The U.S. FDA’s expectations that its new default position of basing marketing authorization of novel drugs on one adequate, well-controlled trial may be overstated. In explaining the policy in a recent article in The New England Journal of Medicine, FDA Commissioner Marty Makary and CBER Director Vinay Prasad said they expect the initiative will create a “surge in drug development,” substantially reduce development costs and will speed drugs to market. While the initiative could reduce the time to the U.S. market, those expectations don’t take into consideration global norms and payer expectations.

$400M IPO backs Generate push in asthma

Generate Biomedicines Inc. priced a handsomely sized IPO, selling 25 million shares at $16 each for proceeds of $400 million. The firm granted underwriters an option to buy as much as about 3.7 million more shares. Goldman Sachs & Co. LLC and Morgan Stanley are acting as joint lead book-running managers, with Piper Sandler, Guggenheim Securities, and Cantor serving as book-running managers. The company’s lead compound is phase III-stage TSLP-targeting antibody GB-0895, and Generate is set to begin trading on Nasdaq under the ticker GENB.

Atrium Tx launches with Avidity's RNA ticker and cardio assets

Targeting rare cardiomyopathy conditions with no approved therapies, Atrium Therapeutics Inc. launched operations in San Diego, assuming the public listing and technology once held by Avidity Biosciences Inc., an RNA company acquired by Novartis AG for about $12 billion. Novartis closed the M&A, announced last October, as Atrium unveiled its pipeline and a $270 million cash position. Atrium’s pipeline consists of two candidates, ATR-1072 for PRKAG2 syndrome, and ATR-1086 for PLN cardiomyopathy, expected to enter clinical trials in the next two years, as well as two earlier stage unnamed assets. “If you take a step back, Avidity had started looking at the precision cardio pipeline about three or four years ago,” Kathleen Gallagher, Atrium’s president and CEO, told BioWorld. “At this point, it was kind of a natural jump” from Avidity’s neuromuscular focus as the heart itself is a muscle.

Biocom 2026: Pharmas give advice on partnering

At Biocom’s Global Partnering and Investor Conference, representatives from the business development departments at various pharmaceutical companies provided an update on their appetites for deals. The mood was fairly upbeat – with the caveat that increasing competition from China and elsewhere can make a seemingly novel product not so novel. The executives also offered advice on how to be a good candidate for a potential deal, be it a license, acquisition or just a collaboration to move the science forward.

Systimmune’s iza-bren hits phase III breast cancer goals in China

In a boon for licensee Bristol Myers Squibb Co., Systimmune Inc.’s next-generation cancer drug, izalontamab brengitecan (iza-bren), hit both progression-free survival (PFS) and overall survival (OS) endpoints in a phase III trial of Chinese patients with advanced triple-negative breast cancer. The phase III BL-B01D1-307 study is the third late-stage study in which iza-bren met its primary endpoint goals. The readout also makes it the first bispecific antibody-drug conjugate to produce positive PFS and OS outcomes in a phase III TNBC study.

US med-tech companies bullish about 2026

U.S. med-tech companies are optimistic about the year ahead and believe that they are well positioned to navigate geopolitical headwinds and the uncertainty that they bring. Their technologies, which spans neurosurgery and tissue reconstruction, to cardiology and radiation protection, address important clinical needs. With the major U.S. corporates accelerating deal-making and acquisitions, these companies see strong momentum building for the year ahead.

CROI 2026: Science and funding cuts reverse decades of progress against HIV

The massive cuts to science, global health and HIV programs that unfolded in 2025 triggered a crisis with worldwide repercussions. The dissolution of USAID, the shutdown of PEPFAR, and the suspension of thousands of NIH research projects led to an immediate collapse of essential services, from HIV prevention to access to treatment. At the 33rd Conference on Retroviruses and Opportunistic Infections held Feb. 22-25, 2026, in Denver, scientists, activists, and health professionals presented data illustrating the scale of the damage and warned of a historic setback in the global HIV response.

Moderna’s combo flu/COVID vaccine gets thumbs up in EU

The EMA’s Committee for Medicinal Products for Human Use recommended approval of Moderna Inc.’s Mcombriax (mRNA-1083), positioning it to potentially become the world’s first combination vaccine for both seasonal influenza and COVID-19. Pending anticipated approval by the EMA, expected in a couple of months, Mcombriax would be cleared for use in people 50 and older in all EU member states, including European Economic Area countries Iceland, Liechtenstein and Norway.

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