The U.S. FDA granted Preceptis Inc. an expanded clearance for its Hummingbird Tympanostomy Tube System for office-based pediatric ear tube procedures. The device was previously cleared in children 6-24 months, but the new clearance allows in-office procedures in all children six months and older. The minimally invasive device is designed to create an incision so the ear tube can be delivered using a single pass down the ear canal, without the use of general anesthesia.
As expected, the U.S. House of Representatives passed, on a 220-207 party-line vote, a legislative package Aug. 12 that, for the first time, allows Medicare to directly negotiate some prescription drug prices, while imposing severe penalties and an excise tax on companies that refuse to negotiate or don’t comply with the government price.
Moderna Inc. has received conditional authorization from the U.K.’s Medicines and Healthcare Products Regulatory Agency for its bivalent COVID-19 booster vaccine mRNA-1273.214 (Spikevax bivalent original/omicron). The conditional approval, which covers adults aged 18 years and older, marks a new phase in the ongoing global effort to curb the COVID-19 pandemic, as the new vaccine represents the first commercial product to incorporate omicron-specific epitopes. It contains 25 micrograms each of the spike proteins of the omicron BA.1 variant and the original Wuhan strain of SARS-CoV-2.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dyad Medical, Hydrix, Preceptis.
Rapid Medical Inc. received FDA clearance for the Tigertriever 13, termed “the smallest and only adjustable thrombectomy device” for treating brain clots causing ischemic stroke. Stealing a page from aerospace engineers, Sunrise, Fla.-based Rapid Medical has developed complex, 3D “braiding” technology enabling its mechanical stent retriever to gain better access to and treat deeply embedded brain clots.
Despite new laws and enforcement efforts, protecting intellectual property (IP) rights in China remains a big challenge for companies based in the U.S. and other countries. A case in point is China’s new patent law that came into effect in June 2021. The law provides for patent term extensions and adjustments, an important consideration for the biopharma industry since the launch of drugs in China could be hampered by long regulatory review times.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Guardant Health, Thermo Fisher.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Argenx, Astrazeneca, Atyr, Everest, Maat, Menarini.
As biopharma and med-tech companies grapple with restrictive data privacy laws in the EU and China while trying to meet the demand for greater diversity reflective of the U.S. population, there’s been more of an interest in conducting clinical trials in the U.S., Stacy Amin, a partner at Morrison & Foerster LLP, told BioWorld.
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