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After a tension-packed two days that saw changes to the MMRV vaccine schedule and COVID-19 recommendations, as well as a delayed hepatitis B vaccine vote, policy experts expressed concern with the reconstituted committee’s dearth of previous experience and “understanding” of their role.
FEATURED STORIES
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.
From a small team of researchers and skipped salaries, CEO Michelle Xia has steered Akeso to become one of the most exciting companies in the industry today.
While the FDA is trumpeting this new initiative as “sweeping reforms” to the way drug companies can advertise, experts say the regulator is going after a problem that doesn’t exist.
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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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VectorY Therapeutics will evaluate the use of SHP-DB1, a capsid developed by Shape Therapeutics, to deliver therapies to the brain, including VectorY’s developmental Huntington’s and Alzheimer’s disease treatments.
In this episode of Denatured, BioSpace’s head of insights Lori Ellis and Colin Zick, partner at Foley Hoag LLP, spend time discussing some of the points brought up in the Bioprocessing Summit last month. They explore the connections between hammers, AI, The Planet of the Apes and monoliths.
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.