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Under the temporary reign of top food executive Kyle Diamantas, the FDA will sustain programs initiated by former Commissioner Marty Makary, including the Commissioner’s National Priority Voucher initiative.
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Partners Summit Therapeutics and Akeso are expected to steal the show at the American Society of Clinical Oncology’s annual conference with data from their potential Keytruda rival, alongside Revolution Medicine’s groundbreaking pancreatic cancer candidate and other assets that could reshape patient care.
The tragic tale of TIGIT is well known. However, RIPK1, myc, STING and alpha-synuclein have also left a trail of failed clinical trials, canceled partnerships and sunk investments in their wake.
Analysts homed in on Duchenne muscular dystrophy and myotonic dystrophy type 1 assets during first quarter earnings as major players like REGENXBIO and Novartis as well as Dyne, Wave, Solid and Sarepta near the regulatory finish line.
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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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Incyte’s povorcitinib met both primary and secondary endpoints to relieve itching and improve skin clearance by 16 weeks, suggesting efficacy that is competitive with Sanofi and Regeneron’s blockbuster Dupixent.
Boehringer Ingelheim has paid $27.3 million upfront to Sosei Heptares to develop a small molecule agonist of GPR52 to treat the positive, negative and cognitive symptoms of schizophrenia.
The Chinese biopharma company will be closing its U.S. headquarters and wet lab in the D.C. suburbs, according to scientists who recently lost their jobs.
With Monday’s FDA rejection of their long-acting glatiramer acetate formulation, Viatris and Mapi Pharma continue the biopharma industry’s recent losing streak in multiple sclerosis.
Early Phase IIb data from 66 patients showed Novartis’ BTK inhibitor remibrutinib has potential outside chronic spontaneous urticaria, leading to symptomatic relief in patients with hidradenitis suppurativa.
Fresh off its $259 million Series C funding round, Alumis unveiled mid-stage data Saturday for its TYK2 inhibitor ESK-001 demonstrating strong symptomatic improvement in moderate-to-severe plaque psoriasis.
Johnson & Johnson’s Protagonist-partnered oral psoriasis candidate was able to sustain its therapeutic benefit through one year, according to data presented on Saturday at the American Academy of Dermatology annual meeting.
Novo Nordisk’s blockbuster weight-loss drug Wegovy was approved on Friday by the FDA to reduce the risk of cardiovascular death, heart attack and stroke in adults who have cardiovascular disease and are obese or overweight.
In this deep dive, BioSpace examines what’s next for Leqembi, the true cost of anti-amyloid antibodies, and what other Alzheimer’s treatments are coming down the pipeline.
The approval, which Bristol Myers Squibb reported on Thursday, positions the company to compete with Astellas and Pfizer’s Padcev.