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In the Phase III FIBRONEER-IPF study, Jascayd demonstrated significant lung capacity improvements over placebo.
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A new study in JAMA contradicts a series of statements made by HHS Secretary Robert F. Kennedy Jr. that paint vaccine advisory committees at the CDC and FDA as hopelessly corrupt.
While the 10-fold increase in dose over injectable Wegovy has raised questions about the launch, Novo Nordisk has assured investors it has the manufacturing capacity to roll out oral semaglutide without restrictions on supply.
The HHS secretary recently canceled $500 million worth of BARDA contracts around mRNA vaccine research. But the U.S. government has already spent billions on this work, which has saved millions of lives.
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4D Molecular Therapeutics today announced that management will participate in fireside chats at upcoming investor conferences in June.
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Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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Both BMS and Novo Nordisk have, in recent months, announced steep layoffs as they strive to cut back on costs.
Brepocitinib remains “ahead of competition” in the dermatomyositis space, according to analysts at Leerink, who projected that the drug candidate could hit $2 billion in sales in 2032.
Supporting Lexicon Pharmaceuticals’ decision to advance the non-opioid analgesic pilavapadin into late-stage development—despite a topline miss in March—is an “improving” regulatory environment for non-addictive options for chronic pain, according to analysts at Jefferies.
The star of the acquisition, which includes a contingent value right of $6 per share, is pegozafermin, an FGF21 analog in late-stage development for metabolic dysfunction-associated steatohepatitis.
In this deep dive, BioSpace explores the next big thing in obesity.
During a hearing in front of the Senate’s HELP committee, Susan Monarez addressed her controversial firing and recalled a conversation where Health Secretary Robert F. Kennedy Jr. allegedly said that “CDC employees were killing children and they don’t care.”
Moving forward, Innate will focus on the clinical development of its antibody-drug conjugate IPH4502, the lymphoma candidate lacutamab and the AstraZeneca-partnered monalizumab.
In letters to Eli Lilly and Novo Nordisk, the FDA accused the companies of downplaying the risks of their GLP-1 weight loss drugs during a prime time special with Oprah Winfrey.
A complex state vs. federal regulatory scheme allows drug compounders to advertise drugs without disclosing risks like a pharma company must do. Experts say it’s time for the FDA to crack down.
The multi-billion, multi-year investment comes as many of GSK’s pharma peers pull away from the U.K., either suspending or completely canceling previous commitments.