Mediar Therapeutics Inc. emerged from stealth, unveiling $105 million in investment and bold ambitions to develop new ways of tackling fibrosis. Cambridge, Mass.-based Mediar is challenging what CEO Rahul Ballal called “the fundamental dogma” of fibrosis therapy: “You have to address fibrosis at its initiation, when inflammation is rampant.” Mediar, in contrast, is focused on developing therapies that either disrupt or reverse the fibrotic process, particularly when it progresses from a moderate to a severe state. Read More
Optimism for the GoCAR-T program had perked somewhat after a mid-February update, but hopes were definitively dashed as Bellicum Pharmaceuticals Inc. made known March 15 its decision to quit the phase I/II study testing two prospects in heavily pretreated cancer. The Houston-based firm’s stock (NASDAQ:BLCM) closed at 43 cents, down 50%, as Wall Street reacted to news regarding the study, designed to test GoCAR-T cell prospects BPX-601 and BPX-603 when combined with the activating agent rimiducid, a lipid-permeable tacrolimus analogue. Read More
Patients with Leber hereditary optic neuropathy who received bilateral injections of Gensight Biologics SA’s Lumevoq (lenadogene nolparvovec) are continuing to see statistically significant visual improvements three years into the phase III REFLECT trial, but the missed primary endpoint at 1.5 years, along with a series of manufacturing mishaps, have left the gene therapy’s approval prospects uncertain. Read More
The NMPA accepted a BLA from Astellas Pharma Inc. for enfortumab vedotin, which is designed for the treatment of patients with locally advanced or metastatic urothelial cancer who previously received treatment with a PD-1/L1 inhibitor and platinum-based chemotherapy. “In China, there were nearly 86,000 new cases of bladder cancer in 2020, and we are working with the NMPA to seek approval for enfortumab vedotin for patients with advanced stage disease,” said Ahsan Arozullah, senior vice president and head of development therapeutic areas at Astellas. Read More
Despite the new Medicare inflation rebate, the U.S. price of 27 Part B drugs grew faster than inflation in the last quarter of 2022, triggering the new rebate provision in the Inflation Reduction Act. The manufacturers of those single-source drugs will be billed for the rebates in 2025, but Medicare beneficiaries should see a drop in their coinsurance for those drugs, for the next quarter at least. According to the Biden administration, the decrease in out-of-pocket costs for those drugs will range from $2 to as much as $390 per average dose from April 1 through June 30. Read More
Pfizer Inc.’s Paxlovid has become such a part of the COVID-19 treatment scene in the U.S. that it’s easy to forget it’s only authorized for emergency use. That could soon change. The FDA is convening its Antimicrobial Drugs Advisory Committee March 16 to consider Pfizer’s NDA for the co-packaged nirmatrelvir and ritonavir treatment. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AB, Acesion, Akeso, Astellas, Atea, Biohaven, Cantargia, Endo, Gradalis, Immutep, Medivir, Puma, Reneo, Servier, Telix, Tscan. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acelrx, Alora, Amplifier, Annji, Avenue, Betagenon, BMS, Cambrian, Defence, Eureka, Exscientia, Hutchmed, Macrogenics, Novo Nordisk, Orano, Synaffix, Takeda, Vesigen. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ellipses, Innoviva, Mirum, Sapience, Truebinding, Xortx. Read More
