Indonesia "Most Promising" Emerging Market in 2015
December 12th 2014With its new healthcare insurance scheme, Jaminan Kesehatan Nasional (JKN), aiming to cover all citizens by 2019, next year will see Indonesia emerge as the most promising emerging market for pharma investment, according the Frost & Sullivan’s Reenita Das.
Key Obamacare Actions for Rx Manufacturers in 2015
December 8th 2014At first glance Obamacare developments for the American Rx industry in 2015 appear fairly benign. However, digging deeper suggests that each, in its own way, could cause various actions with potential for substantial uncertainty for the U.S. pharmaceutical industry next year. If your response to this profound observation was, “Really, what’s new?” - read on.
Breakthrough Drug Initiative Success Creates Manufacturing Challenges
December 2nd 2014The breakthrough drug initiative has accelerated the development and approval of highly effective therapies, enabling important new medicines to reach patients sooner, according to Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER).
Randomized Trials Key to Determining Effectiveness of Ebola Therapies and Vaccines
December 2nd 2014US researchers and regulators continue to support the use of randomized clinical trials to test potential treatments and vaccines to combat the Ebola virus, despite objections that this approach is unethical and unfair to vulnerable populations
Provider Demand to Drive Compounder Registration with FDA
December 2nd 2014The Food and Drug Administration is moving fast to implement the drug compounding provisions of new Drug Quality and Security Act (DQSA), issuing new guidance to spur registration by outsourcing facilities just days after President Obama signed the new bill into law.
What’s All This Talk About Patient Centricity?
December 1st 2014For Moe Alsumidaie, the most concrete definition for patient centricity is “a dynamic process through which the patient regulates the flow of information to and from him/her via multiple pathways to exercise choice that is consistent with his/her preferences, values and beliefs.
Risking It All? Risk-Based Monitoring at Cancer Research UK
November 25th 2014“Only those who risk going too far can possibly find out how far they can go,” said T.S. Elliot. Cancer Research UK (CRUK) followed this advice when it decided to have its Center for Drug Development (CDD) adopt a risk-based monitoring (RBM) approach across its entire portfolio of clinical trials.
Trending: Wearables and Invisibles
November 25th 2014I can’t help imagining the cocktail party of 2018 as a scene from one of those a low-budget sci-fi film aired late at night. Imagine: A living room packed with people too busy to chat with each other as they balance their drinks with one hand and monitor their sleeves of devices and smartphones with the other - emailing, texting checking their wearable ECGs (electrocardiograms); glucose monitors and even insulin pumps.
Breakthrough Therapy Program Exceeds FDA’s Expectations
November 23rd 2014The 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).
FDA "Stymies Competition in Drug Industry", Says PCMA
November 19th 2014The Pharmaceutical Care Management Association (PCMA), an organization that represents the nation’s leading pharmacy benefit managers (PBMs), which administer prescription drug plans for over 210 million Americans, released a new white paper investigating FDA’s influence on drug prices and competition in the pharmaceutical marketplace.