News
BioMarin’s investigational therapy failed to elicit clinical improvements in patients with ENPP1 deficiency, while also missing key secondary endpoints of rickets severity and growth.
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Nusano will bring a massive new radioisotope facility in Salt Lake City online by the end of the year, establishing a supply of starting materials for the next generation of radiopharmaceuticals.
Last month, Revolution Medicines’ RAS inhibitor doubled survival in a Phase 3 pancreatic cancer trial. On the biotech’s heels are Immuneering, Actuate Therapeutics, Erasca and more, looking to improve on that result with increased tolerability—and more time for patients.
The recent approval of Regeneron’s Otarmeni underscores the maturation of gene therapies across a range of diseases. Here, BioSpace reviews genetic medicines in development for the central nervous system, retinal, cardiac and neuromuscular diseases.
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Read our takes on the biggest stories happening in the industry.
The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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BMS will halt a trial investigating the Opdulag combination in colorectal cancer after determining that it would not hit its primary endpoint.
There is no evidence that the lapses have harmed patients who received Spikevax or clinical trial participants who received investigational shots.
Following a U.S. appeals court decision, the company said it is preparing to divest GRAIL through a third-party sale or capital markets transaction.
The biotech reported topline data from a mid-stage study of MM-120, its LSD-based drug, in patients with generalized anxiety disorder.
A European Medicine Agency panel on Friday reaffirmed its decision not to renew the conditional marketing authorization for GSK’s multiple myeloma drug Blenrep.
President Joe Biden has long promised to stand up to Big Pharma, lower prescription drug prices and limit the power of drugmakers—a pledge he seems intent on keeping.
Merck’s HIF-2α inhibitor Welireg has been approved by the FDA to treat advanced renal cell carcinoma after treatment with PD-1 or PD-L1 and VEGF-TKI-based therapies.
Despite pricing concerns for bluebird bio’s FDA-approved sickle cell disease gene therapy, the biotech has inked a deal with an unnamed commercial payer “representing approximately 100 million covered lives” in the U.S.
A week after securing FDA approval, a European Medicines Agency committee has endorsed Vertex and CRISPR Therapeutics’ Casgevy for sickle cell disease and transfusion‑dependent beta thalassemia.
Amid falling COVID-19 revenues, Pfizer continues to invest in antibody-drug conjugates in a deal with Nona Biosciences worth $1 billion as its $43 billion Seagen buy closed on Thursday.