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 8 hours ago

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

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

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

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

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

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

FDA approves first RSV vaccine, clearing GSK’s Arexvy for older adults

The decision represents the first fruits of a scientific breakthrough a decade ago that gave drugmakers, among them GSK, Pfizer and Moderna, a blueprint for an effective shot against the virus.

By Delilah Alvarado • Updated May 3, 2023

Lilly drug slows Alzheimer’s decline in large study

The company plans to quickly submit an application for U.S. approval based on the trial results, which showed a consistent benefit to treatment with the drug, called donanemab.

By Jonathan Gardner , Ned Pagliarulo • Updated May 3, 2023

Pfizer turns focus to new drugs as COVID vaccine revenue falls

The drugmaker beat Wall Street’s first quarter forecasts despite a sales drop that puts pressure on it to succeed with upcoming market launches.

By Jonathan Gardner • May 2, 2023

FDA clears Pfizer’s pneumococcal vaccine for infants and children

Pfizer’s latest Prevnar shot covers 20 strains of the virus, more than the 13 covered by its previous version and the 15 by Merck’s Vaxneuvance.

By Delilah Alvarado • Updated May 3, 2023

AbbVie weathers first months of biosimilar challenge to top-selling Humira

While Humira sales declined, the drop was mostly due to price concessions AbbVie made to secure equal insurer access in the face of copycat competition.

By Ned Pagliarulo • April 28, 2023