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Novartis has launched a program to provide 15 drugs in Kenya, Ethiopia and Vietnam, with plans to eventually expand to 30 low- and middle-income countries. Read More
Mylan has launched a generic version of Janssen’s Invega, following FDA approval of its ANDA for the atypical antipsychotic drug, the company announced Sept. 28. Read More
United Therapeutics has agreed to grant Sandoz a nonexclusive license to manufacture and sell a generic version of its hypertension drug Remodulin beginning in 2018, putting an end to ongoing patent litigation. Read More
The Federal Trade Commission is taking drugmakers to task for tweaking products to maintain exclusivity and block generic competition, warning the practice — known as product hopping — may violate antitrust laws. Read More
The Patent Trial and Appeal Board has invalidated a patent for Novartis’ multiple sclerosis drug Gilenya, in one of the first successful uses of the inter partes review process by generics drugmakers. Read More
U.S. companies taking new biologicals to 11 Pacific Rim nations would get no more than eight years of marketing exclusivity — four less than what they enjoy in the U.S. — under a trade deal agreed to by all 12 countries. Read More
The FDA is warning healthcare providers and patients not to use sterile drugs made by an Oklahoma compounder after the firm refused to cease sterile operations following a failed inspection — the latest in a stream of safety alerts, warning letters and Form 483s having to do with compounders’ sterility practices over the past year. Read More
Eli Lilly is suspending development of its leading heart drug candidate evacetrapib after an independent data monitoring committee determined it wasn’t effective in a Phase 3 clinical trial. Read More
A ruling by the Court of Justice of the European Union has clarified when drug patents expire, in a decision that could prove lucrative for drugmakers even though it adds only a few days of patent protection. Read More
Sen. Amy Klobuchar (D-Minn.) is calling on the Federal Trade Commission to investigate certain drugmakers for possible antitrust violations in light of recent drug price increases. Read More
Eight drugmakers have contributed more than $10 million in recent weeks, with Johnson & Johnson putting in more than half the total, to fight a proposed November 2016 ballot initiative in California that would cut state spending on prescription drugs. Read More