Regulatory twists and turns are coming for biopharma in 2024

New FDA requirements and the IRA will create complexity in the coming year. Here’s how the industry can navigate the changes.

By Kelly Bilodeau • Jan. 8, 2024

10 of our most read articles in 2023

A presidential candidate, a changing biotech market and an enduring murder mystery — here are PharmaVoice’s most-read articles this year.

By Meagan Parrish • Dec. 22, 2023

Explore the Trendline➔

Commercialization, marketing and social media

As the pharma industry stares down a historic patent cliff, macroeconomic headwinds and challenging R&D costs for increasingly complex medicines, nailing the launch of new medicines has become increasingly critical. 

By PharmaVoice staff

Biopharma’s FTC headache deepens with guideline shifts years in the making

Closer scrutiny of pharma deals has made the M&A landscape trickier as a new approach seeks to expand the competitive arena.

By Michael Gibney • Dec. 21, 2023

Study suggests PBMs are gaming pharmacy system to overcharge for drugs

Markups for generics can be as high as 7,000%, the researchers said.

By Alexandra Pecci • Dec. 15, 2023

The many ‘myths’ of clinical trial diversity, and Genentech’s fight to disrupt them

Genentech’s chief diversity officer Quita Highsmith is on a crusade to prove that much of what the industry believes about clinical trial diversity is wrong.

By Michael Gibney • Dec. 14, 2023

A former CDC head on key R&D areas, public trust and if we learned anything from COVID-19

Dr. Julie Gerberding, now president and CEO of the Foundation for the National Institutes of Health, shares lessons learned from a long career in academic, public health and industry.

By Meagan Parrish • Dec. 13, 2023

What’s being done to prepare for the next pandemic?

Will the world be ready when a new outbreak hits? Here’s a look at the efforts to combat emerging viral threats.

By Kelly Bilodeau • Dec. 13, 2023

Real Chemistry’s CEO on biopharma’s outlook in 2024

Shankar Narayanan, CEO of marketing consulting firm Real Chemistry, weighs in on where the industry is headed in the New Year.

By Michael Gibney • Dec. 7, 2023

CRISPR eyes autoimmune disease in revamp of cell therapy plans

The gene editing biotech is shelving two of its most advanced cancer drugs, and joining a growing group of companies exploring cell-based medicines for inflammatory diseases like lupus.

By Ben Fidler • Dec. 6, 2023

4 historic FDA approvals from 2023

This year’s many firsts included a vaccine for RSV and a drug that slows Alzheimer’s disease.

By Alexandra Pecci • Dec. 6, 2023

The digital therapeutics revolution is here. Will payers play ball?

Apps, VR and more could play an increasingly vital role in the wider goals of creating value-based treatments — if the industry can get payers to sign on.

By Kelly Bilodeau • Dec. 5, 2023

Pharma benefited from basing business overseas. An international tax effort could spur a rethink.

U.S. tax law changes six years ago slashed large pharma companies' rates and saved them billions. Now, a push for an international floor could disrupt their R&D accounting.

By Jonathan Gardner • Nov. 29, 2023

Top FDA official Woodcock to retire early next year

The 37-year veteran helmed the agency’s pandemic response, and was a key decision-maker in controversial calls on opioids, an Alzheimer's therapy and muscular dystrophy drugs.

By Jonathan Gardner • Nov. 16, 2023

Can Sarepta’s Duchenne gene therapy still deliver on its promise?

For Sarepta — and DMD patients — there’s a lot riding on the treatment’s next steps.

By Kelly Bilodeau • Nov. 14, 2023

How pharma leaders talk about ethics in a highly criticized industry

The maze of ethical issues in biopharma can confound even the wiliest executive. How do some leaders get by?

By Michael Gibney • Nov. 9, 2023

An at-home flu vaccine? If approved, it could open the door to more DIY options

A new way to administer vaccines at home could help AstraZeneca reach a wider market for FluMist, the nasal influenza vaccine.

By Kelly Bilodeau • Nov. 8, 2023

The thorniest questions facing pharma, according to a leading bioethicist

Bioethics guru Arthur Caplan of NYU gives his outspoken and frank opinion on the industry’s minefield of ethical challenges.

By Michael Gibney • Nov. 6, 2023

In a record year for biotech bankruptcy, here are 3 companies that went under

A challenging funding environment and lack of partnering deals have contributed to the market's ongoing troubles.

By Alexandra Pecci • Nov. 2, 2023

What’s next for COVID dark horse Novavax?

Novavax scored a new COVID vaccine go-ahead for the 2023-24 season, but is it the boost the company needs?

By Kelly Bilodeau • Oct. 30, 2023

Express Scripts sued by independent pharmacies over alleged price fixing

The Cigna-owned pharmacy benefit manager colluded with rival Prime Therapeutics to overcharge pharmacies, according to a lawsuit filed last week.

By Rebecca Pifer • Oct. 25, 2023

The FDA might yank cold medicines from shelves — and that could be just the beginning

Phenylephrine’s future is up in the air with an FDA committee saying it’s not effective and a class action lawsuit alleging false advertising. What comes next could have big repercussions.

By Alexandra Pecci • Oct. 17, 2023

Alnylam CEO, ‘disappointed’ with FDA’s Onpattro rejection, pivots to the future

Yvonne Greenstreet, CEO of RNAi specialist Alnylam, addressed the surprise move by regulators and the company’s new future plans.

By Michael Gibney • Oct. 12, 2023

A decade later, biotech’s CRISPR revolution is still going strong

Once the specialty of a few select drugmakers, CRISPR gene editing is now an essential technology for a growing group of biotechs, many led by former students of the field's pioneering scientists.

By Gwendolyn Wu , Shaun Lucas , Julia Himmel • Oct. 12, 2023

FDA’s ‘ivory tower thinking’ ignores promising biomarkers, says a rare disease CEO

The FDA wouldn’t review a drug that was 90% effective. In rare diseases, this is too common, said Ultragenyx CEO Dr. Emil Kakkis and a leading rare disease researcher.

By Michael Gibney • Oct. 5, 2023

Drugmakers face uphill battle in Medicare negotiation suits

Judges have found fault with drug manufacturers’ First and Fifth Amendment arguments against the IRA’s drug pricing measures.

By Karissa Waddick • Oct. 4, 2023