Axcella Therapeutics Inc. is working on its comeback. 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 registration trial for those with long COVID fatigue. Axcella also has just submitted its IND for a phase IIb/III study for treating long COVID. In its repositioning, Axcella said it would concentrate on developing AXA-1125, six amino acids and derivatives, for treating long COVID while discontinuing its ongoing phase IIb clinical trial of AXA-1125 in nonalcoholic steatohepatitis, reducing its workforce by 85% and paying down its debt. Company stock (NASDAQ:AXLA) was on the rebound Jan. 24 after bumping up to nearly $3 each in the past year but plunged afterward. At midday, shares trading about 39% higher at 60 cents each.

Pooled results in question as FDA’s adcom mulls Cidara prospect for invasive candidiasis

Dicey briefing documents cast uncertainty into the U.S. FDA’s Antimicrobial Drugs Advisory Committee (ADAC) today, which is taking up the matter of Cidara Therapeutics Inc.’s rezafungin, an injectable treatment for candidemia and invasive candidiasis in adults. Agency reviewers disliked Cidara’s pooling of the phase II and phase III study results in the primary assessment of efficacy, and said the approval bid should rely solely on results of the phase III study, with supportive evidence provided by the phase II data. Cidara held up trading of shares (NASDAQ:CDTX) while ADAC deliberated.

Finch drops phase III of CP-101 for C. difficile, reduces staff by 95%

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 shelf. The company opted to discontinue the PRISM4 phase III trial of CP-101. The decision, it said, was due to slower-than-anticipated enrollment of the program, the inability to secure capital or partnerships to help fund the program, broader sector trends, and “the harmful impact of ongoing unauthorized use of the company’s intellectual property.”

Rx import from Canada results in debarment

Years 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 over a five-year period. Now, almost a decade after Palaparty pleaded guilty to introducing misbranded drugs into the U.S., the FDA is debarring the doctor based on that federal misdemeanor.

US FDA seeks simple path forward for COVID-19 vaccines

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, is needed to evaluate and recommend vaccine strain composition changes. 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 Thursday’s meeting of the Vaccine and Related Biological Products Advisory Committee. In the absence of a coordinated global response, the FDA is proposing its own path to simplify U.S. COVID-19 vaccine schedules.

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Adarx, Agenus, Altrubio, Amgen, Amolyt, Apexigen, Astellas, Blueprint, Cadrenal, Catalyst, Cymabay, Cytosorbents, Eden Labs, Genexine, Helsinn, Horizon, Ideaya, Illuminare, Immedica, Ipsen, Mallinckrodt, Mannkind, Neuren, Neurogene, Oncxerna, Pillartree, Pliant, Priothera, Psyence, Regenxbio, Rhythm, Sandoz, Theracosbio, Tme, Tonix, Tscan, Ultimovacs, Xoma