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The Louisiana Department of Health is considering subscription-based payments for manufacturers of hepatitis C drugs as a way to control the state’s spending on drugs and to serve more Medicaid patients. Read More
The HHS Office of Inspector General flagged “questionable billing” and rapid growth in Medicare Part D spending for compounded topical drugs in a report released Thursday. Read More
Drug sponsors may not have to prove that a proposed medicine-assisted therapy helps addicts completely kick opioids but they will have to detail how well it helps cut dependence to win FDA approval, the agency said in a new draft guidance. Read More
AstraZeneca filed suit against generic manufacturer Accord Pharmaceuticals for alleged infringement upon four patents for AstraZeneca’s breast cancer drug Faslodex (fulvestrant). Read More
The Association for Accessible Medicines urged the FDA to clarify its draft guidance on Drug Supply Chain Security Act (DSCSA) waivers by adding an estimated timetable for review decisions. Read More
A federal appeals court ruled a Native American tribe cannot assert sovereign immunity against inter partes reviews by the U.S. Patent and Trademark Office, in the latest ruling in a battle over Allergan’s dry-eye drug. Read More
The Pharmaceutical Care Management Association is concerned about a proposed rule that could remove safe harbor protections for pharmaceutical company rebates and significantly change how U.S. drug prices are formulated. Read More
The European Medicines Agency issued the first report on its open access policy for clinical data submitted by sponsors in their marketing applications for new drugs. Read More
The European Medicines Agency expressed “serious concerns” about drugmakers’ preparedness for the UK’s departure from the European Union in a new report. Read More
UK drug manufacturers will retain access to EU markets during the Brexit implementation period, the MHRA said in an Aug. 6 update, noting EU authorities will continue to recognize the UK’s manufacturing and distribution licenses as well as inspections. Read More
The FDA unveiled new draft guidance on nonclinical testing of orally-inhaled drug products that contain nicotine — and Commissioner Scott Gottlieb said the agency plans to release follow-up guidelines later this year on potentially clinically relevant outcomes. Read More
FDA Commissioner Scott Gottlieb said the agency will consider allowing imports of some drugs that have seen major price increases in the United States. Read More