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

Executive hiring changes reflect a broader biotech comeback

Executive hiring shifts are often indicators of wider trends in the market. Here’s how the hiring landscape for pharma leaders is changing.

By Alexandra Pecci • Jan. 29, 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

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

An ALS treatment wave is approaching, and this biotech CEO is ready to surf

Coya Therapeutics is entering into a phase 2b study for its ALS, and the biotech’s CEO believes it’s on the cusp of a game changer.

By Amy Baxter • Jan. 27, 2025

Natural killer cells, a rising alternative to CAR-T cell therapy

These innate immune cells may provide a safer, lower-cost option in cancer and autoimmune diseases.

By Kelly Bilodeau • Jan. 27, 2025

Gene therapies have been uneven for DMD — but these companies hope to turn the tide

Despite mixed results using gene therapies to treat Duchenne muscular dystrophy, drug developers are pushing ahead with the belief the answer could come down to delivery.

By Meagan Parrish • Jan. 24, 2025

J&J is all in on tau-targeted Alzheimer’s candidates. Will the approach lead to more effective treatments?

Anti-tau candidates haven’t crossed the regulatory threshold like their anti-amyloid counterparts, but J&J’s clinical efforts could lead in the right direction.

By Michael Gibney • Jan. 23, 2025

After an obesity stumble, BioAge reconnects with its longevity pipeline

The company is kicking off the year with a new Novartis partnership and renewed focus on metabolic aging targets.

By Alexandra Pecci • Jan. 22, 2025

Innovate or perish: Industry’s evolution leaves little room for me-too approaches

Novel drug approvals have set the stage for more breakthroughs in pharma.

By Amy Baxter • Updated Jan. 22, 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

‘The bar has risen’: China’s biotech gains push US companies to adapt

Pharma dealmaking for drugs invented in China is putting pressure on U.S. biotechs to compete harder.

By Ben Fidler • Jan. 17, 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

By the numbers: J&J, GSK lead J.P. Morgan deal announcements in 2025, the largest turnout in years

The J.P. Morgan Healthcare Conference has been a focal point for M&A year after year, and after a quiet period, the deals are back on the table.

By Michael Gibney • Jan. 16, 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

Merck is broadening its pipeline as Keytruda’s patent cliff looms

Merck looks ahead with an array of cardiometabolic, immunology, neuroscience and ophthalmology pipelines.

By Alexandra Pecci • Jan. 14, 2025

Will 2025 mark pharma’s pivot to bigger deals after years of lackluster M&A?

A series of uncertainties that kept dealmaking to a minimum last year could be reversing as pharma reloads pipelines ahead of the patent cliff explosion.

By Michael Gibney • 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

3 trial readouts that could shake up the obesity market this year

A wave of new weight loss treatments is on the way, and drugmakers are scrambling for a foot in the door.

By Amy Baxter • Jan. 8, 2025

Subcutaneous options offer convenience for patients — and a valuable window for drugmakers

New formulations for under-the-skin application of drugs give pharmas another opening in a crowded market.

By Kelly Bilodeau • Jan. 7, 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