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Home » Topics » Regulatory

Regulatory
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US-China trade war accelerates with biotech in the crosshairs

April 9, 2025
By Tamra Sami
The U.S. National Security Commission on Emerging Biotechnology (NSCEB) is urging Congress to reinvest in American biotechnology because “the U.S. is dangerously close to falling behind China,” according to a May 8 report. "The United States is locked in a competition with China that will define the coming century," said NSCEB Chair Senator Todd Young (R-Ind.). “Biotechnology is the next phase in that competition. It is no longer constrained to the realm of scientific achievement. It is now an imperative for national security, economic power and global influence.”
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Pill bottle spilling over EU flag

Many US tariffs paused, pharma warned, EU put on notice

April 9, 2025
By Mari Serebrov
The on-again, off-again U.S. tariffs are off again, at least for now, for more than 75 countries that have reached out to the Trump administration to negotiate instead of retaliating. The 90-day pause will provide some breathing room for the med-tech industry. Pharmaceuticals and active pharmaceutical ingredients were among the few products exempted from the reciprocal tariffs, but that exemption for pharmaceuticals was expected to be short-lived. Meanwhile, pharma CEOs warned European Commission President Ursula von der Leyen April 8 that, unless the EU quickly changes its policy, pharmaceutical research, development and manufacturing is increasingly likely to be directed to the U.S.
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Chinese flag and pills

China clears more first-in-class innovative drugs than ever before

April 8, 2025
By Tamra Sami
China approved 48 first-in-class innovative drugs, as well as a significant number of medications for pediatric and rare diseases, thanks to measures aimed at enhancing review efficiency and accelerating patient access to novel therapies, according to a report released by China’s National Medical Products Administration.
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Globe isolated on white background with focus on Asia and Australia

Asia in firing line of Trump tariffs, but health care escapes largely unscathed

April 8, 2025
By Tamra Sami
Following news of U.S. President Donald Trump’s 10% across-the-board tariffs on Australian exports to the U.S., Australia’s Securities Exchange shed nearly AU$55 billion in losses Thursday morning. Even so, pharmaceuticals have escaped the tariffs for now. In China, Trump’s tariffs are not a big concern for China’s health care because drugs and active pharmaceutical ingredients are exempted from the tariffs. Even if tariffs are imposed in the future, Chinese pharmaceutical companies have already significantly de-risked themselves in recent months by increasing out-licensing models with U.S. partners.
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South Korea clears world’s first recombinant anthrax vaccine

April 8, 2025
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety on April 8 cleared Barythrax injection (GC-1109) as the world’s first recombinant anthrax vaccine. The product was codeveloped by GC Biopharma Corp. and Korea Disease Control and Prevention Agency.
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Collection of vials

Much-needed predictability lacking in US biosimilar market

April 8, 2025
By Mari Serebrov
Ill-considered government policies, pharmacy benefit manager market abuses and an unpredictable future are casting doubt on the long-term sustainability of the U.S. biosimilar market, Craig Burton, the executive director of the Biosimilars Council, told a House Ways & Means subcommittee April 8.
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3D illustration and light micrograph of lung cancer.
Immuno-oncology

FDA clears Curevac’s IND for CVHNLC

April 8, 2025
Curevac NV announced that the FDA has cleared its IND application for a phase I clinical study of CVHNLC in patients with squamous non-small-cell lung cancer (sqNSCLC). CVHNLC is Curevac’s investigational mRNA-based precision immunotherapy.
Read More
Edwards Lifesciences - Evoque tricuspid valve replacement device

CMS rolls out draft coverage memo for TEER for the tricuspid valve

April 7, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services (CMS) issued a draft coverage memo for transcatheter edge-to-edge repair for the tricuspid valve (T-TEER), which is a development that promises accelerated competition for this anatomical space.
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US flag, gavel, book

Diopsys agrees to $14M settlement over FCA allegations

April 7, 2025
By Mark McCarty
Diopsys Inc. agreed to pay $14.25 million to settle allegations it violated the False Claims Act (FCA) in encouraging the unnecessary use of the company’s Nova device for retinal testing.
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CMS rule ditches plan for Medicare coverage of obesity drugs

April 7, 2025
By Jennifer Boggs
A late 2024 CMS proposal to include obesity drugs like Novo Nordisk A/S’ Wegovy (semaglutide) and Eli Lilly and Co.’s Zepbound (tirzepatide) under Medicaid and Medicare didn’t make it far under the new U.S. administration. A final rule, set to be published in the Federal Register April 15, will not include the provision that would have added obesity drugs to Part D coverage beginning in 2026.
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