FDA clears monthly dosing of Alzheimer’s drug Leqembi

The approval is the first to come from the FDA since the Trump administration paused external communication by health agencies last week.

FDA webpages on clinical trial diversity removed after Trump orders

The website changes raise concerns about “the interference of politics with the study and the practice” of science and medicine, one physician said.

Sara Brenner, FDA device official, named agency’s acting head

Brenner, who has worked in the FDA’s Center for Devices and Radiological Health, will lead the agency until a permanent commissioner is confirmed.

Novo shares climb on early data for dual-acting obesity drug

An experimental drug called amycretin showed signs it could be more potent than Eli Lilly’s rival Zepbound, though analysts cautioned certain aspects of the study may have inflated its performance. 

Mixed results for Keytruda; AbbVie to work with Neomorph

Merck and Eisai reported new data for a drug regimen of Keytruda and Lenvima. Elsewhere, AstraZeneca expanded in Canada and the FDA delayed a decision on Stealth’s Barth treatment.

The biopharma industry outlook on 2025: Uncertainty and change

The Trump administration is bringing new instability to a sector already grappling with a shaky market as well as threats like competition from China.

Ascentage prices first biotech IPO of 2025, raising $126M

The China-based drug developer’s offering will fund testing of medicines for several blood malignancies — one of which is part of an alliance with Takeda.

Senate sets date to vet RFK Jr.’s nomination to lead HHS

The Senate Finance Committee will meet on Jan. 29 to discuss the confirmation of RFK Jr., whose stances on vaccines and abortion have raised questions from Democrats and Republicans alike.  

J&J joins Pfizer in detailing impact of Part D redesign

The pharma expects a modest financial headwind this year from changes to Medicare prescription drug benefits under the Inflation Reduction Act.

Intellia makes progress on HAE study; 2 more China drug deals

The biotech said it has dosed the first participant in a Phase 3 study of its in vivo gene editing treatment. Elsewhere, the FDA imposed a hold on Atara and lifted another on Amylyx.

J&J oncology sales grow, but shares slide on outlook

CEO Joaquin Duato said the company is positioned for sustained growth in coming years, due in good part to drugs like Darzalex and Carvykti. 

Sionna, Odyssey join queue of biotechs testing investors’ IPO interest

The startups are the fourth and fifth drugmakers to file for initial stock sales since late December — the most IPO activity in more than three months.

Trump reverses Biden healthcare directives, orders WHO withdrawal

The rescinded Biden-era orders include actions to boost the Affordable Care Act exchanges, coordinate the government’s COVID-19 response and deploy artificial intelligence tools.

AstraZeneca, Daiichi’s Enhertu successor gets first FDA OK in breast cancer

The clearance of Datroway comes months after the companies narrowed approval plans in lung cancer and opens up a market opportunity analysts estimate to be worth about $500 million annually. 

Moderna gets $590M from US government for bird flu vaccine

Moderna has been testing an mRNA candidate for influenza viruses like the H5 and H7 strains that are seen as pandemic threats. Others, including GSK and Pfizer, are also at work on similar shots.

Novo shares high-dose Wegovy results; Amgen, AstraZeneca drugs get expanded OKs

A high-dose form of Novo’s obesity drug led to 20% weight loss over 72 weeks. Meanwhile, Atara got a complete response letter and Boehringer reported a Phase 3 failure.

Medicare will negotiate Novo’s GLP-1 drug price. Here’s what that means for Ozempic, Wegovy.

Novo sells semaglutide as Ozempic and Rybelsus for diabetes and as Wegovy for obesity. In price talks, CMS will treat the different forms as a single product.

Ozempic, Ibrance among next drugs picked by Medicare for price talks

Announcement of the 15 medicines chosen for the second round of negotiations was one of the Biden administration’s final health policy acts.

Updated Jan. 17, 2025

JPM25: The FDA’s future, AbbVie’s second thoughts and Lilly’s lesson

AbbVie's CEO hinted his company may be less willing to invest in psychiatry, while Lilly explained what it got wrong forecasting GLP-1 drug demand.

Roche’s new deals head tries to navigate a more ‘complicated’ and ‘expensive’ biotech world

Roche's core research spans five large areas. Boris Zaïtra, who now leads corporate business development, is confident his team of dealmakers can juggle them.

Lilly’s Omvoh approved by FDA for Crohn’s

The clearance broadens use of Omvoh, which is part of a slate of new medicines Lilly is counting on to build on its success in diabetes and obesity. 

At JPM, Biogen CEO tries to take down the deal temperature

While Biogen has made an opportunistic bid for partner Sage, its top executive seemed to play down the urgency for his company to go after larger deals.

Federal watchdog cites concerns with FDA’s accelerated approval process

The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency procedures.

J&J files a potential blockbuster; Lykos shakes up its board

The pharma began submitting its TAR-200 bladder cancer treatment to the FDA. Elsewhere, Sarepta and Madrigal reported strong revenue numbers, while Bausch + Lomb made an acquisition.

5 questions facing emerging biotech in 2025

Young drugmakers confront several harsh realities this year, among them a contracting sector and competition from China.