Breakthrough Therapy Program Exceeds FDA’s Expectations
25 November 2014
The two-year-old initiative to accelerate the development and approval of highly effective drugs and biologics has enabled a number of important new medicines to reach patients sooner, according to Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER). Twelve breakthrough drugs have been approved over the past two years, for several critical conditions as well as cancer, and dozens more are in the pipeline.
2015 Pipeline Report: Burning Bright
25 November 2014
Tracking new therapies as they wind their way through development, regulatory approval, and payer acceptance can be like waiting for paint to dry and then repainting in a different color. It's a slow process and far from linear.
FDA posing options for faster antibacterial development
25 November 2014
FDA's Anti-Infective Drugs Advisory Committee (AIDAC) is being asked to weigh in on the feasibility of clinical trial designs to streamline the development of antibacterial drugs in the face of "more commonplace bacterial resistance."
Health Care M&A Leads Global Deal Surge
24 November 2014
In a big year for deal making, the health care industry is a standout.
Powerful method to speed cancer drug discovery unveiled -
24 November 2014
Research data published in the journal Cell Reports describe a new method that could hasten the discovery of new cancer therapeutics by identifying protein-protein interactions that could be targeted by medicines, Science Daily reported.
Beware sketchy biotechs with big plans for Ebola, SEC says
24 November 2014
The SEC has suspended the trading of a few microcap companies touting unverified Ebola treatments and tests, warning investors of penny stock peddlers looking to cash in on the West African outbreak that has killed thousands.
Smartphone apps to assess mental health based on everyday behavior proliferating
24 November 2014
Diagnostic smartphone apps are proliferating. No, these apps don't somehow turn the phone into a needle for drawing blood; instead they monitor stuff we take for granted, like talking or the movement of our eyes.
World projected to spend $1T on drugs in 2018
21 November 2014
The top-line news from the IMS Institute for Healthcare Informatics is that the world is on track to spend $1.3 trillion on medications by 2018, or 30% more than it did in 2013.
Russian government to start checks for GMP compliance of domestic drug producers
20 November 2014
The Russian government plans to start massive checks of the domestic producers of drugs, as well as drug importers for their compliance of products with Good Manufacturing Practices (GMP) standards, which became mandatory in Russia since the beginning of the current year, according to an official representative of the Russian Ministry of Industry and Trade.
Pharma's top 10 M&A deals of 2014's first half
20 November 2014
Mergers and acquisitions have been non-stop this year, with lots of deals done, and some doozies that were unable to cross the finish line. Here we look at what's happened in the first half of the year; we will round out the entire year's activity in another report early next year.
NovaMedica expands its line of products for the treatment of Alzheimer’s disease
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Children visited the NovaMedica Innotech pharmaceutical manufacturing facility
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HPV vaccine is to be included in Russia’s national immunization schedule by 2026
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New WHO guidance to support manufacturers to reduce AMR risk
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