News & Analysis as of

Clinical Trials

Clinical trials: Digital technology for recruitment, consent, and data capture

by Hogan Lovells on

The conduct of clinical trials still relies heavily on the use of paper documents. Of course, electronic case report forms (eCRF) have been commonly used for many years – the medical information on a patient that is...more

New UK-Wide Model Clinical Trial Agreements Published

by Hogan Lovells on

An updated Model Clinical Trial Agreement (mCTA) has been published for industry-sponsored clinical trials involving patients in National Health Service (NHS) or Health and Social Care (HSC) hospitals in the UK....more

Xeris' Pharmaceuticals Glucagon Progresses Towards FDA Approval

by Knobbe Martens on

Xeris Pharmaceuticals, Inc. (“Xeris”) recently announced successful completion of both adult and pediatric clinical studies for its glucagon rescue pen....more

Janssen’s Erleada Will be the First Participant in FDA’s Clinical Data Summary Pilot Program

by Knobbe Martens on

On February 14, 2018, the U.S. Food and Drug Administration (FDA) approved Janssen Therapeutics’ Erleada (apalutamide), a non-steroidal antiandrogen for the treatment of castration-resistant non-metastatic prostate cancer....more

Delaware Court Of Chancery Dismisses Derivative Breach Of Fiduciary Duty Claims In Connection With Publication Of Non-Final Drug...

by Shearman & Sterling LLP on

On February 28, 2018, Vice Chancellor Tamika Montgomery-Reeves of the Delaware Court of Chancery dismissed claims against the directors of Orexigen Therapeutics Inc. (“Orexigen”) for alleged breaches of fiduciary duty in...more

JHL Biotech Announces Approval For Phase I Clinical Trial of Bevacizumab Biosimilar in Europe

by Goodwin on

JHL Biotech Inc. announced last week that it received approval from the Bulgarian Drug Agency for a Phase I clinical trial of its proposed bevacizumab (Avastin) biosimilar, JHL1149. The trial, set to begin in March 2018, will...more

FDA Amends Regulations For Data From Foreign And Domestic Investigation For Medical Devices

On February 21, 2018, the Food and Drug Administration (FDA) published a Final Rule, amending its regulations on acceptance of data from investigations for medical devices that are performed outside of the United States as...more

Taking Pills for Pay: FDA Releases Information Sheet on Paying Research Subjects

by Baker Ober Health Law on

In clinical research, compensating research subjects as an incentive for their participation is a common practice. However, paying research subjects can also pose ethical issues and create the potential for abuse such as...more

$50 Million Lawsuit Filed Against FDA

by Knobbe Martens on

On January 22, 2018, a $50 million lawsuit was filed against the U.S. Food and Drug Administration (FDA) in the Central District of California. The complaint was filed by Semler Research Center Pvt. Ltd., a contract research...more

Keeping up with NIH rules impacting research involving human subjects

by Bricker & Eckler LLP on

The National Institutes of Health (NIH) made a number of changes to the rules impacting research involving human subjects in recent years, including the launch of several new initiatives that fall into two categories: those...more

Da Volterra Develops Device to Combat Antibiotic Resistance

by Knobbe Martens on

Da Volterra, a biotech company developing products in the antibacterial field, has announced results in a human clinical trial for DAV132, a product said to prevent life-treating bacterial infections during antibiotic...more

"Make in India" Initiative Extends to Medical Devices - India's New Medical Device Rules Are Now in Effect

by Hogan Lovells on

In January 2017, India's Ministry of Health and Family Welfare released the long-awaited Medical Device Rules of 2017 (MDR 2017 or the Act), which took effect on January 1, 2018. Upon implementation, this regulation replaced...more

Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry

by Hogan Lovells on

Right-to-try laws and the future of access to investigational treatments - The treatment of patients with unapproved therapies is often referred to as “compassionate use” or “expanded access”. Under right-to-try laws,...more

Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry

by Hogan Lovells on

State-level right-to-try laws have given patients and their families hope that they might gain access to breakthrough investigational treatments. But traditionally, the FDA and pharmaceutical industry have been cautious about...more

Lupin Announces Positive Results For Etanercept Biosimilar

by Goodwin on

On February 7, 2018, Lupin announced positive results from a Phase III clinical trial for its etanercept biosimilar candidate, YB113. YB113 is being developed by YL Biologics, a joint venture of Lupin and Yoshido, a Japanese...more

Designing Clinical Studies To Avoid Regulatory Scrutiny

Practical advice following the Primex Clinical Laboratories settlement - Earlier this year, the Department of Justice (DOJ) announced a $3.5 million settlement against Primex Clinical Laboratories, a California laboratory...more

Trastuzumab Biosimilar Demonstrates Equivalence

by Goodwin on

The Journal of Clinical Oncology reported that Merck and Samsung Bioepis’ biosimilar to trastuzumab (Herceptin®), SB3, demonstrated equivalence to trastuzumab in recent Phase III trials. According to the report, in a phase...more

Guest Post – Illinois Court Rejects Novel Claims Alleging Deficiencies In Post-Approval Studies

by Reed Smith on

Today we have a guest post from Reed Smith‘s Elizabeth Minerd discussing a PMA preemption case dealing with unusual “parallel claim” allegations involving the conduct of clinical trials. As always our guest posters are 100%...more

FDA Doubles Down on Efforts to Develop Guidance for Clinical Trial Stakeholders

by Morgan Lewis on

The US Food and Drug Administration has updated its Information Sheet on payments to clinical trial subjects, including travel reimbursements, and announced a public meeting on enrollment criteria, signaling the agency’s...more

Akili Interactive Announces Trial Results for Video Game Treatment of ADHD

by Knobbe Martens on

Akili Interactive recently announced results of a trial on the company’s digital medicine product, AKL-T01. According to FierceBiotech, Akili plans to file AKL-T01 with the U.S. Food and Drug Administration (FDA) for...more

Apotex granted damages from contract research organization for delayed FDA approval of two products

by Smart & Biggar on

On December 22, 2017, Patillo J. of the Ontario Super Court of Justice held that Apotex was entitled to $11,303,131.80, plus pre-judgment interest, for losses flowing from delays in the US Food and Drug Administration (FDA)’s...more

Client Alert: U.S. Department of Health and Human Services ("HHS") Delays Effective and Compliance Date for the Revised Common...

The Federal Policy for the Protection of Human Subjects, or the “Common Rule,” was originally published in 1991 and has been adopted and codified in separate regulations by HHS and 15 other federal departments and agencies. ...more

2018 outlook for drugs and medical devices in China: regulatory reform fueled by innovation

by DLA Piper on

The year 2017 ended with a central government directive to reform the regulatory approval system for drugs and medical devices and a subsequent flood of CFDA changes and proposed changes to the system, and we should see...more

Clinical research compliance alert: Common Rule updated, effective date delayed

by Bricker & Eckler LLP on

The U.S. Department of Health and Human Services has delayed the effective and compliance date for the updates to the Common Rule for six months from January 19, 2018, until July 19, 2018. The updates make significant changes...more

China FDA Releases Guidance on Acceptance of Foreign Medical Device Study Data

by Ropes & Gray LLP on

On January 10, 2018, the China Food and Drug Administration (“CFDA”) announced the implementation of the Technical Guidelines Governing Acceptance of Medical Device Clinical Data from Foreign Studies (the “2017 Guidelines”)....more

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