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…nonpartisan watchdog group called Project on Government Oversight published a report…that highlights flaws in the FDA’s 2010 approval of Pradaxa…group says this case study is a "cautionary tale" for U.S. legislators considering the 21st Century Cures Act which aims to expedite the drug approval process…Food and Drug Administration was "lax" and "permissive" in its approval…analysis suggests the FDA rubber-stamped the drug on the basis of a single poorly designed clinical trial that overlooked safety concerns…damning report comes at a time when Congress is considering the 21st Century Cures Act…

Food and Drug Administration…approved Alkermes Plc's longer-acting injectable version of … schizophrenia pill Abilify (Aristada,aripiprazole lauroxil), making the treatment available in two doses…Abilify, developed by Japanese drugmaker Otsuka Pharmaceuticals and sold…by Bristol-Myers Squibb Co, is already facing generic competition.

Asia's largest vaccinemaker just made a play that could affect the race for a vaccine protecting against dengue fever,..Serum Institute of India announced…that it's seeking fast-track approval to launch a dengue treatment in India for which it purchased local rights from U.S. biotech Visterra earlier this month…If successful, the company could be the first globally to launch a drug for the mosquito-borne illness,..a development with potential implications in the ongoing dengue vaccine race between Sanofi, Takeda, and others.

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...

Combination products – medical products that do not fit into the traditional categories of drugs, devices, or biological products – are a growing and important category of therapeutic and diagnostic products under FDA’s regulatory authority…These products, that combine drugs, devices, and/or biological product ("constituent parts") with one another… Products in this category range from familiar products such as prefilled syringes and surgical kits to novel and innovative products, which target and enhance therapies. Examples of groundbreaking combination products include antibodies combined with drugs for targeted cancer therapy and products that mimic or replace organs, such as an artificial pancreas….we’re taking a number of steps to clarify regulatory requirements and improve our internal processes and IT systems.

• Issuing more guidance for review of combination products (e.g., our pending draft guidance document on human factors);
• Enhancing and simplifying data access and sharing for internal staff;
• Making it easier for staff to request and monitor inter-center consults;
• Updating and maintaining our internal contact directory for experts to review a combination product; and
• Improving our internal standard operating procedures for premarket reviews and compliance activities.

FDA is considering approval for an intranasal formulation of the opioid overdose antidote naloxone (Narcan). Naloxone has been the standard of emergency treatment for opioid overdose …only injectable formulations of naloxone are currently approved for use…FDA has granted priority review to Adapt Pharma’s naloxone...nasal spray, which was previously given a fast track designation…

European health regulators…conditionally approved Amgen Inc's rare blood cancer drug, Blincyto (blinatumomab), which is one of the world's most expensive cancer treatments…Food and Drug Administration in December approved Blincyto for acute lymphoblastic leukemia, which has few treatment options once a patient has relapsed…Blincyto is a so-called bispecific antibody, an emerging class of drugs that could prove more potent than conventional antibodies,…

Ever since the Food and Drug Administration approved the use of ...OxyContin for certain children…it has faced unabated criticism from lawmakers and public officials who are wrestling with devastating rates of prescription opioid abuse in their communities…. The crux of the issue is whether the agency’s approval will lead to more prescriptions for OxyContin in young patients. For years, the powerful long-acting drug has been prescribed off-label to…children in severe pain… agency’s approval means those doctors will finally have "information about how to do it appropriately," like dosage recommendations…"This approval allows Purdue Pharma to market and promote this product for use in children, and the obvious concern is this approval will change the pattern of use.".. postmarketing data could prove revelatory and useful..."It’s not a given, but it could help us better address the problem of prescription drug abuse in adolescents....

Shares in Novo Nordisk rose as much as 5 percent on Monday after the Food and Drug Administration approved the diabetes drug Tresiba (insulin degludec),..."This will be Novo's largest drug launch ever and we believe it is very well prepared,"… compete against long-acting insulins Lantus and Toujeo...

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.