Good morning, everyone, and welcome to another working week. This will be an abbreviated session on this side of the pond thanks to a holiday Monday. Nonetheless, we anticipate a busy few days — it would be unusual if it were not, yes? — and so we are brewing some cups of stimulation in order to cope. As always, we invite you to join us. Meanwhile, here is a laundry list of tidbits to get you going. Have a smashing day and do stay in touch …
Pfizer (PFE) agreed to pay $784.6 million to settle a US government investigation into allegations that its Wyeth unit overcharged Medicaid for the Protonix heartburn drug, according to a filing with the US Securities and Exchange Commission. The Justice Department filed a lawsuit against Wyeth in April 2009 over charges the company failed to provide state Medicaid programs the same discounts given to other customers between 2001 and 2006. The feds based their lawsuit partly on allegations in two whistleblower lawsuits previously filed against the drug maker.
An assistant professor of medicine at the University of Chicago Medical Center has developed a questionnaire to help doctors and patients assess the risk a patient faces from the financial burden of their treatments, The Wall Street Journal writes. Dr. Jonas de Souza hopes that doctors can help patients better understand the risks they face and avoid the potential harm caused by the financial costs associated with treatment.
India runs a six-year-old program to collect and submit suspected adverse drug reactions to a World Health Organization database, but there are some big problems, according to Reuters. Staffing and equipment are insufficient, and there is a lack of awareness among medical professionals that the program exists. This means, of course, that many potentially dangerous adverse events go unrecorded.
The Food and Drug Administration rejected a claim by Merck that its Zetia and Vytorin cholesterol-lowering drugs can reduce the risk of heart attacks and strokes in patients with coronary heart disease, Reuters reports. Last December, an FDA advisory panel recommended against approving the claim. The agency determined that Vytorin, which combines Zetia and simvastatin, has no additional benefit beyond what was already established for simvastatin.
Sun Pharmaceutical, which is one of the world’s largest generic drug makers, plans to ask the FDA to re-inspect a plant in Gujarat, India, after the agency criticized manufacturing standards there, The Economic Times tells us. At the same time, Sun and Merck have ended a joint venture, which was begun in 2011, to develop so-called branded generics for emerging markets because of “changes in priorities” at both companies.
Express Scripts does not forecast a surge in sales for new injectable cholesterol treatments from this year, according to Reuters. Meanwhile, the pharmacy benefits manager is closely scrutinizing prescriptions for Valeant Pharmaceuticals products after the drug maker was enmeshed in scandal with a specialty pharmacy over reimbursement tactics, Bloomberg News says.
Repeated use of proton pump inhibitors to treat acid reflux or peptic ulcers was linked to a higher risk for dementia among patients in Germany, Reuters informs us, citing new research in JAMA Neurology.
Pfizer is recalling 124 lots of Advil liquid products for infants and children in Canada because ibuprofen doses could be inconsistent if the products are not shaken as directed before use, The Canadian Press writes.
Martin Shkreli was hit with a $4.6 million lien from the US Internal Revenue Service for unpaid taxes on his midtown Manhattan home, according to Gawker.
CVS (CVS) Pharmacy will pay $8 million to settle civil allegations that its Maryland pharmacies illegally sold controlled substances under prescriptions that were allegedly not issued for a legitimate medical purpose, BayNet says.
Researchers at Carnegie Mellon University created the first robotically driven experimentation system to cut the number of needed experiments in drug discovery by 70 percent, Outsourcing Pharma reports.
Dinesh Thakur, who exposed quality-control problems at Ranbaxy Laboratories, may create a patient advocacy group to increase transparency and accountability among drug makers in India, The Economic Times writes.
Incyte (INCY) ended plans to develop its Jakafi drug, which is already approved to treat a chronic blood cancer and a type of bone marrow disease, for treating solid tumors after a late-stage trial in pancreatic cancer failed, PMLive says.
A federal judge gave preliminary approval to an $830 million settlement in which Merck shareholders accused the drug maker of failing to disclose risks associated with its Vioxx painkiller, The New Jersey Law Journal reports.
Eisai and Charles River Labs, a contract research organization, will jointly work on various synthetic and medicinal chemistry projects at Eisai’s R&D facilities in the UK, Pharma Times writes.