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IN THE NEWS


German Health Watchdog Slams EMA Definition of ‘Commercial Confidential’

A German government regulator says European Medicines Agency plans for implementing its clinical trials database lets drugmakers withhold too much information, such as study protocols, methods and trial results, under the exemption for commercial confidentiality.

India Weighs Opening Markets to FDA, EU-Approved Drugs

Indian regulators may begin letting some FDA and EU approved drugs onto the Indian market without local Phase III clinical trials.

ZMapp Ebola Trial Kicks Off in Liberia, U.S.

A large clinical trial of Mapp Biopharmaceutical’s ZMapp monoclonal antibody cocktail kicked off in Liberia and the U.S.

FDA’s Research Priorities Target Methods for Assessing Generics, Advanced Therapies 

The FDA has laid out a regulatory research agenda for the year that includes identifying better methods for assessing generics, improving drug safety, biosimilars development and finding ways to assess advanced, new drugs as areas where the agency would like to sponsor research.

Novavax Begins Enrollment in Ebola Vaccine Trial

The vaccine could scale up manufacturing to produce millions of doses in a short amount of time.

Merck, BMS Could Lose Breakthrough Therapy Designations

This is the first time the FDA has made such a decision.

700 Drugs Face Suspension in EU Over GVK Biosciences Flap

The European Medicines Agency is recommending halting sales of 700 drugs that were approved based on testing data provided by CRO GVK Biosciences, following an inspection that found the Hyderabad, India, firm manipulated echocardiogram data.

India Finalizes Trial Injury Compensation Formula

India has finalized the formulas sponsors must use to determine compensation for patients who are injured during clinical trials, and one expert says they will do little to attract trials back to the country.

Hundreds of Drugs Suspended in Europe Over GVK Flap

The European Medicines Agency plans to bar sales of 700 drugs that were approved based on testing data provided by CRO GVK Biosciences, following an inspection that found the Hyderabad, India, firm manipulated echocardiogram data.

EMA Clarifies Reexamination Process for Pediatric Trial Plans

Drugmakers should notify the European Medicines Agency within 10 days of receiving an initial opinion on a pediatric investigation plan if they plan to request another review. The official request, due 20 days later, should include the procedure number and a detailed justification for requesting the reexamination, according to updated guidance issued Jan. 22.

FDA Lays Out Endpoints, Monitoring Requirements for cUTI Trials

FDA is doubling the monitoring period for subjects in trials for antibiotics to treat complicated urinary tract infections.

India Approves 28 Clinical Trial Proposals, Seven Trial Waivers

India’s health ministry has given the go-ahead for 28 clinical trials, 14 of which are international studies — a continuation of the rebounding number of studies in the country.

Expert Clarifies Changes to Clinicaltrials.gov

Sponsors and investigators will share responsibilities for gathering and reporting clinical trial information on clinicaltrials.gov, if a November proposed rule is finalized.

Tufts: Investigator Turnover, Noncompliance Rates Too High

Experience levels of principal investigators fluctuate wildly the world over, a fact that could put promising research at risk, according to a Tufts University report on protocol noncompliance rates and principal investigator turnover.

FDA Overhaul Proposal Includes Drug Development Incentives

The House Energy & Commerce Committee, which oversees the FDA, is planning an overhaul of agency procedures to increase orphan drug development, streamline clinical trials oversight and give industry incentives to find new uses for old drugs.

Japan Pushes Advanced Trials for Personalized Medicines

Japanese regulators are weighing whether the agency will need to begin approving some drugs based on Phase II trial data as they implement approval processes for personalized drug products.

FDA Seeks Feedback on Biomarker Development

The FDA wants to expand the use of biomarkers to speed up drug development and is asking for feedback on ones that have the most promise of benefiting drugmakers in the near term.

Novavax Kicks Off Ebola Vaccine Trial

Novavax, a clinical-stage biopharmaceutical company, kicked off enrollment Thursday in an Australian Phase I Ebola vaccine trial.

FDA Guidance Defines Endpoints for Alcoholism Trials

Drugmakers designing trials for alcoholism treatments can use a primary endpoint of no heavy drinking rather than total abstinence, the FDA says, in an acknowledgement that abstinence as a goal in these studies is often unattainable.

FDA Might Take Back Two Breakthrough Therapy Designations

Merck and Bristol-Myers Squibb are in danger of losing the breakthrough therapy designation for their hepatitis C drugs, in a first-ever move that could extend both drugs’ review times.

Novartis Refutes Possible Link Between Heart Failure Therapy and Alzheimer’s

A suggested link between Novartis’ heart failure drug LCZ696 and progression of Alzheimer’s disease could sour hopes of a pipeline replacement for the company’s failed Reasanz heart drug.

FDA Sets Final Trial Requirements for Drugs for Complicated Intra-abdominal Infections

Trials of drugs targeting complicated intra-abdominal infections should use only drugs that are standard of care as active comparators, the FDA says, and studies should minimize the use of outside antibiotics in trial subjects as much as possible to produce clear, definitive trial results.

Japan Pushes Advanced Trials for Personalized Medicines

Japanese regulators are weighing whether the agency will need to begin approving some drugs based on Phase II trial data as they implement approval processes for personalized drug products.

House Committee Reveals Drug Development Incentives, FDA Regulatory Overhaul

The Energy & Commerce Committee is seeking input to work in to a final bill that will address five broad areas of reform.

FDA Finalizes Photosafety Testing Guidance

The FDA emphasized flexibility in a final guidance that attempts to harmonize U.S. and International Conference on Harmonisation drug photosafety testing requirements.

NIH/GSK Ebola Vaccine Trial Shows Positive Results

Phase III trials of two Ebola vaccines will kick off in the next few weeks in Liberia, according to the National Institute of Allergy and Infectious Diseases.

EMA Updates Pediatric Investigation Plan Reexamination Procedure

Drugmakers should notify the EMA within 10 days of receiving an initial opinion on a PIP if they plan to request another review.

House Committee Unveils Drug Development Incentives, FDA Regulatory Overhaul

The House Energy & Commerce Committee that oversees the FDA is planning an overhaul of agency procedures to increase orphan drug development, streamline clinical trials oversight, give industry incentives to find new uses for old drugs and expand U.S. drug manufacturing.

FY 2016 Budget Proposes $1.2 Billion to Combat Antibiotic Resistance

President Obama will ask Congress to approve more than $1.2 billion in funding — nearly double the current amount — to fuel development of new antibiotics.

FDA Finalizes Guidance on Photosafety Testing

The FDA emphasized flexibility in a Monday final guidance that attempts to harmonize U.S. and International Conference on Harmonisation drug photosafety testing requirements.