Main Main Main

IN THE NEWS


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.

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.

EMA Updates Reexamination Procedure for Pediatric Investigation 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.

NICE Updates Process for Reviewing Biosimilars

The UK’s healthcare cost watchdog has updated its methods for reviewing biosimilar applications in anticipation of the products’ increasing availability in the country.

Brazil Clarifies Rules on Public-Private Product Development Partnerships

The Brazilian government is providing more clarity around a voluntary program that encourages public-private partnerships to expand access to affordable drugs, but questions remain about the program’s transparency and how the market would be divided among competing partnerships.

EMA Adaptive Pathway Pilot Underway With Initial Group of Six Medicines

European regulators have selected six drugs out of 34 applicants that submitted proposals for the EMA’s adaptive pathway pilot project.

India Issues Ream of Clinical Trial Regulations at Year End

Indian authorities issued a number of clinical trial regulations last month, covering compensation for trial injuries, exemptions for local Phase III trials and penalties for conducting trials without permission.

Tufts Pegs CROs, Cancer, Trial Design Hottest Trends of 2015

Drug sponsors are expected to expand their investments in developing new cancer therapies this year, spurred by a growing understanding of tumors’ molecular bases and immunotherapy techniques, according to a new report that projects pharma and biotech trends for 2015.

Most GCP Infractions Tied to Sponsors, CROs: EMA

Clinical trial sponsors and contract research organizations incur the majority of good clinical practice violations, a European Medicines Agency panel reports.

FDA Outlines Clinical Pharmacology Considerations in Pediatric Trials

Sponsors submitting pediatric study plans should consider whether a product affects adults and children similarly when choosing an approach, the FDA says.

Year in Review: Transparency Leads the Clinical Trial Conversation Again

Regulators, sponsors and clinical investigators wrestled with trial data transparency and reporting requirements for the second year in a row, with the European Medicines Agency trying to pin down the most effective ways to require sponsors to share the results of their studies. U.S. officials were primarily concerned with stimulating development of new antibiotics, encouraging sponsors and investigators to more deeply analyze subgroup outcomes and promoting the use of biomarkers in drug trials.

FDA Updates Guide on Clinical Study Data eSubmissions

An updated FDA guide on electronically submitting clinical study data, released last month, clarifies a number of requirements for preparing data sets and reviewers’ guides.

2014: A Year Focused on Transparency, Drug Safety and a Crisis in West Africa

Last year saw major strides in increasing transparency around clinical trial data in the EU and trial safety and compensation in India. An international group also set the gears in motion for a harmonized guideline on multiregional clinical studies.

IOM: Governments, Industry Must Plan for Trial Data Sharing

The Institute of Medicine is calling on clinical trial sponsors and governments to develop plans for substantially greater sharing of clinical trial data.

Cancer Drugs and Biologics Among Top 2015 Trends in Tufts Annual Report

The report projects pharma and biotech trends for the upcoming year.

NICE Updates Process for Reviewing Biosimilar Applications

Applications for national coverage will be reviewed under a multiple technology appraisal process along with the reference product.

EMA Adopts Final Guideline on Clinical Considerations for Evaluating Biosimilarity

The European Medicines Agency wants biosimilars makers to use pharmacodynamic markers alongside pharmacokinetic data to demonstrate biosimilarity.

Janssen Commences Ebola Vaccine Trial in UK

The company plans to commence larger trials in the U.S. and Africa this spring.

Cancer Drugs, Biologics, Trial Design Are Among Top 2015 Trends in Tufts Annual Outlook Report

Drug sponsors are expected to expand their investments in developing new cancer therapies this year, spurred by a growing understanding of tumors’ molecular bases and immunotherapy techniques, according to a new report that projects pharma and biotech trends for 2015.

NICE Updates Process for Reviewing Biosimilars

The UK’s healthcare cost watchdog has updated its methods for reviewing biosimilar applications in anticipation of the products’ increasing availability in the country.

Janssen Launches Ebola Vaccine Trial in UK

Johnson & Johnson subsidiary Janssen has launched a human clinical trial of its experimental Ebola vaccine in the UK, with much larger clinical trials expected to start this spring in the U.S. and Africa.

OncoGenex Regains Custirsen Rights from Teva

Washington state oncology drug developer OncoGenex is taking back rights to the experimental cancer therapy custirsen, ending a five-year collaboration with Israeli manufacturer Teva Pharmaceuticals.

EFPIA Proposes Process to Facilitate Early Resolution of Patent Disputes

Brand drugmakers in Europe are calling on the European Commission to implement a system to help resolve patent disputes before the launch of a generic drug, a move they say would address inefficiencies in the current patent litigation system.

Central Nervous System Drugs Lag Behind Others in Clinical Testing: Report

Development and approval times of central nervous system drugs that treat conditions such as depression, Alzheimer’s and Parkinson’s disease lag behind those of other drugs, a recent report finds.

Phase II Ebola Vaccine Trials Delayed By African Regulators

The regulators asked GSK for more info about the studies.

India Finalizes Compensation for Trial-Related Injuries

India has finalized the formulas that drugmakers must use to determine compensation for patients who are injured while in clinical trials, but one expert says the move will do little to attract industry back to the country to conduct trials.

Pharmaceutical Groups Say Europe 2020 Strategy Must Focus on Fostering R&D, Clinical Trial Reforms

Drug industry groups are urging the European Commission to invest more in research and development, streamline regulatory systems and accelerate recently approved clinical trial reforms as ways to bolster the EU’s pharmaceutical industry.