A federal judge invalidated four patents for Allergan's dry-eye drug Restasis, opening the door to possible generic competition, but no such drugs are approved yet, and the company said it will appeal. Allergan has been criticized for transferring patents for Restasis to a Native American tribe in an effort to protect itself from patent challenges.
Prohibiting ultra-high-dosage painkillers, restricting the marketing of opioids to treat chronic pain, improving access to alternative pain treatments, and intensifying efforts to squelch the supply of heroin and fentanyl are some steps the government could take to combat the opioid epidemic, according to former CDC Director Thomas Frieden and opioid policy researcher Andrew Kolodny. Frieden and Kolodny call for a twofold focus on "prevention of addiction among people not currently addicted, and treatment and risk reduction to prevent overdose and death among the millions of individuals in the United States now addicted."
The possibility of Britain exiting from the EU without a trade agreement has prompted medical device and pharmaceutical companies to draw up plans for protecting their supply chains. "Everybody is planning and regretting the fact they didn't start planning earlier," said Neil Armstrong, CEO of medtech regulations-focused consultancy firm MeddiQuest, which is now helping global companies draft their contingency plans and is itself working to relocate from the UK to Ireland in order to remain an EU-authorized representative.
Historically, medical devices have been scary and unorthodox -- and sometimes amounted to outright quackery. For example, shoe stores back in the day had foot X-rays called fluoroscopes that basically were radioactive advertising gimmicks. Yes, colors can affect people's moods, but the early 20th-century Spectrochrome took things to an extreme level when it came to its creator's claims. On the opposite side of the spectrum, some true medtech innovators sometimes went to extreme lengths. Dr. C. Walton Lillehei -- a pioneering Minnesota heart surgeon -- turned to beer hoses and a dairy pump during the1950s as he tried to save a 14-month-old baby. Read the story.
Cognition Therapeutics' CT1812, being developed as a treatment for Alzheimer's disease, has been granted fast-track status by the FDA. The company will announce the results of a Phase Ib/II study of the drug at the Clinical Trials on Alzheimer's Disease meeting in Boston next month.
Bristol-Myers Squibb's marketing application for breakthrough therapy-tagged Opdivo, or nivolumab, to be used as a treatment for patients with high-risk, advanced melanoma, has been granted priority review status by the FDA.
The FDA has given positive feedback on a late-stage study of Immune Design's CMB305, being evaluated as a treatment for patients with synovial sarcoma. The company intends to start a pivotal late-stage study to back its biologics license application filing.
A preliminary review by the FDA found that Novo Nordisk's semaglutide, a once-weekly injection, is an effective treatment for diabetes, carries only a limited risk of diabetic retinopathy and did not cause heart risk. The findings, based on an analysis of clinical trial data, revealed that semaglutide reduced blood glucose levels and resulted in greater weight loss compared with other GLP-1 receptor agonists.
Organic Tarragon has been recalled by Organic Spices because it could be contaminated with salmonella, which was discovered during an FDA routine sampling. The recalled product has the lot number OTW100134, a "best if used by" date of 12/31/20 and was shipped to 21 states via online and retail stores.
A patient at Kantonsspital Baselland in Switzerland underwent the first implantation of REVA Medical's Fantom bioresorbable scaffold, which is designed for the treatment of coronary artery disease. The scaffold is made from the company's proprietary tyrosine-derived polymer, called Tyrocore, intended for vascular scaffold applications.
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