Marking one year as FDA commissioner, Califf lays out vision for agency’s future

Califf outlined hopes to address advisory committees, drug pricing, digital health and more.

By Karissa Waddick • Feb. 16, 2023

Rocket Pharmaceuticals is ready for liftoff in the rare disease space

With two rare disease products on the launch pad for FDA submission in 2023 and a growing pipeline, Rocket is fueled for its next era of growth.

By Taren Grom • Feb. 10, 2023

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

3 ways the FDA’s restructuring plan could impact pharma

FDA’s food program is in for a major overhaul — here’s why pharma should pay attention. 

By Karissa Waddick • Feb. 9, 2023

United by inequity: The healthcare disparities plaguing rare disease patients and Black Americans

Guided by her personal experiences, Tamar Thompson is aiming to improve rare disease care through her advocacy work at Alexion, AstraZeneca Rare Disease.

By Alexandra Pecci • Feb. 7, 2023

Roche, Chiesi and the FDA change major leadership roles as they strive for growth in 2023

From Roche’s new pharma chief to the departure of the FDA’s gene therapy head, these moves are bound to shake up the industry.

By Karissa Waddick • Feb. 6, 2023

Antitrust watchdogs have pharma in their sights, and the landscape is getting thornier

The FTC and DOJ are heightening antitrust enforcement, and pharma deals are a prime target.

By Karissa Waddick • Feb. 2, 2023

Vaxxinity eyes global COVID-19 vaccine market with ‘next-gen’ booster

The biotech aims to complete rolling submissions with regulators in the U.K. and Australia in the first half of 2023.

By Alexandra Pecci • Jan. 31, 2023

Drug price negotiations: 5 key dates to watch

As the CMS readies its new program for lowering drug costs, these are the moments that will matter most to pharma companies.

By Kelly Bilodeau • Jan. 23, 2023

FDA’s 2022 drug approvals fall short of recent norms

The U.S. agency’s lower number of novel drug approvals followed several controversies surrounding a 2021 Alzheimer’s approval.

By Alexandra Pecci • Jan. 19, 2023

After ‘limping along,’ Novavax sees a path forward

With a new CEO and a long-term booster strategy, the company believes there’s plenty of room to grow in the COVID-19 vaccine space.

By Meagan Parrish • Jan. 18, 2023

Lilly, Biogen, Eisai brace for Alzheimer’s boom or bust in 2023

As controversies abound and new drugs rise on the regulatory horizon, this year will be big for Alzheimer’s.

By Michael Gibney • Jan. 5, 2023

The 2023 PharmaVoice Crystal Ball: Peering into the future of life sciences

A preview of the top trends on the minds of industry and market leaders for the new year.

By Taren Grom • Jan. 3, 2023

The 2023 PharmaVoice Year in Preview

Here’s a look at how industry leaders are navigating the key issues of 2023.

Dec. 12, 2022

For Duchenne-focused Sarepta, gene therapy is the natural next step

The company with three marketed RNA drugs for Duchenne muscular dystrophy is taking the logical leap into gene therapies with a candidate under review at the FDA.

By Michael Gibney • Dec. 8, 2022

A historic approval could transform CSL from being ‘the biggest company no one has ever heard of’

The company’s head of R&D on its profile-raising FDA approval of a gene therapy that’s now the world’s most expensive drug. 

By Meagan Parrish • Dec. 6, 2022

An FDA proposal could make OTC switches easier. Here’s what the industry has to say

How the FDA’s proposal to create a new OTC approval pathway could impact the pharma industry.

By Karissa Waddick • Dec. 5, 2022

5 final FDA action dates to watch this year

A potential flurry of regulatory activity could be on the horizon yet this year — and several key drug approvals are at stake.

By Michael Gibney • Dec. 1, 2022

10 of our most popular articles in 2022

Methadone, rock ‘n’ roll, clinical trial overhauls — here’s a look at our most-read stories of the year.

By Meagan Parrish • Nov. 30, 2022

The next era of Greater Boston’s biotech boom

How Boston became the biotech capital of the U.S., and is now preparing for the next era of life sciences growth.  

By Karissa Waddick , Shaun Lucas , Julia Himmel • Nov. 22, 2022

Can a formal needs assessment simplify Speaker Bureau compliance?

In the biopharmaceutical industry, phases of innovation and change are often driven by regulatory action.

Nov. 21, 2022

Why the IRA will drive up the country’s drug bill — not lower it

On the surface, the Inflation Reduction Act is designed to lower drug prices, but its impact on innovation incentives could produce a landscape of new medicines that are costlier for patients.

By John LaMattina • Nov. 14, 2022

3 ways pharma can weather a recession

If “winter is coming” in the form of a recession, pharmas can take advantage of an inherent resiliency by crushing these three fundamentals.

By Michael Gibney • Nov. 10, 2022

What pharma could gain — or lose — from the midterms

With control of the House and Senate both up for grabs, and potentially leaning Republican, here’s what the midterm elections mean for pharma. 

By Karissa Waddick • Nov. 7, 2022

Acumen cruises into the fast lane with novel Alzheimer’s treatment

The company’s distinct amyloid-beta target, which just won a fast track designation, could give it an edge over the competition.

By Meagan Parrish • Nov. 3, 2022

How Europe’s energy crisis is impacting pharma

Inflationary pressures and rising energy costs could further expedite the movement of generics manufacturing from Europe to Asia if governments don’t step in.

By Karissa Waddick • Nov. 2, 2022