Yesterday the agency published a revised draft guidance document, aimed at helping sponsors and pharmaceutical companies to develop therapies for Alzheimer’s disease, particularly in its early stages before the onset of overt dementia.
In a neurology update for investors, Roche touted data from a small Ib/IIa trial for trontinemab, an investigational therapy for Alzheimer’s disease which demonstrated “rapid and robust” amyloid plaque reduction.
Acadia Pharmaceuticals is terminating development of its antipsychotic drug pimavanserin, which did not demonstrate a statistically significant improvement over placebo in the late-stage study’s primary endpoint.
The company stated that Adcetris, extended survival in patients with the most common type of lymphoma in a late-stage study, bolstering efforts to expand the use of the treatment gained through its $43 billion purchase of Seagen.
Bristol Myers Squibb’s Opdivo was recently granted FDA approval in combination with cisplatin and gemcitabine as a first-line treatment for metastatic urothelial carcinoma. With this approval, Opdivo positions itself to compete with Merck & Co’s immune checkpoint inhibitor Keytruda in combination with Astellas and Pfizer’s Padcev, a nectin-4-directed antibody-drug conjugate, according to GlobalData.
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.
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.
Over the weekend, at the American Academy of Dermatology annual meeting, Novartis revealed early Phase IIb data from 66 patients who had been treated with either 25 mg or 100 mg of remibrutinib, which was dosed twice-daily.
The U.S. FDA has declined to approve Viatris and Mapi Pharma’s once-a-month injection for treating relapsing forms of debilitating neurological condition multiple sclerosis (MS), the companies said on Monday.
The country is upping its specialized teams tasked with responding to future infectious disease outbreaks from five to 25.
