FDA

Five things for pharma marketers to know: Wednesday, February 3, 2016

Five things for pharma marketers to know: Wednesday, February 3, 2016

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Seven potential blockbusters set to launch in 2016; Amarin case may lead to 'misleading' marketing; Valeant, Turing raised prices to meet preset targets

Speeding up FDA Approvals Calls for Pause

Speeding up FDA Approvals Calls for Pause

The idea that 30 days is enough time for the FDA to evaluate anything is, of course, quite silly. But Sen. Cruz takes it one step further.

Five things for pharma marketers to know: Tuesday, January 26, 2016

Five things for pharma marketers to know: Tuesday, January 26, 2016

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The FDA accepts bid for new label for Jardiance; Markey puts on a hold on Califf's FDA nomination; GSK is studying the Zika virus

Five things for pharma marketers to know: Friday, January 15, 2016

Five things for pharma marketers to know: Friday, January 15, 2016

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The FDA declines to approve two drugs for Duchenne muscular dystrophy; government watchdog questions FDA's post-market drug tracking; WebMD denies acquisition talks

Five things for pharma marketers to know: Tuesday, January 12, 2016

Five things for pharma marketers to know: Tuesday, January 12, 2016

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HCPs sound off on CMS opioid proposal; Senate committee to decide if Califf gets FDA commissioner nod; Celgene names new CEO

2016 May Bring More Warning Letters, Guidance from FDA

2016 May Bring More Warning Letters, Guidance from FDA

It is worth noting that the FDA sent only nine warning letters last year, all focused on well-recognized violations, such as minimization of risk information and unsubstantiated claims.

Five things for pharma marketers to know: Monday, January 4, 2016

Five things for pharma marketers to know: Monday, January 4, 2016

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The FDA approved 45 new drugs in 2015; Baxalta signs immuno-oncology deal; pharma M&A activity may slow this year

Five things for pharma marketers to know: Tuesday, December 29, 2015

Five things for pharma marketers to know: Tuesday, December 29, 2015

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Generic-drug approval backlog criticized; KaloBios board members step down; Sovaldi costs as little as $4 in India

Five things for pharma marketers to know: Thursday, December 17, 2015

Five things for pharma marketers to know: Thursday, December 17, 2015

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The FDA approves Lilly's Lantus follow-on biologic; AstraZeneca buys majority stake in Acerta Pharma; Shkreli arrested on securities fraud charges

The FDA settles with Pacira, rescinds warning letter

The FDA settles with Pacira, rescinds warning letter

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The FDA withdrew a 2014 warning letter related to Pacira Pharmaceuticals' marketing of its painkiller Exparel as part of a settlement reached by both parties this week.

Five things for pharma marketers to know: Tuesday, December 15, 2015

Five things for pharma marketers to know: Tuesday, December 15, 2015

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Valeant agrees to cut prices in deal with Walgreens; FDA committee votes against Merck's Vytorin claims; Pacira settles off-label marketing case with the FDA

FDA advisory panel recommends Teva asthma antibody

FDA advisory panel recommends Teva asthma antibody

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An FDA advisory committee voted 11-3, recommending approval of reslizumab in adults with severe asthma.

Five things for pharma marketers to know: Wednesday, November 25, 2015

Five things for pharma marketers to know: Wednesday, November 25, 2015

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FDA advisers vote against BioMarin's Duchenne drug; the FDA approves Lilly's lung-cancer drug; criticism mounts for Pfizer's proposed deal with Allergan

Five things for pharma marketers to know: Tuesday, November 24, 2015

Five things for pharma marketers to know: Tuesday, November 24, 2015

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Opdivo receives another indication; increasing generic prescriptions may boost patient adherence; hep.-C drugs should be prescribed during earlier stages of disease

Five things for pharma marketers to know: Wednesday, November 18, 2015

Five things for pharma marketers to know: Wednesday, November 18, 2015

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Califf defends his past; Drug spending to increase by 4%-7% per year through 2020; Samsung Bioepis's Enbrel biosimilar faces decision-date Friday

