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

Explore the Trendline➔

Rare diseases

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

By PharmaVoice staff

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

5 FDA decisions to watch in the fourth quarter

The regulator is considering approval of what would be the first CRISPR medicine, as well as important clearances for Alnylam, Bristol Myers, Amgen and Pfizer.

By Ned Pagliarulo , Jonathan Gardner • Oct. 2, 2023

3 recent FDA adcomm rejections — and why they matter

Decisions that could spell doom for drugs in development and already on the shelves.

By Meagan Parrish • Sept. 29, 2023

How pharma marketers can reclaim the drug pricing narrative

As Medicare negotiations heat up, it’s more important than ever for pharma companies to communicate their value. Here’s how.

By Karissa Waddick • Sept. 28, 2023

As the opioid crisis seethes, a long-lasting treatment could offer new ammunition

Launched this month, Brixadi from Braeburn gives patients a new tool to overcome addiction.

By Michael Gibney • Sept. 21, 2023

PBMs, PhRMA trade blame over drug costs in House hearing

Pharmacy benefit manager lobby PCMA and drugmaker lobby PhRMA pointed fingers over problems in the prescription supply chain during the House committee's second PBM hearing on Tuesday.

By Rebecca Pifer • Sept. 19, 2023

De-risking visible particles through component selection

The visual inspection of injectable drug product has been a regulatory requirement since 1936, however, successful implementation of the standard has been challenging for many organizations.

By John Rech • Sept. 18, 2023

In the renal space, innovation could tackle health disparities. But the system doesn’t reward it.

Reimbursement challenges have created barriers for new dialysis products, according to the chief commercial officer of CorMedix.

By Michael Gibney • Sept. 14, 2023

A healthcare paradox: Drugs are too expensive but ‘easy’ to afford, Americans say

A new poll shows that Americans generally support several key IRA provisions, including Medicare price negotiations.

By Alexandra Pecci • Sept. 12, 2023

Ex-Sanofi executive Sibold joins Madrigal as new CEO

Bill Sibold has led Sanofi's specialty care business unit for the past six years. He replaces Paul Friedman as head of the NASH drug developer.

By Ned Pagliarulo • Sept. 11, 2023