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McKesson has agreed to pay a record civil penalty of $150 million to settle DEA and Justice Department allegations that the drug distributor failed to report suspicious orders of opioids. Read More
Mezzion filed a lawsuit accusing its former manufacturer Dr. Reddy of fraud for concealing significant GMP deficiencies that resulted in the FDA’s refusal to approve an NDA for udenafil, an erectile dysfunction therapy. Read More
The Justice Department filed a motion to intervene in a multistate antitrust lawsuit accusing six generics makers of colluding to raise the prices of the antibiotic doxycycline hyclate and the diabetes drug glyburide. Read More
A federal appeals court temporarily suspended a permanent injunction that bars Sanofi and Regeneron from selling their cholesterol drug Praluent, pending a final ruling on an appeal. Read More
Eli Lilly & Co. had their patent sustained by a federal appeals court, barring generics manufacturer Teva Pharmaceuticals from marketing its own version of the billion-dollar cancer drug Alimta. Read More
A federal judge validated Shire’s patent on its delayed-release Lialda, ruling that Mylan infringed two of the patent’s claims when seeking to launch a generic of the bowel disease drug. Read More
Merck has agreed to pay Bristol Myers Squibb and Ono Pharmaceutical $625 million, plus royalties on global Keytruda sales, to resolve patent-infringement allegations involving an antibody designed to treat cancer by reactivating the body’s anti-tumor immune response. Read More
Teva’s subsidiary Barr Laboratories agreed to pay $225 million to settle a class action lawsuit alleging it reached pay-for-delay settlements that postponed the launch of generic versions of Bayer’s antibiotic Cipro. Read More
The Supreme Court has agreed to hear a case centered on whether a 180-day notification is mandatory or optional — when the appropriate disclosures are made — before a biosimilar launch. Read More