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Feb. 20, 2018

Vol. 17
No. 34


PhRMA and BIO Say European Commission Proposals Hurt Patent Rights

PhRMA and BIO called on U.S. trade officials to add the European Union to a list of countries that do not adequately protect intellectual property following the release of two EU proposals the groups say could hurt patent rights. Read More

Bayer Claims Perrigo Infringed on Six Patents in ANDA

Bayer sued Perrigo for allegedly infringing on six patents in its ANDA for a generic version of its acne and rosacea treatment Finacea Foam (azeleic acid). Read More

DA Files First Suit Against Opioid Makers Under State Consumer Protection Law

The Philadelphia District Attorney is suing opioid manufacturers and is the first to sue under Pennsylvania’s consumer protection law — making it a public enforcement action on behalf of all Philadelphia residents. Read More

FDA Denies Petition to Withdraw Approval for Makena

The FDA denied a petition seeking the withdrawal of the AMAG Pharmaceuticals hormone drug Makena (hydroxyprogesterone caproate), which a patients’ rights group argues has possible links to developmental abnormalities. Read More

FDA Flags Legacy Pharmaceuticals for GMP Violations

The FDA observed various GMP deficiencies in an inspection of a Legacy Pharmaceuticals Switzerland facility, including problems with sterility, maintenance and discrepancy investigations. Read More