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Regulatory
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IgAN again: Novartis gets second approval in rare kidney disease

April 3, 2025
By Lee Landenberger
The U.S. FDA’s accelerated approval of Vanrafia (atrasentan) from Novartis AG for primary immunoglobulin A nephropathy (IgAN) is the company’s second approval for the indication in the past year and a half. The nod also came without a required safety program through a black box warning.
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Face with digital focus on eye

Reproxalap rapped again in DED; second Aldeyra CRL

April 3, 2025
By Randy Osborne
Aldeyra Therapeutics Inc. is hoping that research already underway will satisfy the U.S. FDA, which delivered to the company another complete response letter (CRL) related to the NDA for reproxalap in dry eye disease (DED).
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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 3, 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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DNA testing illustration

With ‘wholesale assault’ on research, bipartisan alarm at institutional failure

April 3, 2025
By Anette Breindl
Biomedical research seems like it should be the ultimate bipartisan issue. But under the Trump administration, unless and until Congress regains its will to make use of its constitutional powers, bipartisan support for research seems to be a thing of the past. On March 3, members of the National Academies of Science, Engineering and Medicine warned that the second Trump administration has been waging a “wholesale assault” on American research.
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Caution tape displaying US flag, tariffs

Biopharma exempt from US reciprocal tariffs, but not untouched

April 3, 2025
By Mari Serebrov
At first glance, it appears that biopharmaceuticals dodged the latest U.S. tariff bullet; med-tech, not so much. According to the executive order President Donald Trump signed in the Rose Garden late yesterday, pharmaceuticals are one of the few things exempt from the new country-by-country reciprocal tariffs that will be going into effect over the next week. However, U.S.-based manufacturers of both drugs and devices could face supply chain disruptions, further market restrictions and increased operating costs as the new tariffs take effect and other countries retaliate.
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Medtronic, Recor commence hostilities over RDN patents

April 2, 2025
By Mark McCarty
The renal denervation patent wars are now in full swing, with subsidiaries of Medtronic plc and Recor Medical LLC, landing the first blow in this chapter of the med tech patent struggles.
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AI-generated digital horse illustration

MHRA’s AI Airlock program includes a generative AI tool

April 2, 2025
By Mark McCarty
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) unveiled the pilot version of its AI Airlock in 2024, and the agency posted a list of the products that are taking part in this version of a regulatory sandbox.
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GE Healthcare

GE Healthcare taps into Japan radiopharma market with Nihon buy

April 2, 2025
By Marian (YoonJee) Chu
GE Healthcare Technologies Inc. gained full ownership of Nihon Medi-Physics Co. Ltd. after acquiring the remaining 50% stake from Sumitomo Chemical Co. Ltd. on March 31.
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Pills, bottle atop $100 bill

US to impose ‘kind reciprocal’ tariffs on country-by-country basis

April 2, 2025
By Mari Serebrov
After several on-again, off-again tariff threats, U.S. President Donald Trump made it official April 2: Beginning immediately, the U.S. will levy “kind reciprocal” tariffs on countries across the world. Focusing on the numbers, Trump didn’t mention whether any goods would be exempt from the new tariffs, and the executive order he signed at the Rose Garden ceremony wasn’t available as of press time. However, in concluding his remarks, Trump said the pharmaceutical industry would “come roaring back” in the U.S., because if biopharma companies don’t, they will be facing big taxes.
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US flag and HHS logo

Kennedy called to Senate HELP hearing on HHS reorg

April 2, 2025
By Mari Serebrov
U.S. Sens. Bill Cassidy, R-La., and Bernie Sanders, I-Vt., invited Robert Kennedy to testify April 10 before the Senate Health, Education, Labor and Pensions (HELP) Committee for the first time in his capacity as Health and Human Services (HHS) secretary. The HELP invitation went out April 1 amid an outcry as thousands of employees across HHS agencies were being notified of their immediate termination and many lawmakers demanded answers about the mass layoffs.
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