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A surprising deal from Vertex Pharmaceuticals adds to Big Pharma’s acquisitive streak as Crinetics folds into the cystic fibrosis drugmaker. Meanwhile, IPOs and venture capital raises trend upward, but mostly for derisked companies. Plus, FDA decisions slow only slightly as the hunt for a permanent leader drags on.
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After debuting on the public markets with $256.3 million and raking in an additional $472 million, Veradermics has emerged as one of biotech’s biggest post-IPO standouts. CEO Reid Waldman credits the weight loss craze for establishing consumer-driven channels.
Molecular glue degraders are gaining traction in the clinic as well as funding from Big Pharma, with their potential to treat previously “undruggable” cancers and immunological diseases. Here are five clinical programs worth keeping an eye on.
Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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Takeda’s layoffs include cutting 247 people in Massachusetts. The workforce reduction is meant to help offset investments in areas including a product launch for oral drug candidate zasocitinib, for which the pharma today announced positive Phase 3 data.
While tonlamarsen missed one of two co-primary endpoints, Kardigan says the drug has shown a clinically meaningful effect on blood pressure, supporting advancement into Phase 2b.
The FDA rejected the high-dose regimen of Spinraza in September last year due to manufacturing concerns.
William Blair hailed a positive readout in cutaneous lupus erythematosus as a turning point for Biogen, while RBC Capital analysts called the results “another derisking step” for the company’s immunology and inflammation pipeline.
The lack of a dose-response effect could be due to the high number of dropouts in the higher-dose Winrevair arm and the relatively small study population, a discussant for Merck explained.
The Insilico Medicine agreement plays into Eli Lilly’s recent AI push, anchored by a partnership last year with NVIDIA to build a supercomputer to optimize drug discovery and shorten the development timeline.
AbbVie’s Skyrizi appears to have stronger efficacy than Johnson & Johnson’s newly approved pill Icotyde, as well as a less frequent dosing schedule that patients could prefer, according to analysts at BMO Capital Markets.
The FDA has some big verdicts lined up in the second quarter, including one for a closely watched obesity drug that many anticipate will further intensify competition in weight loss.
Accumulating scientific evidence and industry interest from Eli Lilly, Altimmune and startup Baseline Therapeutics is driving further research on the therapeutic potential of GLP-1 receptor agonists in treating substance use disorders.
Former ACIP vice chair Robert Malone claimed that Andrew Nixon, spokesperson for the Department of Health and Human Services, “trashed” him with the media, adding that he resigned because “I do not like drama.”