No matter what level of tariff the Trump administration ends up imposing on biopharmaceuticals across the world, drugs and their precursors originating in the EU will face no more than a 15% tariff when imported to the U.S., according to an Aug. 21 EU-U.S. joint statement regarding the trade framework agreement between the two trade partners.
Showing similar results as the first phase III trial completed in 2022, Nicox SA’s nitric oxide-donating bimatoprost eye drop, NCX-470, met the primary endpoint in the phase III Denali trial for open-angle glaucoma or ocular hypertension, clearing the way for regulatory filings in both the U.S. and China.
A new method for accelerating the maturation of neuronal cell models and brain organoids is poised to make it possible to track the etiology of neurodegenerative diseases that develop over decades. The non-invasive technique uses graphene to convert light into electrical cues that prompt neurons to connect and communicate in vitro.
The Medicare Payment Advisory Commission said in a recent report that Medicare spending in the U.S. is poised to nearly double to $1.9 trillion over the coming eight years, a figure that is likely to apply ever-increasing price pressures on makers of devices and diagnostics.
A new method for accelerating the maturation of neuronal cell models and brain organoids is poised to make it possible to track the etiology of neurodegenerative diseases that develop over decades.
With a few tweaks to the protocol, Rocket Pharmaceuticals Inc.’s phase II trial testing RP-A501 in Danon disease is expected to resume following the lifting of the clinical hold, issued by the U.S. FDA in May in response to the death of a patient in the pivotal gene therapy study.
Onward Medical NV secured U.S. FDA investigational device exemption (IDE) approval for a pivotal study to assess the safety and efficacy of its implantable spinal stimulation technology, the ARC-IM system. The Empower study BP study will focus on addressing blood pressure instability in patients with spinal cord injury (SCI).
The U.S. Court of Appeals for the Federal Circuit has overturned a jury finding that Labcorp Inc. was entitled to damages of $4.7 million in a dispute with Qiagen Inc. The case presented another test of the doctrine of equivalents and affirmed that this doctrine has its limits where accusations of infringement are concerned.
The amount of money raised through global biopharma IPOs in the first seven months of 2025 is at the lowest level since 2016, and more than half of the 13 completed through July were done on ex-U.S. exchanges. Only five of the companies have U.S. roots, while the rest are based in Asia: four in China, two in South Korea, one in Taiwan and one in Hong Kong.
For more than 30 years, the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP) worked together to harmonize their evidence-based vaccine schedules. Not anymore.
RSS
