Legal/Regulatory

House passes 21st Century Cures Act that would allow some off-label sharing

House passes 21st Century Cures Act that would allow some off-label sharing

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The bill includes two provisions that would address drugmakers' calls for clarity on sharing off-label information with payers and regulators.

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

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

Will drugmakers get what they're looking for at this week's FDA off-label hearing?

Will drugmakers get what they're looking for at this week's FDA off-label hearing?

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Spurred by recent lawsuits, the FDA is scheduled to hold a two-day hearing this week on whether to allow drugmakers more latitude in promoting therapies off-label.

Off-label promotion: By the numbers

Off-label promotion: By the numbers

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Here are 5 statistics about off-label promotion ahead of the FDA's public hearing this week.

FDA charges KOL with misbranding seizure drug in promo video

FDA charges KOL with misbranding seizure drug in promo video

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Supernus Pharmaceuticals received an untitled letter over a promotional video for Oxtellar XR.

Drugmakers, facing pricing criticism, sell cures in new ads

Drugmakers, facing pricing criticism, sell cures in new ads

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With lawmakers, patients, and physicians crying foul over pricing, drugmakers are trying to shift the narrative — with mixed results. Can a new focus on storytelling help?

Warning letters most often stem from missing risk information

Warning letters most often stem from missing risk information

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The number of warning and untitled letters has dropped in recent years. Only four letters have been sent so far this year, compared to 28 in 2012.

Will Investors Reward Drugmakers That Limit Price Increases?

Will Investors Reward Drugmakers That Limit Price Increases?

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Now here comes the big question. Will the shareholders and directors of KaloBios and Allergan reward or punish their CEOs for what some may see as revenue-capping concessions?

Five things for pharma marketers to know: Friday, October 21, 2016

Five things for pharma marketers to know: Friday, October 21, 2016

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Lawmakers ask for information about price of leukemia drug; Abbott writes down losses from Mylan stake; CVS Health focused on role as health brand

Five things for pharma marketers to know: Monday, October 3, 2016

Five things for pharma marketers to know: Monday, October 3, 2016

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More drugmakers file lawsuits to prevent biosimilar competition; experimental dermatitis drug showeds promising results; pharma blames PBMs for price hikes

The provider gift ban: The day the tchotchkes died

The provider gift ban: The day the tchotchkes died

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For some people in the industry ecosystem, the appeal of promo knickknacks endures.

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 denies approval of abuse-deterrent opioid after promotional warning

The FDA denies approval of abuse-deterrent opioid after promotional warning

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The agency denied Pain Therapeutics' and Durect's abuse-deterrent opioid in a complete response letter after warning the drugmakers about how they promoted the drug.

Five things for pharma marketers to know: Thursday, September 22, 2016

Five things for pharma marketers to know: Thursday, September 22, 2016

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Mylan CEO comes under fire at House Committee hearing; Abbott OxyContin reps went to great lengths to sell the pain pill; UnitedHealth drops Lantus

The FDA warns drugmakers over promotion of experimental opioid

The FDA warns drugmakers over promotion of experimental opioid

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The OPDP sent its second untitled letter this week, this time to Durect and Pain Therapeutics over the presentation of Remoxy ER.

The FDA criticizes Pfizer's safety study for Chantix

The FDA criticizes Pfizer's safety study for Chantix

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The regulator cited inconsistencies with how safety trial data was recorded in a report released ahead of the advisory committee's meeting on Wednesday.

Five things for pharma marketers to know: Thursday, September 8, 2016

Five things for pharma marketers to know: Thursday, September 8, 2016

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A new study found that orphan drug spending will slow through 2018; senators open inquiry into Mylan; Shires launches branded campaign

The FDA sends untitled letter to Jazz subsidiary over ASCO display

The FDA sends untitled letter to Jazz subsidiary over ASCO display

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The regulator charged Celator Pharmaceuticals with promoting an experimental drug as safe and effective even though it has not been approved.

Five things for pharma marketers to know: Wednesday, September 7, 2016

Five things for pharma marketers to know: Wednesday, September 7, 2016

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BIO launches ad campaign defending drugmakers; GSK's experimental COPD drug reduces flare-ups in patients; NY attorney general to investigate Mylan

Five things for pharma marketers to know: Tuesday, September 6, 2016

Five things for pharma marketers to know: Tuesday, September 6, 2016

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MannKind plans to develop inhalable epinephrine; lawmakers accuse Mylan of evading paying higher Medicaid rebates; NICE rejects Roche's cancer drug

The FDA asks for input on off-label comms

The FDA asks for input on off-label comms

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The FDA will hold a public hearing in November to gather input on how it should regulate certain off-label communications.

Five things for pharma marketers to know: Tuesday, August 23, 2016

Five things for pharma marketers to know: Tuesday, August 23, 2016

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Grassley blasts Mylan over EpiPen price increases; Portola Pharmaceuticals receives CRL letter for reversal agent; the FDA approves Pfizer's opioid

Lobbyists create off-label principles following FDA lawsuits

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PhRMA and BIO, which represent life sciences firms, developed principles about sharing truthful and non-misleading information with payers and providers.

W2O faces gender discrimination suit from former staffer

W2O faces gender discrimination suit from former staffer

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Lynn Fox is suing W2O. She was laid off in March, seven months after the agency network bought her San Francisco-based boutique, Fox Communications.

Five things for pharma marketers to know: Monday, July 25, 2016

Five things for pharma marketers to know: Monday, July 25, 2016

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Darzalex may interfere with blood testing; Kaine scrutinized for ties to pharma; medical societies are in support of bill exempting CME reporting

Five things for pharma marketers to know: Wednesday, July 20, 2016

Five things for pharma marketers to know: Wednesday, July 20, 2016

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Spending on CME rose in 2015; the FDA approves Valeant's Relistor; the Justice Department aims to block insurer merger

Califf's Plans May Be Tempered By Election

Califf's Plans May Be Tempered By Election

FDA Commissioner Robert Califf has two plans for what he wants to achieve during his tenure. One is long-term. The other ends in early 2017.

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