Merck, Lilly launch manufacturing R&D consortium to help ‘bolster’ U.S. production

The Young Institute Pharmaceutical Manufacturing Consortium will research and develop new production technologies.

By Alexandra Pecci • Feb. 19, 2025

CRISPR’s cardio catch-all drives a biotech’s broad potential

Scribe Therapeutics hopes to prevent cardiometabolic diseases by targeting underlying causes with CRISPR technology.

By Kelly Bilodeau • Feb. 18, 2025

Explore the Trendline➔

Rare diseases

As drug developers find promise in the rare diseases, deals and treatments are on the rise

By PharmaVoice staff

In the crowded cardio space, it’s David vs. Goliath for small biotechs

What will it take for a clinical-stage biotech to break into the cardio space? One CEO thinks he has the answer.

By Alexandra Pecci • Feb. 11, 2025

Beyond GLP-1s? This biotech is exploring longer-term metabolic treatments

Fractyl Health is entering pivotal studies for a procedure that aims to be an ‘off ramp’ to GLP-1s and exploring how a one-time, ‘smart GLP-1’ gene therapy can Treat type 2 diabetes.

By Amy Baxter • Feb. 10, 2025

Are orexins the next golden child of neuroscience?

An emerging class of orexin-based drugs are on the cusp of disrupting care for sleep disorders — and potentially much more.

By Meagan Parrish • Feb. 10, 2025

As financial headwinds pick up, pharmas are aiming to squeeze more ROI from their R&D

With assets under a knife and pipelines under a microscope, R&D programs are being overhauled to be more efficient and cost effective.

By Alexandra Pecci • Feb. 5, 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After a series of potent executive orders last week, the FDA removed draft guidance on diversity in clinical trials.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

A new, non-opioid pain drug is here. Getting it to patients could be agony.

After decades of research, Vertex Pharmaceuticals now has an approved pain medication. Can one of the world’s most powerful biotechs contend with a healthcare system that’s long favored opioids?

By Jacob Bell • 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

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

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

‘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

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

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

After layoffs, a viral immunotherapy biotech bounced back with a late-stage prostate cancer win

Candel Therapeutics’ CEO had to prioritize a phase 3 program amid layoffs and cuts, and an end-of-year clinical success was the redemption he was looking for.

By Michael Gibney • Jan. 9, 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