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By speeding lifesaving drugs’ way to market and focusing on the underlying causes of disease, the pathway has helped save many lives.
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Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only warranted but essential if these therapies are to reach their full potential.
Since July, several biotechs have been forced to pivot as previous agreements with the FDA around evidence required for approval were reversed, a phenomenon that, according to experts, could portend a more restrictive regulator.
The drugmaker’s dominance of the obesity market is fueling predictions that years of growth lie ahead.
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The Janssen Pharmaceutical Companies of Johnson & Johnson announced updated results from the Phase 1/2 MonumenTAL-1 study of talquetamab, an investigational, off-the-shelf, bispecific T-cell engager antibody.
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Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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AbbVie and Merck/Daiichi Sankyo were hit this week with Complete Response Letters from the FDA, which rejected their respective drugs due to manufacturing issues.
Expansion across its network will mean hundreds of new employees in Cincinnati, increased ability to get complex medicines to patients and more.
Novo Nordisk on Wednesday announced it is stopping a late-stage study after its candidate ocedurenone, which the pharma acquired last year in a potential $1.3 billion deal with KBP Biosicences, failed to meet the primary endpoint.
The FDA on Thursday rejected Merck and Daiichi Sankyo’s HER3-targeted antibody-drug conjugate patritumab deruxtecan in a Complete Response Letter, citing problems with a third-party manufacturer.
New recommendations from the Centers for Disease Control and Prevention call for the use of respiratory syncytial virus vaccines in adults aged 75 and older, but limited its use in 60- to 74-year-olds.
AbbVie and Genmab on Wednesday announced the FDA has expanded the label of their bispecific antibody Epkinly, allowing it to be used in patients with relapsed or refractory follicular lymphoma.
Verona Pharma on Wednesday secured the FDA’s approval for Ohtuvayre, which the company contends is the first inhaled chronic obstructive pulmonary disease medicine with a new mechanism of action in over 20 years.
Looking for a biopharma job in or near Washington, D.C.? Check out these five top companies hiring life sciences professionals like you.
Zealand Pharma is looking to build on last week’s positive Phase Ib trial results by raising around $1 billion in a public offering, with the proceeds being used to advance its obesity candidates.
The biotech incubator said Wednesday the majority of the fund will be for clinical proof-of-concept studies, bringing the total funds raised by Curie.Bio to nearly $1 billion.