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IN THE NEWS


FDA Approves Second Hay Fever Prophylactic in Weeks

The FDA has approved another under-the-tongue hay fever treatment, putting a second product on the market that will replace the routine injections currently prescribed to control symptoms.

FDA: Regulatory Decisionmaking Workshop Rescheduled

Comments are now open until June 11, the agency says.

FDA Allows Vivolux to Take VLX600 into Clinical Studies

Vivolux is taking its cancer drug candidate VLX600 into Phase I/II clinical testing after receiving permission from the FDA.

Impax Refiles NDA After Manufacturing Woes

Impax said Friday it has refiled an NDA for its Parkinson’s disease drug Rytary after implementing quality systems improvements at the plant where the drug was slated to be made.

PhRMA Pushes Forward-Looking Policies to Grow Biopharmaceutical Sector

CEO John Castellani says the industry’s continued success depends on prioritizing innovation.

Genentech Gains Access to Online Patient Network

Genentech will focus its data mining efforts primarily on oncology.

EMA Ups Stability Data Required for Changes to Active Substances

The EMA is tightening stability testing requirements for drugmakers submitting applications for significant post-approval manufacturing changes that involve active substances.

Merck Trial Data Positions Hep C Drug for Second Place in Market

Merck is reporting strong mid-stage trial results for a drug combo to treat hepatitis C, which may position it to be the strongest alternative to Gilead’s Sovaldi.

Eloctate Performs Well in Phase III Trial of Pediatric Hemophilia A

No serious adverse events were seen and no patient developed inhibitors to the therapy, the drugmakers said.

Australia Regulator Seeks Feedback on Low-Value Turnover Exemption Scheme

The review was prompted by drugmakers’ complaints of undue burden.

EMA Updates Assessment, Acceptance Criteria in Final ITP Guidance

The European Medicines Agency has backed off of several controversial limitations it was considering imposing on sponsors of trials for treatments for chronic primary immune thrombocytopenia.

FDA Urged to Use ‘Carrot and Stick’ Approach to Boost Subgroup Research

The FDA should incentivize sponsors to include minorities and other underrepresented groups in clinical trials and delay approving products whose evidence is based on less-inclusive trials, activists say.

Sponsors See Inconsistency in FDA’s Push for More Safety Data for Painkillers

Drugmakers balked at the FDA’s push for sponsors of new chronic pain treatments to submit more safety data, calling it inconsistent and confusing.

Sponsors Must Justify Excess Drugs in Injectable Products

Sponsors of BLAs, NDAs, and ANDAs should justify the amount of excess medication for injectable drug products they plan to pack in vials and ampules, according to an FDA draft guidance.

FDA Presses Broader Use of Bayesian Methods in Phase II, but Not Phase III

While the FDA sees great potential for Bayesian statistics in Phase II clinical trials, the agency is not yet ready to endorse the method for Phase III studies.

Agency Lays Out Orphan Drug Presubmission Meeting Requirements

In a bid to cut down on orphan drug developers wasting agency time, the FDA is outlining new, detailed guidelines for what constitutes a legitimate topic for formal and informal presubmission meetings.

FDA Puts Hold on Halozyme Pancreatic Cancer Candidate Trial

The FDA Tuesday placed a clinical hold on Halozyme Therapeutics’ Phase II study of PEGPH20 for the treatment of pancreatic cancer.

FDA Seeks More Immunogenicity Testing For Low Molecular Weight Heparins

The FDA wants manufacturers of low molecular weight heparin (LMWH) products to do a better job of assessing immunogenicity risk before submitting their products for approval.

GSK Teams With MD Anderson to Develop Cancer Immunotherapies

This is MD Anderson’s fourth and final major collaborative project with large drugmakers.

Mylan Sues Celgene to Gain Access to Branded Products

Mylan is accusing Celgene of violating federal antitrust law by prohibiting the generic drugmaker from obtaining samples of its blockbuster products Thalomid and Revlimid to make generic versions.

Alkermes Lines Up NDA to Fill Abilify Vacuum After Patent Expiration

Alkermes says its once-monthly injectable version of the antipsychotic blockbuster Abilify met its endpoints in a Phase III trial, setting it up for an NDA filing with the FDA sometime in the third quarter.

Industry, Academia Open Data Sharing Site to Boost Cancer Research

Drugmakers and non-profit collaborators are releasing the results of failed cancer trials so that researchers can examine the datasets to look for signals or other useful information that may suggest new research directions.

MHRA Now Accepting Applications to Early Access Program

The UK’s pharma regulator Monday began accepting applications for its Early Access to Medicines Scheme to allow not-yet-approved drugs for life-threatening diseases quicker interim approvals so they can be distributed to patients.

Amgen’s Metastatic Melanoma Candidate Hits Primary Phase III Endpoint

Amgen’s investigational metastatic melanoma candidate talimogene laherparepvec met its primary endpoint of durable response in a Phase III clinical trial, but missed the secondary endpoint of overall survival, the drugmaker said.

FDA Touts Bayesian Methods for Phase II Trials, More Cautious on Phase III

While the FDA sees great potential for Bayesian statistics in Phase II clinical trials, the agency is not yet ready to endorse the method for Phase III studies.

EU, Australia to Collaborate on Orphan Medicines

The EMA says that it already shares much information with its Australian counterpart, such as GMP standards.

BMS Files for Approval of Daclatasvir, Asunaprevir for Hepatitis C

The EMA validated BMS’ application earlier this year, the company says, with priority review underway in Japan.

Safety Concerns Set Back Another Halozyme Mid-Stage Trial

Halozyme has temporarily halted another trial due to safety concerns. This time, the drugmaker decided to hit the brakes after patients treated with PEGPH20, a pegylated form of its anti-cancer enzyme rHuPH20, showed increased risk for certain blood clots.

Merck, Ferring, WHO Join Forces Against Postpartum Hemorrhage

Merck, Ferring Pharmaceuticals and the World Health Organization have partnered up to study a drug aimed at preventing excess bleeding during childbirth — the leading cause of maternal deaths during childbirth in developing countries.

FDA Expands Indication for Dyax’s Kalbitor

Dyax is working on a second plasma kallikrein inhibitor as well.