California Gov. Jerry Brown signed into law "right to try" legislation that allows drug manufacturers to provide terminally ill patients with investigational drugs not yet approved by the FDA. The Right to Try Act covers terminally ill patients who have been previously treated with other FDA-approved drugs.
The FDA on Wednesday gave Medtronic approval for its MiniMed 670G, an artificial pancreas that features a glucose sensor and an insulin pump, allowing the device to monitor blood glucose every five minutes and infuse insulin as needed. The device, which is expected to be available next spring, is indicated for patients with type 1 diabetes ages 14 years and older.
The US government has awarded Carestream a Digital Imaging Network-Picture Archiving and Communication System contract worth up to $150 million to continue providing government facilities with medical image management products and services. The deal, which includes a five-year base contract and a five-year option period, will include Carestream's Vue Motion universal viewer, Vue Beyond management dashboard, MyVue patient portal and Clinical Collaboration Platform.
Monsanto has entered into a licensing deal with the Broad Institute of MIT and Harvard to access CRISPR-Cas9 gene-editing technology for agricultural use. The agreement excludes use of the technology for gene drives and the development of sterile seeds.
Boehringer Ingelheim and Austrian biotech firm ViraTherapeutics will collaborate to develop the latter's oncolytic virus therapy platform and vesicular stomatitis virus glycoprotein lead candidate in a deal worth up to about $235 million. Boehringer also gains the rights to acquire ViraTherapeutics after early-stage development of VSV-GP.
Food flavorings sometimes come from unexpected or synthetic sources, and the FDA advises consumers concerned about ingredients to read product ingredient lists carefully. Labels must state whether flavorings are derived from artificial sources, the FDA said in a consumer update, and the word "-flavored" is one indicator that flavorings are not 100% pure.
Mediation to resolve the dispute between Alere and Abbott Laboratories over their pending $5.8 billion merger agreement has ended without resolution, according to Alere's filing with the SEC. Alere said its lawsuit, which seeks to force Abbott to complete the deal and promptly meet regulatory requirements, is still pending.
An iHealthcareAnalyst report predicts the worldwide minimally invasive surgery market will reach $9.8 billion by 2020 with a 6.4% compound annual growth rate due to technological advancements. Abbott Laboratories, Zimmer Biomet, Intuitive Surgical, DePuy Synthes, Medtronic, Philips Healthcare and Stryker are among the leading market players.
Early-stage biopharmaceutical companies and patient advocacy groups increasingly work together to raise awareness and funds, design and fill clinical trials, and bring promising therapies to market. "The science should not be dictated by patients, but the patients' voice should be heard," said Annie Ganot, head of patient advocacy at Solid Biosciences.
A case study in the New England Journal of Medicine describes a 38-year-old Utah man who likely contracted the Zika virus from direct contact with the tears and sweat of his father, who had a Zika infection. Researchers suggested the father had highly elevated levels of the virus.
- Page 1