It is worth noting that the FDA sent only nine warning letters last year, all focused on well-recognized violations, such as minimization of risk information and unsubstantiated claims.
The FDA withdrew a 2014 warning letter related to Pacira Pharmaceuticals' marketing of its painkiller Exparel as part of a settlement reached by both parties this week.
21st Century Cures legislation passes the House; Novartis's heart-failure drug may launch with "beyond the pill" services; Purdue and GSK are working on using Apple's ResearchKit; the FDA issues warning letter on co-pay card
Eli Lilly's lung-cancer antibody, necitumumab, has incremental benefits, according to an FDA advisory panel.
Last year's increase in CME support from manufacturers came after six straight years of declining budgets.
Three panelists from the FDA's advisory panel offered their views on the panel's decision to recommend approval of Sprout Pharmaceuticals' flibanserin
Rep. Billy Long introduced legislation that is meant to push the FDA to implement clearer guidelines for regulating drug product information on social media.
Mylan considers higher bid for Perrigo; Boehringer Ingelheim partners with health system on COPD; EMD Serono's experimental cancer drug gets Fast Track status
AstraZeneca diabetes drug may have increased mortality rate; Pfizer accused of knowing about birth defect risks from Zoloft; Eisai to cut 25% of its US workforce
Delivering smarter dynamic communications rather than static timed communications based on self-reported data can help connect patients to information and support that drive brand loyalty and program success.
Medtronic, as part of the settlement, will pay $602,000 to a whistleblower to settle charges it caused physicians to submit false claims to federal health programs.
Judge rules Actavis must keep Alzheimer's drug on the market; Wyeth CEO joins Roche board, dispelling rumors he may be next Sanofi CEO; Two senators propose new FDA designation which would award 15 years of marketing exclusivity.
An Italian court backs the anti-trust's stand that Novartis and Roche colluded in Lucentis marketing; AstraZeneca is the test case for the court's new interpretation of pay-for-delay; early-stage results prompt Biogen Idec to take its experimental Alzheimer's treatment to Phase-III.
AstraZeneca and Ranbaxy pay-for-delay case marches on; FDA extends Novartis multiple myeloma Priority Review timeline; Endo pays $25 for testosterone nasal gel.
The north-of-the-border solution comes amid climbing heroin abuse in the US.
CRS asks if high prices are a tool to offset CMS rebates, the FDA adds another DTC study to its lineup, and the NIH proposes making more clinical trial data public.
Drug makers favor big spending on speakers' events and doctor outreach.
Sanofi vets Takeda, devicemaker CEO candidates; Shaq returns for IcyHot; Royalty Pharma buys royalties on Vertex's Kalydeco.
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.
Lilly's weekly GLP-1 shot is approved, BI expands its lung-cancer portfolio, GSK's China investigation closes, NY proposed Sovaldi triage and India imposed price limits on 36 new medicines.
NY's attorney general alleges that a formulation switch is an attempt to create monopoly.
Takeda closes out a good-news, bad-news kind of week, AstraZeneca adds a new clinical trial for its experimental PD-1, and researchers link a funeral to the Ebola outbreak.
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 drugmaker will dole out $35 million in a deal with 41 state attorneys general after a New York County Supreme Court judge said Wyeth allegedly promoted the immuno-suppressive drug improperly.
The Windy City seeks $9.5 million in damages in a lawsuit that accuses manufacturers of misleading consumers.
Orange and Santa Clara counties are suing painkiller makers like Purdue and Endo, a suit akin to deceptive ad cases launched against the tobacco industry.
Astellas has settled a False Claims case with the Department of Justice over the 2010-2013 marketing of an antifungal medication. Astellas denies the allegations.
The drugmaker is accused of burying cancer risks associated with the diabetes medication.
With just days before the enrollment deadline, courts are pulsing with legal opposition to heatlhcare reform insurance subsidies.
The Arkansas Supreme Court's decision puts $1.2 billion back into J&J's coffers.
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