Amgen sues Sanofi and Regeneron over PCSK9 patents; FDA panel wants Chantix black box to stay; Valeant-Allergan uproar rises in pitch; Pharmacyclics and Roche team up against CLL; and GSK's Ebola vax may "miss" the current crisis.
A draft guidance publication date determines whether drugmakers get three or five years of market exclusivity.
NY's attorney general alleges that a formulation switch is an attempt to create monopoly.
J&J subsidiary Janssen has abandoned its patent lawsuit over the anti-seizure medication topiramate, which is part of Vivus's prescription weight-loss drug Qsymia.
The Japanese drugmaker is looking to add as much as a year onto the patent life of some of its drugs after the DEA dragged out their scheduling decisions.
The regulator and patients will chat for two days in October.
The generic ED pills sell for five cents less than Pfizer's branded blue pill, but the undercutting is a bit deeper.
The WSJ reports that Merck, Sanofi and GSK are looking to put older medications at arm's length.
A London court knocked down two Roche/Genentech patents, making a clearer path for biosimilars of the breast cancer drug. The primary patent lapses in July.
A court granted Lilly six more years of patent protection for the almost $3-billion-dollar-a-year cancer drug.
A study by consulting firm Accenture shows that patients not only expect digital outreach, but that their desire to be engaged is consistently being ignored.
The company is suing Torrent Pharmaceuticals, which wants to market a drug before the patent lapses in 2019.
Analysts indicate the earlier-than-expected patent loss will not be a significant upset to Pfizer's present. The drugmaker plans to appeal the decision.
India's Ranbaxy logged yet another recall, while the country's stance on patent protection keeps the industry on edge.
The White House's proposed FY 2015 budget gives an additional 1% to the FDA.
PMLive has documents that outline a strategy to keep intellectual property laws from relaxing in South Africa.
Purdue Pharma says it will appeal.
Three drug purchasing companies have taken the Denmark drugmaker to court in the US. The charge: wrongfully keeping generics off the market.
Teva said a settlement will allow it to sell a copy of the blockbuster ED pill prior to the official LOE.
A court refuses to compel a government agency to schedule the firm's epilepsy drug, as the med's patent clock ticks.
Researchers say it's not just payers supporting the switch, and all ages appear to be brand agnostic.
The generics maker says it may take five years for its iteration of the GSK asthma/COPD brand to hit the market.
Echoing a strategy similar to that posed by Merck, the drug maker told investors that its strategy for hitting revenue targets includes efficiencies. It also depends on a regulatory-friendly pipeline.
Eisai lobbies to push back Belviq's patent clock; a case against Paula Deen is dismissed; Merck and Avanir team up to promote Januvia; and another healthcare-reform measure is pushed back
GSK seeks a new ovarian cancer indication for Votrient; a bill that would extend exclusivity for some combination drugs is introduced in Congress; Otsuka's tolvaptan gets a thumbs-down from an FDA advisory committee; NICE rejects Roche's Perjeta; India tosses Herceptin patents; and China revokes Gilead's patent on Viread
The positive way to frame the companies' quarterly results: "less bad," as generics continued to plague their balance sheets.
The Indiana drug maker logged a 6% sales increase over the same period last year. Higher prices were responsible for the majority of the growth.
GlaxoSmithKline second-quarter sales rose 2% over the same period last year. CEO Andrew Witty says it is too early to tally the impact of China's corruption allegations.
GSK says change is afoot in China; Vivus fight reportedly results in a new CEO; Biogen Idec enters a collaboration in Edinburgh; Astellas wins and FDA approval; Myriad's patent fight continues
The FDA's priority review for the Phase III chronic lymphocytic leukemia drug comes on top of Breakthrough Therapy designation, which the agent won in May.
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