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A fresh FDA review for Biohaven’s embattled ataxia drug lifted the biotech’s shares, while a late-stage lung cancer miss battered ArriVent, which failed to rebound even after encouraging early ADC data.
With companies including AstraZeneca, Pfizer and Revolution Medicines clamoring to get in on Summit Therapeutics’ Akeso-partnered PD-1xVEGF antibody, one analyst calls the asset “the next major backbone” of cancer treatment.
Former biologics boss Peter Marks had a vision. With the FDA’s latest draft guidance, it’s coming to fruition. Speaking with BioSpace, current CBER leader Karim Mikhail said the “adapted pathway” is designed to develop personalized gene therapies more quickly.
Saudi Arabia is building the regulatory framework, partnerships infrastructure and IP landscape needed to support a biotech ecosystem, despite regional political instability. Whether it can produce sustainable biotech companies and a resilient manufacturing base for global production remains an open question, but the future looks bright.
If approved, BridgeBio Pharma’s BBP-418—which, according to one Jefferies analyst, boasts “pretty darn compelling” data—would be the first therapy for limb-girdle muscular dystrophy. The FDA has an action date of Nov. 27.
Strong immunology and neuroscience sales fueled AbbVie’s latest quarterly beat as the pharma’s stock continues to hit all-time highs.
Follow along as BioSpace tracks job cuts and restructuring initiatives.
“You don’t spend one and a half billion dollars without creating jobs,” AstraZeneca CEO Pascal Soriot said as the pharma announced a new cost savings program alongside third quarter earnings.
Regeneron executives struck an upbeat tone on an investor call Friday as the biotech posted a consensus-beating $5.1 billion in third quarter earnings and CEO Leonard Schleifer touted the company’s ‘disease agnostic’ pipeline and approach to business development.
Focused on ensuring growth beyond Dupixent, Sanofi wants to acquire derisked assets that may benefit from the French pharma’s commercial capabilities, executives said on Friday as they reported third-quarter earnings.