FDA

Five things for pharma marketers to know: Friday, May 22

Five things for pharma marketers to know: Friday, May 22

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Amgen's PSCK9 inhibitor gets a position opinion in the EU; the FDA plans to study how spouses influence perception of DTC ads; Botox may relieve depression

21st Century Cures bill advances to House floor

21st Century Cures bill advances to House floor

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The legislation would allow drugmakers to share economic information with payers beyond what is included on the FDA-approved label.

OPDP finds fault with Rapaflo website

The FDA's advertising division said images and copy for the BPH drug Rapaflo are misleading.

Five things for pharma marketers to know: Wednesday, May 20

Five things for pharma marketers to know: Wednesday, May 20

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FDA official says DTC risk claims are a waste of time; one analyst believes Afrezza could turn around sluggish sales; J&J inks billion-dollar deal to commercialize HCV drugs

Five things for pharma marketers to know: Friday, May 15

Five things for pharma marketers to know: Friday, May 15

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Genentech alums launch a new biotechnology company; Mallinckrodt sues the FDA over a drug reclassification; Sanofi takes on celiac disease

Five things for pharma marketers to know: Friday, May 8

Five things for pharma marketers to know: Friday, May 8

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Amarin sues FDA over off-label discussions; spike in HCV infections in US blamed on Endo opioid; Pfizer settles gambling, eating and sex addiction lawsuit

Five things for pharma marketers to know: Monday, May 4

Five things for pharma marketers to know: Monday, May 4

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Drugmakers engage early with insurers; patients push for implant to be pulled from the market; about one-third of new drugs qualify for special approval pathways

Five things for pharma marketers to know: Thursday, April 30

Five things for pharma marketers to know: Thursday, April 30

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FDA advisory panel recommends Amgen's T-Vec; Teva again makes the case for a merger with Mylan; the FDA approves injection to treat double chins

Lawmakers advance 21st Century Cures draft; proposal would allow sharing of off-label economic data

Lawmakers advance 21st Century Cures draft; proposal would allow sharing of off-label economic data

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The draft would allow drugmakers to share off-label economic data with payers, a practice that until now has been considered taboo, and require the FDA to assess patient experience data in regulatory decisions, in addition to boosting funding for the NIH.

FDA takes aim at Abilify marketing material

The regulator's marketing watchdog said a sales tool makes promises that the drug's label cannot support.

Five things for pharma marketers to know: Tuesday, April 21

Five things for pharma marketers to know: Tuesday, April 21

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Teva proposes acquisition of Mylan; start-up offers BRCA testing for $249; Botox receives another label expansion

FDA takes unusual stance on ALS drug

FDA takes unusual stance on ALS drug

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The FDA asked private biotech Genervon to release all available clinical trial data for its experimental ALS treatment.

Five things for pharma marketers to know: Friday, April 17

Five things for pharma marketers to know: Friday, April 17

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The FDA approves generic Copaxone; AstraZeneca's experimental lung-cancer drug demonstrates that it can delay disease progression; PhRMA CEO John Castellani to step down

Five things for pharma marketers to know: Tuesday, April 14

Five things for pharma marketers to know: Tuesday, April 14

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IBM takes on healthcare data; Mylan settled a lawsuit allowing it to launch generic Viagra by 2017; an FDA committee will meet today to discuss Onglyza

Five things for pharma marketers to know: Friday, April 10

Five things for pharma marketers to know: Friday, April 10

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AstraZeneca diabetes drug may have increased mortality rate; Pfizer accused of knowing about birth defect risks from Zoloft; Eisai to cut 25% of its US workforce

 Five things for pharma marketers to know: Thursday, April 9

Five things for pharma marketers to know: Thursday, April 9

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Novartis reported highest drug sales in 2014; state Medicaid programs spent $1.33 billion on hepatitis-C drugs; former FDA commissioner argues against shortening regulatory review times

FDA Onglyza panel review set for Tuesday

FDA Onglyza panel review set for Tuesday

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The panel will focus on heart failure hospitalization rates associated with the diabetes medication.

Hospira gets fifth FDA warning in two years

The company has received seven warning letters since 2010.

Five things for pharma marketers to know: Wednesday, April 8

Five things for pharma marketers to know: Wednesday, April 8

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FDA accepts previously rejected Novo Nordisk insulin application; Merck HCV doublet regimen receives Breakthrough designation for patients with kidney disease; researchers say that rising costs for cancer drugs aren't reasonable

How to Make DTC Ad 'Warnings' More Effective

How to Make DTC Ad 'Warnings' More Effective

A more general warning encourages consumers to engage in a personal discussion with their doctor about a drug, and it promotes engagement with longer-format printed or digitally-delivered information.

Five things for pharma marketers to know: Tuesday, April 7

Five things for pharma marketers to know: Tuesday, April 7

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Merck funds protein-degrading technology; Shire expects approval for a new ADHD medication in 2017; state biosimilar notification laws focus on subtext

FDA finalizes opioid guidance

Opioids lacking abuse-foiling technology will remain available.

Five things for pharma marketers to know: Thursday, March 26

Five things for pharma marketers to know: Thursday, March 26

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Regeneron's Eylea won its fourth indication; Sun Pharma wants to revive trust in its products; confidentiality agreements keep Amgen from telling patients their cancer risk

Five things for pharma marketers to know: Monday, March 23

Five things for pharma marketers to know: Monday, March 23

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Eleven new drugs with blockbuster potential are expected to launch this year; a bill would require FDA to quickly review drugs approved in the EU; Biogen reinforces its focus on hard-to-treat diseases

Five things for pharma marketers to know: Friday, March 20

Five things for pharma marketers to know: Friday, March 20

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A judge rules against Amgen in Neupogen case; FDA advisory panel recommends Breio Ellipta for adults with asthma; AstraZeneca partners with Daiichi Sankyo to sell Movantik

Five things for pharma marketers to know: Thursday, March 12

Five things for pharma marketers to know: Thursday, March 12

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The SEC said some company drug prices can be made public, 23andMe launched an R&D division, and Public Citizen is asking the FDA to withdraw a proposal it says will undermine drug safety information.

FDA letter focuses on UCLA claims about an unapproved diagnostic

The agency's Office of Prescription Drug Promotion said a website indicated safety and effectiveness of a diagnostic tool that has not been approved by the FDA.

FDA releases new e-informed consent guidance in bid for more efficient trials

FDA releases new e-informed consent guidance in bid for more efficient trials

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The agency hopes the adoption of electronic informed consent measures could help participants retain and understand information as well as allow quicker timing of updates.

Five things for pharma marketers to know: Friday, March 6

Five things for pharma marketers to know: Friday, March 6

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FDA approves the first biosimilar, judge rules that FDA panel members had conflicts of interest, and a new venture will evaluate the effectiveness of digital health technologies.

Orexigen pleases shareholders, irks FDA

The drugmaker released interim clinical trial information in an SEC filing that the FDA wanted kept quiet until the trial was completed.

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