A U.S. FDA advisory committee’s backing keeps Alnylam Pharmaceuticals Inc.’s Onpattro (patisiran) on the road to a supplemental approval in treating a rare heart disease, but it couldn’t stop the company stock from sliding. Shares (NASDAQ:ALNY) closed Sept. 14 down 8.8% at $193.06, the day after the Cardiovascular and Renal Drugs Advisory Committee voted 9-3 that patisiran’s benefits outweigh the risks in treating cardiomyopathy of transthyretin-mediated amyloidosis.
Authors of a multi-center study welcomed results from a device that works with a smartphone or tablet to capture medical images for a more detailed understanding of infected wounds. By capturing heat produced by a wound and using bacterial fluorescence, the Swift Ray 1 developed by Swift Medical Inc., may help clinicians tell the difference between inflammation and a potentially dangerous infection.
Awak Technologies Pte Ltd. raised more than $20 million in a series B round that will position the company to potentially transform the management of chronic kidney disease with its wearable and portable peritoneal dialysis (PD) device designed to enable patients with end-stage kidney disease to have dialysis on the go.
Arizona State University (ASU) reported the receipt of a patent for a device with colorimetric sensors for measuring excreted ketones in a body fluid. Additional sensors may be incorporated to measure flow rate of the body fluid, barometric pressure, humidity, and chemicals such as oxygen and carbon dioxide present in the fluid, and a system to measure metabolic rate and respiratory quotient via oxygen consumption rate and carbon dioxide production rate.
To streamline the development of biosimilars and align it with current analytical science, regulators across the globe are reevaluating a routine requirement for comparative clinical efficacy studies for biosimilar candidates.
Orthofix Medical Inc. terminated its CEO, chief financial officer and chief legal officer in a move that plunged the stock from $18.63 at Monday’s close to $13.01 by the end of Tuesday. The clean sweep of the executive suite followed the “unanimous decision by the board’s independent directors to terminate for cause Keith Valentine, John Bostjancic and Patrick Keran,” the company said in a statement that named their interim replacements. Valentine was also asked to resign from the board.
The question of third-party litigation funding has been front and center for life science companies in recent years, with one of the key considerations a lack of transparency as to the source of the funding behind much of this litigation. That lack of transparency was front and center in the Sept. 13 hearing in the U.S. House of Representatives, but the tenor of the hearing made clear that some members of Congress will stand in opposition to any reforms even though the lack of transparency is widely seen as enabling meritless litigation.
The Medical Imaging & Technology Alliance (MITA) has filed its comments for two draft Medicare rules, citing ongoing concerns over how Medicare pays for a variety of aspects of medical imaging procedures.
Australia’s Therapeutic Goods Administration (TGA) posted a Sept. 6 hazard alert for the Scandinavian Total Ankle Replacement (STAR) device by DJO Global, a subsidiary of Wilmington, Del.-based Enovis Corp. TGA said the polyethylene insert used to eliminate friction between the device’s moving parts has demonstrated a higher-than-expected fracture rate, and that the device has been delisted from the Australian Register of Therapeutic Goods (ARTg).
Instead of the bivalent COVID-19 vaccines comprising both the original and omicron BA.4/BA.5 SARS-CoV-2 strains that have been in use in the U.S. since April, the CDC’s Advisory Committee for Immunization Practices voted 13-1 Sept. 12 to recommend the universal use of updated monovalent XBB-containing COVID-19 vaccines as authorized or approved by the FDA.
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