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Sackler family directed – and covered up – Purdue Pharma’s opioid sales tactis. Now it should pay the price says the Attorney General

April 18, 2019 The Sackler family, composed of former Purdue CEO Richard Sackler plus other family members Beverly, David, Ilene, Lefcourt, Jonathan, Kathe, Mortimer, and Theresa, controlled the Purdue board and should be held accountable for Massachusetts’ opioid epidemic, Healey said in an amended lawsuit filed in Massachusetts state court.  Along the way, they avoided leaving … Read more

Congo approves 4 more experimental Ebola drugs to fight outbreak

April 16, 2019 Congolese health authorities started administering mAb114, a monoclonal antibody developed by the National Institute of Allergy and Infectious Diseases (NIAID), on Aug. 11, 2018 Reuters reported.  The treatment is based on an antibody found in the blood of a patient who had survived an earlier Ebola epidemic in Congo.  The 10 patients … Read more

FDA creating innovation office to speed drug development

April 09, 2019 FDA Commissioner Scott Gottlieb, M.D., was due to reveal the new office in early January 2019 via videolink at the J.P. Morgan Healthcare Conference.  In creating the office, Gottlieb thinks the FDA can leverage improved understanding of biomarkers and other advances to build tools that take some of the risks and costs … Read more

Never mind the January 2019 hikes…Pharma sill puts pricing at the top of its worry list

April 06, 2019 Slightly more than half of respondents to a GlobalData survey tagged pricing and reimbursement as their biggest worry this year, the analytics firm said.  As that pricing pressure rolls on, GlobalData analysts also expect “aggressive negotiation tactics to drive down drug prices.” The survey results come as the biopharma industry flocked to … Read more

Bose wins FDA green light for direct-to-consumer hearing aid

April 02, 2019 The de novo clearance makes it the first hearing aid authorized by the Agency that allows users to fit, program and control the device on their own, without help from a healthcare provider.  The Bose Hearing Aid is a wireless amplifier placed in the ear canal that can be adjusted by the … Read more

After New Year’s, expect more drug pricing fireworks in 2019

March 28, 2019 Already since the midterms, Democratic lawmakers have floated a bill directing the Department of Health and Human Services (DHHS) Secretary to break patents and allow generic competition when U.S. branded drug prices come in above their median price in Canada, the U.K., Germany, France and Japan. Additionally, Sen. Elizabeth Warren and Rep. … Read more

‘Bad drug’ lawsuit ads hurt doc-patient relationships and need regulation, says industry coalition

March 26, 2019 Sound familiar?  Trial lawyer “bad drug” ads have proliferated for years; however, one newly formed organization is pushing back.  The Partnership to Protect Patient Health is a coalition of national physician and patient advocacy groups that believe the lawsuit advertising needs to be addressed as a healthcare issue that can disrupt physician-patient relationships. … Read more

The Apple Watch’s ECG features are live

March 21, 2019 The watch can now also track a person’s pulse in the background and send the wearer a notification if it detects what could be atrial fibrillation, the most common form of irregular heart rhythm.  The notification feature will also work with heartbeat sensors on earlier versions of the Apple Watch, alerting the … Read more

National Cancer Institute’s Sharpless to Serve as Acting FDA Commissioner

March 19, 2019 Sharpless, who has served as NCI director since October 2017, previously served as Director of the University of North Carolina (UNC) Lineberger Comprehensive Cancer Center, a position he held since January 2014.  He earned his medical degree from the UNC School of Medicine, completed his internal medicine residency at the Massachusetts General … Read more