Kennedy’s MAHA agenda is tackling ‘conflicts of interest’ — and could take aim at FDA adcomms

Health agency job cuts and a newly-established MAHA commission leave many unanswered questions about potential reforms and impact on drug approvals.

By Amy Baxter • Feb. 24, 2025

In FDA job cuts, experts see threat of far-reaching impact

"Any place that gets cut, it's going to have an impact, because there's not any spare personnel at FDA,” said former agency commissioner Robert Califf, of the layoffs.

By Jonathan Gardner , Delilah Alvarado • Feb. 21, 2025

Explore the Trendline➔

Artificial intelligence & machine learning

After years of excited buzz around the potential of artificial intelligence and machine learning, pharma has begun to realize the true implications and potential value of these technologies.

By PharmaVoice staff

A look at Trump’s healthcare cuts — so far

How the federal workforce crackdown has impacted the agencies that oversee pharma and healthcare.

By Meagan Parrish • Feb. 21, 2025

Medicare’s next list of drugs for price negotiation could get ‘very interesting’ — and have a bigger impact on pharma

The Biden-era law is now in the hands of a new administration, and drugmakers are scanning the horizon for hints of a massive overhaul or incremental change.

By Michael Gibney • Feb. 11, 2025

Tariffs raise concern among generic drugmakers, and advocacy groups are seeking exemptions

While the 10% tariff on Chinese goods won’t have too much impact on branded drugs, generics are struggling to pivot.

By Kelly Bilodeau • Feb. 7, 2025

RFK Jr. will face these critical tests if confirmed as head of the HHS

After a Senate committee advanced President Trump’s nominee to lead HHS, Robert F. Kennedy Jr. is poised to secure the top job at the nation’s healthcare agency.

By Amy Baxter • Feb. 5, 2025

Looming USAID shutdown threatens global health presence and a legacy of medical foreign aid

As President Trump and his cohorts plan to shut down the U.S. Agency for International Development, here’s what that could mean for global health and the drugmaking industry.

By Michael Gibney • Feb. 4, 2025

What should pharma make of the FDA going dark on DEI?

After a series of potent executive orders last week, the FDA removed draft guidance on diversity in clinical trials.

By Meagan Parrish • Feb. 4, 2025

Drugmakers prep for bird flu outbreak, despite continued low risk

While the virus hasn’t made a sustained leap into humans, vaccines and treatments are coming through the pipes if it does.

By Kelly Bilodeau • Feb. 3, 2025

Pharma’s forecast for 2025: Sowing seeds of a rebound

Despite regulatory uncertainty, pharma is bouncing back from a market slump and is being fueled by innovation. 

By Meagan Parrish • Jan. 31, 2025

Is federal funding frozen? Has it already thawed? Flip-flop leaves biopharma on edge

NIH grants that help fund drug development were caught in the mix of confusing executive orders this week.

By Amy Baxter • Jan. 31, 2025

RFK Jr. faces reconciliation of past vaccine statements at Senate HHS hearing

“Are you supportive of these onesies?” Sen. Bernie Sanders asked Kennedy, pointing to infant clothing stamped with anti-vaccine slogans — and more from yesterday’s confirmation hearing.

By Michael Gibney • Jan. 30, 2025

A long-awaited alternative to opioids is on the FDA doorstep. Can Vertex seal the deal?

Vertex Pharmaceuticals’ non-opioid pain medication is up for FDA approval this week. Other drugmakers have found safer alternatives to expand the pain management landscape.

By Amy Baxter • Updated Feb. 4, 2025

Bringing drugs to market has ‘never been more challenging,’ and pharma is learning to adapt

As changes to the U.S. regulatory foundation take hold, pharmas need to change their strategies to keep innovation — and the bottom line — above the surface.

By Michael Gibney • Jan. 28, 2025

In pharma’s competitive climate, companies need evidence beyond clinical trials

Early planning and market research are crucial in an era of rising cost pressures.

By Kelly Bilodeau • Jan. 21, 2025

Musk’s rare disease torpedo, hospitals’ pharma fix and other policies leaders are tracking

There’s more to pharma's regulatory story in 2025 than just the IRA.

By Meagan Parrish • Jan. 17, 2025

What to expect in the sequel to Medicare’s drug price negotiation program

CMS is expected to publish up to 15 drugs for the second cycle of the program by Feb. 1, and these are some of the drugs most likely to make the list.

By Amy Baxter • Jan. 15, 2025

FTC releases second report slamming pharmacy benefit managers

Agency commissioners voted unanimously on Tuesday to publish the report, which makes similar allegations against the controversial drug middlemen as the agency’s first report released last summer — but relies on more data.

By Rebecca Pifer • Updated Jan. 14, 2025

The ability to pivot will be ‘key’ as pharma’s tariff threat looms

Companies are looking to new countries like Vietnam for manufacturing needs, but change comes at a cost.

By Kelly Bilodeau • Jan. 13, 2025

FDA ‘stuck to its corner’ with AI draft guidance, leaving plenty of questions unanswered

The first draft guidance provides an initial framework for how the agency will assess AI models in drug development, but the industry is still looking for more.

By Amy Baxter • Jan. 13, 2025

PharmaVoice’s Crystal Ball: Industry shifts in R&D, policy and clinical trials

Coming changes that could impact pharma from drug development to launch.

By Meagan Parrish • Jan. 10, 2025

PharmaVoice’s Crystal Ball: The industry’s AI future

How AI will further transform the business of drug discovery and development in 2025.

By Meagan Parrish • Jan. 7, 2025

PBMs have evaded lawmakers’ reform attempts so far. Could 2025 turn the tide?

How regulators could hit PBMs from multiple sides in the coming year.

By Amy Baxter • Jan. 6, 2025

4 closely watched FDA approval dates in 2025 from J&J, Novo and more

A first-in-class pain med and blockbusters with new indications are just a few of the possible approvals to keep an eye on in the new year.

By Alexandra Pecci • Jan. 6, 2025

FDA approves drugs from Vertex, Novo, Bristol Myers to wrap 2024

The agency’s main drug review office cleared 50 novel medicines last year, short of 2018’s record total but on the higher end of recent annual tallies.

By Ben Fidler • Jan. 3, 2025