FDA

FDA guidelines for payer, off-label communications: OK as long as 'truthful'

FDA guidelines for payer, off-label communications: OK as long as 'truthful'

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Two FDA guidance documents aim to help pharma companies show the value of their drugs to payers beyond what's included in FDA labeling.

Drug list prices in DTC ads? Easier said than done

Drug list prices in DTC ads? Easier said than done

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For one of President Trump's proposals for lowering the cost of drugs, the path to implementation could be long.

Understanding FDA's Blueprint for Transparency

Understanding FDA's Blueprint for Transparency

The Food and Drug Administration regulates more than a third of the U.S. economy. And its new commissioner, Scott Gottlieb, is trying to shake up how it does so.

No slowing down: Orphan drug designations skyrocket in 2017

No slowing down: Orphan drug designations skyrocket in 2017

The pace may even pick up again this year.

FDA to study HCP views of pharma promotions this year

FDA to study HCP views of pharma promotions this year

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The research will also cover topics including disease awareness ads.

Five things for pharma marketers to know: Tuesday, February 20, 2018

Five things for pharma marketers to know: Tuesday, February 20, 2018

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Gilead wins reversal of $2.5 billion payment order; Aimmune Therapeutics' peanut allergy therapy shows promise; AstraZeneca wins FDA approval on key cancer drug.

Did Congress just kill the Orphan Drug Act?

Did Congress just kill the Orphan Drug Act?

By allowing companies to claim a 50% tax credit for qualified clinical testing expenses, developing drugs for rare diseases became economically feasible for the first time.

Cost over sight? Spark's blindness cure has the industry talking

Cost over sight? Spark's blindness cure has the industry talking

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Spark has priced its cure for a rare form of blindness at $425,000 per eye. But rather than the science or the cost, pharma is buzzing over the company's outcomes-based pricing model

Scanning FDA's New Approach to Digital Health

Scanning FDA's New Approach to Digital Health

FDA Commissioner Dr. Scott Gottlieb has been saying all the right things regarding digital health.

Five things for pharma marketers to know: Friday, January 19, 2018

Five things for pharma marketers to know: Friday, January 19, 2018

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Biogen, UCB reportedly showing interest in Acorda acquisition; Kite Pharma and Pfizer to develop combo lymphoma therapy; hospitals to form generics nonprofit

Five things for pharma marketers to know: Thursday, January 18, 2018

Five things for pharma marketers to know: Thursday, January 18, 2018

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Senate committee votes in favor of Azar as new HHS head; FDA and DoD launch breakthrough designation program; Walmart offers free opioid disposal solution

Five things for pharma marketers to know: Wednesday, January 17, 2018

Five things for pharma marketers to know: Wednesday, January 17, 2018

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Celgene reportedly in talks to buy Juno; Novartis' Kymriah receives fast-track reviews in U.S. and Europe; BI's Gilotrif gets expanded approval in lung cancer

Sandoz lines up potential third-to-market Humira copy

Sandoz lines up potential third-to-market Humira copy

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Although if approved, it's not likely to launch in the U.S. for quite some time.

Five things for pharma marketers to know: Tuesday, January 16, 2018

Five things for pharma marketers to know: Tuesday, January 16, 2018

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Merck's Keytruda combo therapy succeeds in Phase-III lung cancer trial; FDA launches pilot to address trial transparency; Spark's Luxturna overpriced, ICER says

Five things for pharma marketers to know: Friday, January 12, 2018

Five things for pharma marketers to know: Friday, January 12, 2018

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Pharma looks to Spark for pricing blueprint; Ipsen hires Amgen exec as CEO of North America; FDA could improve social-media approach, study finds

Taxpayers Need to Cough up the Cash to Keep Federal Agencies Afloat

Taxpayers Need to Cough up the Cash to Keep Federal Agencies Afloat

As we continue to debate the proper size and role of government in society, cast your eyes on recent polls by Gallup and Pew that found the majority of Americans felt their income tax was fair.

