FDA

Five things for pharma marketers to know: Monday, December 5, 2016

Five things for pharma marketers to know: Monday, December 5, 2016

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The FDA approves new indication for Jardiance; Novartis' CAR-T therapy eliminates leukemia in 82% of patients in trial; doctors report risks associated with immunotherapy

Five things for pharma marketers to know: Thursday, December 1, 2016

Five things for pharma marketers to know: Thursday, December 1, 2016

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Valeant doesn't plan to offload Salix; heart docs back Califf as commish; Saunders says pricing issues aren't affected by election

Five things for pharma marketers to know: Monday, November 28, 2016

Five things for pharma marketers to know: Monday, November 28, 2016

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J&J in talks to buy Actelion; Novo Nordisk pulls ads on Breitbart News; Takeda to market Ninlaro in Europe

Five things for pharma marketers to know: Tuesday, November 22, 2016

Five things for pharma marketers to know: Tuesday, November 22, 2016

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Intarcia submits diabetes drug-delivery pump for FDA approval; Shire to build rare-disease innovation hub; AstraZeneca to resume durvalumab trials

10 Things for Trump to Consider When It Comes to Healthcare

10 Things for Trump to Consider When It Comes to Healthcare

Peter Pitts calls for Trump to eliminate the Independent Payment Advisory Board and direct the FDA to issue guidance on off-label communications.

Five things for pharma marketers to know: Friday, November 18, 2016

Five things for pharma marketers to know: Friday, November 18, 2016

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Chicago requires pharma rep to have licenses, Acorda CEO backs Califf to remain FDA commish, high-prescribing medicare docs are on the rise

Five things for pharma marketers to know: Tuesday, November 15, 2016

Five things for pharma marketers to know: Tuesday, November 15, 2016

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The CMS spent more on Harvoni than any other drug; Novartis considers selling Alcon; the EMA recommends approval of Lantus biosimilar

Pharma pushes to share off-label info with payers at FDA hearing

Pharma pushes to share off-label info with payers at FDA hearing

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Insurers and pharmacy benefit managers already have a sophisticated understanding of clinical data, the industry argued.

What's Next for the FDA During the Trump Administration

What's Next for the FDA During the Trump Administration

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Expect major changes in the way the FDA does business with drug companies after the Trump administration takes over in January.

Five things for pharma marketers to know: Friday, November 11, 2016

Five things for pharma marketers to know: Friday, November 11, 2016

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Trump says he will reform the FDA; pharmaceutical M&A expected to pick up; superbug causing infections in cystic-fibrosis patients

5 questions raised at the FDA's off-label hearing

5 questions raised at the FDA's off-label hearing

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The FDA asked questions about the risks and benefits of allowing off-label communications.

Five things for pharma marketers to know: Tuesday, November 8, 2016

Five things for pharma marketers to know: Tuesday, November 8, 2016

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FDA solicits public comment to study online character space limit; Biogen's Spinraza shows positive results in SMA study; Valeant cuts earnings forecast

Five things for pharma marketers to know: Monday, November 7, 2016

Five things for pharma marketers to know: Monday, November 7, 2016

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Bayer submits Stivarga to FDA for liver-cancer indication; emails show FDA's divisiveness over Duchenne drug approval; insurers want new president to address ACA financial risks

Five things for pharma marketers to know: Friday, November 4, 2016

Five things for pharma marketers to know: Friday, November 4, 2016

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Pharma may face price-collusion charges; FDA approval team can't fill vacancies; OPDP issues letter over promo video

Five things for pharma marketers to know: Thursday, November 3, 2016

Five things for pharma marketers to know: Thursday, November 3, 2016

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Sprout investors sue Valeant; FDA raises safety concerns for Cempra's experimental pneumonia drug; NHS gets approval to prescribe eribulin to breast cancer patients

Five things for pharma marketers to know: Thursday, October 27, 2016

Five things for pharma marketers to know: Thursday, October 27, 2016

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BIO released a video explaining drug costs; the FDA commits to shorter generic approval process; Kaléo to launch EpiPen competitor

Drugmakers spar with FDA over proposed DTC animation study

Drugmakers spar with FDA over proposed DTC animation study

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The FDA responded to criticism from industry about its proposed research of DTC animation.

If Roche's Ocrevus is approved, the already competitive MS market will gain another player

If Roche's Ocrevus is approved, the already competitive MS market will gain another player

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The experimental therapy is positioned to fill a market gap in primary progressive multiple sclerosis.

Five things for pharma marketers to know: Monday, October 24, 2016

Five things for pharma marketers to know: Monday, October 24, 2016

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GSK files for FDA approval of shingles vaccine; Chinese drugmaker reportedly files for largest IPO since 2013; Sunovion completes deal to buy Cynapsus

Five things for pharma marketers to know: Wednesday, October 19, 2016

Five things for pharma marketers to know: Wednesday, October 19, 2016

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Roche gets FDA approval for immunotherapy Tecentriq; insurers are sued for discrimination; the FDA proposes yanking generic ADHD drugs from market

Five things for pharma marketers to know: Thursday, October 13, 2016

Five things for pharma marketers to know: Thursday, October 13, 2016

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Aetna inks value-based deal with Merck in diabetes; new research claims co-pay cards increased drug spend; Xarelto data not affected by device

Five things for pharma marketers to know: Tuesday, October 11, 2016

Five things for pharma marketers to know: Tuesday, October 11, 2016

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Opdivo fails in lung cancer trial; hedge fund sues Theranos; Takeda and Crescendo partner to develop humabody-based therapies

Five things for pharma marketers to know: Wednesday, October 5, 2016

Five things for pharma marketers to know: Wednesday, October 5, 2016

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The FDA to require black-box warnings for hep.-C drugs; AstraZeneca's Brilinta fails to meet study goals; ICER says PD-1s are too pricey

30 years later, DTC's complicated past still hasn't deterred marketers

30 years later, DTC's complicated past still hasn't deterred marketers

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Given its modern-day ubiquity, it's easy to forget that pharma DTC didn't exist until the 1980s rolled around.

Why the FDA's view of patient communication evolved over time

Why the FDA's view of patient communication evolved over time

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The agency's ambitions were fueled in part by external criticism. The barbs that stung most sharply were ones suggesting a certain indifference on the FDA's part.

How the FDA Advanced DTC Advertising

How the FDA Advanced DTC Advertising

Five decades ago, pharmaceuticals were the protected province of health professionals. Today we have DTC ads, the internet, and pharmacy handouts.

The FDA, Astellas, and Accenture use innovation competitions to help address business challenges

The FDA, Astellas, and Accenture use innovation competitions to help address business challenges

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The organizations are using innovation competitions to challenge internal and external audiences with coming up with new ideas.

The FDA approves Amgen's biosimilar version of Humira

The FDA approves Amgen's biosimilar version of Humira

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Amgen's drug is set to compete with AbbVie's Humira, which is the second-best selling drug in the U.S. in 2015.

Five things for pharma marketers to know: Friday, September 16, 2016

Five things for pharma marketers to know: Friday, September 16, 2016

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The FDA approves a combination of aspirin and heartburn medication; Teva partners with Intel to develop wearable; New Mexico AG sues BMS and Sanofi

Five things for pharma marketers to know: Thursday, September 15, 2016

Five things for pharma marketers to know: Thursday, September 15, 2016

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Mylan CEO to appear before House committee about EpiPen pricing; job-related health premiums rise; GSK's experimental shingles vaccine shows 90% effectiveness

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