Clinical Trials

News & Analysis as of

Employee Benefits Developments - May 2016

Agencies Issue New FAQs on the Affordable Care Act.The Departments of Labor, Health and Human Services, and the Treasury (the agencies) issued another set of frequently asked questions (FAQs) regarding the implementation of...more

Sorrento Announces Successful Trial with Omalizumab Biosimilar

On May 16, 2016, Sorrento Therapeutics announced successful results from a Phase 2 and 3 clinical study for a biosimilar to Xolair. Xolair (omalizumab) is marketed by Genentech and Novartis to treat allergic asthma and...more

New FDA Draft Guidance on the Use of Electronic Health Record Data in Clinical Investigations

FDA emphasizes interoperability and outlines other best practices for effectively using EHR data in FDA-regulated studies. Acknowledging the increased use of electronic health records (EHRs) in clinical studies, and the...more

Despite Barriers, Community Speciality Clinics are Eager to Adopt Precision Medicine Tools

Fueled by technological advances, scientific breakthroughs and significant financial investments, precision medicine (PM) has emerged as a promising approach to disease prevention and treatment. A multi-faceted solution to...more

Is Overreporting Adverse Event Information Always In A Company’s Best Interest?

Recently, we moderated a panel at the Food and Drug Law Institute’s Annual Conference, where a senior Food and Drug Administration official participated. The individual from the Center for Drug Evaluation and Research made an...more

A Global Phase III Trial for Avastin Biosimilar Has Begun

Samsung Bioepis – the joint venture between Samsung and Biogen Idec – has started a phase III clinical trial for a biosimilar version of Roche’s cancer drug Avastin (bevacizumab). Bevacizumab slows the growth of new blood...more

The Proposed Common Rule: The Tribe Has Spoken, and They Have Concerns

On September 8, 2015, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a notice of proposed rulemaking (NPRM) to update the federal policy for the Protection of Human Subjects, more...more

New FAQs Address Implementation of the Affordable Care Act, Mental Health Parity and Addiction Equity Act, and the Women’s Health...

In Depth - The US Departments of Labor (DOL), Health and Human Services (HHS) and Treasury (collectively, the Departments) published frequently asked questions (FAQs) on April 20, 2016, clarifying the implementation of...more

SEC Prevails In Jury Trial Against Former CEO of Drug Firm

The SEC prevailed at trial against the former CEO of a biopharmaceutical company on claims that he made false and misleading statements regarding the regulatory approval status of the firm’s only drug. Following a two week...more

New ACA, et. al. FAQs Cover Items From “Top” to “Bottom”

On April 20, the “Big Three” agencies (DOL, Treasury/IRS, and HHS) released another set of FAQs (the 31st, for those of you counting at home). Consistent with earlier FAQs, the new FAQs cover a broad range of items under the...more

Newly Released FAQs Address Health Plan Compliance Issues

The questions address a wide range of issues, including preventive care, coverage for clinical trials, required disclosures, the Women’s Health and Cancer Rights Act, rescissions, reference pricing and mental health parity...more

Xarelto’s Approval by the FDA

The controversy over Xarelto’s approval by the FDA and alleged irregularities in the conduct of the ROCKET-AF clinical trial continue to hang over the heads of Bayer and Janssen (a division of Johnson & Johnson), the...more

China Issues First Update to Medical Device Clinical Trial Guidelines in 12 Years

The Chinese Food and Drug Administration (“CFDA”) recently announced its first update to the medical device clinical trial guidelines in 12 years. The finalized revision to the 2004 Medical Device Clinical Studies Rules...more

FDA Regulatory and Compliance Monthly Recap — March 2016

FDA warning letter calls out exoskeleton device manufacturer for repeatedly avoiding FDA requests for postmarketing surveillance - The FDA sent a warning letter to Argo Medical Technologies after the company averted...more

China FDA Announces Good Clinical Practices for Medical Devices

On March 23, 2016, the China Food and Drug Administration (“CFDA”) and the National Health and Family Planning Commission jointly promulgated the final revision to the 2004 Medical Device Clinical Studies Rules (“MDCSR”), the...more

European Life Sciences Review: Issue 2

Welcome to the second issue of our EU life sciences alerter that covers some of the most critical developments in the pharmaceutical and medical technology sectors in the last month and is produced by our life sciences...more

Think Mink, part 2: Florida Federal Court Slams Door on Parallel Claims

Last November we blogged about "specialized" preemption issues in several cases, including Mink v. Smith & Nephew, Inc., 2015 WL 7356285 (S.D. Fla. Nov. 19, 1015). The plaintiff in Mink claimed physical injuries from a...more

PTAB Institutes Kyle Bass IPR Against Pharmaceutical Patent Based On SEC Document

Kyle Bass has filed numerous prior IPR petitions against pharmaceutical patents, some of which have been denied due to use of prior art references that were not sufficiently proven to be “publicly accessible” (see “Clinical...more

Second Circuit Affirms District Court in Tongue v. Sanofi

On March 4, 2016, the United States Court of Appeals for the Second Circuit affirmed the District Court for the Southern District of New York in Tongue v. Sanofi, No. 15-588-CV, 2016 WL 851797 (2d Cir. Mar. 4, 2016), holding...more

The Proponent Testimony Goes Unrefuted As Renowned Physician Dr. Sue Sisley Highlights The Testimony Of Ten Witnesses Before The...

Thursday, February 17, 2016, was the first evening session of the Ohio House of Representatives’ Medical Marijuana Task Force (“Task Force”), which heard a full complement of testimony, all in support of legalizing medical...more

Xarelto Litigation – February Updates

There have been a number of recent noteworthy developments in the national litigation involving Xarelto. Currently, there are approximately 5,000 individual lawsuits pending in state and federal courts against the...more

Health Alert (Australia) - February 1, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Commonwealth. Administrative Appeals Tribunal 22 January 2016 - JLSP and Innovation Australia [2016] AATA 23 This...more

FDA-regulated industries: Plan now for these changes in 2016

In our last post, Life Sciences Decoded took a look at new food industry regulations that will roll out in 2016 under the FDA’s Food Safety and Modernization Act. But it’s not just the food industry that will need to prepare...more

It Proved Impossible to Do What the Doctor Ordered...and that Still Hurts

I can remember the morning but not the year – it was around 1999 or 2000 -- when my boss, Al Minahan, and I drove from downtown to Brookline to meet a prospective client. We had an appointment with a recently retired surgeon...more

Ministry of Health of Ukraine amends the procedure for conducting clinical trials of medicinal products (Ukrainian)

On December 31, 2015 the changes to the Ministry of Health’s Order No. 690, establishing the Procedure for Conducting Clinical Trials of Medicinal Products (the Procedure), have become effective. Below you can review the...more

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