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PhRMA, AAM Spar on Hatch-Waxman Provisions The Hatch-Waxman Act did not strike a good balance between generic access and brand-name innovation, according to public comments to the FDA from both PhRMA and the Association for Accessible Medicines — however the two groups disagree as to how. The Hatch-Waxman amendments’ incentives have not worked as intended, PhRMA said, in comments submitted following an ... Read More
Public Citizen Urges FDA to Pull Olmesartan-Containing Drugs Public Citizen called on the FDA to ban the sale of olmesartan, arguing the hypertension drug puts patients’ health at risk. The drug, an angiotensin II receptor blocker, is marketed under several brand names, including Benicar, Tribenzor, Benicar HCT and Azor, as well as several generics. The drug can cause the severe gastrointestinal disorder sprue-like enteropathy, ... Read More
New York Indicts Pharmacist, Pharmacy Owner for Stealing From Medicaid New York’s attorney general indicted a pharmacy owner, pharmacist and three pharmacies for defrauding Medicaid of $3 million in reimbursements for drugs that were never dispensed. Hin T. Wong of Manhattan and Mery Gooden of the Bronx collaborated with three Manhattan pharmacies to fraudulently bill the federal government for prescription refills, according to AG Eric Schneiderman. The ... Read More
NICE Issues Recommendations for Bayer Cancer Drug The National Institute for Health and Care Excellence issued recommendations for Bayer’s regorafenib as an option for metastatic or unresectable gastrointestinal stromal tumors in adults who have either seen progression on or are intolerant to prior treatment with imatinib and sunitinib. Healthcare professionals should factor in any sensory, physical or learning disabilities and make necessary adjustments, ... Read More
Automation of Process Control within the Pharmaceutical Industry While most pharmaceutical businesses have adopted process automation in one format or another, the technology has evolved considerably over the past few years, leading to improvements in design, efficiency and reliability. One of the major drivers for businesses to increase levels of automation is legislation, but the need to compete in the market place and reduce ... Read More