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Pharmalot.. Pharmalittle.. We’re catching up on Pharma lobbying, Biogen and…

coffee thx to chichacha on flickr creative commons [1]

coffee thx to chichacha on flickr creative commons

Good morning, everyone, and how are you today? We are just fine, thank you. In fact, we are thrilled to report that we have made it to the middle of the week. This is the sort of accomplishment that calls for a cup of stimulation and, as always, we invite you to join us. It may be needed to get to the end of the week, after all. Meanwhile, here are some tidbits. Hope you conquer the world today and do keep us in mind when you run across anything juicy…

The 21st Century Cures Act has [2] garnered an unusually broad support and one reason is that lawmakers softened up the usual opponents of looser rules with a big carrot — billions of dollars in new federal medical research funding for the National Institutes of Health, ProPublica [3] writes. After years of austerity, that money is awfully difficult to turn down. Supporters range from Republican lawmakers and conservative think tanks to the White House, patient advocacy groups, Democrats and nonprofit organizations that are typically leery of industry pushes for deregulation.

Biogen plans to cut about 11 percent of its workforce of 7,550 employees and end some development programs in a restructuring aimed at saving $250 million a year, The Boston Globe [4] reports. The move comes after a slowdown in growth of Biogen’s multiple sclerosis drug, Tecfidera, and another MS drug, Tysabri, failed in a late-stage clinical trial in a form of the disease known as secondary progressive MS.

The Indian Patent Office has denied a patent to Boehringer Ingelheim for key HIV drug, Viramune XR, yet again thwarting attempts by big drug makers to gain an “exclusivity” extension and block affordable generics, The Economic Times [5] reports. The application was refused since it lacking an inventive step, violating the same section of the Indian Patent Act under which Novartis lost the patent on its blockbuster drug Gleevec in 2013.

A nurse who admitted taking $83,000 in kickbacks from Insys Therapeutics, which makes the Subsys painkiller, was pressured by sales reps to increase her prescribing so Subsys sales would also increase, The Hartford Courant [6] says, citing court documents. The narcotic is approved only for cancer patients, but “prior authorizations” submitted on behalf of patients falsely represented that they had cancer, misleading insurers into paying for the drug.

A half dozen drug makers, including Pfizer and J&J, will invest in a $100 million fund with the U.K. government to explore new approaches to Alzheimer’s disease and other forms of dementia, Bloomberg News [7] tells us.

Novartis broadened its immuno-oncology pipeline with the acquisition of Admune Therapeutics and through licensing agreements with small drug developers Xoma and Palobiofarma, PMLive [8] reports.

Subway plans to eliminate antibiotic use in US meat supplies, making the sandwich seller the largest restaurant chain to adopt this pledge amid public-health concerns over drug-resistant bacteria, The Wall Street Journal [9] writes.

Merck’s experimental hepatitis C drug combinations were effective against two common strains of the disease in a mid-stage trial as the company tries to show an edge over Gilead Sciences and AbbVie, Bloomberg News [10] says.

The FDA issued an alert [11] to the public not to take drugs marked as sterile by Qualgen, after an agency inspection [12] found quality problems, but the compounder refused to cease operations and only agreed to a voluntary recall.

23andMe plans to relaunch its direct-to-consumer genetic test two years after the FDA ordered it to stop marketing health-related information from the test without agency approval, according to The Wall Street Journal [13].

Indian drug maker Cipla was tagged for nine observations by FDA inspectors at its Indore manufacturing unit during an inspection that was conducted during July and August, The Economic Times [14] informs us.

GlaxoSmithKline reported positive results from two head-to-head studies pitting its Incruse Ellipta drug for COPD against Boehringer Ingelheim’s Spiriva and Novartis’ Seebri, Pharma Times [15] reports.