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The UK’s health cost-effectiveness watchdog is recommending coverage of Norgine’s Targaxan to treat adults with a serious and potentially life-threatening brain condition caused by liver failure. Read More
Generic launches of the antibiotic Zyvox and the blood-thinner Lovenox have bolstered Teva’s U.S. injectables portfolio, the Israeli generics maker said Tuesday. Read More
CDER Director Janet Woodcock has tapped Jonathan Jarow for a 120-day stint as acting director of the Office of Medical Policy, effective Feb. 23. Read More
A federal appeals court issued an injunction halting sales of Actavis’ generic version of AstraZeneca’s inhaled asthma drug Pulmicort Respules, just four days after the generics maker launched its version. Read More
Canada has fired back in its dispute with Eli Lilly over court rulings that invalidated patents covering two of the drugmaker’s therapies, charging that Lilly has grossly mischaracterized the country’s patent policies. Read More
Injectables giant Hospira is launching its Remicade biosimilar Inflectra in at least 10 new European markets, nearly doubling the product’s presence on the continent. Read More
The FDA is seeking additional comment from industry on its highly controversial proposed rule giving generics makers the same authority brandmakers have to update their product labels without agency approval when new safety information about a drug emerges. Read More
A U.S. District Court in New Jersey ruled Friday that the patent protecting AstraZeneca's inhaled asthma drug Pulmicort Respules is invalid, opening the door to generic competition. Read More
The FDA is pushing ahead with efforts to spur development of hard-to-copy generics, this time sponsoring research into bioequivalence testing for long-acting periodontal drugs and developing methods for assessing generic, long-acting injectables. Read More
A federal appeals court has upheld a lower court ruling that allowed Lupin to manufacture a generic of one of ViiV Healthcare’s HIV therapies, while blocking Teva’s ANDA of a related drug. Read More