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A new analysis of pharma research and development data shows that drugmakers have become increasingly successful in identifying the right candidates for drug development and getting them to market in recent years…From 2010 to 2014, one out of every 13 drugs in phase-I development came to market—compared to one of 19 phase-I drug candidates making it from 2007 to 2011,…Developing a drug takes 10 years on average currently, which is 40% longer than it took 15 years ago…Drug discovery—defined as all the work leading up to human clinical trials—has remained steady, taking four years on average.

Japan's Ministry of Health, Labour and Welfare received around 50 formal applications and has cleared screening for the "sakigake" fast-track drug and device review process before the Pharmaceuticals and Medical Devices Agency,… The "sakigake designation system" is aimed at expediting the review of innovative drugs, regenerative medicines and devices developed in Japan earlier than the rest of the world. This includes prioritized consultations and priority review status….products considered must display a novel mechanism of action, be scalable commercially, show high efficacy and be developed and planned for approval in Japan ahead of the rest of the world,…

Food and Drug Administration calls a ‘breakthrough’ drug is often not the same as what a layperson would call a breakthrough,…FDA uses the term...for smaller advances, than people use it colloquially, and this may lead patients to have unwarranted confidence in new drug claims…the...Safety and Innovation Act (2012),..allows the FDA to give breakthrough designation to any drug treating a serious or life-threatening condition that "may demonstrate a substantial improvement over existing therapies"…"Breakthrough" is an aspirational term, chosen for the 2012 act to help expedite the new drug approval process,...

The proposal was put forward by the Central Drugs Standard Control Organization…vitamins should be reclassified if there is a claim for treatment, mitigation or prevention of any diseases or disorder… also concluded that supplements containing vitamins already found in　schedule V　 products should be labelled as drugs even if the ingredient is below recommended daily allowance limits...Drugs Controller General of India, Dr GN Singh, has requested industry feedback on the proposed reclassification...

…Food and Drug Administration's unapproved-drugs initiative,...program is well known to some physicians and hospitals and their patients, who blame it for huge increases in the price of drugs that have been in common use for decades…it underscores an enormous flaw in our drug-approval process that rewards a few clever manufacturers at the expense of patients. The agency's unapproved-drugs initiative has laudable aims…to bring grandfathered medications that were in use before the FDA instituted rigorous testing requirements for safety and efficacy into line with modern standards…federal law also allows the FDA to incentivize drug research and development by granting marketing exclusivity to manufacturers who demonstrate a new use for a drug, or even a new dosing regime

United States is the only country with a strong pharmaceutical regulatory infrastructure that allows direct-to-consumer advertising of prescription drugs in print, broadcast, and electronic media. U.S. consumers are accustomed to full-page ads in newspapers and magazines detailing a drug's benefits… That may soon change, however, as the Food and Drug Administration moves to enact new regulations regarding risk communication in DTCA…. responds to mounting research showing that reprinting highly technical package inserts in print ads does very little to communicate risks to consumers. The goal is to communicate those risks in a new vernacular.

Medicare donut hole forces participants to face an expensive gap in coverage in their Part D prescription drug plans… the costs of prescription drugs covered by a plan get split up in various ways, depending on your total prescription costs for a given year… donut hole simply forced participants to pay these additional drug costs entirely on their own, causing huge financial stress… Affordable Care Act,…started to fill in the donut hole… Over time,..discounts will gradually rise…by 2020, participants will pay only 25% of the net cost of brand-name and generic prescription drugs.

Lower costs for newer medicines through subsidies are going begging in Australia as drug companies increasingly look to avoid putting products through regulation paces needed to qualify,… 9 in 10 big pharmaceutical companies say they have considered not applying for subsidies--which could lower costs for newer medicines… Cost and access in Australia's reimbursed drug program, the Pharmaceutical Benefits Scheme, is a central political issue with costs for newer medicines, particularly oncology therapies, a target for the Treasury...industry alleges the system that approves and sets reimbursement prices is broken...

In an extensive interview with Bloomberg BNA, IACP's (International Academy of Compounding Pharmacists)David G. Miller, RPh, Executive Vice President & CEO, discusses concerns over the Drug Quality & Security Act (DQSA), emphasizing the need for clarification over which regulatory authority is responsible for the oversight of compounding pharmacy.

Food and Drug Administration is making changes to the requirements for monitoring, prescribing, dispensing, and receiving the schizophrenia medicine clozapine, to address continuing safety concerns and current knowledge about…severe neutropenia…There are two parts to the changes in the requirements for treating patients with clozapine. First, we have clarified and enhanced the prescribing information for clozapine that explains how to monitor patients for neutropenia and manage clozapine treatment. Second, we approved a new, shared risk evaluation and mitigation strategy called the Clozapine REMS Program…