11 Mar 2019

PATIENTS NEED TRANSPARENCY AND RELIEF FROM HIGH DRUG COSTS, NOT DEFENSE OF THE STATUS QUO

By: John O’Brien The current drug pricing system is broken and indefensible. Right now, everybody but the patient benefits as list prices climb higher and higher. President Trump has proposed to bring transparency to the system, end the status quo of kickbacks from drug companies to middlemen and plans, known in

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07 Mar 2019

FDA COMMISSIONER SCOTT GOTTLIEB RESIGNS

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, resigned March 5, but will remain in his position until April 5. Dr. Gottlieb, who has led the FDA since May 2017, did not offer a reason for his departure in his resignation letter, although he included: “We were strong

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06 Mar 2019

FIRST STEP: LILLY RELEASES HUMALOG GENERIC, SLASHING INSULIN LIST PRICE IN HALF

    Lilly has released Lispro, a generic form of its insulin drug of Humalog, cutting the list price in half and ideally reducing out-of-pocket patient costs. Insulin Lispro will go for $137.35 per vial or $265.50 for a pack of five KwikPens. Because Humalog and Lispro are fast-acting forms of insulin,

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19 Feb 2019

DOJ DEFENDS APPROVAL CONSIDERATIONS IN CVS-AETNA MERGER

As a federal judge reviews the merger between CVS Health and Aetna, the Department of Justice is sticking by its agreement with the two companies, according to an article in FierceHealthcar Feb 19. In a court filing in mid-February, DOJ defended that deal. Judge Richard J. Leon of the U.S. District Court

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14 Feb 2019

ENCOURAGE AGING PATIENTS TO DEVELOP A LATE LIFE PLAN

  By Judith Graham About 25 million Americans who are aging in place rely on help from other people and devices such as canes, raised toilets or shower seats to perform essential daily activities, according to a new study documenting how older adults adapt to their changing physical abilities. But a substantial

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10 Feb 2019

MICHIGAN CONGRESSMAN JOHN DINGELL, A FORCE IN HEALTHCARE POLICY, DIES AT 92

Former Rep. John Dingell, the Michigan Democrat who holds the record as the longest-serving member of the U.S. House, died Feb. 7 in Michigan. He was 92. And while his name was not familiar to many, his impact on the nation, and on healthcare in particular, was immense. For more

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14 Jan 2019

MEDTRONIC SETTLES DOJ CLAIMS LODGED AGAINST ACQUIRED FIRMS FOR $50.9M

  Medtronic has agreed to pay the U.S. Department of Justice $50.9 million to resolve three claims against Covidien and ev3, two companies Medtronic acquired in 2015. One payment is for $13 million and settles the DOJ’s investigation of the STRATIS Registry, which was designed to assess clinical outcomes of Covidien’s

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09 Jan 2019

ENDOLOGIX RECALLS NELLIX SYSTEM FOR PATIENT SAFETY

Endologix Inc., a developer and marketer of treatments for aortic disorders, has stopped unrestricted sales and use of the Nellix System in order to ensure optimal outcomes for patients. The existing inventory will be voluntarily recalled as described in a Field Safety Notification (FSN) issued in January. The Nellix System

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08 Jan 2019

INTERVENTIONAL RADIOLOGY SOCIETIES CALL FOR EXPANDED STROKE TRAINING

The Society of Interventional Radiology (SIR), the Cardiovascular and Interventional Radiology Society of Europe and the Interventional Radiology Society of Australasia have formed a Joint Commission committed to providing necessary stroke training to interventional radiologists in order to alleviate the shortage of physicians trained in endovascular stroke therapies. The ability for patients

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07 Jan 2019

MEDTRONIC GETS OK TO STUDY PATIENTS WITH BICUSPID AORTIC VALUES USING COREVALVE EVOLUT TAVR SYSTEM

The U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) for Medtronic to initiate a single-arm study to evaluate the CoreValve Evolut TAVR system in patients with bicuspid aortic valves who are at low risk of surgical mortality. Medtronic separately received FDA approval for revised commercial

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