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Analysts are extremely encouraged by Phase 2 trial results for Relay Therapeutics’ PI3KA inhibitor in treating vascular malformations (VM), prompting the biotech to eye a potential path to accelerated approval.
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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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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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While Merck lost out to Pfizer earlier this year in snapping up Seagen, this week the company closed a deal worth a potential $22 billion with Daiichi Sankyo—further evidence of the industry’s insatiable appetite for ADC technology.
Tarlatamab achieved a 40% objective response rate in small cell lung cancer patients with advanced disease who had failed two or more prior lines of treatment, the company announced Friday.
The two-part formulation of subcutaneous nivolumab combined with Halozyme’s proprietary recombinant human hyaluronidase achieved two primary endpoints while also showing a noninferior overall response rate.
The non-alcoholic steatohepatitis space is still a “big mystery,” analysts tell BioSpace, but its connection to weight loss could provide an additional opportunity for contenders.
Despite increasing antitrust scrutiny across the biopharma industry, the European Commission on Thursday said it found no competitive issues with Pfizer’s buyout of the antibody-drug conjugate company.
Seeking to deepen its immuno-oncology business, Merck has closed a deal potentially worth $22 billion across three of Daiichi Sankyo’s DXd antibody-drug conjugates for various solid tumor indications.
Sail Biomedicines combines Laronde’s circular eRNA platform with Senda’s nanoparticle delivery technology in the pursuit of a new class of programmable medicines across therapeutic areas.
The trial, which is the first late-stage study of an in vivo CRISPR treatment in the U.S., will start by the end of 2023. Intellia’s NTLA-2001 is a treatment candidate for transthyretin amyloidosis cardiomyopathy.
The contracting COVID-19 market has led to lower third-quarter sales for the Swiss drugmaker, which made the decision to eliminate four clinical programs following underwhelming readouts.
Following a delay and an initial rejection, UCB’s IL-17A/IL-17F blocker bimekizumab was approved for moderate-to-severe plaque psoriasis, which will now be marketed with the brand name Bimzelx.