Five things for pharma marketers to know: Thursday, January 4, 2018

Five things for pharma marketers to know: Thursday, January 4, 2018

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Allergan to cut 1,000 jobs; McKesson acquires RxCrossroads from CVS Health; Pfizer and Sangamo enter collaboration to develop ALS gene therapy

Five things for pharma marketers to know: Wednesday, January 3, 2018

Five things for pharma marketers to know: Wednesday, January 3, 2018

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Utah Senator who backed Orphan Drug Act will not seek reelection; medicines more expensive in 2018; Spark's genetic therapy for rare blindness costs $850,000

Five things for pharma marketers to know: Tuesday, December 26, 2017

Five things for pharma marketers to know: Tuesday, December 26, 2017

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Roche to buy Ignyta for $1.7 billion; FDA OKs Valeant eye drop for OTC sale; Kmart settles prescription drug fraud allegations

Five things for pharma marketers to know: Thursday, December 21, 2017

Five things for pharma marketers to know: Thursday, December 21, 2017

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BI to pay $13.5 million for misleading marketing; ICER: CAR-T therapies more cost-effective than chemotherapy; FDA approves Roche's breast cancer combo therapy

Five things for pharma marketers to know: Wednesday, December 20, 2017

Five things for pharma marketers to know: Wednesday, December 20, 2017

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Tax bill could lead pharma to move overseas; global pharma sales increased 45% in nine years; FDA OKs first gene therapy for rare retinal disease

FDA campaign reframes quitting for smokers

FDA campaign reframes quitting for smokers

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The Every Try Counts campaign to change how smokers see their last attempt to quit.

Five things for pharma marketers to know: Tuesday, December 19, 2017

Five things for pharma marketers to know: Tuesday, December 19, 2017

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Pharma industry spent $57 million on lobbying in 2016; Humana, private equity firms to buy Kindred for $4 billion; price of old glaucoma drug skyrockets

MM&M 2018 staff predictions: From gift bans to Google Assistant

MM&M 2018 staff predictions: From gift bans to Google Assistant

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From gift bans to Google Assistant, POC to OPDP, MM&M staff members give their predictions on what to expect in healthcare marketing in 2018

Five things for pharma marketers to know: Monday, December 18, 2017

Five things for pharma marketers to know: Monday, December 18, 2017

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CVS/Aetna deal will affect healthcare benefits; lawmakers pressure DEA to curb painkiller supply; Allergan and Richter's Vraylar sees positive results for bipolar depression

Five things for pharma marketers to know: Thursday, December 14, 2017

Five things for pharma marketers to know: Thursday, December 14, 2017

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Pharma R&D return on investment falls to eight-year low; FDA approves Pfizer's biosimilar to J&J's Remicade; Novartis to downsize generics business

Five things for pharma marketers to know: Friday, December 15, 2017

Five things for pharma marketers to know: Friday, December 15, 2017

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FDA approves first topical skin growth treatment; Teva to cut 14,000 jobs; Novartis Oncology CEO resigns

Five things for pharma marketers to know: Wednesday, December 13, 2017

Five things for pharma marketers to know: Wednesday, December 13, 2017

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Teva diminishes debt with job cuts and sale; FDA to study whether consumers can detect misleading ads; AbbVie, Roche present positive Phase-III data at ASH

Five things for pharma marketers to know: Tuesday, December 12, 2017

Five things for pharma marketers to know: Tuesday, December 12, 2017

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FDA issues prescription drug promotion guidance; FDA approves first follow-on biologic of Lilly's Humalog; drugmakers allegedly hired nurses to promote drugs

Five things for pharma marketers to know: Monday, December 11, 2017

Five things for pharma marketers to know: Monday, December 11, 2017

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Pfizer's Viagra generic to sell for half the price; GSK seeks oncology deals; Ionis' experimental Huntington's drug tackles toxic protein for the first time