Regulatory
For patients with diabetes, the new indication could become a key for survival as there is a well-established link between cardiovascular disease and type 2 diabetes.
Recipharm AB, through its directly wholly-owned subsidiary Recipharm Holdings Limited, published an offer document setting out the full terms and conditions of its recommended cash offer to acquire the entire issued and to be issued share capital of Consort Medical plc .
As the J.P. Morgan Healthcare Conference winds down for 2020, one of the big topics was the general lack of big deals. Still, there were some general trends and for today, some news.
Investigators found that the U.S. Food and Drug Administration is approving drugs faster than ever. Unfortunately, it appears that the agency is also approving those drugs on less data and weaker evidence.
In a painful blow to the San Francisco-based company, the committees voted unanimously, 27 to 0, not to recommend approval.
The Institute of Cancer Research, London, strongly welcomes the recommendation by the Scottish Medicines Consortium to make the prostate cancer drug abiraterone, when given alongside hormone therapy, available to men with advanced prostate cancer as first-line treatment on the NHS in Scotland.
Auris Medical Holding Ltd. announced that the European Patent Office has issued a notice of “Intention to Grant” for its patent application entitled “Treatment of Tinnitus Through Modulation of Chloride Co-Transporter NKCC1 in the Auditory System”.
Joe Rymsza, vice president of Pharmacovigilance and Regulatory Technology Solutions for IQVIA, took time out to discuss trends in PV and regulation in the biopharma industry in the coming year.
With a new year underway, the U.S. Food and Drug Administration is doing some house-cleaning of sorts.
The State of California is considering a measure to sell its own brand of generic drugs in an effort to get in on those cost-savings. California’s Gov. Gavin Newsom is expected to reveal the scheme today in his new state budget.
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