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Implemented as part of a broader initiative to make more targeted and efficient use of inspection resources, the pilot program will use artificial intelligence to enable shorter, focused screenings to complement standard FDA inspections.
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In Salt Lake City, biotech founders new and seasoned reflect on ways to ride out the industry’s challenges, such as sending cold emails to investors and learning to address leadership weaknesses.
As Q1 earnings arrive, three biotechs have big quarters ahead, with two—Amylyx and Neumora Therapeutics—betting at least partly on novel assets for obesity.
Altitude Labs, an offshoot of AI-focused techbio Recursion, is teaching scientists to build companies, one founder at a time.
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Follow along as BioSpace tracks job cuts and restructuring initiatives.
First quarter earnings continue to arrive, with analysts demanding more from cautious Pfizer and Eli Lilly expecting more revenue; the FDA taps Katherine Szarama as Vinay Prasad’s controversial FDA tenure ends; oncology veterans miss Richard Pazdur at the agency’s first adcomm in nine months; and QurAlis and Corcept Therapeutics spark renewed hope in ALS.
A legal settlement has put wind behind Pfizer’s sales into 2029—at which point key obesity moves will take the helm.
The action affects BioNTech sites in Germany and Singapore, where the company expects to have excess capacity.
Despite the continued decline of Pfizer’s COVID-19 products, shares stayed stable on Tuesday morning after the New York pharma reported a first quarter beat, which was led by Eliquis and Ibrance.
While some analysts may regard Vertex Pharmaceuticals’ first quarter results as “unremarkable,” BMO Capital Markets wrote on Monday, the second half of 2026 could be big for the biotech, with the potential approval of IgAN therapy povetacicept.
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.
A subsidiary of Indian drugmaker Hetero Group mistakenly packaged two types of antidepressants in packs of sertraline, potentially posing risks to patients.
Passage Bio, which has been working toward a registrational trial for a drug candidate whose indications include frontotemporal dementia, is exploring strategic alternatives in addition to cutting staff.
Amid disruption to the outsourced fill/finish market, PCI is investing $100 million to more than double the capacity to fill ready-to-use prefilled syringes and cartridges at its San Diego campus.