Showing that lower drug prices are possible, even in the U.S., Theracosbio Inc. announced today that its SGLT2 inhibitor, Brenzavvy (bexagliflozin), is coming to market through the Mark Cuban Cost Plus Drug Company PBC at a price that’s less than the copay most patients have to pay for other drugs in the class. A new molecular entity approved in January to help with glycemic control in adults with type 2 diabetes, Brenzavvy has a monthly price tag of $47.85, plus shipping and handling. A 30-day supply of other SGLT2 inhibitors costs hundred of dollars, with some approaching $600 a month. Put another way, the other drugs would cost about $18 a day if a patient had to cover them out of pocket. “We just changed that number to $1.40 something,” Theracosbio President and CEO Albert Collinson told BioWorld.

Surf’s not up? First Wave phase II ‘likely’ missed efficacy endpoint

First Wave Biopharma Inc. is taking apart the top-line data from its phase II study of adrulipase for treating nutrition deficiencies in cystic fibrosis patients and seems unsure exactly what it found. The company said that while the initial data found the formulation of adrulipase was safe, well-tolerated and was an improvement over other formulations, the preliminary data also indicate that “it is likely the primary efficacy endpoint was not achieved.” First Wave added that it will assess the data and then ask the U.S. FDA about what might be needed for a registrational phase III study. In the meantime, the company stock (NASDAQ:FWBI) was taking a drubbing at midday, with shares down 30% to 95 cents each.

Roche MS data with subcutaneous Ocrevus clip TG shares

Shares of TG Therapeutics Inc. (NASDAQ:TGTX) were trading midday at $22.15, down $3.31, or 13%, after competitor Genentech, a unit of Roche Holding AG, disclosed positive data from the phase III Ocarina-II study testing Ocrevus (ocrelizumab) as a twice a year, 10-minute subcutaneous injection for relapsing forms of multiple sclerosis (MS) or primary progressive MS. The I.V. version of Ocrevus, a compound designed to target CD20-positive B cells, was cleared by the U.S. FDA in March 2017. Ocarina-II met its primary and secondary endpoints. TG markets Briumvi (ublituximab), a one-hour I.V. CD20 therapy for MS that was approved in December of last year.

BIX Korea: Leqembi may be overpriced, but it’s worth the fight, experts say

Questionable efficacy, high priced and risky side effects are some words to describe Leqembi (lecanemab), the latest amyloid beta-targeting antibody approved by the U.S. FDA, Korean experts said, but none of that diminishes the profound significance of the drug for Alzheimer’s disease (AD). Five neurology, psychiatry and biopharma experts convened at a packed session at Bioplus-Interphex (BIX) Korea 2023 at COEX, Gangnam-gu, Seoul, on July 13, with moderator Dong-Won Yang, from the Catholic University of Korea, Seoul St. Mary’s Hospital, leading the heated discussion on the latest approval amid ongoing developments in AD, both abroad and in Korea.

Glial cells get all-too-rare star turn at biannual meeting

In brain research, be it basic or clinical, neurons have long hogged the limelight. But at the 2023 European Meeting on Glial Cells in Health and Disease, neurons take a back seat to glia – cell types that have often been described as support cells and treated as an afterthought, but that play critical roles in all aspects of brain function, including information processing.

China approves Daiichi Sankyo/Astrazeneca’s Enhertu for HER2 low metastatic breast cancer

China’s NMPA approved Daiichi Sankyo Co. Ltd. and Astrazeneca plc’s Enhertu (fam-trastuzumab deruxtecan) as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer. The approved indication is for the treatment of adult patients with unresectable or metastatic HER2-low immunohistochemistry (IHC 1-positive or IHC 2-positive/in-situ hybridization [ISH]-negative) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.

Also in the news

60 Degrees, Abionyx, Achieve, AI, Aridis, Astrazeneca, Beigene, Bicycle, Capricor, Cellectis, Direct, George Medicines, Hutchmed, Incyte, Junshi, Leap, Molecular Templates, Rarebase, Savara, Sciwind, Sisaf, Takeda, Therapeutic Solutions