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…
The World Trade Organization ratified an amendment to the Trade Related Aspects of Intellectual Property Rights (TRIP) agreement, authorizing developing countries with limited production capacity to import generics when facing…
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…
Teva alleges six generics makers infringed a patent covering its multiple sclerosis therapy Copaxone when seeking approvals for copycat versions of the drug. Source: Generic Line
Six generics makers are facing a civil lawsuit for allegedly colluding to fix the prices of the antibiotic doxycycline hyclate and the diabetes drug glyburide. Source: Generic Line
Gilead will have to pay Merck $2.5 billion for infringing a patent that covers the active ingredient of its blockbuster hepatitis C drugs, Salvadi and Harvoni, in the country’s largest…
The U.S. solicitor general has urged the Supreme Court to review a Federal Circuit decision that requires some biosimilar makers wait six months after receiving FDA approval to launch a…
UK’s antitrust agency has accused Actavis of breaching competition law by raising the price of generic hydrocortisone tablets for Addison’s disease by more than 12,000 percent since 2008. Source: Generic…
The FDA has again updated guidance on its criteria for refusing to receive an ANDA, providing a broader definition for major deficiencies and downgrading four major deficiencies to minor ones…
Juno has filed a lawsuit against Kite Pharma for the alleged infringement of eight patent claims covering a cancer immunotherapy that uses a chimeric T cell receptor. Source: Generic Line