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After decades without much movement, a handful of new treatments for this rare autoimmune disease are now approved, and several companies, including argenx and Regeneron, have recently released promising late-stage trial results.
While Eli Lilly’s orforglipron is top of mind heading into the European Association for the Study of Diabetes meeting this week, experts told BioSpace the conference will also provide important insights into the therapeutic benefits of incretin therapies beyond weight loss.
FDA
On the FDA’s docket for the back half of September is Merck’s proposed subcutaneous formulation of its blockbuster cancer drug Keytruda.
Job Trends
Pfizer Inc. (NYSE: PFE) invites investors and the general public to view and listen to a webcast of a discussion with William Pao, Chief Development Officer, Executive Vice President, at the Goldman Sachs 44th Annual Global Healthcare Conference on Tuesday, June 13, 2023 at 8:00 a.m. Pacific Daylight Time.
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Read our takes on the biggest stories happening in the industry.
During the COVID-19 pandemic, Health Secretary Robert F. Kennedy Jr.—along with FDA Commissioner Marty Makary and CBER Director Vinay Prasad—argued against vaccine mandates, partly because they limited medical choice. This week, the FDA under their leadership approved updated COVID-19 vaccines with restrictions that do the same.
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A lawsuit filed by the Pharmaceutical Research and Manufacturers of America, which claims the Inflation Reduction Act’s Medicare Drug Price Negotiation Program is unconstitutional, now goes back to a lower Texas court.
With Friday’s approval, Sanofi’s anti-CD38 antibody Sarclisa will go head-to-head with the first such therapy for multiple myeloma, Johnson & Johnson’s Darzalex, which raked in nearly $10 billion last year.
As the FDA prepares to render a verdict on BMS’ closely watched schizophrenia drug, BioSpace takes a closer look at the late-stage pipeline for this neuropsychiatric disorder.
The European Society for Medical Oncology’s annual meeting this week featured the hottest emergent areas of cancer treatment—antibody-drug conjugates, bispecifics and radiopharmaceuticals—while anti-TIGIT therapies made a bit of a comeback.
Novo Nodrisk’s cannabinoid receptor–targeting obesity pill was picked up in the $1.1 billion acquisition of Inversago Pharmaceuticals last year.
The positive readout in patients with non-relapsing secondary progressive multiple sclerosis comes on the heels of back-to-back failures in which tolebrutinib was unable to improve relapse rates in patients with relapsing MS.
With Thursday’s positive opinion from the Committee for Medicinal Products for Human Use, the matter now heads to the European Commission which will have the final say on whether Wegovy’s label will be updated.
IRA
While unlikely to pass this year, given the Democrats’ control over the White House and Senate, the proposed legislation might be a harbinger of the Republicans’ agenda next year for the Inflation Reduction Act should they win the November elections.
An unusual placebo effect in Aligos Therapeutics’ Phase IIa trial is driving shareholder skepticism for its metabolic dysfunction-associated steatohepatitis candidate, according to Jefferies analyst Michael Yee.
The drop in interest rate is slightly bigger than anticipated and good news for the biotech industry, but little will change in the near term.