Regulatory

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.

India to reorg pharmaceutical agencies

The reason: coordination and effectiveness.

Vancouver tests prescription heroin

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

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.

FDA approves abuse-deterrent Hysingla ER

The first approved hydrocodone formulated to discourage misuse raises a challenge to controversial Zohydro.

Five things for pharma marketers to know: Thursday, November 20

Five things for pharma marketers to know: Thursday, November 20

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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.

FDA delays rule on generic drug labeling amid controversy

As generic drug use soars, the agency intends to "create parity" in label-change rules for brands and generics.

FDA clears new tool for Ebola arsenal

A US Senate bill would also make treatments for the disease eligible for priority review vouchers.

J&J offers government payer hep. C guarantee

The drugmaker is offering Scotland's NHS a money-back guarantee for Olysio patients.

Five things for pharma marketers to know: Friday, October 3

Five things for pharma marketers to know: Friday, October 3

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Salix-Cosmo tax-inversion deal quashed, chronic heart failure market set to expand, rising generic drug prices get lawmakers' attention, NICE gives leukemia drug a thumbs-down, FDA has a good rep

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As US pharma continued its quest for a Grand Prix at the Lions Health international festival of creativity, MM&M went on location to Cannes, France. Missed our coverage from June? Now, we're giving you an opportunity to catch up on some of what you missed. Download our e-book on the two-day festival, recapping the event, rounding up the best of the speakers, offering perspective and listing all of the winners. Click here to download.


The most recent MM&M Skill Sets Live event surveyed a range of issues relating to one of the hottest promotional spaces in healthcare. Speakers and panelists at the morning-long session, including promotional- and multichannel-minded executives from GSK, Epocrates, Treato and Montefiore Medical Center, weighed in on topics designed to help marketers demystify the challenges associated with non-personal promotion. Click here.