with the sales stoppage. |
By Eric Sagonowsky Bluebird's FDA approval for sickle cell disease gene therapy Lyfgenia left something to be desired because the agency rejected a request for a priority review voucher. Without that voucher, bluebird is moving fast to try to fund its launches. |
By Kevin Dunleavy The FDA has signed off on Astellas and Pfizer’s Padcev in combination with Merck’s Keytruda as a first-line treatment for bladder cancer. The full endorsement, which follows an accelerated nod eight months ago, puts the combo on course to replace chemotherapy as the standard of care in locally advanced or metastatic urothelial cancer. |
By Max Bayer Biotech investors are licking their wounds after a year that's likely to have the lowest level of new fundraising in four years. Will 2024 finally be the rebound year? |
By Kevin Dunleavy In July, for Checkpoint Therapeutics, it was all about complete response rates adding momentum for its promising skin cancer candidate. Five months later, a complete response letter (CRL) has flipped the script on cosibelimab. On Monday, Checkpoint said that the U.S. regulator had rejected cosibelimab because of findings during an inspection of a facility of its third-party contract manufacturer. |
By Ben Adams “Don’t confuse us with BlackRock,” sing the staffers from venture capital firm Blackstone, a major life sciences funding business. It may well be that BlackRock, known for its own controversies, may not want to be associated with Blackstone. |
By Helen Floersh A new form of gene therapy designed to treat the most treatment-resistant form of childhood epilepsy appears to reduce seizures in mice. |
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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