Clinical Trials

News & Analysis as of

NIH Signals “Paradigm Shift” with Policy on Multi-Site Studies

Federally-funded clinical trials conducted at multiple sites will move to a single Institutional Review Board (IRB) review scheme under a new National Institutes of Health (NIH) Policy. The NIH has finalized its policy to...more

Connecticut's New "Right to Try" Law Provides Hope for Patients and Providers, but FDA Remains in the Driver's Seat

Connecticut has recently joined the wave of states enacting a so-called “Right to Try” law, which ostensibly permits terminally ill patients access to investigational drugs (including biologics) and medical devices as a...more

EMA’s New Draft Guideline On Good Pharmacogenomic Practice - Implications For Personalized Medicine

Embracing personalized medicine, the European Medicines Agency (EMA) released a draft guidance document titled Draft Guideline on Good Pharmacogenomic Practice (“Guidance”) on good pharmacogenomic practice with the stated...more

Merck’s Lantus Biosimilar Queued for an FDA Submission?

Merck, known as MSD outside the United States and Canada, announced promising results from two Phase III studies evaluating MK-1293 – Merck’s biosimilar to Lantus (insulin glargine). Lantus is used for the treatment of...more

Samsung Bioepis Presents New Biosimilars Data at EULAR 2016

At the Annual European Congress on Rheumatology (EULAR 2016), held last week in London, Samsung Bioepis presented new clinical data on its etanercept, adalimumab, and infliximab biosimilars. According to a press release from...more

LG Life Sciences Begins Phase III Trials for Humira Biosimilar

LG Life Sciences recently announced the start of phase III clinical trials for its Humira® (adalimumab) biosimilar in South Korea.  The clinical trials will test the effectiveness of the biosimilar on rheumatoid arthritis...more

Mylan and Biocon Present Trastuzumab Biosimilar Data at ASCO

On June 3, Mylan N.V. and Biocon Ltd. presented phase 3 clinical data regarding their trastuzumab product (dubbed MYL-1401O), which is a proposed biosimilar to Genentech’s Herceptin, at the 2016 American Society of Clinical...more

FDA Issues Guidance on Expanded Access

The Agency improves the process for access to investigational drugs and biologics for patients who lack other options. On June 2, the US Food and Drug Administration (FDA or the Agency) announced that it finalized three...more

Health Alert (Australia) June 6, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Queensland 24 May 2016 - Zahedpur v Idameneo (No 123) Pty Ltd [2016] QCA 134 - Mr Zahedpur is a medical...more

Is Sponsor-Submitted Clinical Data Safe?

The U.S. Food and Drug Administration has a tricky task at hand when it comes to reviewing, evaluating, investigating and eventually approving prescription medications. Yes, the agency has a mission to ensure patient safety,...more

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

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