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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.
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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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Chinese flag and pills

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

April 7, 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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Judge's gavel with US flag

US court says no to NIH indirect rate cut, another suit filed

April 7, 2025
By Mari Serebrov
The nationwide preliminary injunction keeping the U.S. NIH from slashing its indirect cost rate to a flat 15% has become permanent. In issuing the permanent injunction and final judgment April 4 in three challenges to the rate change, Judge Angel Kelley, of the U.S. District Court for the District of Massachusetts, said the NIH’s Feb. 7 notice that it would begin imposing the 15% rate Feb. 10 to all existing and future grants violated the Administrative Procedure Act, as the action was arbitrary and capricious, was impermissibly retroactive and failed to follow notice-and-comment procedures.
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CMS logo and website

US Senate confirms Mehmet Oz as CMS administrator

April 4, 2025
By Mark McCarty
Mehmet Oz won the U.S. Senate’s nod as the administrator of the Centers for Medicare & Medicaid Services. Oz brought in 53 aye votes to 45 nays in the Senate’s April 3 confirmation tally, and inherits a complicated task as the Medicare breakthrough devices coverage program continues to face substantial challenges.
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