DCTs create fresh privacy challenges for review boards. Now there are guidelines.

A new toolkit developed by industry stakeholders paves the way for faster reviews.

By Kelly Bilodeau • July 17, 2023

FDA’s upcoming psychedelic review looms large for a budding industry

A new psychedelic guidance from the agency gives a clue into how it could analyze drugs in the space, but industry leaders are eager for more.

By Karissa Waddick • July 12, 2023

Explore the Trendline➔

Oncology R&D

Cancer research remains a prime focus for the industry and often leads to pharma’s most impactful breakthroughs.   

By PharmaVoice staff

A rare disease veteran, Inozyme’s new CEO sharpens the company’s focus

After taking the reins from the company’s founding CEO, Douglas Treco is guiding Inozyme through the clinic.

By Alexandra Pecci • July 11, 2023

Merck’s New Jersey campus is getting a biotech makeover

With a purchase of the pharma giant’s Kenilworth campus, Onyx Equities is looking to make the spot a go-to biotech hub.

By Michael Gibney • July 11, 2023

Cancer R&D is shifting — here’s what’s changing most

A report from IQVIA shows China gaining ground in cancer drug R&D, and a growing industry focus on new drug targets.

By Kelly Bilodeau • July 10, 2023

Following FDA’s full approval of Leqembi, here’s what else is in the Alzheimer’s pipeline

Leqembi’s U.S. approval is a milestone in Alzheimer’s research and medicine — and there are a few other late-stage biologic drugs that could follow.

By Michael Gibney • July 7, 2023

Pharma’s strike-from-all-sides attack on the IRA could be decided by the Supreme Court

New lawsuits challenging the Inflation Reduction Act’s price negotiation program hit the government with multiple Constitution-based challenges.

By Alexandra Pecci • July 6, 2023

Women’s healthcare investments are hot. So where are the new menopause drugs?

NK3 receptor antagonists offer a new option, but experts say more are needed.

By Kelly Bilodeau • July 5, 2023

The stories you’ve read the most in 2023 (so far)

From staff shortages to presidential candidates and the M&A outlook, here are our most-read stories from the first half of the year.

By PharmaVoice Staff • July 3, 2023

A pharma summer — how leaders unwind and recharge their teams in the warmer months

Vacation is calling, but so are patients. Here's how the industry adjusts in the summer. 

By Michael Gibney • June 30, 2023

Major clinical trial trends transforming life sciences research

From AI to diversity and decentralized trials, here’s how clinical trial operations are evolving.

By Karissa Waddick • June 29, 2023

Transgender patients are rarely included in clinical trials. Can pharma fix it?

Transgender and nonbinary patients suffer more adverse health outcomes than the general population, yet are often underrepresented in clinical research. Now, there’s momentum to change the status quo.

By Karissa Waddick • June 29, 2023

Pharma is still figuring out how to make DEI work. Here are some of the strategies companies are trying

Although DEI efforts have ramped up, the industry is still searching for proven ways to get results.

By Alexandra Pecci • June 28, 2023

Intercept’s NASH retreat is the latest setback for a challenging liver disease

Intercept Pharmaceuticals has stepped out of the race to the first U.S. approved treatment for the complicated liver disease NASH, leaving room for other pharmas to get their foot in the door.

By Michael Gibney • June 27, 2023

Woman of the Week: Stealth BioTherapeutics’ Reenie McCarthy

How the CEO navigated a regulatory odyssey to bring the company’s lead program for an ultra-rare disease to a fast track approval.

By Taren Grom • June 21, 2023

AI has secured a footing in drug discovery. Where does it go from here?

The AI revolution is bringing a new era of drug discovery, and the potential for more uses is greater and faster than ever before.

By Michael Gibney • June 20, 2023

3 pressing molecular bioanalysis factors confronting gene therapy developers

It’s exciting to be part of today’s gene therapy development community; however, three issues are at the top of the industry’s mind—the regulatory landscape, critical molecular bioanalysis considerations: biodistribution, transgene expression, vector shedding and assay-related challenges.

By Paul Byrne, Senior Director, Genomics, ProtaGene • June 20, 2023

Shaking up pharma: Change that leaders would like to see

Industry execs give voice to the “game changers” they believe would have the greatest impact on the healthcare ecosystem for all.

By Taren Grom • June 16, 2023

Boosting the cell and gene therapy workforce with a skilled, localized approach

Experts provide a roadmap for how the industry can work with academia to ensure a robust talent pipeline for the burgeoning field.

By Karissa Waddick • June 15, 2023

How steep is pharma’s patent cliff?

The big pharma patent cliff is almost here — and could change the face of the industry. Here’s a look at the key stats behind the coming wave of blockbuster losses.  

By Meagan Parrish • June 14, 2023

Woman of the Week: Gamida Cell’s Abbey Jenkins

The first-time CEO discusses the lessons she has learned since taking the role last year and how she’s pivoting the company into a commercial entity.

By Taren Grom • June 14, 2023

The ingredients of a successful biopharma collaboration

Collaboration is important along the entire spectrum and lifecycle of biopharma, and finding an effective partner is harder than it sounds.

By Michael Gibney • June 13, 2023

Zai Lab looks to expand beyond China and make a global impact in oncology

Focused on making a “transformational” impact, the company is developing targeted treatments driven by specific cancer mutations.

By Kelly Bilodeau • June 12, 2023

Yes, biopharma still has a reputation problem. These leaders are looking for solutions.

Negative news is breaking down the public’s perception of the biopharma industry — but leaders around the industry have some ideas to fix it.

By Michael Gibney • June 8, 2023

FDA’s decentralized trials guidance leaves slate of fresh questions for industry

Recent FDA guidance aims to bolster DCT adoption but provides little clarity on the patchwork of telemedicine laws that pose an obstacle to the approach.

By Karissa Waddick • June 8, 2023