FDA

Five things for pharma marketers to know: Thursday, June 22, 2017

Five things for pharma marketers to know: Thursday, June 22, 2017

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The FDA plans public meeting to encourage generic competition; Mylan reportedly offered rebates to six Medicaid programs; Republicans to present draft bill for Obamacare replacement

The FDA attempts to understand how disclosures affect drug ads

The FDA attempts to understand how disclosures affect drug ads

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The FDA recently proposed studies designed to determine how disclosures in drug ads affect how viewers frame information.

Five things for pharma marketers to know: Wednesday, June 21, 2017

Five things for pharma marketers to know: Wednesday, June 21, 2017

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Insurance companies balk at expensive PCSK9 inhibitors; Publicis to focus investments on AI platform; clinical trial reveals Novartis' eye drug requires less frequent injections

Five things for pharma marketers to know: Monday, June 19, 2017

Five things for pharma marketers to know: Monday, June 19, 2017

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Adamis receives FDA approval for EpiPen rival Symjepi; Clovis reports positive trial results for ovarian cancer drug Rubraca; hedge fund billionaire John Paulson joins Valeant board of directors

Five things for pharma marketers to know: Friday, June 16, 2017

Five things for pharma marketers to know: Friday, June 16, 2017

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Apple reportedly working to bring EMRs to iPhone; FDA to study disclosures in ads; Trump admin discussing drug price EO

Bayer aims to drive patient-HCP dialogue with data-sharing app for MS

Bayer aims to drive patient-HCP dialogue with data-sharing app for MS

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The FDA-approved app will allow MS patients to share their medication injection history with HCPs.

Five things for pharma marketers to know: Monday, June 12, 2017

Five things for pharma marketers to know: Monday, June 12, 2017

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Teva gets FDA approval for Truvada generic; the FDA rejects Coherus' Neulasta biosimilar; only 17% of Americans find health industries to be innovative

PDUFA amendment would broaden off-label rules

PDUFA amendment would broaden off-label rules

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The bill, introduced in March, is being considered as an amendment in the upcoming PDUFA reauthorization legislation.

Five things for pharma marketers to know: Thursday, June 1, 2017

Five things for pharma marketers to know: Thursday, June 1, 2017

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50% of consumers say they will share their health data with tech giants; pharma CEOs expect pricing proposal from Trump administration; FDA approves generic versions of Strattera

Five things for pharma marketers to know: Friday, May 26, 2017

Five things for pharma marketers to know: Friday, May 26, 2017

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FDA presents ideas to tackle drug prices; patients aware of side effects more likely to report them; scientists use Apple's Research Kit for clinical purposes

The FDA cites risk info in letter over Contrave DTC ad

The FDA cites risk info in letter over Contrave DTC ad

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The regulator also took issue with how Orexigen Therapeutics presented the risk information

Five things for pharma marketers to know: Tuesday, May 23, 2017

Five things for pharma marketers to know: Tuesday, May 23, 2017

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Disease awareness ads can boost drug sales; AstraZeneca's experimental asthma drug cuts steroid use; FDA approves Regeneron and Sanofi's RA drug

Five things for pharma marketers to know: Monday, May 22, 2017

Five things for pharma marketers to know: Monday, May 22, 2017

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Amgen's osteoporosis drug set back by safety issue; new FDA digital biz to hire 13 engineers; Celgene's MS drug bests Avonex in trial

Five things for pharma marketers to know: Wednesday, May 17, 2017

Five things for pharma marketers to know: Wednesday, May 17, 2017

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FDA requires boxed warning for J&J's Invokana; Amazon to reportedly hire GM to enter pharmacy industry; WannCry ransomware affects some health organizations

Califf calls for marketers to develop off-label 'code of ethics'

Califf calls for marketers to develop off-label 'code of ethics'

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The former FDA commissioner said marketers need to focus on ensuring that off-label promotion is "non-misleading."

Five things for pharma marketers to know: Thursday, May 11, 2017

Five things for pharma marketers to know: Thursday, May 11, 2017

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FDA approves Merck/Lilly combo for lung cancer; new PhRMA requirements result in expulsion of 22 members; Pfizer to pay Sangamo $7 million for gene therapy programs

Five things for pharma marketers to know: Wednesday, May 10, 2017

Five things for pharma marketers to know: Wednesday, May 10, 2017

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The Senate confirms Gottlieb as FDA commissioner; Endo shares DTC plans for Xiaflex; an AstraZeneca asthma drug fails in late-stage study

Five things for pharma marketers to know: Monday, May 1, 2017

Five things for pharma marketers to know: Monday, May 1, 2017

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The FDA approves osteoporosis drug; groups warn that latest healthcare bill would cut protections for pre-existing conditions; Dupixent gets PBM coverage

Five things for pharma marketers to know: Friday, April 28, 2017

Five things for pharma marketers to know: Friday, April 28, 2017

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Express Scripts-Anthem deal highlights profitability for PBMs; Sarepta CEO steps down; study says NHS cancer drug fund was ineffective

Five things for pharma marketers to know: Wednesday, April 26, 2017

Five things for pharma marketers to know: Wednesday, April 26, 2017

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GSK warns Advair generic competition may affect business in 2017; Lilly plans to meet FDA about baricitinib; FDA warns companies selling 'illegal' products

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