Cymabay Therapeutics Inc.'s chief scientific officer, Charles McWherter, told BioWorld that the concept of liver enzyme scores as a powerful indicator of efficacy vs. liver fat reductions in nonalcoholic steatohepatitis (NASH) "is not an entirely made-up idea, just because we got this result" in the phase IIb study of peroxisome proliferator-activated receptor (PPAR) delta agonist seladelpar. "If you had to choose between reducing fat, which can be harmful or can be inert, or showing evidence of improving the underlying lesions and injury" as a way of showing a drug's worth in NASH, he said, researchers might choose the latter as "more proximal to the injury," McWherter said. As Newark, Calif.-based Cymabay's chief medical officer, Pol Boudes, put it, "the fat story is not the end of the story" in NASH. Read More
DUBLIN – Shares in Genmab A/S gained as much as 4.4% Tuesday on news of an option deal with the Janssen Biotech arm of Johnson & Johnson involving a next-generation successor to their current multiple myeloma blockbuster, Darzalex (daratumumab), which employs Genmab's Hexabody technology. Read More
Deciphera Pharmaceuticals Inc. and Zai Lab Ltd. agreed to develop and commercialize ripretinib in mainland China, Hong Kong, Macau and Taiwan for patients with gastrointestinal stromal tumors (GIST). Read More
HONG KONG – Suzhou-based Alphamab Oncology Co. Ltd. pocketed $60 million in a series B financing to advance into the clinic with its potentially first-in-class PD-L1/CTLA4 bispecific antibody, KN-046, and to prepare for commercialization of its more advanced product, subcutaneous PD-L1 antibody KN-035 (envafolimab). Read More
Public hearings, drafted recommendations and new legislation are all recent efforts by pain and addiction stakeholders, including government and industry, to effectively change standards of practice that have abandoned patients for years. Read More
The Senate Finance Committee recently met to review the theft of biomedical research funded by taxpayer dollars, but Sen. John Cornyn (R-Texas) said he will shortly issue legislation to address the problem. Cornyn said he may have difficulty voting for funding increases for agencies that do not take such theft seriously, adding that he will soon introduce legislation that would require that the U.S. federal government act to thwart theft from a number of nations, including China, the target of frequent concerns regarding intellectual property theft. Read More
The NIH isn't the only U.S. agency under scrutiny as a potential target for Chinese espionage. Sens. Chuck Grassley (R-Iowa) and Marco Rubio (R-Fla.) Monday wrote to the acting inspector general for Health and Human Services (HHS) to express concerns that the Centers for Medicare & Medicaid Services (CMS) may be providing payments for genetic testing or analysis to U.S. companies that have domestic partnerships with Wuxi Nextcode Genomics, Shenzhen BGI Technology Co. and other genomics firms with ties to the Chinese government. Read More
LONDON – Startup Biome Ltd. secured new funding from Dupont Microbiome Venture (DMV) and will now work with its researchers on the next stage of developing its smart orally delivered capsule for sampling gut microbiota. Read More
Delmar Pharmaceuticals Inc., of Vancouver, British Columbia, updated the terms of its previously announced rights offering. The subscription period for the rights offering will now expire on June 25. Unit pricing remains $1,000 per unit of series C convertible preferred stock and warrants to purchase Delmar's common stock. But each unit will now consist of 209 warrants to purchase the company's common stock at an adjusted exercise price of $3.10 per share. Read More
Luxembourg and the Netherlands this week joined the growing list of European countries to be included in the mutual recognition agreement between the EU and the FDA. Their inclusion followed the FDA's confirmation that their regulators have the capability to conduct inspections of biopharma manufacturing facilities at a level equivalent to that of the U.S. Read More
Precision Therapeutics Inc., of Minneapolis, which applies artificial intelligence to personalized medicine and drug discovery, said it rebranded as Predictive Oncology Inc. The company said its common stock, currently trading on Nasdaq as AIPT, is expected to begin trading under the Nasdaq ticker POAI on or about June 13. Read More
