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Investor reaction to the deal was muted, with BMO Capital Markets analysts saying they “continue to look for more” from Bristol Myers Squibb before they can “get excited about the near term turnaround story.”
FEATURED STORIES
Aside from the rare disease market, Novo Nordisk also scored a key regulatory win last month for its blockbuster GLP-1 drug Wegovy, which can now be used to treat patients with metabolic dysfunction-associated steatohepatitis.
ALS
After a demoralizing period punctuated by the withdrawal of one of the few marketed therapies for ALS, investment in new biotechs, state-backed collaborative initiatives and buzz at BIO2025 suggest a new day in drug development for one of medicine’s most intractable diseases.
With a flurry of recent Big Pharma investment in radiopharmaceutical therapeutics, the FDA issued draft guidance last month in a move former FDA Commissioner Stephen Hahn sees as the regulator “trying to get ahead on a new set of therapy that they see becoming very important for cancer.”
Job Trends
4D Molecular Therapeutics today announced that the Company will present the initial interim 24-week landmark analysis from the Population Extension cohort of the PRISM Phase 2 Clinical Trial evaluating 4D-150 in a broad wet AMD patient population at the ASRS Annual Scientific Meeting being held in Stockholm, Sweden from July 17-20, 2024.
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Following restricted vaccine approvals and changes to CDC immunization schedules, Merck, Pfizer, GSK and Sanofi are all suffering revenue hits to their vaccine programs.
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Truist analysts called the results “encouraging” while pointing out certain unknowns in the data. Immuneering plans to kick off a registrational trial for atebimetinib later this year.
The decision to stop the Phase IIb study was driven by “strategic business reasons,” according to a federal clinical trials database.
FDA
Three draft recommendation documents published on Wednesday are intended to guide drug sponsors and accelerate the development of cell and gene therapies.
While Harmony management has not disclosed future plans for ZYN002, Jefferies analysts expect the asset to be shelved.
Talent acquisition leaders at leading pharma and biotech organizations are leveraging technologies, including automation, to develop internal talent marketplaces and systems that support upskilling and reskilling their workforce. BioSpace spoke to leaders at Pfizer and Bayer about their evolving approach to resourcing.
Acadia Pharmaceuticals was testing the drug, an intranasal formulation of the oxytocin analogue carbetocin, for its potential to ease hyperphagia in the rare neurological condition.
Sanofi Ventures, which now has $1.4 billion in total assets, will focus its investment efforts on early players working in immunology, rare diseases, neurology and vaccines.
If approved, uniQure’s gene therapy AMT-130—which slowed disease progression by 75%—would be the first genetic treatment for Huntington’s disease. A BLA submission is planned for the first quarter of 2026.
The issues the regulator found include the failure to comprehensively review complaints and product defects.
Lilly expects to open 615 high-wage roles in Texas in connection with its new facility, plus around 4,000 construction roles.