Today's ambitious marketers and media people want to be the ones to not only figure out how to work within the regulations but also to create better work than ever before.
The number of warning and untitled letters has dropped in recent years. Only four letters have been sent so far this year, compared to 28 in 2012.
The FDA declines to approve Novartis biosimilar; GSK partners with Apple's ResearchKit; drugmakers partner with Lyft for clinical trial participants
The FDA expands use for Pfizer's Prevnar 13 vaccine; an FDA panel votes in support of Novartis biosimilar; U.S. healthcare spending rises 5.5% in 2015
A government watchdog criticizes the FDA; the FDA strengthens kidney warnings for Invokana and Farxiga; people with diabetes are living longer
Social listening can help all along the value chain—from research and discovery to developing marketing plans and strategy.
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
Dr. Stephen Ostroff took over as the FDA's acting commissioner when Dr. Margaret Hamburg stepped down in March.
Rep. Billy Long introduced legislation that is meant to push the FDA to implement clearer guidelines for regulating drug product information on social media.
Amgen's PSCK9 inhibitor gets a position opinion in the EU; the FDA plans to study how spouses influence perception of DTC ads; Botox may relieve depression
Drugmakers engage early with insurers; patients push for implant to be pulled from the market; about one-third of new drugs qualify for special approval pathways
Novartis reported highest drug sales in 2014; state Medicaid programs spent $1.33 billion on hepatitis-C drugs; former FDA commissioner argues against shortening regulatory review times
FDA's application programming interfaces, or openFDA, reached 6,000 users less than a year after its launch.
FDA posted a revised draft guidance document on its brief summary and adequate directions for use concerning risk information in DTC print ads to reflect "recent social science research."
FDA has named Kathleen Uhl as permanent director of the Office of Generic Drugs.
Sandoz received FDA biosimilar nod; new technique yields 25 antibiotics; Novartis sends two COPD drugs for FDA review.
GSK opts to hold onto $1.6 billion portfolio of older drugs; Sanofi upheavals continue with exit of US diabetes sales exec; Takeda gains breakthrough status on AL amyloidosis therapy.
Jakafi becomes the first drug approved for treating polycythemia vera.
Despite drugmaker discount, VA still can't afford Sovaldi without additional funds; Ousted Sanofi CEO Viehbacher faces lawsuit for an alleged kickback scheme; GSK slims sales and R&D workforce.
Amgen's Blincyto was approved for a rare form of leukemia after receiving Breakthrough Therapy designation and a Priority Review.
The agency sent a Warning Letter to three marketers over their use of metatags in search engine marketing tactics.
An advisory panel voted against adding warnings to steroid injection labels.
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 Center for Drug Evaluation and Research's director says there is a need for new opioids and cuts off dosing comparisons between extended-release and immediate-release opioids.
The north-of-the-border solution comes amid climbing heroin abuse in the US.
The reason: coordination and effectiveness.
BioMarin to acquire Dutch biotech Prosensa; Woodcock says significant efficacy key to Breakthrough Therapy designation; Stryker considers $16 billion bid for UK devicemaker Smith and Nephew.
EMA revises its conflict of interest policy; AbbVie all-oral HCV combo drug receives positive EU recommendation; Merck may help NewLink Genetics scale production of its Ebola vaccine.
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- Five things for pharma marketers to know: Thursday, February 23, 2017
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- Why Pharma Refuses to See Value in 'Influence'
- Five things for pharma marketers to know: Wednesday, February 22, 2017