The first weekly therapy for adult growth hormone deficiency (GHD) has arrived in the U.S. with FDA approval for Novo Nordisk A/S' Sogroya (somapacitan). It’s the first of Novo's regulatory filings for the medicine, also submitted in the EU and Japan, to win approval. Sogroya replaces endogenous growth hormone in adults who don't produce enough of it. Novo said it is working to finalize plans to make the therapy available and has not yet disclosed pricing.
Two days ahead of its Sept. 3 PDUFA date, Bristol Myers Squibb Co. received the FDA’s approval for Onureg, an oral form of azacitidine, for continuing treatment of adults with acute myeloid leukemia (AML). The indication is specifically for patients achieving first complete remission (CR) or CR with incomplete blood count recovery following intensive induction chemotherapy and who are not able to complete intensive curative therapy. BMS said Onureg is the first and only FDA-approved continued AML treatment for patients in complete remission.
Baxter International Inc. has scored a win from the U.S. FDA, which has granted the de novo application for Theranova, the company’s novel dialysis membrane. For his part, Cowen’s Josh Jennings noted that de novo designations are rare in the dialysis space, echoing a company statement. “We think the de novo classification strengthens any argument for the uniqueness of the technology, which should help its commercial experience,” he added. “BAX had expected an FDA clearance in [second half of] '20, so this action falls on the early end of that range.”
The U.S. Centers for Medicare and Medicaid Services (CMS) capped off the month of August 2020 with one of the more significant Medicare coverage documents in recent memory. The more immediately impactful part of the proposed rule would offer immediate coverage for devices approved or cleared under the FDA’s breakthrough devices program, but the broader element of this proposed rule offers a definition for the term “reasonable and necessary,” a development that itself constitutes a breakthrough in the world of Medicare coverage of medical technology.
In a bid to build public confidence and demonstrate its transparency in determinations about potential COVID-19 vaccines, the FDA will convene its Vaccine Advisory Committee for a virtual meeting Oct. 22 to discuss the general development of the vaccines for the U.S. market.
Neurovascular bioelectronics medicine company Synchron Inc. has received good news in the form of a breakthrough device designation for its Stentrode. The U.S. FDA granted the designation for the fully implantable medical device that can translate brain activity or stimulate the nervous system from inside a blood vessel. As a bonus for patients, the device does not require open brain surgery. “As this is a first-of-its-kind device, we look forward to working closely with the FDA to prioritize development of the Stentrode and ensure access for patients with paralysis, as well as lay the groundwork for future indications for brain-computer interfaces,” said Thomas Oxley, CEO of Synchron.
Foundation Medicine Inc.’s string of 2020 wins continues, with the U.S. FDA giving its thumbs up to Foundationone Liquid CDx, the company’s comprehensive pan-tumor liquid biopsy test.
The U.S. Department of Justice (DOJ) unveiled two interim final rules intended to deal with enforcement activities in connection with policies enunciated over the past four years, including the so-called Brand memo, which banned federal prosecutors from using federal agency guidance as leverage in prosecutions of private-sector entities.
The U.S. FDA has cleared the way for Abbott Laboratories sixth COVID-19 test, a near-patient, point-of-care antigen test that gives results in 15 minutes and can be run without laboratory equipment. The company has priced the Binaxnow COVID-19 Ag Card rapid test at $5 and is offering a complementary mobile app that allows people to display their test results when asked by organizations for verification.
With the FDA approval of Cassiopea SpA’s Winlevi (clascoterone cream 1%) to treat acne in patients 12 years and older, the European company hailed it as the first acne drug in 40 years with a new mechanism of action.
RSS
