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UK publishes paper on Brexit and medicines regulation

by Hogan Lovells on

On the same day as the European Council voted to move the European Medicines Agency (EMA) from London to Amsterdam, the UK Parliament issued a briefing paper on Brexit and medicines regulation. ...more

CMS Releases CY 2019 Proposed Rule for Medicare Advantage and Part D

Last Thursday, November 17, 2017, the Centers for Medicare & Medicaid Services (CMS) released its proposed contract year 2019 Medicare Advantage and Part D regulations. The proposed rule is scheduled to be published in the...more

Samsung Bioepis Receives EU Marketing Authorization For Trastuzumab Biosimilar

by Goodwin on

Samsung Bioepis announced today that the European Commission (EC) has granted marketing authorization for Ontruzant®, a biosimilar for Herceptin® (trastuzumab), across all 28 European Union member states and the European...more

Ready to Release a New Pharmaceutical? What to Think About When Selecting Your Drug Name

by Foley & Lardner LLP on

Pharmaceutical name clearance in the United States can be complicated. This post aims to provide insight into the regulatory safety review process and the trademark registration process for candidate drug names. This...more

FDA Approves Zelboraf for Treatment of a Rare Cancer

by Knobbe Martens on

On November 6th, 2017, the U.S. Food and Drug Administration (FDA) approved the drug Zelboraf (vemurafenib), for the treatment of Erdheim-Chester Disease (ECD). The FDA approved Zelboraf under Priority Review, Breakthrough...more

More of What You Will See on Personal Jurisdiction Following BMS

by Reed Smith on

We wrote a few months ago about what you will see from the plaintiffs’ side as they try to evade the Supreme Court’s opinion in BMS v. Superior Court. That opinion has combined with Bauman to reset personal jurisdiction and...more

European Medicines Agency heads for Amsterdam

by Allen & Overy LLP on

Today the 27 member states of the European Union have decided on Amsterdam as the new home of the European Medicines Agency. The decision came after three rounds of voting, with Amsterdam eventually emerging the winner after...more

OIG Turns Its Attention to Telehealth Medicaid Compliance

by Baker Ober Health Law on

Telehealth providers participating in and receiving payment from Medicaid for telehealth services should take heed of the newly initiated items included in the OIG's November 2017 Work Plan update. (Beginning June 2017, the...more

AGG Food and Drug Newsletter - November 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

BMS and Nationwide Class Actions

by Reed Smith on

We have not been shy in predicting that Bristol-Myers Squibb Co. v. Superior Court, 137 S.Ct. 1773 (2017) (“BMS”), and Daimler AG v. Bauman, 134 S. Ct. 746 (2014) (“Bauman”), should restrain certain abusive class action...more

Elder Abuse: Are Granny Cams A Solution, A Compliance Burden, Or Both?

by Jackson Lewis P.C. on

In Minnesota, 97% of the 25,226 allegations of elder abuse (neglect, physical abuse, unexplained serious injuries and thefts) in state-licensed senior facilities in 2016 were never investigated. This prompted Minnesota...more

Opioid Litigation Over Insurance Coverage – Coming to a Jurisdiction Near You

by Nexsen Pruet, PLLC on

A very recent appellate ruling in California provides a roadmap for opioid litigation over insurance coverage that is about to ramp up all over country. In Travelers Prop. Cas. Co. of Am. v. Actavis, Inc. et al, 2017 WL...more

WORD OF THE DAY® – 8+2+1

by Latham & Watkins LLP on

Latham partner Robbie McLaren explains the term 8+2+1 from the Book of Jargon® – Healthcare & Life Sciences. The Book of Jargon® – Healthcare & Life Sciences is one of a series of practice area and industry-specific...more

The Opioid Epidemic: Are We Headed Toward a Tipping Point?

by Burr & Forman on

Health care law and policy occupy a prime place in the current news cycle. Much of the attention revolves around the actions or inactions of Congress and the White House, particularly with regard to their impact on the future...more

C.D. Cal. Excludes Three Plaintiff Experts in Breast Implant Case

by Reed Smith on

It is not as if we are delighted to see efforts to resuscitate breast implant litigation, but we won’t groan when the rulings are as good as they are in Laux v. Mentor Worldwide, LLC, No. 2:16-cv-01026-ODW(AGR) (C.D. Cal....more

White Collar Courier: Delivering News and Providing Guidance in White Collar Matters

by Burr & Forman on

Before joining Burr & Forman, I was a federal prosecutor for a little over a decade focusing on health care fraud and general white collar matters. In that role, I was a member of a prosecution team that secured guilty...more

How to Pay the Piper: FDA Issues New Guidances for PDUFA VI and GDUFA II

by Arnall Golden Gregory LLP on

FDA recently issued two draft guidances: Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 (GDUFA II), which...more

Lessons To Be Learned From The Breach Of Nearly 500,000 Individual Health Records Reported In September 2017

by Jackson Lewis P.C. on

A recent report indicates that nearly 500,000 individual health records were breached in September 2017. This figure is taken from the 39 healthcare data breaches involving more than 500 records that were reported to the...more

FDA Finalizes Policy for Sharing Patient-Specific Data from Medical Devices

by Reed Smith on

FDA recently released guidance (“Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request”) finalizing its policy on medical device manufacturers sharing patient-specific information...more

Three Years Later, Foley Survey Reveals Positive Prognosis for Telemedicine

by Foley & Lardner LLP on

When we launched Foley’s inaugural Telemedicine and Digital Health Survey in 2014, it was apparent that health care executives weren’t ready to make telemedicine a significant focus of their business and patient strategies....more

New rules for expanded access in Italy

by Hogan Lovells on

Fast track for orphan diseases and rare forms of cancers - By Ministerial Decree of 7 September 2017 (DM 7 September 2017), published in the Italian Official Journal on 2nd November2017, the Ministry of Health enacted new...more

Non-News: Warnings Claims For A Generic Drug Preempted (Still)

by Reed Smith on

We can be inundated with news. Old news. New news. Fake news. Breaking news. News that makes you want to break something. News that makes you want to go back to bed. In trying to be discerning consumers of the news, it...more

FCC Closes Loopholes and Expands Telephone Consumer Protection Act “TCPA” Consumer Protections in Declaratory Ruling and Order

by Womble Bond Dickinson on

On July 10, 2015, the Federal Communications Commission (“FCC” or “Commission”) released a Telephone Consumer Protection Act (“TCPA”) Declaratory Ruling and Order (“TCPA Declaratory Ruling and Order” or “Order”) offering...more

2017 Health IT Leadership Summit Insights

by Arnall Golden Gregory LLP on

Arnall Golden Gregory was a gold sponsor of the Health IT Leadership Summit, held on November 7, 2017 in metro Atlanta. More than 500 people attended the Summit, which was created in 2010 by the Georgia Department of Economic...more

Louisiana Adopts Price Reporting Law

by Kelley Drye & Warren LLP on

A new law in Louisiana requires drug manufacturers to report wholesale acquisition cost (WAC) information directly to the state. Louisiana law defines WAC as “the manufacturer’s list price for the pharmaceutical drug or...more

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