Policy & Regulation
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Along with NIH cuts come risks to patient safety and scientific data
The abrupt withdrawal of research funds affected 74,000 clinical trial participants, including some already taking the drugs being studied.
By Kelly Bilodeau • Nov. 26, 2025 -
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4 takeaways from pharma’s manufacturing boom
As pharma’s U.S. facility investments top $370 billion over the next five years, there are a few things to keep in mind, according to construction experts.
By Alexandra Pecci • Nov. 25, 2025 -
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TrendlineArtificial 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 -
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Pharma faces a critical ‘turning point’ in 2026, years in the making
While Trump’s manufacturing and pricing deals with pharma shape the industry’s future, COVID’s impact still ripples throughout the health landscape.
By Michael Gibney • Nov. 21, 2025 -
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FDA unveils new regulatory roadmap for bespoke drug therapies
The “plausible mechanism” pathway, outlined by Dr. Martin Makary and Dr. Vinay Prasad, is designed to help accelerate treatments custom-made for individuals with rare and serious diseases.
By Ben Fidler • Nov. 13, 2025 -
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Drugs are winning approval even when trials fail — but should they?
About 10% of FDA-approved drugs in recent years have won clearance despite a trial failure, raising safety and ethical concerns.
By Kelly Bilodeau • Nov. 12, 2025 -
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Tariffs, pricing, backroom deals — how pharma can navigate wildly shifting policies
Gaming out new regulations and various potential outcomes will help keep companies on more solid footing.
By Kelly Bilodeau • Nov. 3, 2025 -
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How Trump’s do-or-die agenda is impacting Big Pharma’s CEO chatter
Among tariffs, pricing policies and ongoing negotiations, pharma leaders can’t help but address their dealings with the Trump administration in third-quarter earnings reports.
By Michael Gibney • Oct. 30, 2025 -
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Massachusetts biotech hub is limping amid layoffs and low investment
The state’s difficulties in the last year are indicative of wider industry problems during a time of market trepidation, as optimism gives way to resilience.
By Michael Gibney • Oct. 23, 2025 -
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Why a treatment older than the FDA is getting new regulatory scrutiny
MAHA-aligned patients and providers are pushing back to ensure access to an animal-derived thyroid hormone treatment.
By Kelly Bilodeau • Oct. 20, 2025 -
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Pregnant women, long excluded from drug trials, are back in the spotlight
The White House has raised concerns around women’s health, but R&D on pregnant and breastfeeding women is still lacking.
By Meagan Parrish • Oct. 17, 2025 -
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Ultra-rare diseases got a boost from recent FDA approval signalling more regulatory flexibility
Stealth BioTherapeutics’ FDA win could help build momentum in the broader rare disease space.
By Alexandra Pecci • Oct. 15, 2025 -
Ermath, Michael. (2020). "Individualized Therapies Workshop" [Photograph]. Retrieved from Flickr.
Dr. Peter Marks, former top FDA vaccine official, joins Eli Lilly
Six months after his abrupt resignation as CBER director, Marks has been hired to run discovery and infectious disease work at the big Indianapolis drugmaker.
By Jonathan Gardner • Oct. 8, 2025 -
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As setbacks plague other companies, MindMed becomes a front-runner in the psychedelics race
Challenges faced by other drugmakers have reinforced, rather than discouraged, MindMed’s approach to psychedelic drug R&D for anxiety and other disorders.
By Alexandra Pecci • Oct. 7, 2025 -
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Trump administration could lower drug prices by making other nations pay more
The Trump administration often touts its efforts to lower prices in the U.S. by matching what other countries pay, but there’s more to this policy story.
By Kelly Bilodeau • Oct. 6, 2025 -
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AstraZeneca’s at-home flu vaccine is a breakthrough that could pave the way for others
FluMist Home could be a test case for at-home vaccines against a backdrop of challenging regulatory shifts.
By Alexandra Pecci • Oct. 1, 2025 -
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Top pharma industry conferences in 2026
Where pharma leaders will converge, discuss and navigate the industry’s shifting landscape in 2026.
By Meagan Parrish • Oct. 1, 2025 -
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Is pharma’s IRA pricing battle running out of steam?
Despite recent court losses, the legal tides could still turn in the industry’s favor.
By Meagan Parrish • Sept. 26, 2025 -
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With DTC ads under fire, pharma companies need to pivot
An executive order from HHS doesn’t prohibit direct outreach to consumers, but drugmakers will need to rethink their outreach strategies.
By Kelly Bilodeau • Sept. 22, 2025 -
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3 FDA approval firsts that could be around the corner
Several market-altering decisions are on the agency’s docket for the rest of 2025.
By Meagan Parrish • Sept. 19, 2025 -
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At Senate hearing, lawmakers express dissatisfaction with RFK Jr.’s vaccine moves
Robert F. Kennedy Jr. faced criticism Thursday even from Republican lawmakers over changes to federal vaccine policy as well as a leadership crisis at the CDC.
By Delilah Alvarado , Jonathan Gardner • Sept. 5, 2025 -
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International appeal: Europe and UK lure US scientists with financial incentives
With slashed budgets and decimated research programs, American scientists are increasingly looking for career opportunities abroad.
By Alexandra Pecci • Sept. 4, 2025 -
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Why drugmakers may need to borrow from quantum theory to confront tariff and pricing threats
With so many unknowns surrounding regulatory and policy shifts, pharma companies might need to consider fundamental changes to how they operate, a Deloitte analyst said.
By Michael Gibney • Sept. 3, 2025 -
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FDA approves updated COVID boosters, but narrows use
In a post on X, HHS Secretary Robert F. Kennedy said the FDA has cleared vaccines from Pfizer, Moderna and Novavax for use in "high risk" individuals.
By Delilah Alvarado • Updated Aug. 27, 2025 -
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Why an FDA decision for a new drug could ripple through the ultra-rare disease space
All eyes are on Stealth BioTherapeutics as it awaits a long-delayed approval for its first-in-class treatment for Barth syndrome.
By Alexandra Pecci • Aug. 26, 2025 -
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FDA’s new accelerated pathway could open pharma up to risks, as well as benefits
Faster review times will leave drugmakers vulnerable to litigation, while new Trump administration priorities add more uncertainty in the drug approval process.
By Amy Baxter • Aug. 25, 2025