Five things for pharma marketers to know: Monday, October 26, 2015

Five things for pharma marketers to know: Monday, October 26, 2015

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FDA panel recommends AZ gout drug for approval; Valeant to form committee to examine specialty pharmacy ties; patients treated with Keytruda had longer survival than those who took chemo

Five things for pharma marketers to know: Wednesday, October 21, 2015

Five things for pharma marketers to know: Wednesday, October 21, 2015

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23andMe relaunches its DTC genetic test; Valeant's woes increase as shares plummet; the FDA questions the safety of AstraZeneca's gout drug

Five things for pharma marketers to know: Wednesday, October 7, 2015

Five things for pharma marketers to know: Wednesday, October 7, 2015

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Califf reportedly removes name from research questioning FDA oversight of clinical trials; Express Scripts to cover both PCSK9 inhibitors; trial for experimental cancer drug halted after patient death

Omitting risk info in ads is top reason for FDA warning

Omitting risk info in ads is top reason for FDA warning

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An analysis conducted by J&J executives found that 58% of FDA warning letters and untitled letters over the last two years omitted risk information.

FDA forms first patient engagement committee

FDA forms first patient engagement committee

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The agency announced a new committee to help integrate patient perspectives into the regulation of medical devices.

Five things for pharma marketers to know: Friday, September 11, 2015

Five things for pharma marketers to know: Friday, September 11, 2015

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Proteus and Otsuka seek approval of "digital" drug; J&J moves its US media-buying business back to UM; FDA committee votes no on Purdue's new opioid

Five things for pharma marketers to know: Wednesday, September 9, 2015

Five things for pharma marketers to know: Wednesday, September 9, 2015

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Pacira sues the FDA over marketing limitations; nonprofit says PCSK9 inhibitors are priced too high; GSK's Breo fails to extend life

Five things for pharma marketers to know: Friday, September 4, 2015

Five things for pharma marketers to know: Friday, September 4, 2015

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Longer-term use of AstraZeneca's Brilinta approved; Google streamlines health-related searches; Zarxio's price is higher than expected

Five things for pharma marketers to know: Monday, August 31

Five things for pharma marketers to know: Monday, August 31

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Kim Kardashian posts corrective information on Instagram and Twitter; DPP-4 inhibitors are linked to joint pain; doctors question off-label prescriptions of PCSK9 inhibitors

Five things for pharma marketers to know: Friday, August 28

Five things for pharma marketers to know: Friday, August 28

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Amgen's Repatha receives FDA nod; Mylan shareholders vote in favor of Perrigo deal; doctors push for below-average price of experimental cancer drug

Sunovion prepares for FDA decision on Aptiom

Sunovion prepares for FDA decision on Aptiom

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The FDA is expected to announce this week whether it has approved the epilepsy drug as a monotherapy for partial-onset seizures.

Five things for pharma marketers to know: Thursday, August 27

Five things for pharma marketers to know: Thursday, August 27

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The FDA releases biosimilar-naming draft guidance; PD1 drugs linked to a rare type of diabetes; Amgen's PCSK9 inhibitor faces approval decision

Experts: Sprout needs to show Addyi is not Viagra for women

Experts: Sprout needs to show Addyi is not Viagra for women

Contrary to popular belief, Addyi is not the female Viagra. That's the message drug-maker Sprout must get across to doctors and patients in the coming weeks.

Five things for pharma marketers to know: Friday, August 21

Five things for pharma marketers to know: Friday, August 21

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The FDA encourages clinical testing of testosterone; Google spins out its life-sciences business; Novartis buys remaining rights to Arzerra

Five things for pharma marketers to know: Wednesday, August 19

Five things for pharma marketers to know: Wednesday, August 19

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Sprout's controversial sexual-desire drug receives FDA approval; prescription-drug coverage impacts cash sales at Walmart; Mylan warned about manufacturing violations

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