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IN THE NEWS


OncoGenex Granted FDA Fast-Track Designation for Cancer Drug Custirsen

OncoGenex Pharmaceuticals Wednesday said the FDA has granted fast-track designation for the drugmaker’s investigational drug custirsen as a second line treatment for men with metastatic castrate-resistant prostate cancer (CRPC) and non-small cell lung cancer.

FDA Hosts Drug Development Meeting for Neurologic Manifestations of Inborn Metabolism Errors

The meeting is one step toward fulfilling the agency’s patient-focused drug development requirements under PDUFA V.

Spectrum Pharmaceuticals’ Captisol-Enabled Melphalan Meets Endpoint in Pivotal Trial

The drugmaker said that its Melphalan is free of propylene glycol, which is associated with cardiac and renal failure.

GSK, Theravance Studying Combination Drug in Phase III for COPD

The drugmakers said that the study will eventually support an application for approval of the combination in Japanese patients.

Pfizer Touts Positive Results in Phase III Psoriasis Trials

Tofacitinib is part of a new class of medicines being studied in patients with moderate-to-severe plaque psoriasis, according to the drugmaker.

Guidance Targets Basic Clinical Trial Design Flaws

The UK’s Health Research Authority is helping drugmakers do a better job justifying their trial designs and protocol assumptions early on to avoid trial failures due to insufficient information.

Emergent BioSolutions Looks to Expand Biothrax Indication Under Animal Rule

Emergent BioSolutions has received an orphan drug designation for an expanded indication for BioThrax, its anthrax vaccine already in wide use by the U.S. military.

GSK, Genmab Leukemia Combo Gets FDA Approval

The FDA has approved GlaxoSmithKline and Genmab’s Arzerra and Leukeran as a first-line combination treatment for the most common form of blood and bone marrow cancer.

Opko Health Acquires Israeli Devicemaker

Opko Health said Thursday it has signed a definitive agreement to acquire Israeli-based Inspiro Medical, giving the drugmaker a delivery vehicle for its respiratory therapies.

Group Hopes to Turn Around Failed Lung Cancer Drugs

A UK coalition of drugmakers and a cancer research group are launching an analysis of failed Phase III lung cancer drug trials that will search for treatments that, despite failing overall, are effective for certain subpopulations.

BI’s Volasertib Is an Orphan Drug in the U.S. and EU

U.S. and EU regulators have both determined that Boehringer Ingelheim’s volasertib for acute myeloid leukemia is an orphan drug, the German drugmaker said Thursday.

Baxter Plans NDA for Blood Disorder Drug After Phase III Positive Results

Baxter said Wednesday that its Bax 111 treatment for Von Willebrand disease met its primary endpoint in a pivotal clinical trial, setting it up for NDA filing later this year.

EU Parliament Committee Adopts IMI2

The initiative will likely kick off this year and run through 2024.

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.

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.

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.

Australia Regulator Seeks Feedback on Low-Value Turnover Exemption Scheme

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

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.

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 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.

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.

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.