Bristol Myers says KRAS drug succeeds in key trial

Confirmatory results for Krazati, which Bristol Myers acquired via its buyout of Mirati, could help the drug win full approval while Amgen has been set back.

Biotech veteran Art Krieg postpones retirement to build an unorthodox drug startup

With Zola Therapeutics, Krieg plans to design and sell a series of cancer immunotherapies without the help of outside investors, he told BioPharma Dive.

Boundless Bio breaks IPO lull with $100M fundraise

The startup’s performance will test investors’ appetite for early-stage drugmakers, as Boundless has only advanced as far as Phase 1 clinical trials.

FDA approves Akebia anemia pill, two years after rejection

The agency gave Akebia’s drug an OK after receiving more safety data, but imposed a strict boxed warning for its use that may limit uptake. 

Gilead bets on Xilio cancer drug as biotech restructures

Xilio will get just over $40 million from Gilead in return for a license to its experimental IL-12 immunotherapy. The biotech is also discontinuing other work and laying off staff.

FDA approves Merck lung disease drug acquired in $11B deal

Merck is couting on Winrevair, which it acquired by buying Acceleron Pharma, to help soften the blow when Keytruda loses patent protection later this decade.

Updated March 27, 2024

Moderna gets Blackstone backing for flu vaccine R&D

An arm of the private equity firm pledged up to $750 million to support Moderna’s development of its mRNA technology for influenza shots.

European study finds popular ALS drug ineffective

The failure of a medicine known as TUDCA is yet another disappointment for ALS patients, as it comes just after Amylyx’s therapy Relyvrio proved unsuccessful in confirmatory testing.

SQZ, Portal founder Armon Sharei on starting over in biotech

“I still care way too much about cell therapies,” said Sharei, weeks after his former startup, SQZ Biotechnologies, was liquidated.

Viking stays in obesity drug race with early data for weight loss pill

The results are from a small Phase 1 study, but suggest Viking’s oral GLP-1 drug may not come with high rates of gastrointestinal side effects. 

Supreme Court weighs abortion opponents’ standing in mifepristone case

The high court's treatment of the case, which centers on a conservative challenge to FDA decisions expanding abortion pill access, is seen as potentially consequential for the drug agency. 

Stoke shares surge on updated results for Dravet drug

The biotech is trying to develop a Spinraza-like drug for the condition, a form of genetic epilepsy. Fresh data appear supportive of a high dose’s effectiveness. 

FDA rejects Regeneron lymphoma drug, setting back company’s oncology push

The agency wants Regeneron to make more progress with a confirmatory trial before clearing odronextamab, a “bispecific” antibody being developed for multiple blood cancers. 

AbbVie to buy immune drug developer Landos

Worth about $138 million upfront, the deal is another example of pharma interest in new drugs for inflammatory conditions like Crohn’s.

Axsome drug succeeds in narcolepsy symptoms trial

Despite the late-stage victory, shares of the New York-based biotech dipped more than 3%. One analyst argued that Axsome’s drug has “largely been falling under investor radars.”

Novo to acquire heart failure drug in $1B deal for Cardior

Cardior’s therapy is currently in mid-stage testing and, should the deal close, Novo plans to start another Phase 2 trial.

FDA clears first-of-its-kind Duchenne drug for broad use

The approval of Italfarmaco’s Duvyzat is the first for an oral, non-steroidal Duchenne drug and was issued for all patients at least six years of age, regardless of their genetic underpinnings.

Medicare to cover Novo’s obesity drug for some patients

Two weeks after the FDA updated Wegovy’s label, Medicare changed its stance to allow people with a history of heart disease to receive treatment, a shift that could boost access to the fast-selling medicine. 

Bayer streamlines pharma leadership team amid company shakeup

The executive team will reportedly shrink from 14 to eight in the latest step in new CEO Bill Anderson’s plan to slash management and reduce “bureaucracy” at the healthcare conglomerate. 

Mirador debuts with $400M, picking up where immune drugmaker Prometheus left off

The financing for the startup, which is led by former executives of a biotech Merck recently bought for nearly $11 billion, is the sector’s largest for a privately held company this year.

Roche autoimmune disease drug disappoints in closely watched trial

Though the medicine hit its goal in a Phase 3 study in myasthenia gravis, the results fell short of expectations in a boost to rival drug developers like Argenx and AstraZeneca.

NextCure to lay off 37% of staff, dial back research plans

The job cuts at the cancer biotech will primarily impact manufacturing roles, but will touch on several other parts of the organization too, the company said.

Orchard sets out to sell world’s priciest gene therapy

Orchard is counting on the long-term data it’s accrued to convince insurers to cover Lenmeldy’s $4.25 million list price, the highest of any genetic medicine to come to market. 

Acelyrin eye drug heads to late-stage testing after trial win

The biotech, which raised $540 million in an initial public offering last year, is pitching the medicine as a potential challenger to Amgen’s blockbuster eye drug Tepezza.

Clasp launches with $150M and a plan for precision cancer immunotherapies

The company claims its approach could yield more effective and safer T-cell engagers, a type of cancer medicine that’s attracted significant interest from drugmakers in recent years.