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In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis and Miruna Sasu, CEO of COTA, discuss the challenges of inclusion and exclusion criteria of clinical trial patients, and reflect on current investment approaches around women’s health.
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The drugmaker’s dominance of the obesity market is fueling predictions that years of growth lie ahead.
Novo Nordisk goes “on the offensive” following Trump deal that also included rival Eli Lilly, putting an exclamation point on rapidly declining GLP-1 drug prices. Experts say the unusual situation makes it hard to predict what’s next.
Drug candidates don’t usually move among Big Pharma, but these five biotechs helped facilitate such hand-offs, scooping up assets from one pharma on the cheap before being bought out for billions by another.
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Thermo Fisher Scientific Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared the Thermo Scientific B·R·A·H·M·S PlGF plus KRYPTOR and B·R·A·H·M·S sFlt-1 KRYPTOR novel biomarkers, the first and only immunoassays to receive breakthrough designation and clearance for the risk assessment and clinical management of preeclampsia, a severe pregnancy complication.
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Read our takes on the biggest stories happening in the industry.
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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Novavax’s shared jumped 12% in pre-market trading on the news.
In February 2024, the FDA put two Phase II studies of zelnecirnon under a clinical hold after a case of liver failure was deemed potentially related to the drug.
The companies did not provide detailed data for Tezspire, however, and William Blair’s Matt Phipps said in a note he does not expect the antibody to outperform Dupixent.
GSK’s departure comes as the industry anticipates the incoming Trump administration and as it continues to grapple with the threat of the BIOSECURE Act and losses of legal challenges to the IRA’s drug price negotiation program.
Digitization enables each drug to have a software-enhanced version optimized for individual patients.
The past four years have brought disappointment for the Huntington’s community, but optimism is growing as companies including Prilenia and Wave Life Sciences eye paths to approval of therapies that could address the underlying cause of the disease.
A fatal, highly hereditary illness with no disease-modifying treatments, Huntington’s is long overdue for a therapeutic win. Here, BioSpace looks at five candidates that could change the trajectory for patients.
With Eisai and Biogen’s Leqembi and Eli Lilly’s Kisunla launching onto the market, the 2024 Clinical Trials of Alzheimer’s Disease conference focused on the role these drugs might play, as well as combination therapies and innovative new treatment options.
Leqembi’s sales continue to be underwhelming, according to analysts, who contend the companies’ Alzheimer’s disease therapy is being held back by barriers such as coverage, infusion centers and time to diagnosis.
With Novo Holdings’ $16.5 billion buyout of Catalent being reviewed by regulators, what work the contract drug manufacturer may or may not be performing for Eli Lilly remains a point of contention.