Drugmakers to FDA: Let us share off-label study data with payers
17 November 2016
Now that pharma has prevailed in free-speech legal battles concerning off-label marketing, it’s pushing the FDA to relax its regulations—and drugmakers believe the first step should involve sharing info with payers.
EU drug agency head fears loss of expert staff after Brexit
17 November 2016
The head of Europe's drugs regulator is braced for disruption following Britain's vote to leave the European Union (EU) and said he feared losing expert staff if, as widely expected, the regulator is forced to decamp from London.
Epic Sciences Validates Single CTC Sequencing, Identifies Clonal Heterogeneity in Metastatic Cancer
16 November 2016
Epic Sciences, in collaboration with pharma co-authors, published an analytic validation of their sequencing assay in single circulating tumor cells (CTC) and demonstrated clinical feasibility in metastatic prostate cancer patients (mCRPC). In addition to profiling genome wide copy number variation (CNV) from single cells, the authors also validated the ability to characterize the extent of genomic instability within individual CTCs.
Tech billionaire starts late-stage life science VC fund
16 November 2016
An entrepreneur who made his fortune building a $14 billion tech company is setting up a life science venture capital fund. The Israel-focused fund will target maturing life science startups with a view to helping companies grow into the next Teva ($TEVA) rather than sell up or outlicense their programs, Reuters reports.
New lasers to fight cancers and analyze gases under way in Russia
16 November 2016
Rostec, Russia’s largest government-owned umbrella corporation for technology development, is developing new 2-5µm infrared quantum-cascade type semiconductor lasers. The solution is expected to help fight cancers through targeted destruction of cells in malignant tumors.
3D printed endoprosthesis production deal inked outside Moscow
16 November 2016
Technospark, a nanotech park in Troitsk just outside Moscow, and LVM AT, a Russian tech engineering company, have inked an agreement with Germany’s Concept Laser which is paving the way for Russia’s pioneering production of 3D printed endoprostheses for joints, interbody fusion cages and implants for intracranial and oral/maxillofacial surgery, announced Rusnano, Russia’s largest nanotech company.
15 November 2016
Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a biopharmaceutical company dedicated to the development of innovative therapeutics to treat epilepsy and neuropsychiatric disorders, presented preclinical data showing that the combination of its CNS-selective GABAA modulator ganaxolone and diazepam administered intravenously (IV) produced a synergistic effect in blocking pilocarpine-induced seizures in a benzodiazepine refractory model of status epilepticus (SE).
15 November 2016
Clearside Biomedical, Inc. (NASDAQ:CLSD), a late-stage biopharmaceutical company developing first-in-class drug therapies to treat back-of-the-eye diseases, today announced the enrollment of the first patient in a Phase 1/2 clinical trial (the “HULK” trial) of Zuprata™, its proprietary suspension formulation of the corticosteroid triamcinolone acetonide, for the treatment of diabetic macular edema (“DME”).
Pharma's Not Off the Hook for High Drug Prices
15 November 2016
Even with a presumably business-friendly president-elect in Donald Trump, drugmakers that have been battered by criticism over high prices in the past year are bracing for Republican and Democratic lawmakers to take aim at the industry.
Drugmakers improve access for poo
15 November 2016
The world's top drugmakers have improved access to medicines in developing countries but still need to do more to make a wider range of products affordable, according to a report on Monday.
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