AI in medtech is taking off. Here are 4 trends to watch in 2025.

New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain around insurance coverage and generative AI.

By Elise Reuter • Jan. 23, 2025

BridgeBio’s Neil Kumar on an underdog drug launch and wooing deal-hungry investors

In an interview, the CEO discussed trying to gain support from investors hyper-focused on M&A, and competing with Pfizer and Alnylam.

By Ben Fidler • Jan. 23, 2025

Explore the Trendline➔

Cell therapy

The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases or in reprogramming cells inside the body.

By BioPharma Dive staff

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.

By BioPharma Dive staff • Jan. 22, 2025

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.

By Delilah Alvarado • Jan. 21, 2025

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.

By Ben Fidler • Jan. 21, 2025

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.

By BioPharma Dive staff • Jan. 17, 2025

‘The bar has risen’: China’s biotech gains push US companies to adapt

Pharma dealmaking for drugs invented in China is putting pressure on U.S. biotechs to compete harder, according to investors and executives interviewed by BioPharma Dive earlier this year.

By Ben Fidler • Jan. 16, 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.

By Gwendolyn Wu , Jonathan Gardner , Ned Pagliarulo • Jan. 16, 2025

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.

By Jacob Bell • Jan. 15, 2025

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.

By BioPharma Dive team • Jan. 15, 2025

JPM25: Amgen’s defense, Merck’s patent ‘hill’ and Viking’s long-term planning

Executives at Amgen made the case for MariTide's differentiation, while Merck's CEO contended Keytruda's coming loss of exclusivity can be managed.

By Ben Fidler , Gwendolyn Wu , Jonathan Gardner • Jan. 14, 2025

Regenxbio licenses gene therapies to Japan’s Nippon Shinyaku

Nippon Shinyaku will pay Regenxbio $110 million upfront for U.S. and Asia rights to treatments for Hunter and Hurler syndromes.

By Ned Pagliarulo • Jan. 14, 2025

5 questions facing emerging biotech in 2025

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

By Ben Fidler , Gwendolyn Wu , Ned Pagliarulo • Jan. 14, 2025

JPM25: Deals, Summit’s bravado and gene therapy headwinds

Drug executives talked M&A and the incoming administration, but also weighed the outlook for cell and gene therapy developers after a difficult year. 

By Ben Fidler , Delilah Alvarado , Gwendolyn Wu • Updated Jan. 14, 2025

Biogen’s ‘cold and calculated’ offer to buy Sage receives a mixed reaction on Wall Street

Analysts say the deal, which would give Biogen full control over the drug Zurzuvae, could be a smart financial move. Yet it's also unlikely to appease broader investor concerns.

By Jacob Bell • Jan. 13, 2025

Moderna shares tumble on slashed sales guidance

The company lost more than $3 billion in market value after cutting its forecast for 2025 revenue from its COVID-19 and RSV vaccines.

By Delilah Alvarado • Jan. 13, 2025

Tune raises $175M for hepatitis B medicine, epigenetic research

The biotech plans to use the funding to advance clinical testing of an epigenetic silencing therapy it hopes could treat chronic hepatitis B infections.

By Gwendolyn Wu • Jan. 12, 2025

Pfizer’s PD-1 drug succeeds; AbbVie writes down $3.5B in Cerevel assets

Sasanlimab, a subcutaneous immunotherapy developed by Pfizer, could help treat bladder cancer. Elsewhere, Royalty Pharma moved to simplify its corporate structure and Biogen made another hire.

By BioPharma Dive staff • Jan. 10, 2025

Intellia to stop work on rare disease therapy, lay off staff

The CRISPR company will reduce its workforce by 27% over the course of the year as it discontinues a treatment for alpha-1 antitrypsin deficiency.

By Ned Pagliarulo • Jan. 10, 2025

Ouro, backed by GSK, joins hunt to bring bispecifics to autoimmune disease

“Practice of medicine could fundamentally change with these types of therapies,” said CEO Jaideep Dudani.

By Ben Fidler • Jan. 10, 2025

Healthcare venture capital investment boosted by AI in 2024: report

Nearly 30% of the funding poured into healthcare startups last year, including for biotechs, went to companies leveraging artificial intelligence, according to Silicon Valley Bank.

By Emily Olsen • Jan. 9, 2025

Verdiva starts up with $411M and a portfolio of obesity drugs from China

The newly launched biotech is equipped with rights to a trio of weight loss medicines licensed from China-based Sciwind Biosciences, led by an oral therapy ready for Phase 2 testing.

By Kristin Jensen • Jan. 9, 2025

Kidney disease drugmaker Maze files for IPO

Maze fits the mold of biotechs that have pulled off successful offerings recently: The seven-year old startup, which raised about $500 million privately, has a drug in Phase 2 testing.

By Gwendolyn Wu • Jan. 8, 2025

Tenvie raises $200M for brain drug R&D; Sana spikes on single patient’s results

The Arch-backed startup begins life with several assets acquired from Denali Therapeutics. Elsewhere, Jasper got a negative reaction to data for its hives drug and Stoke finalized Phase 3 trial plans.

By BioPharma Dive staff • Jan. 8, 2025

Galapagos, after research struggles, will split in two and revamp Gilead deal

Alongside plans to spin out a new company, the Belgian drugmaker said it will cut some 300 positions, or about 40% of its current workforce.

By Kristin Jensen • Jan. 8, 2025