Is the FDA headed for a major reorganization?

A leaked document revealed details about changes that could impact how the agency operates, but recent comments from FDA Commissioner Dr. Marty Makary have muddied the picture. 

By Amy Baxter • April 30, 2025

FDA’s job cuts paint mixed picture for drugmakers’ R&D plans

After a 20% cut to the FDA’s workforce, biotechs and pharmas are bracing for delays. But the impacts won’t be consistent.

By Amy Baxter • April 28, 2025

Explore the Trendline➔

Clinical trial diversity

As pharma wises up to the fact that the current playbook for improving clinical trial diversity has yet to make a meaningful impact, the quest is on to refine that approach.

By PharmaVoice staff

Will Cobenfy’s clinical stumble derail a once-predicted rise?

BMS hopes to broaden the applications for the new schizophrenia drug into areas such as Alzheimer’s disease.

By Kelly Bilodeau • April 28, 2025

Trump reveals pharma reform priorities in drug pricing executive order

The order takes aim at fixing the IRA’s “pill penalty,” as well as PBM reform and other attempts to lower drug prices.  

By Amy Baxter • April 23, 2025

Beyond the drug: Closing the knowledge gap for injectable diabetes meds

As the diabetes and weight loss market booms, more collaboration between pharma and medtech could help patients get the most out of injectable drugs. 

By Michael Gibney • April 22, 2025

Genetic breakthroughs could point pharma to a long COVID drug

The discoveries also hold potential benefits for patients with other conditions, such as chronic fatigue syndrome.

By Kelly Bilodeau • April 22, 2025

Can anything threaten Novo and Lilly’s obesity market dominance?

Five GLP-1 products will collectively bring in $470 billion by 2030, and the market leaders are working to hold back competition.

By Amy Baxter • April 21, 2025

How a scrapped Pfizer drug became a winner for SpringWorks

SpringWorks Therapeutics and the Children’s Tumor Foundation salvaged a shelved asset for neurofibromatosis and got it over the regulatory finish line.

By Alexandra Pecci • April 21, 2025

HHS layoffs may be illegal, legal experts say

The federal health department sidestepped normal procedures as it laid off 10,000 employees, according to sources. One union has already filed an internal complaint, while at least two law firms are exploring suits.

By Rebecca Pifer • April 17, 2025

Novartis scores NFL deal to tackle health outcomes

The non-traditional marketing approach comes amid a potential crackdown on TV drug ads. 

By Amy Baxter • April 17, 2025

Amid an onshoring push, Raleigh is poised to be pharma’s next manufacturing hub

Lower operating costs and a supply of high-skilled workers are helping the North Carolina region pull in billions of pharma manufacturing investments. 

By Alexandra Pecci • April 16, 2025

The fallout from UnitedHealth’s CEO slaying

Brian Thompson’s murder has raised questions about the cost of U.S. healthcare, embroiling insurers, drugmakers and PBMs in a battle for the future of the industry.

By PharmaVoice staff • April 15, 2025

Pharma’s capital allocation could shift as tariffs threaten an already fragile profit model

Major changes to the dynamics of the pharmaceutical ecosystem are making executive decisions even tougher.

By Michael Gibney • April 14, 2025

Pharma’s US manufacturing moment: Where companies are making the biggest moves

The tariff war has prompted new calls to reshore manufacturing. Several large pharmas have already made the leap.

By Meagan Parrish • April 11, 2025

Trump’s tariff tirade and sudden calm keep Big Pharma on its toes

A wild ride in an escalating trade war has torn at Big Pharma’s shares while global markets flag in the back-and-forth winds.

By Michael Gibney • April 10, 2025

US risks losing biotech edge to China, report warns

“There will be a ChatGPT moment for biotechnology,” a bipartisan commission wrote in the new report, which calls for the U.S. to invest at least $15 billion into the sector over the next five years.

By Ned Pagliarulo • April 9, 2025

Big Pharma is rewriting the R&D playbook to account for seismic shifts in the investment landscape

The top 20 pharma companies are focusing on novel drugs, innovative dealmaking and playing to their strengths to bolster R&D ROI.

By Alexandra Pecci • April 9, 2025

US vs. EU: When it comes to novel Alzheimer’s drugs, regulators can’t seem to agree

The FDA is much more flexible in approving first-in-class drugs compared to European regulators.  

By Amy Baxter • April 7, 2025

The year’s biggest biotech haul shows investors are still chasing the AI dream

Isomorphic Labs recently raked in $600 million to help develop its drug discovery platform.

By Meagan Parrish • April 4, 2025

Industry leaders react to HHS being ‘reduced to a shell’

What healthcare watchdogs have said about the far-reaching job cuts this week.

By Meagan Parrish and Amy Baxter • April 3, 2025

Is the FDA ‘finished’? Leadership drain hits agency hard.

Amid widespread staff reductions at health agencies, a number of key officials have bid farewell to pharma’s top regulator.  

By Amy Baxter • April 2, 2025

Former Pfizer CSO Mikael Dolsten on writing his next chapter, embracing AI and asking the ‘big questions’

Dr. Mikael Dolsten, Pfizer’s former chief scientific officer, is embarking on a journey of curiosity and interconnectedness in his post-Big Pharma career.

By Michael Gibney • April 1, 2025

With government health info in limbo, drugmakers lose credible sources

The lack of clear communication from the government could spark wide-ranging issues in pharma — from sowing confusion about clinical trial design to further eroding public trust.

By Alexandra Pecci • April 1, 2025

In the obesity triple-agonist blockbuster race, a familiar battle looms: Novo vs. Lilly

The two market leaders are targeting new obesity alternatives in their pipelines with an eye toward a triple threat.  

By Amy Baxter • March 31, 2025

FDA’s ‘mixed signals’ on diversity have entangled clinical trials. Here’s how pharma can push ahead.

The agency is still unclear about where it will stand on clinical trial diversity, but companies are looking for answers and leaning toward good science.

By Meagan Parrish • March 28, 2025