Axcella Therapeutics Inc. is working on its comeback to make something else go away. Just before Christmas, Axcella said it was repositioning itself to focus on long COVID-19 and was just granted regulatory guidance on a primary endpoint and study design from the U.K.’s MHRA to conduct a single registration trial of AXA-1125 for those with long COVID fatigue. Axcella will be meeting with the MHRA in the near term to discuss getting an innovative licensing and access pathway application, which is designed to accelerate the approval process. Axcella also has just submitted its IND to the U.S. FDA for a global phase IIb/III study for treating long COVID. Read More

Albeit with complaints and provisos, the U.S. FDA’s Antimicrobial Drugs Advisory Committee (ADAC) rubber-stamped Cidara Therapeutics Inc.’s rezafungin, an injectable treatment for candidemia and invasive candidiasis (IC) in adults. Panelists were asked to vote on a single question: “Is the overall benefit-risk assessment favorable for the use of rezafungin for treatment of candidemia/IC in adults with limited or no alternative treatment options?” The balloting turned out 14 yes, one no. Read More

Microbiome company Finch Therapeutics Group Inc. has suffered one blow after another in the past year with dwindling cash, delayed programs, a terminated deal and three workforce reductions. The latest reduction will bring the once healthy 189-person company down to a handful of employees, and it places the lead program – the oral microbiota product, CP-101, for Clostridium difficile infection – on the sidelines. Read More

Long before the U.S. Congress approved a path for importing prescription drugs from Canada to take advantage of their cheaper price, Poornanand Palaparty, an oncologist in Ohio, purchased cancer drugs from a Canadian distributor from 2004 to 2009. Now, nearly a decade after Palaparty pleaded guilty in 2013 to introducing misbranded drugs into the U.S., the FDA is debarring the doctor based on that federal misdemeanor. Read More

As the SARS-CoV-2 virus that’s responsible for COVID-19 continues to evolve across the world, a global response, similar to what’s used with influenza, would be ideal in evaluating and recommending vaccine strain composition changes from year to year. But “the current diversity of vaccine manufacturers and complexities in global supply of COVID-19 vaccines would make a globally coordinated, simultaneous vaccine composition evaluation and recommendation quite challenging,” the U.S. FDA said in its briefing document for the Jan. 26 meeting of the Vaccine and Related Biological Products Advisory Committee.  Read More

New hires and promotions in the biopharma industry, including: Biocorrx, Codexis, Egenesis. Read More

Biopharmas raising money in public or private financings, including: Apexigen, Cymabay, Pliant. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adarx, Agenus, Altrubio, Ideaya, Illuminare, Ipsen, Mallinckrodt, Mannkind, Oncxerna, Pliant, Priothera, Regenxbio, Rhythm, TME, Ultimovacs. Read More

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amgen, Amolyt, Astellas, Eden, Helsinn, Horizon, Immedica, Novartis, Pillartree, Psyence, Sandoz, Tonix and Xoma. Read More

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Blueprint, Cadrenal, Genexine, Neuren, Neurogene, Theracosbio, Tscan. Read More