FDA, citing safety concerns, places partial hold on Merck KGaA’s MS drug

Evidence of possible liver damage among study participants adds to growing concerns about the potential of BTK inhibitors to treat MS, a strategy being pursued by several large drugmakers. 

By Kristin Jensen • April 12, 2023

AbbVie removes two approvals for blood cancer drug Imbruvica

In paring back use of Imbruvica, the drugmaker has become the latest developer to voluntarily withdraw indications for a cancer medicine following a setback in confirmatory testing.

By Delilah Alvarado • April 7, 2023

Explore the Trendline➔

Top 5 stories from BioPharma Dive

Looming patent expiries this decade and intensifying competition from China are forcing drugmakers to adapt, while new opportunities open up in oncology and in neuroscience.

By BioPharma Dive staff

In NEJM, full Pfizer data show RSV vaccine’s protection

Shots from Pfizer and GSK could soon become the first approved for the common respiratory infection. Results published in the high-profile medical journal give a closer look at the former.

By Delilah Alvarado • Updated April 6, 2023

Pharma partner Sartorius eyes gene therapy market with $2.6B deal

The biotech tools supplier is acquiring Polyplus, a French company that makes components essential to the viral vector backbones of gene therapies.

By Ned Pagliarulo • March 31, 2023

Acquired patents aid J&J defense of top-selling drug from biosimilar challenge

The company is asserting patents gained via its 2020 acquisition of Momenta in litigation to forestall entry of a biosimilar to its psoriasis drug Stelara.

By Jonathan Gardner • March 29, 2023

Novartis, following Lilly, claims success in early breast cancer study

The Swiss drugmaker believes the findings could support an approval of Kisqali in adjuvant breast cancer and, potentially, broader use than Lilly’s rival drug Verzenio.  

By Jonathan Gardner • March 27, 2023

Pfizer returns cancer immunotherapy rights to Merck KGaA

Analysts had speculated Pfizer might divest its Bavencio interest to help close its Seagen buyout. A Pfizer spokesperson said the move was “conceived independently” of any other deal, however.

By Ned Pagliarulo • March 27, 2023

Biosimilar brands bring buzz to pharma marketing

Bracing for biosimilars? Learn how biosimilar launches differ from traditional biologics.

March 27, 2023

The 3 biggest barriers to patient services program utilization

Not getting traction with your patient services program? Here’s why and what to do about it.  

March 27, 2023

Novo partners with Dewpoint to mine an emerging field for new drugs

The companies will collaborate to identify compounds that could treat insulin resistance by targeting shape-shifting cellular droplets known as biomolecular condensates.

By Delilah Alvarado • March 22, 2023

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

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, which Pfizer closed Dec. 14, gives it control of a top-selling lymphoma drug and a pipeline of medicines that 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