Eli Lilly and Co.'s tirzepatide, a high-profile entrant in global anti-obesity race, hit a key milestone, becoming the first investigational medicine to deliver more than 20% weight loss on average for non-diabetics in a phase III study, said Jeff Emmick, vice president of product development at the company. The outcome put tirzepatide, with its dual action against GIP and GLP-1, in good standing vs. its primary competitor, the Novo Nordisk A/S medicine Wegovy (semaglutide). It also sparked talk of pursuing an expedited U.S. FDA approval in indication, as work to develop it for the treatment of type 2 diabetes and other metabolic disorders continues. The announcement topped a raft of positive first-quarter earnings news for Lilly, which included an 81% jump in revenue for its COVID-19 antibodies vs. Q1 2021. Company shares (NYSE:LLY) rose 3.2% by midday.

Arecor eyes fast development for concentrated insulin product after phase I readout 

Arecor Therapeutics plc has presented early stage clinical data from a novel concentrated insulin formulation, which it hopes will outperform marketed rivals by allowing lower volume and reduced frequency doses. Cambridge, U.K.-based Arecor has a formulation technology that it hopes will produce new versions of marketed insulins that could outperform marketed rivals. Data announced at the International Advanced Technologies and Treatments for Diabetes meeting comes from AT-278, an investigational meal-time concentrated (500 U/mL) novel formulation of insulin. 

No ‘easy targets’ for Omass, which adds $95M series B for small-molecule work

Omass Therapeutics Ltd. has raised £75.5 million (US$94.6 million) in a series B round, as it continues to advance five small-molecule programs against previously intractable membrane-bound targets to the clinic. Despite the early stage of these programs, the company attracted a trio of heavyweight international investors, with Sanofi Ventures, Northpond Ventures and GV (formerly Google Ventures) co-leading the round. 

Mycovia’s Vivjoa wins FDA nod as first therapy for RVVC

Mycovia Pharmaceuticals Inc. is prepping to launch its first commercial product following U.S. FDA approval of oral antifungal oteseconazole for use in recurrent vulvovaginal candidiasis (RVVC). Branded Vivjoa, the drug is expected to be available to patients in the second quarter. It’s the first FDA-approved medication for RVVC, though it’s indication is limited to women who have a history of RVVC and who are not of reproductive potential – i.e., permanently infertile and postmenopausal women. Mycovia submitted the NDA last year and was granted six-month priority review. The FDA’s decision came roughly three months after the original Jan. 27, 2022, PDUFA date. 

Califf: Commissioner turnover can be a destabilizing force at US FDA

In his second stint as U.S. FDA commissioner, Robert Califf today discussed the challenges in leading a massive agency that has seen seven commissioners come and go over the past 10 years. That kind of turnover can be destabilizing for the agency, as each commissioner has different priorities, Califf said as he testified during a budget hearing before the Senate Appropriations Subcommittee on Agriculture, Rural Development and FDA. There’s a reason for the turnover – and for why people younger than 70 are hesitant to serve as FDA commissioner, Califf said, adding that careful thought should be given to how the position is structured.

Newco news: Chimera going for ‘Gold’ as AFCR award boosts funding round 

Chimera Bioengineering Inc. has been selected as the winner of the Asian Fund for Cancer Research's (AFCR) 2021 BRACE Award Venture Competition, contributing $500,000 as part of a recent $7.5 million capital infusion and bringing to $26 million the company’s total amount raised to date. “The most recent funding will enable us to select our lead CBIO-007 construct, continue lentiviral process development, and further develop our pipeline and platform,” Vlad Hogenhuis, newly appointed CEO of Chimera, told BioWorld. Chimera generates its pipeline using its Gold Platform technology designed to harness programmable, RNA-based gene regulation circuits inherent to immune cells to control CAR T therapies conditionally armed with therapeutic payloads that target solid tumor microenvironments.

Also in the news

AB Science, ABVC, Alzinova, Anaptysbio, Arecor, Astrazeneca, Beigene, Bioinvent, Cara, Clarus, CNS, Delpor, Edesa, Eli Lilly, Galmed, GC, Hibercell, Hightide, Immune, Janssen, Jasper, Moderna, Mycovia, Nevakar, Nova Mentis, Ocuphire, Opiant, Promis, Serenity Bioworks, Sio Gene Therapies, SQZ, Statera, Timber, Transcenta, Tryp, Turning Point, Vaxxinity, Vifor, Virios, Wuxi, Xbiotech, Zai Lab, Zymeworks