FDA

Five things for pharma marketers to know: Tuesday, April 18, 2017

Five things for pharma marketers to know: Tuesday, April 18, 2017

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Novartis gets Breakthrough designation for its CAR-T therapy; Duchesney continues working with Kardashian; new user-fee deal to speed up FDA approvals

Five things for pharma marketers to know: Friday, April 7, 2017

Five things for pharma marketers to know: Friday, April 7, 2017

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The FDA rejected an outcomes update to the Januvia label; digital-health funding dropped in Q1 of 2017; the FDA approves 23andMe's genetic test

Five things for pharma marketers to know: Thursday, April 6, 2017

Five things for pharma marketers to know: Thursday, April 6, 2017

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The FDA approves drugs faster than EMA; Botox goes to late-stage testing for depression; GSK recalls nearly 600,000 asthma inhalers

Five things for pharma marketers to know: Friday, March 24, 2017

Five things for pharma marketers to know: Friday, March 24, 2017

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Lilly to invest $850 million in the U.S.; President Trump gives GOP leaders ultimatum on healthcare bill; Pfizer, Merck KGaA receive FDA approval for Bavencio

Five things for pharma marketers to know: Wednesday, March 22, 2017

Five things for pharma marketers to know: Wednesday, March 22, 2017

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Novartis' heart-failure drug fails in clinical trial; Sanofi, Regeneron file Dupixent patent suit; FDA approves Newron's Xadago for PD

Five things for pharma marketers to know: Monday, March 20, 2017

Five things for pharma marketers to know: Monday, March 20, 2017

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Study finds SGLT-2 inhibitors lowered risk of death; former FDA commissioners raise drug importation issues; Bayer, J&J's Xarelto lowered VTE risk in study

Five things for pharma marketers to know: Friday, March 17, 2017

Five things for pharma marketers to know: Friday, March 17, 2017

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The FDA delays final rule related to off-label use; Amgen's Repatha reduces risk of death by 20%, study finds; FDA rejects AstraZeneca's hyperkalaemia drug

Gottlieb Likely to Take On Off-Label, Predictability at the FDA

Gottlieb Likely to Take On Off-Label, Predictability at the FDA

In short, he'll be further along the learning curve than anyone ever tapped for the nation's number-one public health regulatory slot.

Industry groups petition the FDA over off-label rule

Industry groups petition the FDA over off-label rule

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PhRMA, BIO, and the Medical Information Working Group filed a citizen petition over a final rule they say raises risks for drugmakers.

Five things for pharma marketers to know: Wednesday, March 15, 2017

Five things for pharma marketers to know: Wednesday, March 15, 2017

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The FDA considers creating Office of Patient Affairs; Alexion to cut 7% of workforce; FDA committee votes against painkiller's benefits

Five things for pharma marketers to know: Tuesday, March 14, 2017

Five things for pharma marketers to know: Tuesday, March 14, 2017

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Pershing Square sells entire Valeant stake; FDA approves Novartis breast-cancer drug combo; Express Scripts asks Gilead to lower hep-C drug prices

Five things for pharma marketers to know: Monday, March 6, 2017

Five things for pharma marketers to know: Monday, March 6, 2017

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Gilead exec blames PBMs for high drug prices; Google uses AI to detect signs of breast cancer; Sanofi and Regeneron drug effective in treating eczema

When It Comes to the FDA, Does It All Come Down to Money?

When It Comes to the FDA, Does It All Come Down to Money?

In our struggle with the bean counters and the stockbrokers, can't we make patient needs a priority, too?

Five things for pharma marketers to know: Wednesday, March 1, 2017

Five things for pharma marketers to know: Wednesday, March 1, 2017

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Trump reiterates call to bring down drug prices; Novartis renews its focus on immunotherapies; a new bill would allow drugs to be imported

Why President Trump Won't Overhaul the FDA

Why President Trump Won't Overhaul the FDA

In short, the Trump team, I predict, will seek to tweak FDA.

Is the Trump Administration the Cure the FDA Needs?

Is the Trump Administration the Cure the FDA Needs?

Finally, a Congress and president who see pharma as a resource and not a villain, Flaum writes.

Five things for pharma marketers to know: Friday, February 24, 2017

Five things for pharma marketers to know: Friday, February 24, 2017

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PBMs' use of "clawbacks" prompt lawsuits; Merck's experimental antiviral drug prevents infection; EMA recommends Novartis' lung-cancer combo drug

Five things for pharma marketers to know: Thursday, February 16, 2017

Five things for pharma marketers to know: Thursday, February 16, 2017

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The FDA approves Valeant's psoriasis drug; PhRMA to review its membership criteria; Lions Health announces pharma and health and wellness jury presidents

Five things for pharma marketers to know: Wednesday, February 15, 2017

Five things for pharma marketers to know: Wednesday, February 15, 2017

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Pharma execs raise concerns about Trump's plans for the FDA; Merck ends study of experimental Alzheimer's drug; Amgen seeks new indication for Blincyto

Five things for pharma marketers to know: Friday, February 10, 2016

Five things for pharma marketers to know: Friday, February 10, 2016

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Industry files petition over FDA off-label draft guidance; Marathon secures new DMD drug approval; Price confirmed as head of HHS

Five things for pharma marketers to know: Tuesday, February 7, 2017

Five things for pharma marketers to know: Tuesday, February 7, 2017

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Teva CEO steps down; Mylan to pay $96.5 million to settle pay-for-delay claims; Merck files Keytruda with the FDA for bladder cancer

Five things for pharma marketers to know: Wednesday, February 1, 2017

Five things for pharma marketers to know: Wednesday, February 1, 2017

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Trump wants to speed up drug approvals; Sanofi allergy drug gets OTC approval; Lilly ends final solanezumab trial

A Reformed FDA Under Trump Likely Means Uncertainty

A Reformed FDA Under Trump Likely Means Uncertainty

It's hard to be against the concept of reform, but Trump is better known for epithets than policy details, Kamp writes.

Five things for pharma marketers to know: Wednesday, January 25, 2017

Five things for pharma marketers to know: Wednesday, January 25, 2017

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Novartis forecasts slower growth in 2017; Actelion reports trial failure for PAH drug; HHS nominee Tom Price denies conflict of interest claims

Five things for pharma marketers to know: Tuesday, January 24, 2017

Five things for pharma marketers to know: Tuesday, January 24, 2017

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Endo settles pay-for-delay charges; Trump signs order withdrawing U.S. from TPP; administration considers Patrick Soon-Shiong for healthcare role

FDA guidance seeks to clarify pharma comms with payers

FDA guidance seeks to clarify pharma comms with payers

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But it may also increase the reporting burden for drugmakers.

Five things for pharma marketers to know: Thursday, January 19, 2017

Five things for pharma marketers to know: Thursday, January 19, 2017

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The FDA releases three documents; PBM rebates eating into drugmaker revenue: PhRMA; most oncologists on Twitter receive money from pharma

Five things for pharma marketers to know: Thursday, January 12, 2017

Five things for pharma marketers to know: Thursday, January 12, 2017

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Trump says pharma is "getting away with murder"; Senate majority votes to repeal ACA; IBM Watson Health and FDA to study blockchain technology

Five things for pharma marketers to know: Tuesday, January 10, 2017

Five things for pharma marketers to know: Tuesday, January 10, 2017

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Illumina and IBM enter DNA sequencing partnership; J&J to outline price increases in new report; Egalet's opioid Arymo ER gets FDA approval

The FDA to study whether people can recognize misleading drug ads

The FDA to study whether people can recognize misleading drug ads

The agency has faced questions about how it regulates off-label communications.

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