Macrogenics Inc., agreeing with an independent data monitoring committee, has discontinued dosing patients in the troubled phase II Tamarack study of vobramitamab duocarmazine as a second-line treatment for metastatic castration-resistant prostate cancer.
The U.S. FDA has approved Sun Pharmaceutical Industries Ltd.’s Leqselvi (deuruxolitinib), a JAK1 and JAK2 inhibitor for adults with severe alopecia areata, a chronic autoimmune disease. The twice-daily, oral treatment will be targeting a company-estimated market of about 300,000 people in the U.S. This is the third FDA-approved treatment for severe alopecia areata in the past three years.
The dealmaking continues at Boehringer Ingelheim GmbH as it plans to buy Nerio Therapeutics Inc. for $1.3 billion. The German company is bolstering its cancer programs with the Nerio acquisition, which will be added to multibillion-dollar deals cut earlier this year for cancer immunotherapies and nonalcoholic or metabolic dysfunction-associated steatohepatitis (NASH/MASH) treatments.
The U.S. FDA has approved Sun Pharmaceutical Industries Ltd.’s Leqselvi (deuruxolitinib), a JAK1 and JAK2 inhibitor for adults with severe alopecia areata, a chronic autoimmune disease. The twice-daily, oral treatment will be targeting a company-estimated market of about 300,000 people in the U.S. This is the third FDA-approved treatment for severe alopecia areata in the past three years.
Viking Therapeutics Inc. is diving more deeply into developing obesity treatments and investors like an accelerated timetable the company has proposed. On June 25, Viking shares (NASDAQ:VKTX) catapulted 28.3% upward to close at $64.68 each.
A new collaboration with Dren Bio Inc. means Novartis Pharma AG has negotiated two of the biggest deals of 2024, with its parent company Novartis AG signing a third. Privately held Dren is getting $150 million up front and the chance to ultimately bring in $2.85 billion. The $150 million up-front payment includes a $25 million equity investment.
Many respiratory syncytial virus (RSV) disease vaccines are for older adults but Merck & Co. Inc.’s monoclonal antibody, MK-1654 (clesrovimab), which just produced positive top-line phase IIb/III data, aims at a far smaller and younger market. Data for protecting healthy preterm and full-term infants from RSV disease show the double-blind, randomized, placebo-controlled clinical trial hit all its primary efficacy and safety endpoints, including the incidence of RSV-associated medically attended lower respiratory infection for 150 days compared to placebo.
New research shows the costs of delays in developing a drug candidate and in drug sales are outdated and based on anecdotal evidence, contends the Tufts University School of Medicine’s Center for the Study of Drug Development. The center’s director, Ken Getz, spoke to the BioWorld Insider podcast this week about updating the outdated numbers and what they mean for companies and investors.
Tufts University professor Ken Getz had an everything-you-know-is-wrong moment when he looked at new research showing the costs of delays in drug development and sales. The results prompted more than a few gulps from others. The old numbers are outdated and based on anecdotal evidence, the center concluded, and with the new data, it’s time to hit the reset button.
Interim data from two early stage Friedreich’s ataxia (FA) cardiomyopathy studies from Lexeo Therapeutics Inc. hit the mark by reducing heart muscle thickness, a key cause of death among patients with the rare disease. The results came from the Sunrise-FA phase I/II study and an investigator-initiated phase Ia study of LX-2006, an adeno-associated virus-mediated gene therapy encoding the human frataxin gene. The drug is designed to improve frataxin protein expression to improve mitochondrial cell function.
