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The U.S. Attorney for the Southern District of New York filed a lawsuit against an herbal drug manufacturer for selling unapproved drugs using claims that they can cure or prevent conditions including diabetes, syphilis, arthritis, cancer, heart disease and asthma. Read More
The FDA released final guidance Tuesday spelling out its review goals for amendments to abbreviated new drug applications and prior approval supplements under GDUFA II. Read More
Nearly nine in 10 professionals who prescribed Mallinckrodt’s HP Acthar gel (repository corticotropin) to Medicare patients in 2015 received some compensation from the company, a new study by Oregon researchers claims. Read More
The National Association of Medicaid Directors called the decision “disappointing for Massachusetts and for a lot of other states that really want to do something similar.” Read More
The video “fails to provide material information about the consequences that may result from the use of the drug and creates a misleading impression about the drug’s safety,” the agency said. Read More
The regulations allow pharmaceutical manufacturers to request that information they submit to the department be considered trade secrets and kept confidential. Read More
PhRMA, the Biotechnology Innovation Organization (BIO) and the State of Nevada agreed to dismiss a case regarding the constitutionality of a Nevada drug pricing law that required companies to disclose confidential business information. Read More
A former drug distributor filed a class action lawsuit against Novartis and Par Pharmaceuticals Friday, accusing the drugmakers of a pay-for-delay scheme to block generic competition for Novartis’ blood pressure drug Exforge (amlodipine and valsartan). Read More