Thermo Fisher Scientific suggested that its shareholders reject private investment firm TRC Capital's unsolicited mini-tender offer of $181.75 per share in cash for up to 1 million shares of its stock. The offer was about 4.43% lower than Thermo Fisher's closing price on Nov. 17.
A proposed update was issued by the CMS for the national coverage decision for implantable cardioverter-defibrillators. The agency said the proposed update was for "relatively minimal changes," including ending the requirement for data collection in a registry, accepting cardiac MRI for left ventricular ejection fraction diagnostic imaging and reducing waiting periods for some patients, among others.
A European research project called Liver Investigation: Testing Marker Utility in Steatohepatitis was announced to develop, validate and quantify improved diagnostic tools for nonalcoholic fatty liver disease testing. The project, with approximately $40 million in funding, will be joined by companies from the European Federation of Pharmaceutical Industries and Associations, academic experts and clinicians.
Japan gave Volpara Solutions regulatory approval for its VolparaEnterprise suite of quantitative breast imaging software as a Class II medical device. Taiwan also cleared the company's VolparaDensity and VolparaDose as Class II medical devices, but VolparaEnterprise software does not need approval because the country does not classify it as a medical device.
Shenogen Pharma agreed to collaborate with Lee's Pharmaceutical to develop and market in China the combination of Lee's ZKAB001 and Shenogen's icaritin for the treatment of late-stage cancers. Shenogen is conducting a Phase III trial of icaritin in hepatocellular carcinoma patients.
Okanagan Specialty Fruits' Arctic Apple is the first of a new group of biotech foods aimed at consumers, and it took 10 years to get it through the regulatory process and onto the market. New technologies such as CRISPR-Cas9 may help shorten that timeline, but questions remain on how these foods will be regulated.
Sinopec subsidiary Zhenhai Refining and Chemical produced aviation biofuel derived from waste cooking oil to power a Hainan Airlines flight from Beijing to Chicago. The biofuel will take better advantage of waste and help decrease carbon dioxide emissions, Sinopec said.
A study in the journal Lasers in Medical Science tested a technique called laser-induced fluorescence to measure the amount of collagen in burn tissue, which increases as healing occurs. “We have promising results in tissue samples from burn patients and with further analyses and studies, we hope to have this tool routinely used for patients in near future," lead researcher Krishna Mahato said.
Researchers found that extracorporeal shockwave therapy improved the healing of patients with digital skin ulcers because of systemic sclerosis. The controlled study, presented at the 2017 ACR/ARHP Annual Meeting, suggested the noninvasive treatment could be a therapeutic option for systemic sclerosis.