Regulatory

The Highly Regulated Healthcare Industry Can Draw in Top Marketers

The Highly Regulated Healthcare Industry Can Draw in Top Marketers

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.

Warning letters most often stem from missing risk information

Warning letters most often stem from missing risk information

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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.

Five things for pharma marketers to know: Tuesday, July 19, 2016

Five things for pharma marketers to know: Tuesday, July 19, 2016

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The FDA declines to approve Novartis biosimilar; GSK partners with Apple's ResearchKit; drugmakers partner with Lyft for clinical trial participants

Five things for pharma marketers to know: Thursday, July 14, 2016

Five things for pharma marketers to know: Thursday, July 14, 2016

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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

Five things for pharma marketers to know: Thursday, June 16, 2016

Five things for pharma marketers to know: Thursday, June 16, 2016

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A government watchdog criticizes the FDA; the FDA strengthens kidney warnings for Invokana and Farxiga; people with diabetes are living longer

Leadership Exchange: Social Listening

Leadership Exchange: Social Listening

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Social listening can help all along the value chain—from research and discovery to developing marketing plans and strategy.

FDA panel says benefits outweigh risks for Lilly's lung-cancer drug

Eli Lilly's lung-cancer antibody, necitumumab, has incremental benefits, according to an FDA advisory panel.

Drug industry's CME support swings to a 2% gain

Drug industry's CME support swings to a 2% gain

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Last year's increase in CME support from manufacturers came after six straight years of declining budgets.

FDA advisory panelists describe decision to recommend approval of "female Viagra"

FDA advisory panelists describe decision to recommend approval of "female Viagra"

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Three panelists from the FDA's advisory panel offered their views on the panel's decision to recommend approval of Sprout Pharmaceuticals' flibanserin

Steady Leadership, Focus on Infrastructure Expected from the FDA's "Acting" Head

Steady Leadership, Focus on Infrastructure Expected from the FDA's "Acting" Head

Dr. Stephen Ostroff took over as the FDA's acting commissioner when Dr. Margaret Hamburg stepped down in March.

New bill seeks to spur FDA to form clearer social media rules

New bill seeks to spur FDA to form clearer social media rules

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Rep. Billy Long introduced legislation that is meant to push the FDA to implement clearer guidelines for regulating drug product information on social media.

Five things for pharma marketers to know: Friday, May 22

Five things for pharma marketers to know: Friday, May 22

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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

Five things for pharma marketers to know: Monday, May 4

Five things for pharma marketers to know: Monday, May 4

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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

 Five things for pharma marketers to know: Thursday, April 9

Five things for pharma marketers to know: Thursday, April 9

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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 open-data platform gains traction

FDA's application programming interfaces, or openFDA, reached 6,000 users less than a year after its launch.

FDA updates DTC ad policy on risk information

FDA updates DTC ad policy on risk information

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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 appoints Office of Generic Drugs director

FDA has named Kathleen Uhl as permanent director of the Office of Generic Drugs.

Five things for pharma marketers to  know: Thursday, January 8

Five things for pharma marketers to know: Thursday, January 8

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Sandoz received FDA biosimilar nod; new technique yields 25 antibiotics; Novartis sends two COPD drugs for FDA review.

Five things for pharma marketers to know: Friday, December 5

Five things for pharma marketers to know: Friday, December 5

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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.

Incyte drug gains expanded indication for bone marrow disease

Jakafi becomes the first drug approved for treating polycythemia vera.

Five for things pharma marketers to know: Thursday, December 4

Five for things pharma marketers to know: Thursday, December 4

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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.

FDA approves Amgen leukemia immunotherapy

Amgen's Blincyto was approved for a rare form of leukemia after receiving Breakthrough Therapy designation and a Priority Review.

FDA takes issue with metatags

The agency sent a Warning Letter to three marketers over their use of metatags in search engine marketing tactics.

FDA panel recommends against steroid injection warning

An advisory panel voted against adding warnings to steroid injection labels.

Five things for pharma marketers to know: Tuesday, November 25

Five things for pharma marketers to know: Tuesday, November 25

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AstraZeneca and Ranbaxy pay-for-delay case marches on; FDA extends Novartis multiple myeloma Priority Review timeline; Endo pays $25 for testosterone nasal gel.

FDA tempers opioid approval impact

FDA tempers opioid approval impact

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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.

Vancouver tests prescription heroin

The north-of-the-border solution comes amid climbing heroin abuse in the US.

India to reorg pharmaceutical agencies

The reason: coordination and effectiveness.

Five things for pharma marketers to know: Monday, November 24

Five things for pharma marketers to know: Monday, November 24

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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.

Five things for pharma marketers to know: Friday, November 21

Five things for pharma marketers to know: Friday, November 21

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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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