EU recommends suspending hundreds of drugs tested by Indian firm

Reuters, 25 March 2017
Author: Ben Hirschler
“Europe’s medicines regulator has recommended the suspension of more than 300 generic drug approvals and drug applications due to “unreliable” tests conducted by Indian contract research firm Micro Therapeutic Research Labs.”
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Prescription Drug Regulation, Promotion, And Advocacy Has Gotten More Vexing In 2017

Health Affairs Blog, 23 March 2017
Author: Jerry Avorn
“Early 2017 has been one of the most interesting and challenging times for anyone concerned with medication regulation and evidence-based prescribing — as well as for the patients and health care professionals who will be so heavily impacted recent policy changes.”
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Many Doctors Get Payments From Drug Companies

MedicineNet, 21 March 2017
Source: HealthDay News
“Many American doctors receive payments from drug companies, but few patients know about those financial ties, a new study finds. The study found that within the previous year, 65 percent of patients visited doctors who got payments or gifts from drug or medical device companies, but only 5 percent of the patients were aware of those doctor-industry links.”
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Crunch week looms for Sanofi, Roche and GSK at U.S. drugs agency

Reuters, 23 March 2017
Author: Ben Hirschler
“Three of Europe’s top drugmakers face critical verdicts from U.S. regulators next week, with Sanofi and Roche likely to win approvals for two new products, while GlaxoSmithKline braces for a potential generic rival. The two FDA decisions, due by March 28 and 29 respectively, mark important landmarks for both firms, since Dupixent and Ocrevus are expected to be the biggest new drug launches from the global pharmaceuticals industry in 2017.”
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Swisse cheese: there are too many holes in complementary medicine regulations already

The Conversation, 22 March 2017
Author: Michael Vagg
“Swisse is by no means the only vitamin company to have issues with truth in advertising. Blackmores is another Australian brand with overseas ambitions. They are pushing into the enormous Chinese supplement market, and apparently not letting trivial things like fines for false advertising get in the way of a surging share price. The essential problem here for manufacturers is that they simply have to mislead to sell their product, and our therapeutic claims regulatory code inconveniently forbids this.”
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9 Deaths Are Linked to Rare Cancer From Breast Implants

NYT, 21 March 2017
Author: Denise Grady
“A rare cancer first linked to breast implants in 2011 has now been associated with nine deaths, the Food and Drug Administration said Tuesday. As of Feb. 1, the agency had received a total of 359 reports of the cancer associated with the implants. The deaths were not caused by breast cancer, the agency said, but by a rare malignancy in the immune system, anaplastic large-cell lymphoma. The agency said it was impossible to say how many cases exist, because of limited reporting of problems and a lack of worldwide sales data on implants.”
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Strong regulation is healthy for complementary medicines

SMH, 21 March 2017
Author: Editorial
“The vitamin and supplement giant Swisse has asked to be liberated from federal government oversight of its advertising claims. When promoting its products, it wants to be spared the scrutiny of the Therapeutic Goods Administration and be subject instead to an industry-funded self-regulation system administered by the Advertising Standards Bureau.”
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U.N. drugs body places fentanyl ingredients on control list

Reuters, 16 March 2017
Authors: Francois Murphy, Alison Williams
“A U.N. body on Thursday added two chemicals used to make the drug fentanyl, which killed music star Prince, to an international list of controlled substances, which the United States said would help fight a wave of deaths by overdose. Fentanyl is a man-made opioid 100 times more powerful than morphine. Roughly 20,000 U.S. overdose deaths in 2015 involved heroin or synthetic opioids such as fentanyl, according to the U.S. Centers for Disease Control and Prevention.”
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Calls for ibuprofen sale restrictions after study finds cardiac arrest risk

The Guardian, 15 March 2017
Author: Matthew Weaver
“There have been fresh calls for restrictions on the sale of the painkiller ibuprofen after another study found it heightens the risk of cardiac arrest. Taking the over-the-counter drug was associated with a 31% increased risk, researchers in Denmark found. Diclofenac, available over the counter in the UK until 2015 and still taken on prescription, raised the risk by 50%.”
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