EMA Issues Guideline on Fast Tracking Drugs for Unmet Needs
05 August 2015
The European Medicines Agency (EMA) announced on July 27, 2015 that it has revised its guideline on the implementation of accelerated assessment and conditional marketing authorization to improve existing framework. These guidelines are part of European legislation targeting the acceleration of patient access to innovative therapies.
Health experts caution against wide range of scope devices amid superbug outbreaks
05 August 2015
Duodenoscope devices have drawn the public's ire this past year, with the FDA and patients pushing back against the products in light of superbug outbreaks and mounting safety concerns. Now, healthcare experts are cautioning against a variety of scopes, saying similar devices could lead to potentially deadly infections.
Marinus Pharmaceuticals Provides Business Update and Reports Second Quarter 2015 Financial Results
04 August 2015
Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a biopharmaceutical company dedicated to the development of innovative therapeutics to treat epilepsy and neuropsychiatric disorders, today provided a business update and announced its financial results for the second quarter ended June 30, 2015.
In a first, drug using 3D printing technology gets FDA nod
04 August 2015
The U.S. Food and Drug Administration has, for the first time, approved a drug that uses 3D printing technology, paving the way for potential customization of drugs to suit patients' needs.
Romania investigates suspected drug company bribes
04 August 2015
Romanian anti-corruption prosecutors have conducted a series of searches at drug companies, hospitals and clinics this week to investigate suspected bribes paid to doctors for prescribing cancer drugs.
Scientists create noninvasive spinal stimulation tech to help paralyzed move
04 August 2015
Spinal cord stimulation is the med tech trend du jour, and researchers are harnessing the technology to create a noninvasive method that helps restore movement in paralyzed individuals.
Europe's public biotechs blast past 2014 fundraising total in just 6 months
03 August 2015
Biotechs listed on European stock exchanges have raised more money in the first half of 2015 than in all of last year, according to a report by Biocom. Over the first 6 months of 2015, €3 billion ($3.3 billion) flowed into Europe's 161 listed biotechs, one-quarter more than they added to their coffers in all of 2014.
Regulators in Europe propose bans on plants in China and India
03 August 2015
FDA actions taken against Indian drugmakers have grabbed a lot of attention in recent years, but Europe has also been pushing foreign suppliers to hit higher standards. Each country does its own inspections but then shares any issues it finds through a common website. Most recently, Italy flagged problems with three plants, two in China and one in India.
Report Calls for Measures to Preserve India’s Brand in Global Pharma Market
03 August 2015
A new report to the government of India suggests the adoption of a slew of measures to help domestic pharma firms, especially small firms that form the bulk of the industry, better understand the global regulatory landscape and meet compliance standards in advanced countries.
FDA issues draft guidance on quality manufacturing metrics
03 August 2015
After years of dealing with avoidable manufacturing issues that led to questionable meds and drug shortages, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), initiated the Office of Pharmaceutical Quality last January. The idea is for it to work up guidelines that will push even reluctant drugmakers toward quality manufacturing and establish a risk-based method for setting inspections. The office is now providing an idea of how that will work.
14 March 2024
26 February 2024
NovaMedica team wishes you a Merry Christmas and a Happy New Year!
26 December 2023
Putin has stated that Russia will support Africa in the struggle against epidemics
19 April 2024
The Russian government has expanded the list of vital and essential drugs
19 April 2024
Achieving FAIR bacterial identification
18 April 2024
Unique testing regimen could prevent nuclease contamination
18 April 2024