Friday, September 2, 2016

Pharmalot, Pharmalittle: Valeant under criminal investigation for defrauding insurers

Good morning, everyone, and how are you today? We are doing reasonably well, thank you, given an especially busy week. But this is to be expected in a busy world, yes? So please join us as we cope by quaffing yet another cup of stimulation. Remember, a prescription is not required. Meanwhile, here are some tidbits to help you along. We hope you have a smashing day and do drop us a line when something fascinating occurs …

Federal prosecutors are pursuing a criminal investigation into whether Valeant Pharmaceuticals defrauded insurers by hiding its relationship with Philidor Rx Services, a pharmacy that was used to boost prescriptions of its medicines, the Wall Street Journal reports. At issue is whether insurers thought Philidor was neutral rather actively promoting Valeant drugs. Valeant had acquired an option to buy Philidor, but did not disclose that for many months and only acknowledged the relationship after this report.

In its quest to win customers in India, some Abbott Laboratories managers instructed employees to pursue sales at virtually any cost, the New York Times reports. But this was allegedly done in violation of Indian law, professional medical standards, and the company’s own ethics guidelines. Last month, Ashish Awasthi, 35, was found dead on a railway track and a note recovered from him blamed the company and pressure to hit sales targets for his death.

The US Department of Veterans Affairs is extending coverage of new antiviral treatments to all veterans with hepatitis C, regardless of the stage of their illness and whether they contracted these infections during military service, according to the Journal of the American Medical Association. The agency is starting therapy for 1,100 patients a week — double from a year ago — and hopes to increase that to 2,000 patients a week by the end of this year.

The US Food and Drug Administration agreed to review a Marathon Pharmaceuticals treatment for Duchenne muscular dystrophy, the Chicago Tribune tells us. Known as deflazacort, the drug is already available outside the US, where it has been approved for other uses. But because the steroid does not have FDA approval, the medication is not widely available here.

Tax breaks for drug makers: Allergan will use over $58 million in incentives from a New Jersey state agency to consolidate its current operations and develop a new US headquarters at a facility in Madison by the end of 2017, NJBiz writes. Separately, Pfizer has won the first part of its request for a tax break on a planned $145 million expansion of its manufacturing plant in Portage, Mich., according to MLive.

AstraZeneca has invested another $140 million in Moderna Therapeutics, raising its stake to 9 percent in the company, which is developing drugs based on a molecule known as messenger RNA, Reuters says.

Clinical trial volunteers in India complained to the National Human Rights Commission that some clinical research organizations violated certain regulations and exploited participants, PharmaBiz tells us.

A former partner at the Hunton & Williams law firm and his investment adviser were criminally charged with participating in an insider-trading scheme ahead of a Pfizer deal, the Wall Street Journal writes.

After two rejections, the FDA finally approved Heron Therapeutics’s long-acting injection for preventing chemotherapy-induced nausea, Reuters reports.

PharmaTech recalled more drugs made at a Florida plant that was linked an outbreak of B. cepacia last month, according to InPharma Technologist.

The National Health Service in England launched a 45-day public consultation on a proposed clinical commissioning policy for the PrEP HIV treatment, PharmaTimes writes.

Australia’s Therapeutic Goods Administration approved changes to labels for prescription and nonprescription medicines so they align with international practices, Regulatory Focus informs us.

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