Policy & Regulation
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Why FDA’s CRL release could open the door to lawsuits against pharma
In a push for “radical transparency” the FDA released 200 CRLs for drugs that were later approved — some of which are now public for the first time.
By Meagan Parrish • July 18, 2025 -
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FDA invites more data from abroad — with a wary eye on China
The FDA approved four drugs last year without any U.S. trial participants, but has maintained a tougher stance on China, even as it grows into an R&D powerhouse.
By Amy Baxter • July 16, 2025 -
Explore the Trendline➔
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TrendlineCommercialization, marketing and social media
As the pharma industry stares down a historic patent cliff, macroeconomic headwinds and challenging R&D costs for increasingly complex medicines, nailing the launch of new medicines has become increasingly critical.
By PharmaVoice staff -
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Biotech IPO momentum gained steam last year, but market ‘turmoil’ has slowed the train again
The IPO market is a mixed bag in 2025, with some signs of life but several headwinds keeping activity relatively low.
By Michael Gibney • July 15, 2025 -
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Pricing watchdog will take on the rising cost of drugs at launch
ICER’s upcoming report could shed light on how the launch price of newly approved drugs affects overall cost and access from a patient perspective.
By Michael Gibney • July 10, 2025 -
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Trump says ‘very high’ pharmaceutical tariffs coming soon
While Trump indicated drug levies would be as high as 200%, he added that pharma firms would first be given time to bring manufacturing back to the U.S.
By Philip Neuffer • July 9, 2025 -
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Can China sustain a surge in oncology drug innovation?
The country’s trajectory may get a boost from anticipated results of a Keytruda rival’s U.S. trials.
By Kelly Bilodeau • July 2, 2025 -
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FDA’s new mission to speed drug reviews
FDA Commissioner Dr. Marty Makary is leading a handful of controversial new initiatives to make the drug review process more streamlined.
By Amy Baxter • June 30, 2025 -
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3 of the year’s most notable FDA nods
The agency has granted approvals steadily in the first part of the year, including nods for several breakthrough therapies.
By Meagan Parrish • June 27, 2025 -
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CDC panel, newly remade by RFK Jr., questions vaccine evidence
New members of the ACIP panel raised questions about the evidence supporting COVID vaccines, and signaled plans to look at other established shots, like those for measles and hepatitis B.
By Delilah Alvarado • June 26, 2025 -
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Biopharma is on edge about NIH funding cuts and what the future holds for research
Proposed cuts to public funding for early science have led to an outcry in scientific circles. For biopharma leaders, the effects are still up in the air.
By Michael Gibney • June 26, 2025 -
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Is DTC pharma advertising coming to an end?
A bill introduced in Congress fulfills a Trump administration goal of ending direct pharma ads to patients.
By Amy Baxter • June 18, 2025 -
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FDA to speed reviews for drugs supporting ‘national interests’
A new pilot program announced by FDA Commissioner Dr. Martin Makary would award vouchers that could cut drug reviews to one or two months — but only for products that meet a special criteria.
By Jonathan Gardner • June 18, 2025 -
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How a patient group tackled research diversity for one disease and triggered change for pharma
A policy win by the Foundation for Sarcoidosis Research has built momentum for other shifts that could bolster diversity in clinical trials.
By Meagan Parrish • June 17, 2025 -
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Locked in a federal stalemate, states take PBM reform into their own hands
Arkansas is leading the nation in banning PBMs from owning pharmacies, as other states advance new restrictions.
By Amy Baxter • June 16, 2025 -
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Will pharma finally score a policy win for 340B?
The industry is awaiting guidance on a rebate approach to the contentious drug discount program for hospitals and aiming for tighter oversight.
By Kelly Bilodeau • June 16, 2025 -
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Pharma’s wins and losses in the budget bill
Key pharma reforms are up in the air as Republicans battle over their mammoth legislation that includes significant healthcare spending cuts.
By Amy Baxter • June 11, 2025 -
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COVID vax restrictions may not hamper uptake — but the market is still under pressure
If insurers stop covering the shots and approvals become more restrictive, the most recent policy shifts could heap more challenges onto pharma’s vaccine space.
By Alexandra Pecci • June 10, 2025 -
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FDA’s Elsa AI is here, and the industry has questions
The agency has provided few details about its AI pilot as it makes moves on its “aggressive timeline” for rollout.
By Amy Baxter • June 5, 2025 -
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Biotech CEO confidence hits rock bottom amid policy shifts
A new survey sheds light on the way early-stage company leaders are grappling with regulatory headwinds.
By Meagan Parrish • June 4, 2025 -
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COVID’s remaining biotech contenders navigate a dwindling market
With policy and funding evolving, companies are being forced to rethink strategies.
By Kelly Bilodeau • June 2, 2025 -
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The MAHA agenda won’t include expanding GLP-1 coverage — for now
Despite axing a Biden-era proposal for government coverage of obesity drugs, health officials have signaled a potential path forward.
By Amy Baxter • June 2, 2025 -
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What’s next for Trump’s ‘most favored nation’ policy?
HHS set drug price targets last week for pharma manufacturers, while lawmakers proposed new reforms.
By Amy Baxter • May 27, 2025 -
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The placebo effect: How a new FDA rule could pile more strain onto vaccine developers
The proposed plan would require placebo testing for all new vaccines and could mean additional costs and time for R&D.
By Alexandra Pecci • May 20, 2025 -
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With the third round of Medicare price negotiations on the way, here’s how the policy is shifting
HHS issued guidance for the third cycle, teeing up another 15 drugs to be selected by early next year.
By Amy Baxter • May 19, 2025 -
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Tracking a moving target: Drugmakers brace for a looming tariff impact
With policies in flux, companies seek to be proactive and understand their supply chain.
By Kelly Bilodeau • May 19, 2025
