The CMS issued a final rule that requires Medicare Advantage and Part D plans to offer a drug cost transparency tool that can be integrated into prescribers' EHRs and also requires Part D plans to share price transparency and low-cost alternative information in monthly letters to beneficiaries. The final rule also bans contract clauses that restrict pharmacist-patient conversations about drug prices, but it does not include measures requiring price concessions to be passed to consumers, nor does it include proposed changes to management of protected drug classes.
A select recall of Ethicon's Endo-Surgery endoscopic and non-endoscopic staplers with adjustable height staples has been labeled Class I by the FDA. The Johnson & Johnson subsidiary issued the recall following issues with uncut washers and malformed staples caused by insufficient firing.
Masimo has received 510(k) clearance from the FDA for its Radius PPG, a Masimo SET-powered tetherless sensor solution to continuously monitor patients while allowing them to move freely. The product makes a cabled connection to a pulse oximetry monitor unnecessary.
Johnson & Johnson division Biosense Webster has unveiled the CARTONET platform, a cloud-based network to enable health care providers and health systems to share and review data involving ablation procedures, including those from the company's CARTO 3 mapping system. The network will allow data to be accessed via laptops or tablets and will provide statistics through a clinical dashboard.
Abiomed will release its Impella CP with SmartAssist at the Society for Cardiovascular Angiography & Interventions Scientific Sessions. The product comes with improvements to simplify patient management, integrate clinical data informatics and make the product easier to use.
MorphoSys announced the completion of its midstage trial that assessed its lead candidate, MOR208, in combination with Celgene's Revlimid, or lenalidomide, as a treatment for patients who have relapsed or refractory diffuse large B cell lymphoma and are not eligible for autologous stem cell transplantation and high-dose chemotherapy. Data show the study achieved its primary endpoint, with a 60% objective response rate among the 80 participants and a complete response rate of 43%.
Rigel Pharmaceuticals has started enrollment for patients participating in its late-stage clinical study to evaluate its drug Tavalisse, or fostamatinib disodium hexahydrate, for the treatment of warm antibody autoimmune hemolytic anemia. The 24-week study will test the drug in approximately 80 patients, with topline data expected to be available in early 2021.
All children with tumors that have ALK, ROS1 or NTRK1/2/3 gene fusions or ALK mutations who received entrectinib, an investigational tyrosine kinase inhibitor, had "rapid and durable" treatment response, according to a study to be presented at the American Society of Clinical Oncology's annual meeting. "Although the target fusions are rare and the chances of finding the fusion may be low, clinicians should be looking for these gene aberrations because the impact of therapy is very promising -- especially when alternative treatment options are limited," said researcher Dr. Giles Robinson.
Genentech has acquired rights to develop and market Parvus Therapeutics' Navacim nanoparticle therapeutics for the treatment of inflammatory bowel disease, celiac and autoimmune liver diseases. Under the terms of the deal, Parvus will get an undisclosed upfront payment plus milestone payments for each indication and royalties.
Beijing Capital Agribusiness has acquired the license to Britain-based Genus' virus-resistant biotech pigs. Under the terms of the deal, Genus will get upfront and milestone payments of $20 million, and Beijing Shou Nong Future Bio-Tech, which will soon be launched by BCA, will fund the development of the pigs, which are resistant to porcine reproductive and respiratory syndrome, and seek its regulatory approval in China.
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