Abbott, Novartis and Sanofi Targeted in NPPA Clampdown on Drugs Sold Without Price Approval

RAPS, 23 May 2017
Author: Nick Paul Taylor
“The National Pharmaceutical Pricing Authority (NPPA) of India is taking action against drugmakers including Abbott, GlaxoSmithKline, Novartis and Sanofi. These top pharmaceutical firms allegedly introduced drugs without seeking price approval and may have to pay back what they overcharged. In a letter to the companies the director of enforcement at NPPA, accused the businesses of altering scheduled formulations, either by changing the dose or combining the drug with a non-scheduled medicine. To NPPA, such changes represent the introduction of new drugs. As such, the companies should have obtained approval from NPPA for the prices of their new products before introducing them to the market.”
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Modi’s generics-only drugs plan worries health experts, Indian pharma sector

Reuters, 25 May 2017
Author: Zeba Siddiqui
“India’s plan to bring in a law to ensure doctors prescribe medicines only by their generic names risks proliferating the sale of substandard drugs in a country where regulation is already lax, doctors and pharmaceutical executives say. Prime Minister said last month that the government was looking at such a law to improve affordability of medicines in the country of 1.2 billion people. Pharmaceutical executives said any law would have to stipulate that the drugs consumers get from pharmacists meet certain quality standards.”
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Many patients with early-stage breast cancer receive costly, inappropriate testing

EurekAlert, 24 May 2017
Author: Fred Hutchinson Cancer Research Center
“A study from Fred Hutchinson Cancer Research Center shows that asymptomatic women who have been treated for early-stage breast cancer often undergo advanced imaging and other tests that provide little if any medical benefit, could have harmful effects and may increase their financial burden.”
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Ethics Survey: Drug testing remains a clinical tug of war

Behavioural Net, 18 May 2017
Author: Julie Miller
“In recent weeks, the American Society of Addiction Medicine (ASAM) prepared comprehensive guidelines on drug testing within the continuum of care. The goal is to present evidence-based recommendations for the frequency and application of testing, which payers and providers can adopt as best practices. It’s significant because up until now, there was no true consensus. And there’s also no denying that some treatment operators have aimed to maximize their profit streams through the overuse of testing and subsequent billing of insurance companies.”
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In Bold Move, FDA Approves Cancer Drug For Any Advanced Tumor With Genetic Changes

Forbes, 23 May 2017
Author: Elaine Schattner
“For the first time, the FDA has approved a drug for use in cancer—of any type—that harbors certain molecular features. Merck’s Keytruda, an immune oncology drug, may be prescribed for any resistant, metastatic tumor with microsatellite instability (MSI) or other evidence for defective DNA mismatch repair. This is good news for patientsby trying this medication if they have advanced cancer of any form with pathological MSI or DNA mismatch repair defects.”
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Disease-awareness ads lead to overdiagnosis, boost Rx sales

ModernHealthcare, 22 May 2017
Author: Alex Kacik
“Ads that try to bring awareness of diseases boost prescription drug sales and over diagnosis in the U.S., according to a new study. There is a fine line between direct-to-consumer drug ads, which the Food and Drug Administration regulates, and ads meant to create disease awareness that often skirt the purview of the FDA, per the article published in JAMA. Disease awareness advertisements, particularly for conditions that only have one approved drug treatment, can bolster drug sales and lead to “inappropriate” prescriptions as patients turn to their doctors and request the drugs they see advertised.”
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Sigma shares plunge on legal wrangle

News, 24 May 2017
Author: Melissa Jenkins
“Sigma Healthcare is planning legal action against the My Chemist/ Chemist Warehouse Group over an alleged breach of a supply agreement, sparking a dive in its share price. Sigma said its proposed action relates to the My Chemist/ Chemist Warehouse Group’s intention to obtain certain products from another wholesaler, which Sigma maintains it is not entitled to do under their existing agreement.”
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French drugmaker Servier to face trial over weight-loss Mediator

Reuters, 24 May 2017
Authors: Simond Carraud, Matthias Blamont, Emmanuel Jarry and Leigh Thomas
“The Paris prosecutor’s office said on Wednesday that drugmaker Servier as well as the French drug regulator should face trial over weight-loss pill Mediator, believed to have caused at least 500 deaths in one of France’s worst health scandals. Once licensed as a diabetes treatment, the drug was widely prescribed as an appetite suppressant to help people lose weight. The prosecutor’s indictment covers charges of misleading claims as well as manslaughter and targets 14 people as well as 11 institutions including Servier and the French drug regulator ANSM.”
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Deadly brain infection in German MS patient prompts Roche investigation

Reuters, 24 May 2017
Authors: John Miller, Bill Berkrot, Greg Mahlich and Lisa Shumaker
“A person in Germany treated with Roche Holding AG’s new multiple sclerosis drug Ocrevus has been diagnosed with an often-deadly brain infection after switching from another medication earlier this year. Roche said it was investigating a case of Progressive Multifocal Leukoencephalopathy (PML) in a patient previously being treated for three years with Biogen Inc’s Tysabri and who had received a single dose of Ocrevus in February. Ocrevus was approved in the United States in March.”
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EU probes Aspen price gouging allegations

PharmaPhorum, 16 May 2017
Author: Richard Staines
“The European Commission is to investigate into whether South Africa’s Aspen abused a dominant market position by raising the price of a group of generic cancer drugs. Pharma pricing is already under scrutiny in the US, where president Trump has vowed to take action against high drug prices. But now authorities across the Atlantic are also concerned over so-called “price gouging”, where companies impose significant price rises for badly needed drugs.”
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