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Analysts are cautiously optimistic about an IPO rebound for biopharma. BioSpace is keeping track of companies that seek to trade on the public markets this year.
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The first gene therapies approved to treat sickle cell disease in December 2023 are struggling on the market. But there are glimpses of forward momentum as Vertex and Genetix Bio provide updates.
After last year’s ‘stampede’ for FGF21 assets, the focus for the metabolic dysfunction-associated steatohepatitis space has shifted toward differentiated approaches, such as THR-β agonists and combination treatments, that seek to mirror the commercial success of Madrigal’s Rezdiffra.
Maintaining America’s momentum demands that policymakers resist policies that undermine research and development incentives.
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Read our takes on the biggest stories happening in the industry.
Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
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While San Diego remains a top biotech hub behind Boston and San Francisco, the city—which hosts this week’s BIO International Convention—has seen employment drop amid economic headwinds.
While more programs now involve candidates with different targets, experts say anti-amyloid therapies will remain a primary player in treating the memory-robbing disease.
LSD, ketamine, ibogaine and related treatments are moving forward in clinical trials for substance use disorders, including alcohol use disorder and opioid use disorder.
Regeneron and Sanofi will have to wait until September 2024 for the FDA to decide whether to expand Dupixent’s label to include uncontrolled chronic obstructive pulmonary disease.
In addition to missing the mark in overall survival, Gilead reported Thursday a higher number of deaths in the Trodelvy arm of the confirmatory metastatic urothelial cancer study.
Novartis’ Scemblix posted stronger results with fewer discontinuation rates than both its own Gleevec and a stronger second-generation TKI, positioning it for a potential first-line indication in chronic myeloid leukemia.
As evidenced by this week’s buyouts by J&J and Merck, Big Pharma appears to have found a sweet spot favoring smaller deals over megabillion-dollar acquisitions.
The American Society of Clinical Oncology annual meeting kicks off today in Chicago, with highly anticipated presentations that include reports on a bispecific antibody, an ADC and a BCMA-targeted CAR-T cell therapy.
The Roivant spinout is shifting its attention away from batoclimab to anti-FcRn candidate IMVT-1402, which will target autoimmune disorders, while allowing argenx’s Myasthenia Gravis drug Vyvgart to maintain its lead position for now.
Tempting as it may be to turn to full automation to meet burdensome requirements, the potential for hallucination and other issues means biopharma companies must proceed with caution.