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Cellares, which last year became the first company to receive the FDA’s new advanced manufacturing technology designation, expects to support clinical production this year and offer commercial-scale manufacturing services in 2027.
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With the biopharma industry performing better of late, analysts, executives and other industry watchers are “cautiously optimistic”—a term heard all over the streets of San Francisco at the J.P. Morgan Healthcare Conference earlier this month.
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
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The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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A report from J.P. Morgan shows an increase in biopharma activity so far this year and where some improvement can be made.
Eisai presented a plethora of data on the drug at the Alzheimer’s Association International Conference, including a study showing the consequences of pausing treatment.
Systemic administrative and policy challenges, including updated CDC guidelines regarding the use of RSV shots in seniors, have forced GSK to lower its 2024 outlook for its vaccines business.
The FDA will have six months to review Vertex Pharmaceuticals’ suzetrigine, potentially the first new class of drugs for acute pain in more than 20 years, according to the company.
Incyte announced Tuesday it is realigning its research and development priorities to focus on dermatology and inflammatory assets obtained from the $750 million acquisition of Escient Pharmaceuticals.
In addition to facing generic competition, Entresto is among the initial 10 drugs selected for the Inflation Reduction Act’s Medicare Drug Price Negotiation Program, with the maximum fair prices to be published by Sept. 1.
Second-quarter earnings season continues with Big Pharma beating Wall Street expectations, the author of an encrypted email sent to BioSpace has a proposal for Moderna and Merck, Roche and Viking seek quicker entry to the obesity market, and AAIC is in full swing.
Sangamo and Pfizer’s hemophilia A gene therapy candidate scored a Phase III victory last week. However, with the genomic medicine company soon to run out of cash, Sangamo’s short-term prospects look bleak but not unsalvageable, analysts say.
After more than 20 years at Eli Lilly, Leslie Sam moved into independent consulting. To prepare for the transition, she focused on becoming technically deep and earning industry recognition.
The BIOSECURE Act’s prohibition on doing business with China-based companies may have implications for biotech and biopharma markets on both sides of the Pacific.