Policy & Regulation: Page 2


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    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
  • Trendline

    Artificial 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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    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
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    Executives want in, but researchers want out — how pharma’s US job picture is changing

    While academics are eyeing friendlier work opportunities abroad, America’s manufacturing boom is drawing industry leaders to its shores.

    By Alexandra Pecci • March 10, 2026
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    What 3 recent FDA rejections reveal about shifts inside the agency

    The FDA’s approval strategy has been difficult to pin down, but recent decisions provide clues for how some of the most volatile initiatives will play out.

    By Alexandra Pecci • March 4, 2026
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    How PBM reforms could push drugmakers into the pricing spotlight

    The Consolidated Appropriations Act's landmark PBM overhaul removes financial incentives tied to pharma list prices, potentially leaving drugmakers to defend their own practices.

    By Alivia Kaylor • Feb. 27, 2026
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    Biohaven says FDA roadblocks leave rare disease patients in limbo

    An FDA rejection last year for a rare disease drug from Biohaven reflects the amount of work left to get patients the treatments they need, the company says.

    By Michael Gibney • Feb. 26, 2026
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    Will the FDA yank mRNA vaccines?

    Adding increased obstacles and sowing safety doubts may be enough to chill mRNA vaccine use and development.

    By Alexandra Pecci • Feb. 24, 2026
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    How does the FDA really feel about psychedelics? We could soon find out.

    Compass Pathways’ psilocybin-based drug is edging closer to an approval but faces mixed signals from officials.

    By Kelly Bilodeau • Feb. 23, 2026
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    Will vaccine regulatory uncertainty chill innovation? Pharma execs sound off.

    Moderna’s clash with U.S. health agencies over its flu shot reflects a difficult time for vaccinemakers, but many are still playing the waiting game.

    By Michael Gibney • Feb. 19, 2026
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    New FDA guidance that’s a ‘huge deal’ for clinical trials

    Why using Bayesian statistics could transform trial design for rare diseases and beyond.

    By Kelly Bilodeau • Feb. 10, 2026
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    Why TrumpRx is stumbling before it gets off the ground

    Concerns about potential kickbacks, costs and conflicts have triggered calls for oversight.

    By Kelly Bilodeau • Feb. 4, 2026
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    AI regulation lags despite entering higher-risk patient care

    While more pharma companies launch DTC platforms, states, not the federal government, are providing guardrails to protect patient privacy and safety.

    By Kelly Bilodeau • Feb. 2, 2026
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    Year in Preview

    Pharma’s outlook in 2026: Smoother sailing ahead?

    After a turbulent year, the industry has a clearer picture of its new landscape and how to navigate the challenges and opportunities ahead. 

    By Jan. 30, 2026
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    Q&A

    Politicization runs deeper than ever at FDA, risking long-term impacts

    Wide-ranging shifts at the FDA have set the stage for decisions that drag the agency through the political mud, according to an economist and public policy expert.

    By Michael Gibney • Jan. 29, 2026
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    Has Novavax cracked the code for survival in the vaccine arena?

    The company’s new partnership with Pfizer is worth up to $530 million — and could be just the beginning.

    By Jan. 28, 2026
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    Biopharma layoffs surged last year, but 2026 is a chance to turn the page

    Companies are adjusting to turbulence in the U.S. market, and more traditional job loss factors will likely be at play in the coming year.

    By Kelly Bilodeau • Jan. 26, 2026
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    US drug pricing policies are ‘red lights’ for investors, and China beckons

    Pricing policies like most-favored nation and the Inflation Reduction Act, as well as a destabilized FDA, are pushing investors to look outside the U.S.

    By Michael Gibney • Jan. 22, 2026
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    Lilly, Takeda targeted by legal strategy usually reserved for the mob

    A case targeting alleged fraud around the safety risk of a blockbuster diabetes drug is leveraging the RICO pathway and could have a ripple effect in pharma.

    By Kelly Bilodeau • Jan. 20, 2026
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    Trump unveils healthcare affordability plan

    The “Great Healthcare Plan” is vague, but would send money directly to ACA enrollees and entrench Trump’s drug pricing deals.

    By Rebecca Pifer Parduhn • Jan. 16, 2026
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    Lilly, Novo test direct-to-employer approach that could cut out PBMs and lower costs

    The GLP-1 giants are the first to try out this new model, but more companies may follow. 

    By Kelly Bilodeau • Jan. 14, 2026
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    The wellness industry is HHS’ new belle of the ball

    Congressional leaders and health experts are sounding the alarm about potential conflicts of interest among the agency’s new leaders.

    By Kelly Bilodeau • Jan. 8, 2026
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    Year in Preview

    5 FDA drug approvals to watch in 2026

    Potential blockbusters and root-cause treatments from Eli Lilly, Merck, Takeda and others could get a regulatory nod this year.

    By Alexandra Pecci • Jan. 7, 2026
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    Opinion // Year in Preview

    PharmaVoice’s Crystal Ball: Market and policy forces shaping the industry

    How pharma leaders believe the regulatory and investment market landscape will change in 2026. 

    By Jan. 6, 2026
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    Biopharma CEO optimism is wavering in the US

    The overall leadership outlook was positive in a recent survey but varied between executives in the U.S. and those overseas.

    By Kelly Bilodeau • Dec. 22, 2025