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Generic firm Glenmark Pharmaceuticals wants a federal appeals court to rehear its case over rights to the combination hypertension drug Tarka, arguing that an April decision was invalid because it incorrectly attributed exclusive patent rights. Read More
Endo Pharmaceuticals and Impax Laboratories are facing a lawsuit alleging that the two drugmakers conspired to keep a generic version of Endo’s pain medication Opana ER off the market. Read More
A federal judge rejected AstraZeneca’s motion to block generics from making versions of its inhaled corticosteroid Pulmicort Respules, and instead will consider that request and broader patent issues on the drug when the trial resumes this fall. Read More
A federal appeals court needs to rethink its definition of “a patient” or risk upholding a dangerous precedent in future Hatch-Waxman cases, trade groups BIO and PhRMA argued after a recent patent ruling on the colon cleanser Suprep. Read More
The FDA and Customs and Border Protection (CBP) yesterday began accepting applications for an 18-month pilot of a “trusted trader” program to reduce inspections and oversight of imports from drugmakers that establish tough internal import control programs of their own. Read More
The FDA plans to clear up questions about the types of off-label information drugmakers may communicate to physicians and payers in a series of guidances planned for later this year that will address four key areas that have long tripped up industry. Read More
Teva cleared a major hurdle last week in its bid to launch a generic version of Bristol-Myers Squibb’s hepatitis B drug Baraclude after a federal appellate court upheld a lower court’s decision invalidating the drug’s patent. Read More
British authorities continue to investigate 21 cases of blood poisoning in babies who received potentially contaminated batches of an intravenous liquid feed at neonatal intensive care units in England, but said the manufacturer of the product was following good manufacturing practice guidelines. Read More
A federal appeals court needs to rethink its definition of “a patient” or risk upholding a dangerous precedent in future Hatch-Waxman cases after a recent patent ruling on the colon cleanser Suprep, trade groups BIO and PhRMA argue in a joint legal brief. Read More