Policy & Regulation
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RFK Jr.’s autism fixation hearkens back to his stance on vaccines
The head of HHS is seeking the “root causes” of autism spectrum disorder through a large government research project.
By Amy Baxter • May 9, 2025 -
Prasad’s FDA appointment pressures cell and gene therapy stocks
A vocal opponent of his predecessor Peter Marks, Dr. Vinay Prasad will now lead the office tasked with reviewing some genetic medicines, adding more uncertainty to an already struggling field of research.
By Ben Fidler • May 7, 2025 -
Explore the Trendline➔
Stock via Getty ImagesTrendlineRare diseases
As drug developers find promise in the rare diseases, deals and treatments are on the rise
By PharmaVoice staff -
With TV ads under threat, here’s how pharma can leverage social media
RFK Jr.’s plan to ban TV advertising may shift more marketing attention to online platforms.
By Amy Baxter • May 7, 2025 -
On tariffs and pricing, Big Pharma CEOs are waiting out the storm while planning for the worst
Chief executives at the largest drugmakers in the world are confident tariffs and pricing measures won’t be a major problem. But they’re still poised for change.
By Michael Gibney • May 6, 2025 -
Is pharma ready to let go of animal testing?
Regulators have signaled their willingness to embrace alternative tests and guide the industry in new directions.
By Meagan Parrish • May 2, 2025 -
J&J scores FDA OK for immune drug touted as future blockbuster
The company has predicted that Imaavy — now approved for myasthenia gravis — could eventually earn more than $5 billion in annual sales at its peak.
By Ned Pagliarulo • May 1, 2025 -
Q&A
Can real-world evidence bear some of the burden left by NIH cuts? This CEO sees an opportunity.
Turmoil at the NIH has led to handwringing among researchers and drugmakers who rely on public funding.
By Michael Gibney • May 1, 2025 -
Is the FDA headed for a major reorganization?
A leaked document revealed details about changes that could impact how the agency operates, but recent comments from FDA Commissioner Dr. Marty Makary have muddied the picture.
By Amy Baxter • April 30, 2025 -
US backlash against mRNA vaccines could hinder scientific progress
U.S. health agencies are taking the fight to vaccine and mRNA research, which could have lasting repercussions on medical and scientific advancements.
By Michael Gibney • April 29, 2025 -
FDA’s job cuts paint mixed picture for drugmakers’ R&D plans
After a 20% cut to the FDA’s workforce, biotechs and pharmas are bracing for delays. But the impacts won’t be consistent.
By Amy Baxter • April 28, 2025 -
What’s being cut at NIH
A look at the government’s far-reaching rollback in research grants so far.
By Meagan Parrish • April 25, 2025 -
Trump reveals pharma reform priorities in drug pricing executive order
The order takes aim at fixing the IRA’s “pill penalty,” as well as PBM reform and other attempts to lower drug prices.
By Amy Baxter • April 23, 2025 -
How a scrapped Pfizer drug became a winner for SpringWorks
SpringWorks Therapeutics and the Children’s Tumor Foundation salvaged a shelved asset for neurofibromatosis and got it over the regulatory finish line.
By Alexandra Pecci • April 21, 2025 -
A big moment is coming for psychedelics
Compass Pathways expects to publish the first phase 3 results from a large-scale, psilocybin drug trial by the end of this quarter.
By Meagan Parrish • April 18, 2025 -
Deep Dive
HHS layoffs may be illegal, legal experts say
The federal health department sidestepped normal procedures as it laid off 10,000 employees, according to sources. One union has already filed an internal complaint, while at least two law firms are exploring suits.
By Rebecca Pifer • April 17, 2025 -
Novartis scores NFL deal to tackle health outcomes
The non-traditional marketing approach comes amid a potential crackdown on TV drug ads.
By Amy Baxter • April 17, 2025 -
The fallout from UnitedHealth’s CEO slaying
Brian Thompson’s murder has raised questions about the cost of U.S. healthcare, embroiling insurers, drugmakers and PBMs in a battle for the future of the industry.
By PharmaVoice staff • April 15, 2025 -
‘Chaos’ in the biotech market has dampened hopes of a rebound. What does that mean for dealmaking and IPOs?
The biotech market is taking a beating amid Trump’s turbulent economic policies.
By Amy Baxter • April 15, 2025 -
Pharma’s capital allocation could shift as tariffs threaten an already fragile profit model
Major changes to the dynamics of the pharmaceutical ecosystem are making executive decisions even tougher.
By Michael Gibney • April 14, 2025 -
Pharma’s US manufacturing moment: Where companies are making the biggest moves
The tariff war has prompted new calls to reshore manufacturing. Several large pharmas have already made the leap.
By Meagan Parrish • April 11, 2025 -
Trump’s tariff tirade and sudden calm keep Big Pharma on its toes
A wild ride in an escalating trade war has torn at Big Pharma’s shares while global markets flag in the back-and-forth winds.
By Michael Gibney • April 10, 2025 -
US risks losing biotech edge to China, report warns
“There will be a ChatGPT moment for biotechnology,” a bipartisan commission wrote in the new report, which calls for the U.S. to invest at least $15 billion into the sector over the next five years.
By Ned Pagliarulo • April 9, 2025 -
US vs. EU: When it comes to novel Alzheimer’s drugs, regulators can’t seem to agree
The FDA is much more flexible in approving first-in-class drugs compared to European regulators.
By Amy Baxter • April 7, 2025 -
Dr. Oz confirmed to lead CMS
Dr. Mehmet Oz, a physician and TV personality, will lead the agency during a turbulent time for federal health programs as the HHS lays off thousands of staffers and Republicans float potential cuts to Medicaid.
By Emily Olsen • April 4, 2025 -
Opinion
Industry leaders react to HHS being ‘reduced to a shell’
What healthcare watchdogs have said about the far-reaching job cuts this week.
By Meagan Parrish and Amy Baxter • April 3, 2025