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).
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.
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.
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.
Counterintuitively, use of cerebral embolic protection failed to reduce the incidence of stroke in the 72 hours following a transcatheter aortic valve replacement or implantation found a late-breaking clinical trial presented at ACC.25, the American College of Cardiology’s annual scientific session held March 29-31 in Chicago and simultaneously published in the New England Journal of Medicine.
CMR Surgical Ltd. secured more than $200 million in funding to bring its surgical robotic system, Versius, to the U.S. market and expand elsewhere. The financing, which came in the form of equity and debt, is “highly important” for the company and comes at the right time as it is “expanding and growing nicely,” company CEO Massimiliano Colella told BioWorld.
The renal denervation patent wars are now in full swing, with Medtronic plc and Recor Medical LLC landing the first blow in this chapter of the med tech patent struggles.
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.
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.
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.