Policy & Regulation
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Sanofi’s vaccine bump; the new FDA commish
Some of the biggest news and trends captured in PharmaVoice’s newsletter this week. Sign up here to receive the newsletter daily. Sanofi’s vaccine bump ‘Sanofi’s vaccine sales are on the upswing this year, thanks to a boost from its newly acquired hepatitis ...
By PharmaVoice staff • May 15, 2026 -
Permission granted by Ovid Therapeutics
Q&AFormer Ovid CEO Dr. Jeremy Levin’s rallying cry for biotech
The long-time pharma exec is on a quest with a new book and bold message for biotech leaders and U.S. lawmakers.
By Meagan Parrish • May 15, 2026 -
Explore the Trendline➔
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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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FDA chief’s exit clouds already murky drug approvals
During Dr. Martin Makary’s tenure as commissioner, the FDA faced pushback over high-profile drug rejections for Replimune and UniQure.
By Kelly Bilodeau • May 14, 2026 -
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India’s pharma industry is going global. But can it catch up to China?
A record Sun Pharma acquisition signals global ambitions. But infrastructure, capital and policy gaps could stand in the way of India becoming an R&D powerhouse.
By Kelly Bilodeau • May 13, 2026 -
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Why the FDA’s push for real-time clinical trials could favor Big Pharma
The agency's new initiative promises faster drug approval times, but smaller trial sponsors could struggle to keep up.
By Alivia Kaylor • May 13, 2026 -
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How tough is it getting for vaccine makers in the U.S.?
As federal policy chills domestic demand, some companies are increasingly leaning on sales from international markets.
By Kelly Bilodeau • May 12, 2026 -
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A new company rises from the ashes of Purdue Pharma
Knoa Pharma will still sell the opioid medications that triggered a national crisis, but with guardrails.
By Kelly Bilodeau • May 6, 2026 -
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What’s at stake in Amgen’s showdown with the FDA?
The agency accused Amgen of manipulating data for its fast-growing drug Tavneos and wants it pulled from the market, but the large pharma is digging its heels in.
By Meagan Parrish • May 5, 2026 -
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Protein degraders gain speed as Arvinas scores landmark approval
Although excitement over the biotech’s “Protac” protein degrader is being tempered by narrower-than-expected clinical benefit, R&D in the field is heating up.
By Kelly Bilodeau • May 4, 2026 -
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As biosimilars gain US traction, patent thickets are under more scrutiny
A 10-year push for more biosimilars in the U.S. has led to a surge in copycat entrants, bringing more attention to the legal barriers.
By Michael Gibney • April 28, 2026 -
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FDA’s need for speed could strain small biotechs. Here’s how they can keep up.
In a more politically charged environment, getting drugs across the finish line is increasingly complex and uncertain.
By Kelly Bilodeau • April 27, 2026 -
Michael Gibney/PharmaVoice
HHS, industry leaders spar over drug pricing, TrumpRx and PBMs
Debate about drug costs erupted among prominent healthcare figures, including Dr. Oz, Mark Cuban, Calley Means and PhRMA in Washington, D.C., but they all agreed on one thing: The system is broken.
By Michael Gibney • April 23, 2026 -
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Who is Dr. Houman Hemmati, potentially CBER’s next leader?
Where the rumored frontrunner stands on key issues like vaccines and public health policy.
By Kelly Bilodeau • April 20, 2026 -
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5 notable pharma CEO pay hikes in 2025
Several of pharma’s top leaders scored large pay bumps last year, including two new chiefs who joined the “$30 million club.”
By Alexandra Pecci • April 14, 2026 -
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Will RFK Jr.’s peptide push bolster the gray market for obesity drugs?
With competition fierce in the weight loss space, a potential change to how the FDA classifies peptides could increase pressure in the market even more.
By Alivia Kaylor • April 10, 2026 -
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Tariffs are back. What does it mean now for pharma?
While the Trump administration has again levied large new tariffs, drugmakers willing to make deals could gain some relief.
By Kelly Bilodeau • April 6, 2026 -
Retrieved from NASA's Moderate Resolution Imaging Spectroradiometer.
How Trump’s war in Iran is scrambling pharma’s shipping options
A blockade at one of the world’s largest shipping lanes could shape the way pharma companies think about manufacturing and distribution.
By Michael Gibney • April 2, 2026 -
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mRNA is poised to rise beyond infectious diseases, if it’s not derailed by R&D cuts
Research into areas like cancer could become collateral damage of a broader anti-mRNA push, according to a new study.
By Alexandra Pecci • March 31, 2026 -
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The FDA’s shame game
The agency is becoming more open about its criticisms of pharma companies and leaders, raising new privacy concerns in the industry.
By Kelly Bilodeau • March 30, 2026 -
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Mixed signals cloud the orphan drug market
The field is making gains despite regulatory inconsistency, but rising competition from obesity candidates and evolving global pressures could erode orphan drugs’ market share.
By Kelly Bilodeau • March 25, 2026 -
Permission granted by Gilead Sciences
Deep DiveGilead could potentially end HIV. But will it be able to?
After launching a PrEP medication that was 100% effective in clinical trials, the company is facing a complex global rollout and leveraging its network of partners for help.
By Meagan Parrish • March 20, 2026 -
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Federal court blocks RFK Jr.’s moves to upend US vaccine policy
HHS ignored established protocols in altering the childhood immunization schedule and overhauling a CDC panel, according to the ruling.
By Delilah Alvarado • March 17, 2026 -
Permission granted by Bayer
What’s at stake for Bayer in its Supreme Court showdown?
A key case being heard by the Supreme Court could help the large pharma put its Roundup litigation to rest.
By Kelly Bilodeau • March 16, 2026 -
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Keytruda’s reign continues; pharma’s megadeal drought
Merck & Co.’s landmark cancer drug is still the industry’s bestseller despite the rise of GLP-1s — and other topics on our radar this week.
By PharmaVoice Staff • March 13, 2026 -
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New FDA guidance could elevate pharma’s biosimilar market
Biologic copycats are making a bigger impact on drug prices as U.S. regulators open the doors wider, and new guidance could improve their standing even more.
By Michael Gibney • March 12, 2026
