Merck TIGIT drug misses goal in lung cancer trial, adding to doubts over approach

The combination drug didn’t help patients any more than chemotherapy, but Merck will continue the trial to test it together with chemo.

By Jonathan Gardner • March 17, 2023

In Pfizer-Seagen review, FTC has chance to set new pharma precedent

The regulator’s review of the planned $43 billion deal could reveal how it plans to apply a new philosophy toward drugmaker mergers.

By Jonathan Gardner • March 14, 2023

Explore the Trendline➔

The expanding world of RNA therapies

Vaccines from BioNTech and Moderna proved the power of messenger RNA in medicine. A growing field of RNA-targeting therapies is advancing alongside them.

By BioPharma Dive staff

VA to cover Leqembi for veterans with early Alzheimer’s

The agency’s decision on Eisai and Biogen’s new drug contrasts with a stringent Medicare policy that limits coverage to patients in clinical trials.

By Christopher Newman • March 14, 2023

Sanofi acquires diabetes drug via Provention buyout

The deal builds on a licensing agreement between Sanofi and Provention to market the first-of-its-kind treatment, called Tzield and approved to slow the disease’s progression.

By Delilah Alvarado • March 13, 2023

Pfizer to buy Seagen in $43B cancer drug deal

The acquisition would give Pfizer control of a top-selling lymphoma drug and a pipeline of medicines that have made the Seattle-based company one of the sector’s most valuable biotechs.

By Ned Pagliarulo • Updated March 13, 2023

FDA advisers back earlier use of Roche lymphoma drug

The positive vote comes despite doubts from FDA scientists and increases the chance that Polivy could soon be approved as a first-line treatment alongside a drug regimen called R-CHOP.    

By Jonathan Gardner • March 10, 2023

Pfizer’s Biohaven deal pays dividends with new drug approval

The medicine, a nasal spray for migraines to be sold as Zavzpret, was a key part of Pfizer’s roughly $12 billion buyout of Biohaven last year. 

By Ben Fidler • March 10, 2023

Lilly reaches end of the road with long-studied Alzheimer’s drug

Prior trial failures hadn’t halted testing of solanezumab, once Lilly’s top Alzheimer’s drug candidate. But its final study defeat may help scientists better understand how to target the brain disease.

By Jonathan Gardner • March 9, 2023

Sandoz, betting on biosimilar sales, to build new production plant

The Novartis division will invest at least $400 million in a new manufacturing facility in Slovenia amid expectations that demand for copycat biologics will surge in the coming years.

By Delilah Alvarado • March 9, 2023

Novartis takes step toward expanding supply of in-demand cancer drug

The company has struggled to maintain supply of its prostate cancer drug Pluvicto, hampered by production issues and higher-than-expected demand.

By Delilah Alvarado • March 3, 2023

Exelixis reports trial failure for cancer drug combination

The setback is the second for the pairing of Cabometyx and Roche’s immunotherapy Tecentriq, dimming Exelixis’ hopes of further expanding its drug’s use before a key patent expires.

By Jonathan Gardner • March 3, 2023

GSK’s RSV vaccine wins FDA panel backing, matching Pfizer

Committee members appeared more confident in their recommendation of GSK's shot, with fewer dissents in separate votes on its safety and effectiveness.

By Delilah Alvarado • March 2, 2023

FDA asks advisers to review Lynparza amid growing scrutiny of PARP drugs

The meeting to discuss Lynparza's use as a frontline treatment for prostate cancer follows a string of withdrawals for drugs in its class, and evidence it didn’t meaningfully extend survival in late-stage testing.

By Jonathan Gardner • March 2, 2023

Novo Nordisk to create Boston R&D hub

Along with adding new jobs and lab space, the company plans to transfer or close down operations at some other research sites as it works to cement the Boston area as its main U.S. location for R&D.

By Jacob Bell • March 2, 2023

Lilly to lower insulin prices by 70%

The pharma company, along with its diabetes drug rivals Novo Nordisk and Sanofi, has long been under pressure over the high cost of insulin — scrutiny that has recently ramped up in the U.S.

By Jonathan Gardner • March 1, 2023

Merck reports two Phase 3 study misses for Keytruda

The negative results in prostate and lung cancer are rare trial failures for the immunotherapy, and could limit expanded use of the drug in treating those tumor types.

By Jonathan Gardner • Feb. 28, 2023

Viatris taps new CEO to lead second phase of business revamp

Celgene veteran Scott Smith will take over for Michael Goettler on April 1 as the generic drugmaker prepares for a return to growth after divestitures and the addition of a new eye care division.

By Delilah Alvarado • Feb. 27, 2023

How life sciences benefits from broader healthcare transformation

Digital transformation has much to offer life sciences as well as healthcare — and the synergies between the two can further optimize the power of digital health, clinical trials and patient outcomes.

Feb. 27, 2023

Med EdVolution

Medical education, or med ed, to be far less flashy, or as important as traditional healthcare advertising. 

By Karen Campbell Senior Vice President Senior Management Supervisor, Ogilvy Health • Feb. 27, 2023

European regulator signals rejection for Merck’s COVID pill

The EMA's drug committee concluded a clinical benefit “could not be demonstrated” for the antiviral pill Lagevrio, a decision Merck and partner Ridgeback said they will appeal.

By Christopher Newman • Feb. 24, 2023

Novartis backs away from NASH, furthering its research revamp

The pharma is handing back rights to an experimental medicine for the liver disease that had been licensed from biotech Pliant Therapeutics. 

By Jacob Bell • Feb. 24, 2023

Doctors largely comfortable with biosimilar drugs, but question economics: report

Weeks after the first Humira copycat launched in the U.S., a survey by Cardinal Health suggests insurer mandates will drive biosimilar adoption.

By Jonathan Gardner • Feb. 22, 2023

Big pharma’s looming threat: a patent cliff of ‘tectonic magnitude’

Many top-selling products will lose patent protection by the end of the decade, putting pressure on companies to replace lost revenue with new medicines.

By Jonathan Gardner • Feb. 21, 2023

Reasons matter: uncovering insights into medication discontinuation in immunology

Real-world data and advanced analytics reveal patterns and insights into why patients stop therapies

By Stefan C. Weiss, MD, MHSc, MBA, Managing Director, Dermatology, OM1 • Feb. 21, 2023

Moderna shares sink on mixed study results for flu vaccine

The company’s shot sparked a strong enough immune response against only one of two groups of influenza strains it was tested against in a closely watched Phase 3 trial.

By Delilah Alvarado • Feb. 17, 2023