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While some biopharma companies beat expectations, others fell short for various reasons, with some deciding to return or axe assets.
The layoffs are intended to help provide an operating runway into the fourth quarter of 2026.
The Swiss company’s monoclonal antibody Nemluvio is also undergoing regulatory review for atopic dermatitis, which is a potentially larger market for the first-in-class IL-31 blocker.
On the heels of the FDA’s denial of its petition, a Delaware district court on Monday handed Novartis another loss in its efforts to keep the market free of Entresto copycats.
By the end of the year, Novo Nordisk intends to make a regulatory filing for the combination of its icodec and semaglutide, keeping its once-weekly insulin program afloat.
The acquisition announced Monday will give Crown access to Revance’s Daxxify, a competitor to AbbVie’s Botox, which is indicated for frown lines and for cervical dystonia.
At a private event held amid the fallout from the CrowdStrike incident, cybersecurity issues took a front seat, with the consequences of the evolving EU AI Act and the Loper Bright and Corner Post decisions also raising concerns for quality assurance and regulatory affairs professionals.
Pfizer on Monday reported a “strong neutralizing response” against both subtypes of respiratory syncytial virus across all cohorts and age groups, according to topline data.
The Connecticut-based biotech, which emerged from stealth last year, has secured $202 million to date as it looks to move two assets targeting prostate and breast cancer into the clinic.
FibroGen expects its headcount reduction, which is tied to eliminating 75% of its U.S. workforce, to be mostly complete by the end of the first quarter of 2025.
Ascendis Pharma’s palopegteriparatide was previously rejected by the regulator due to manufacturing problems, and the review period for its resubmitted application was extended by three months.
A day after the regulator denied approval of Lykos’ MDMA-assisted PTSD therapy, a medical journal pulled three studies related to the use of the psychedelic in the indication.
Humacyte’s stock price dropped 18% in after-hours trading Friday after the company announced the FDA requires additional time to review its Biologic License Application. No reason was given for the delay or an updated decision date.
ARS Pharma’s neffy on Friday became the first FDA-approved nasal spray to address severe allergic reactions, including those that might lead to life-threatening anaphylaxis.
Hundreds of companies are currently running clinical trials in the increasingly lucrative obesity space. BioSpace looks at five candidates with data expected before the end of the year.
In the next two weeks, the FDA will hand down its verdicts for three drug applications, including ones for multiple myeloma and hypoparathyroidism therapies.
Clinical trial concerns and a negative advisory committee vote ultimately sunk the treatment.
AN2 is discontinuing a study that evaluated epetraborole for treatment-refractory MAC lung disease and plans to shift focus to its boron chemistry platform.
Merck is paying $700 million upfront to buy Curon Biopharmaceutical’s bispecific antibody which depletes B cells and is being investigated for non-Hodgkin’s lymphoma and B cell acute lymphocytic leukemia.
With Medicare expenditures on Stelara increasing nearly tenfold, a new report from the HHS Office of Inspector General has found major differences in drug payment amounts under Part B versus Part D.