Farmington, Conn.-based biotech startup Lambdavision Inc. is preparing to test the benefits of microgravity in producing its protein-based artificial retina, thanks to a $5 million, three-year award from the National Aeronautics and Space Administration (NASA). The first-of-a-kind treatment aims to restore vision to people who have lost all or much of their sight due to advanced retinitis pigmentosa (RP). Read More
The U.S. FDA reported that it has expanded the emergency use authorization for the Labcorp polymerase chain reaction (PCR) test for SARS-CoV-2 to include the company’s Pixel self-collection kit, a development that may presage a wider testing paradigm that is needed to restore the U.S. economy to normalcy. Read More
Pi-Cardia Ltd. has raised a $27 million round of financing led by Sofinnova Partners. The Rehovot, Israel-based company will use the round to back parallel U.S. feasibility and European pivotal trials of its catheter-based, nonimplant heart valve calcification treatment. Read More
Biofourmis Inc. has acquired Los Angeles-based Gaido Health from Takeda Pharmaceuticals in a move designed to significantly expand the company's oncology offerings. Gaido Health's solution will be integrated into Boston-based Biofourmis' Biovitals platform, enhancing its ability to remotely monitor oncology patients at home using a single sensor. Read More
With a coronavirus task force briefing unfolding at the White House late on April 17, an FDA eager to show its ongoing commitment to tackling other disease amid the pandemic, granted accelerated approval to Incyte Corp.'s Pemazyre (pemigatinib), the first treatment approved for adults with certain types of previously treated, advanced cholangiocarcinoma. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brainlab, Inspire Medical Systems, Labcorp, Roche. Read More
Keeping you up to date on recent developments in oncology, including: Targeted Interleukin-12 heats up cold tumors; Therapy allows immune system to ‘manganese’ up against cancer; Proton therapy less toxic than IMRT in new study; Technetium supplies struggling under distribution headaches. Read More