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The FDA’s Oncologic Drugs Advisory Committee narrowly voted against the approval of Zusduri, citing the lack of a completely randomized study to back up the application.
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J&J has a multi-year head start, but Gilead believes it can win market share by delivering a drug with better safety and at least as good efficacy.
A new report from Pitchbook suggests we’re in for a period of more sustainable investing, with VC firms continuing to create and invest in companies, just more carefully.
Jefferies has predicted more small tuck-in deals to come, as biotechs struggle to access capital despite key clinical milestones on the horizon.
Job Trends
Bristol Myers Squibb has made significant cuts to its workforce since last year as part of a strategic reorganization aimed at saving $3.5 billion through 2027. The latest cuts in Lawrenceville, New Jersey, bring that area’s total number of disclosed cuts this year to 806.
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Read our takes on the biggest stories happening in the industry.
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.
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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.
Looking at licensing deals struck in the past 10 years, Jefferies found that many Big Pharmas do not ultimately follow through with M&A after earning a right of first negotiation. Sanofi, on the other hand, almost always does, as it did with Vigil recently.
Gene therapies have ridden investor mania to huge valuations but commercialization challenges have pushed market caps to the floor. At a roundtable last week, FDA leaders promised faster approvals and broad support to the industry.
BioSpace did a deep dive into executive pay, examining the highest compensation packages, pay ratios and golden parachutes—what a CEO would get paid to leave.