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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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Contingent value rights are rising in a down market, helping to close the gap between buyer and seller expectations in biotech transactions.
Executives at Novartis have not been shy about a desire to buy more companies, with cardiovascular a big focus. In total, the Swiss pharma has put $17.23 billion on the line in M&A and licensing deals this year.
Ori Biotech’s CEO said the prioritization of review by FDA, coupled to the impact of the technology, could shave up to three years off development timelines.
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BMS is letting go of 68 employees in Lawrenceville, New Jersey. The pharma has now cut over 1,000 employees there since April 2024 as part of its cost-cutting measures.
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While it’s not unusual for certain positions to turn over with a new administration, the number of senior-level FDA staffers who have recently left the agency is unprecedented. The lack of communication, transparency and human decency is as well.
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The settlement agreement will extend market exclusivity for AbbVie’s JAK inhibitor in the U.S. until 2037—providing pediatric exclusivity is granted.
Ocaliva won accelerated approval for primary biliary cholangitis in 2016, which the FDA refused to upgrade to full approval last year after an advisory committee was unable to verify a favorable risk/benefit profile.
President Donald Trump is considering tariff exemptions for certain “non-patented” pharmaceuticals, though the White House has yet to release specific guidelines.
LB Pharma landed on the Nasdaq Thursday, with 3 million additional shares sold than expected.
A draft executive order obtained by The New York Times purports to clamp down on the pharmaceutical industry’s ability to buy new molecules from biotechs based in China, along with a number of other proposed reforms.
The biopharma job market remains challenging, based on BioSpace data. In August, job postings live on the website dropped 32% year over year. In addition, during the first eight months of 2025, over 26,000 people were laid off or projected to be laid off.
New York City has seen increased life sciences employment during the past decade as public funding and key projects like JLABS @ NYC have given the area a boost. A Partnership Fund for New York City executive discusses the city’s strengths and a notable challenge facing businesses.
Capsida has yet to disclose the exact cause of death. The patient had received the gene therapy CAP-002 for a type of epilepsy.
New draft guidelines suggest the FDA is open to exercising regulatory flexibility for non-opioid drugs being developed for chronic pain.
Analysts at BMO Capital Markets expect the lack of other exon-44-skiping therapies to facilitate a “smooth” approval process for Avidity’s del-zota.