Given the costly consequences of people with diabetes rationing or doing without their insulin because they can't afford it, Rep. Michael Burgess (R-Texas) asked a House subcommittee Tuesday, "Why do we even charge for insulin?" Read More
Evoke Pharma Inc. and Intelgenx Corp. each received FDA complete response letters (CRL) regarding NDAs for products in their pipelines. Evoke's CRL for Gimoti states that the FDA cannot approve the NDA in its present form and provided recommendations to address two remaining approvability issues for an NDA resubmission. Read More
Fusion Pharmaceuticals Inc., a Canadian-born company developing targeted alpha-particle radiotherapeutics to treat cancer, has completed an oversubscribed $105 million series B financing led by Varian Medical Systems Inc. and new investor Orbimed. The company said the funds will be used to advance and broaden the scope of its ongoing clinical program and accelerate a pipeline of new radiopharmaceuticals and combination therapies. Read More
LONDON – The rare diseases charity Esperare Foundation has rescued a novel protein replacement treatment after it failed in a clinical trial in newborn babies, securing FDA and EMA approval for a pivotal trial in which the drug will instead be administered in utero, via the amniotic fluid. Read More
No good deed goes unpunished. Successful development of a PD-1/PD-L1 checkpoint blocker, for example, can get you a grilling by Richard Pazdur, director of the FDA's Oncology Center of Excellence at the annual meeting of the American Association for Cancer Research (AACR). Read More
HONG KONG – Asian drugmakers are increasingly embracing the artificial intelligence (AI) technology for drug discovery. The latest example is Japanese drug developer Ono Pharmaceutical Co. Ltd., which recently entered a partnership with U.S. AI-backed biotech firm Twoxar Inc. Read More
LONDON - Agomab Therapeutics NV has arrived on the scene with a €21 million (US$23.5 million) series A and plans to take a fresh approach to modulating hepatocyte growth factor (HGF) activated repair pathways, using monoclonal antibodies. Read More
The budget of the U.S. NIH has been the target of proposed cuts in the past couple of years, but an April 2 hearing in the House of Representatives suggested that at least one side of Capitol Hill will not allow any cuts. The tenor of the hearing suggests that many members of a House Appropriations subcommittee will instead vote to award more money to NIH rather than less, and one Republican member of the committee reassured NIH managers that the Senate is of the same persuasion. Read More
Precision Biosciences Inc., of Durham, N.C., said it closed its IPO of 9.08 million shares, which includes the full exercise of the underwriters' option to purchase 1.18 million additional shares, at $16 per share. The total gross proceeds were approximately $145.4 million. Read More
IGEM Therapeutics Ltd., of London, secured a Biomedical Catalyst award of a £1.45 million (US$1.9 million) from the U.K.'s innovation agency, Innovate UK. Read More
