Pfizer’s PARP drug follows Lynparza with narrow clearance in prostate cancer

As with Merck and AstraZeneca’s medicine, the agency has only cleared Talzenna for use in a subset of newly diagnosed patients who appear most likely to benefit from treatment.

By Jonathan Gardner • June 21, 2023

Bavarian Nordic says chikungunya vaccine succeeds in late-stage study

The shot, which the Danish company acquired from Emergent BioSolutions, spurred protective antibodies against the mosquito-borne virus in older adults.

By Delilah Alvarado • Updated June 20, 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

A right-first-time approach to development

Avoid costly delays, don't let development oversights derail your advanced therapy commercialization. Read the article.

June 20, 2023

Astellas delves deeper into protein degrading drugs with Cullgen deal

The alliance is Astellas’ second recent partnership involving protein degraders, an emerging area of drug research the company has recently made a focus.

By Ben Fidler • June 15, 2023

Pharmaceutical supply chains raise data concerns as traceability law nears final step

Companies have had 10 years to comply with the Drug Supply Chain Security Act, but some fear the industry is not ready for a Nov. 27 deadline.

By Deborah Abrams Kaplan • June 7, 2023

Merck sues to block Medicare negotiation of drug prices

The drugmaker’s lawsuit claims the new pricing powers granted by the Inflation Reduction Act are unconstitutional and “tantamount to extortion.”

By Christopher Newman • Updated June 6, 2023

Unlocking the impact of medical affairs: Overcoming challenges in defining and measuring success

Discover how medical affairs teams can overcome challenges to define and measure their impact, with a focus on KOL engagement, using a scientific journey approach and a comprehensive strategy.

June 5, 2023

Pfizer says antibiotic is effective against tough-to-treat infections

A drug the company acquired from AstraZeneca and developed for gram-negative infections — a growing public health threat — could be headed for a regulatory review later this year.

By Delilah Alvarado • June 2, 2023

AstraZeneca abandons experimental bowel disease drug

The drugmaker cited testing delays and an evolving “competitive landscape” in its decision to discontinue development of its IL-23 inhibitor brazikumab.

By Delilah Alvarado • June 1, 2023

Racing to the finish line: help for reducing risks, ensuring security and driving faster speed-to-market

When pharma manufacturers are racing to bring a new product to market, catastrophic printing errors and mislabeled materials can have a significant impact on timelines and budgets.

May 22, 2023

Teva puts rival to Prometheus, Pfizer drugs at center of turnaround plans

At an investor day, executives highlighted an experimental inflammatory disease drug targeting the protein TL1A as important to their long-term growth.

By Jonathan Gardner • Updated May 19, 2023

Supreme Court sides with Sanofi, Regeneron in patent fight with Amgen

The court’s ruling could open the door for challenges to older classes of antibody therapies, said one legal expert, who added that it will give competitors “solace.” 

By Christopher Newman • Updated May 18, 2023

On heels of Amgen lawsuit, FTC broadens investigation of PBMs

The regulator is probing the business practices of two more drug purchasing organizations, deepening an investigation that began last year.

By Kristin Jensen • May 18, 2023

Gilead picks former Roche executive to run cell therapy unit Kite

Cindy Perettie, the former Foundation Medicine CEO who most recently ran Roche’s molecular lab division, will follow Christi Shaw in the role. 

By Ned Pagliarulo • May 17, 2023

FTC sues to block Amgen’s $27.8B deal for Horizon

The regulator’s challenge will test a more expansive view of how pharmaceutical mergers could harm consumers. Amgen remains confident it can complete the deal, however.

By Jonathan Gardner • May 16, 2023

Sanofi, AstraZeneca study results add support for their RSV drug in infants

The antibody reduced RSV infections requiring hospitalization by 83% in a large study, bolstering evidence for the drug ahead of a U.S. approval decision later this year.

By Christopher Newman • May 12, 2023

Roche pays China-based biotech $70M for a new HER2 drug

The drug, currently in Phase 1, is an oral medicine designed to cross the blood-brain barrier and better treat HER2 tumors that have spread to the brain.

By Jonathan Gardner • May 9, 2023

Novavax cuts workforce by 25% as COVID vaccine sales fall

The layoffs, which will affect hundreds of employees, are part of a major restructuring designed to reduce operational and research spending by as much as half.

By Delilah Alvarado • May 9, 2023

Catalent cuts outlook, delays results as it reveals new hurdles

The pharmaceutical CDMO said it found “significant” issues with its forecasts over the past year, compounding manufacturing problems at three of its plants.

By Ned Pagliarulo • May 8, 2023

Pharma’s commercial model of tomorrow starts today

Today’s commercial model cannot support pharma’s future. A new future calls for bold transformation.

May 8, 2023

Print can help you cut through misinformation

Providing accurate information to protect patients from misinformation is a key goal for pharmaceutical companies, and print media can be a crucial part of the solution.

May 8, 2023

Novo reveals another setback in obesity drug’s launch

U.S. supply of Novo’s Wegovy will be “reduced temporarily,” while the Danish drugmaker gets a new contract manufacturer up and running, executives said.

By Jonathan Gardner • May 4, 2023

Valneva, Pfizer push back timeline for Lyme disease vaccine

After issues with a contract research group, the partners now expect to file an approval application for their shot in 2026, one year later than initially anticipated.

By Delilah Alvarado • May 4, 2023

J&J spinoff Kenvue raises $3.8 billion in year’s largest IPO

Separating out the consumer health division will leave J&J as a slimmed-down company focused on prescription drugs and medical devices.

By Kristin Jensen • May 4, 2023

Lilly’s fortunes rise on back-to-back success for Alzheimer’s, obesity drugs

At more than $400 billion, Lilly’s market value is nearing J&J’s despite the company earning less than one-third as much revenue. Strong data for medicines donanemab and Mounjaro are why. 

By Jonathan Gardner • May 4, 2023