The Latest
-
Deep Dive
10 clinical trials to watch in the second half of 2024
Study results are expected for two closely watched obesity drugs, while key tests await for a high-priced AbbVie acquisition and one of 2023’s largest IPOs.
-
Two biotechs cut staff; AbbVie weathers biosimilar threat
Glycomimetics and Cue Biopharma both revealed layoffs. Elsewhere, AbbVie’s earnings impressed Wall Street and an FDA panel recommended changing testing requirements for some lung cancer drugs.
-
Sanofi’s immunology bet starts to pay off
Some analysts described Sanofi’s pipeline of immune system therapies, which includes more than half a dozen drugs in mid- to late-stage testing, as “underappreciated” by investors.
-
Viking shares jump on plans to speed obesity drug into late-stage testing
The drug’s advancement continued what one analyst described as a “torrid” pace for Viking’s closely watched medicine, which started human testing in 2022 and could reach a Phase 3 trial next year.
-
Pfizer says hemophilia gene therapy meets late-stage study goal
While the study results were positive, questions remain about the longer-term potential of hemophilia treatments like Pfizer’s.
-
Deep Dive
Biotech M&A is on the upswing. Track the latest deals here.
As of mid-July, half of the 26 acquisitions worth at least $50 million in upfront value this year were of private biotechs, according to BioPharma Dive data.
Updated July 23, 2024 -
FDA medical device chief Shuren to step down after 15 years
Michelle Tarver, deputy director for transformation, will serve as acting director of the FDA’s medical devices office.
-
Biogen, Sage tremor drug fails key trial
Known as SAGE-324, the drug was one of the key assets Biogen gained rights to through a billion-dollar research deal inked back in 2020.
-
News roundup
Novartis invests in bispecifics for cancer; Bob Langer steps down from Moderna board
The Swiss pharma is paying Dren Bio $150 million to partner on “targeted myeloid engagers.” Elsewhere, Geron is losing its commercial chief and Biovectra will sell to Agilent for $925 million.
-
Merck claims late-stage study success for RSV antibody
The drug, a rival to Sanofi and AstraZeneca’s fast-selling Beyfortus, met its main goals in a Phase 3 trial. But undisclosed study results leave its full potential unclear.
Updated July 23, 2024 -
Deep Dive // Patent thickets
Drug patents protect pharma profits. Track when they’ll expire.
The erosion of Humira’s U.S. sales is expected to accelerate, with analysts at Leerink Partners predicting a year-over-year sales decline of 32% when AbbVie reports earnings next week.
Updated May 13, 2024 -
Autobahn raises $100M on investor interest in neuropsych drugs
Autobahn’s lead candidate is designed to stimulate thyroid hormone receptors as a way to complement existing antidepressants.
-
PBMs battle bipartisan scrutiny as lawmakers eye reforms
Top executives at CVS Caremark, Optum Rx and Express Scripts made a rare congressional appearance to defend their companies’ drug pricing policies.
-
Startup led by former J&J executives raises $165M for cancer, immune disease drugs
Peter Lebowitz, who for years led J&J’s oncology R&D, is the CEO of the startup, called Third Arc Bio and launched by Omega Funds in 2022.
-
US government declines to clear Bluebird fertility support for Zynteglo patients
The Health and Human Services' inspector general issued a "negative opinion" on Bluebird's request one week after Vertex sued the federal government over access to fertility preservation services.
-
Deep Dive // Emerging biotech
Biotech IPOs are the industry’s lifeblood. Track how they’re performing.
With Artiva’s IPO, four immune drug developers have raised a combined $703 million in new stock offerings this year, surpassing the totals of all other therapeutic areas.
Updated July 19, 2024 -
Ionis plots next steps for Angelman drug Biogen passed on
The company plans to start a late-stage study next year, after a smaller trial found its drug offered “robust and consistent” benefits on communication, cognition and motor function.
-
J&J seeks expanded approval for antidepressant Spravato
The company is seeking a monotherapy approval for Spravato, sales of which have climbed in recent quarters.
-
Global tech outage hits US hospitals
At least 11 health systems were experiencing issues Friday after an update by cybersecurity firm CrowdStrike went awry.
Updated July 19, 2024 -
News roundup
Lilly alone in bidding for Morphic; Novartis won’t yet file MorphoSys drug
Federal filings showed no companies other than Lilly made an offer to buy Morphic, while Novartis executives said they’re still waiting for more data on pelabresib.
-
Emerging biotech
Artiva prices $167M IPO, riding optimism for autoimmune cell therapy
The offering comes days after the publication of a paper showing what analysts said was early proof that “off-the-shelf” cell therapies can treat inflammatory diseases.
-
Boehringer cuts price of Humira biosimilar in bid to build use
The German drugmaker will offer a 92% discount on a copycat version of Humira for people who pay cash for the drug through GoodRx.
-
In strengthening Spravato sales, a positive sign for psychedelic drugs
Jefferies analyst Andrew Tsai views growing sales for J&J’s depression treatment as evidence that psychedelics like it can be commercially viable.
Updated July 23, 2024 -
Obesity pill from Roche shows promising weight loss in small study
Treatment led to "clinically meaningful" weight loss over four weeks, but longer studies will be needed to compare it to Wegovy and Zepbound.
-
Gilead’s CMO to depart next year
Merdad Parsey joined Gilead as its chief medical officer in 2019 and has helped lead the company’s expansion into oncology, with mixed success.