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According to Makary, reducing user fees—which make up just under half of the FDA’s budget—could make it easier for smaller companies, individual investors and academics to participate in the process.
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While it’s not unusual for certain positions to turn over with a new administration, the number of senior-level FDA staffers who have recently left the agency is unprecedented. The lack of communication, transparency and human decency is as well.
Bo Wang is a renowned AI scientist at the University of Toronto. He’s bringing his open-source culture and computational biology to Xaira Therapeutics in June.
With the recently announced layoffs of 3,500 FDA staffers and exits of branch directors Patrizia Cavazzoni and Peter Marks, there could be a wealth of talent available to biopharma companies. Does this pose an ethical quandary? It depends on who you ask.
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Intern alumni from Moda Health and Novo Nordisk Inc. join forces with the AMCP Foundation for a groundbreaking Health Disparities research internship, appointing Daria Sinclair, a PharmD Candidate at Howard University, College of Pharmacy, as the inaugural intern.
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Read our takes on the biggest stories happening in the industry.
The FDA has vowed to fix a pharma ad loophole—but they’re targeting the wrong one.
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Instead of homing in on PSMA—currently the most validated target in prostate cancer—BMS and Philochem will instead collaborate on an early-stage molecule that binds to a novel marker called ACP3.
The company’s intein-based technology is initially aimed at Stargardt disease, a type of macular degeneration.
The American Medical Association is also urging an “immediate reversal” of the HHS Secretary’s decision to oust all 17 members of the CDC’s vaccine advisory board.
The layoffs will heavily affect Vertex’s operations in Rhode Island, where the biotech will consolidate three facilities into one.
Guggenheim Partners called Insmed’s Phase IIb readout “impressive across the board,” with an efficacy profile that positions TPIP to be best-in-class in pulmonary arterial hypertension.
For $812 million, Novo Nordisk will enlist Deep Apple to discover and develop a non-incretin therapy for obesity, months after the Danish pharma’s amylin efforts underwhelmed investors.
The deal is Lilly’s second obesity tie-up in a week, after sinking up to $870 million into an agreement with Camurus to develop long-acting versions of molecules against GLP-1 and other incretins.
HHS Secretary Robert F. Kennedy Jr. made waves this week, firing the remaining members of the CDC’s Advisory Committee on Immunization Practices; Metsera’s amylin drug produced weight loss of 8.4% at 36 days; and FDA leaders gathered last week to discuss the future of cell and gene therapy, a sector that has been in turmoil since the ousting of CBER Chief Peter Marks.
Some companies’ preferences for people who already have industry experience and the tough job market are among the hurdles those just starting out in biopharma must navigate, two recruitment experts told BioSpace.
Despite substantial investments in groundbreaking treatments, companies struggle to communicate value early and to the right audience. Here’s how they can do better.