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Cantor Fitzgerald analyst Olivia Brayer found supplementary bone mineral density data for Amgen’s obesity candidate MariTide that could point to a potentially greater fracture risk than previously revealed, but some other analysts view the findings as a nonissue.
FEATURED STORIES
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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Takeda announced that the European Commission has granted Marketing Authorization for LIVTENCITYTM for the treatment of cytomegalovirus infection and/or disease that are refractory to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet, in adult patients who have undergone a haematopoietic stem cell transplant or solid organ transplant.
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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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Despite Biohaven’s bispecific protein degrader cutting autoantibody IgG levels by up to 37% in an early-stage study, investors saw it as “below the high bar” of 60%, according to William Blair analysts.
FDA
Tris Pharma on Wednesday secured the FDA’s green light for Onyda XR, the first liquid non-stimulant nighttime treatment for attention deficit hyperactivity disorder in pediatric patients.
FDA
In the next two weeks, the FDA is scheduled to decide on four drug applications and hold two highly anticipated advisory committee meetings.
Experts say approval of Lykos Therapeutics’ MDMA capsules for post-traumatic stress disorder would open the door to further research into psychedelic-assisted therapies.
Johnson & Johnson on Wednesday reported late-stage trial data showing its first-in-class orexin receptor antagonist reduced major depressive disorder symptoms as an adjunctive treatment in patients with insomnia.
AstraZeneca on Wednesday unveiled Phase I results for its PCSK9 inhibitor, acquired from Dogma Therapeutics in 2020, which when combined with a statin reduced LDL-C levels in patients with high “bad” cholesterol.
Merck on Wednesday announced a deal worth $3 billion to buy EyeBio and its first-in-class trispecific antibody Restoret, marking the pharma’s return to the ophthalmology space after nearly a decade.
In a late-stage trial, Insmed’s small molecule DPP1 inhibitor cut yearly exacerbation rates by around 20% in bronchiectasis patients, according to topline data.
Driven by growing market demand and an improving supply chain, the global weight-loss drug market is expected to hit $150 billion in value by the early 2030s, according to analysts cited by Reuters.
FDA
Amgen on Tuesday secured the FDA’s green light for the first interchangeable biosimilar to AstraZeneca’s Soliris to treat two rare diseases: paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.