IN THE NEWS
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.
The meeting is one step toward fulfilling the agency’s patient-focused drug development requirements under PDUFA V.
The drugmaker said that its Melphalan is free of propylene glycol, which is associated with cardiac and renal failure.
The drugmakers said that the study will eventually support an application for approval of the combination in Japanese patients.
Tofacitinib is part of a new class of medicines being studied in patients with moderate-to-severe plaque psoriasis, according to the drugmaker.
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 has received an orphan drug designation for an expanded indication for BioThrax, its anthrax vaccine already in wide use by the U.S. military.
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 said Thursday it has signed a definitive agreement to acquire Israeli-based Inspiro Medical, giving the drugmaker a delivery vehicle for its respiratory therapies.
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.
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 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.
The initiative will likely kick off this year and run through 2024.
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.
Comments are now open until June 11, the agency says.
Vivolux is taking its cancer drug candidate VLX600 into Phase I/II clinical testing after receiving permission from the FDA.
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.
CEO John Castellani says the industry’s continued success depends on prioritizing innovation.
Genentech will focus its data mining efforts primarily on oncology.
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.
The EMA is tightening stability testing requirements for drugmakers submitting applications for significant post-approval manufacturing changes that involve active substances.
The review was prompted by drugmakers’ complaints of undue burden.
No serious adverse events were seen and no patient developed inhibitors to the therapy, the drugmakers said.
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.
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.
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.
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 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.
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.
The FDA Tuesday placed a clinical hold on Halozyme Therapeutics’ Phase II study of PEGPH20 for the treatment of pancreatic cancer.