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If workloads aren’t adjusted as needed, the company’s priorities are already compromised. Executive coach Angela Justice explores what happens when goals move forward without removing unnecessary work and what to do about it.
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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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The drug came to AstraZeneca through its acquisition of CinCor Pharma in 2023, with the hopes of beefing up its cardiovascular and kidney disease pipelines.
Takeda’s oveporexton improved wakefulness, attention and other key narcolepsy endpoints “with a high degree of statistical significance,” according to Jefferies analysts.
The development saga for the depression molecule has been rocky for years, unable to ease symptoms in multiple late-stage trials.
The FDA cited manufacturing issues but did not flag problems with Ultragenyx’s data package for UX111, with the biotech noting that the regulator found its neurodevelopmental findings for the gene therapy to be “robust.”
Through its recently unveiled Priority Voucher program, the FDA seeks to accelerate the review process for companies that promise to keep prices down.
New data and analyses presented at the American Diabetes Association’s annual meeting highlight the priorities for the next generation of weight loss medicines: muscle preservation, limited side effects and novel targets.
The FDA has several big-ticket decisions lined up to close out July, including applications in lymphoma, rare diseases and a hormone deficiency, while GSK dares to DREAMM again in multiple myeloma.
Market reaction to recent readouts from Compass Pathways and Beckley Psytech/atai in treatment-resistant depression speaks to the hurdles psychedelic therapies must clear to quell concerns about commercial viability.
Only with the adoption of digital imaging and AI-powered analysis will next-generation precision oncology therapies reach their full potential and ensure no eligible patient is overlooked.
In its complete response letter, the FDA cited insufficient evidence establish deramiocel’s effectiveness for cardiomyopathy associated with Duchenne muscular dystrophy. The decision comes after CBER Director Vinay Prasad canceled an advisory committee meeting for the therapy.