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IN THE NEWS


FDA Approves Merck’s Gardasil Nine-Strain HPV Vaccine

The product previously was approved to combat four types of the virus.

Geneva Hospital Halts NewLink Genetics’ Ebola Vaccine Trial

Several patients reported unexpected side effects.

Phase II Ebola Vaccine Trials Delayed By National Regulators

Phase II trials of a much-lauded Ebola vaccine have been pushed back until at least the second week of February, after African regulators asked GlaxoSmithKline for more information about the upcoming studies.

EMA Selects First Group of Applicants for Adaptive Pathway Pilot

European regulators have selected nine applicants out of 29 manufacturers who submitted proposals to participate in the EMA’s adaptive pathway pilot project, which aims to speed drug approvals by authorizing products in stages for targeted populations.

EFPIA Proposes Process to Ease Early Resolution of Patent Disputes

Drugmakers say it would address inefficiencies in the current patent litigation system.

FDA Releases Draft Guidance on Clinical Pharmacology in Pediatric Studies

Sponsors may extrapolate from well-known adult data to children using biomarkers characteristic of adult drug responses.

Geneva Hospital Hits Pause Button on Ebola Vaccine Trial

Investigators have temporarily halted a trial of NewLink Genetics’ experimental Ebola vaccine after several patients reported unexpected side effects.

FDA Finalizes Guidance on Vaginal Microbicides for HIV Prevention

Clinical studies evaluating the safety and tolerability of vaginal microbicide gels to prevent HIV infections should use a scoring system to measure the presence and severity of rash, swelling, immune response and damage to local tissue, FDA final guidance says.

Revised Indications MAPP Tells Sponsors When to Seek Help

Future FDA guidance on developing drugs for specific indications will include key milestones to help manufacturers plan their product development programs and guide potential talks with the agency’s review division.

Proposed Rule Asks for Trial Data on Failed Products

Drug and device manufacturers would have to submit all clinical trial data to the federal government — including data for products never approved by the FDA — under a massive, proposed expansion of data collection.

CNS Drugs Lag Behind Others in Clinical Testing: Report

Central nervous system drugs that treat conditions such as Alzheimer’s and Parkinson’s disease lag behind other drugs in clinical development and approval times, a recent report finds.

Tufts: Drug Development Costs Average $2.6 Billion

Pharma companies today spend on average $2.6 billion to get new products to market, a 145 percent increase in R&D costs compared with a decade ago, the Tufts Center for the Study of Drug Development reports.

Biomarkers for Drug-Induced Kidney Injury Get Boost From EMA, FDA

The European Medicines Agency is lending support to an initiative to qualify biomarkers that can provide early warning of an investigational compound’s risks of causing drug-induced kidney injuries.

EU Ombudsman Wants Regulator To Explain Trial Data Redaction

The EU ombudsman is questioning the European Medicines Agency’s claim that it wasn’t violating any laws when it allowed AbbVie to redact information from clinical study reports.

Coalition Proposes Framework to Determine Trial Authorship

A coalition of pharma companies and medical researchers is proposing a framework for determining authorship of clinical trial publications, with the aim of increasing transparency and public trust in medical research.

FDA’s 2015 Priorities Agenda Includes International Device Trials

The FDA expects to release rules on international clinical trials by the end of next year, according to HHS’ 2015 agenda, which was unveiled Nov. 24.

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.

FDA Releases Draft Guidance on Clinical Pharmacology in Pediatric Studies

Sponsors submitting pediatric study plans for a drug have several options to determine optimal dosing for children when no standard dosing information exists, according to an FDA draft guidance on clinical pharmacology in pediatric studies.

Tufts Study Says Drug Development Costs $2.6 Billion

Development costs spiked 145 percent over the past decade.

Impact of Republican Senate Takeover on FDA Remains Uncertain

The Republican landslide in the midterm election will put GOP lawmakers in the driver’s seat on the generics labeling rule, user-fee negotiations and agency funding, but experts say the political shift’s impact remains uncertain.

Tufts: Drug Development Costs $2.6 Billion

Pharmaceutical companies today spend an average of $2.6 billion to get their products to market, according to a new report that finds R&D costs have increased 145 percent over the past decade.

FDA Finalizes Guidance on Vaginal Microbicides for HIV Prevention

Companies developing vaginal microbicide gels to prevent HIV infections should have a scoring system to measure the presence and severity of rash, swelling, immune response and damage to local tissue in human studies evaluating the safety and tolerability of the products, says a new final guidance.

Merck’s Hepatitis C Combo Falls Short in Study

An experimental four-week, triple-therapy regimen proved largely ineffective.

AZ & Amgen: Brodalumab Superior to Stelara for Plaque Psoriasis

Amgen and AstraZeneca said their experimental psoriasis compound brodalumab demonstrated better outcomes than Janssen’s therapy Stelara in a Phase III trial, a development that moves the drug one step closer to market in the competitive therapeutic area.

Three Ebola Drugs to Undergo Clinical Trials in West Africa in December

Clinical trials of three experimental Ebola therapies are set to begin in West Africa next month with results due as soon as February, according to Doctors Without Borders.

FDA Advisors Reject Novartis’ Multiple Myeloma Drug

The oncology-drug advisory committee said safety concerns overwhelmed benefits.

EMA Tries to Allay More Concerns About Data Redaction

European regulators yesterday told the European Union ombudsman that they adhered to the law when allowing manufacturer AbbVie to redact information from its clinical study reports, marking the latest twist in the debate over European trial data transparency.

Biomarkers for Drug-Induced Kidney Injury Receive Boost From EMA, FDA

The European Medicines Agency has lent its support to an initiative to qualify biomarkers that can provide an early warning on an investigational compound’s risks of causing drug-induced kidney injuries, an endorsement that researchers say is necessary to move to the next phase of development.

Merck’s Hepatitis C Combo Falls Short

Merck’s effort to expand its footprint in the lucrative hepatitis C market stumbled, with an experimental four-week, triple-therapy regimen proving largely ineffective.