Tag:

Minnesotans could get their prescription drugs from Canada by 2017 if a state representative has his way…State Representative Joe Atkins plans to introduce a bill next legislative session that would make it legal for Minnesotans to buy…prescription drugs from Canada through their local pharmacies…"Right now – we're turning Americans into criminals. We've got Minnesotans driving up to Canada to buy these drugs at much lower prices.".. His bill would require the commissioner of the Minnesota Department of Human Services to establish the program where local pharmacies could sign up, as well as creating a web site for ordering prescriptions.

Food and Drug Administration has revoked an approval issued in March to India's Sun Pharma Advanced Research Company Ltd to launch a drug (Elepsia XR, levetiracetam), for seizures, citing manufacturing quality problems at its production site…setback to SPARC, the research arm of India's largest drugmaker,…FDA issued it a "Complete Response Letter" in which it said "the compliance status of the manufacturing facility was not acceptable on the date of approval".

Aims for a 'more patient-centered medical product development and assessment process'…As healthcare enters an era in which "patients and their care partners participate actively in decision-making and priority-setting," FDA has launched its first-ever Patient Engagement Advisory Committee…the group will offer perspective...on issues related to regulation of technology and medical devices, and their use by patients. FDA will learn about patient-related topics and better integrate those patient perspectives into its regulatory process.

At least three reviewers recommended against Addyi (flibanserin) approval..They warned about possible side effects and expressed concern that “the marginal clinical benefits do not outweigh the serious risks,” according to a memo posted online that summarized the analysis within the U.S. regulatory agency… One reviewer particularly wanted more study of the interaction between Addyi and alcohol because the tests were conducted almost exclusively with men… FDA had rejected the drug,…in 2010 and 2013 before approving it in August...

Israel-based MediWound has signed a five-year, $112 million contract with the U.S. authority that handles public health medical emergencies to further develop and buy the company's drug treatment for severe burns (NexoBrid,bromelain)…Investment group Clal Biotechnology, which has a 45 percent stake in MediWound, said in a statement that the deal with the Biomedical Advanced Research and Development Authority would raise preparedness for mass-casualty incidents.

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,…

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.

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...

…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

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,...