Legal/Regulatory

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

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.

Five things for pharma marketers to know: Monday, July 11, 2016

Five things for pharma marketers to know: Monday, July 11, 2016

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Purdue Pharma reportedly knew about OxyContin trafficking; Amgen's Repatha approved for monthly dosing option; Clinton proposes new healthcare measures

Five things for pharma marketers to know: Friday, July 8, 2016

Five things for pharma marketers to know: Friday, July 8, 2016

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The FDA said Amgen's biosimilar of Humira is safe and effective; Juno trial halted due to patient deaths; the CMS bans Theranos founder

Five things for pharma marketers to know: Monday, June 27, 2016

Five things for pharma marketers to know: Monday, June 27, 2016

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Former FDA commissioners said agency should be independent from HHS; Sanofi and BI confirm asset swap; FDA panel to vote on new Jardiance data

Five things for pharma marketers to know: Friday, June 24, 2016

Five things for pharma marketers to know: Friday, June 24, 2016

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Brexit votes creates EU regulatory uncertainty; Obama plans to veto health saving accounts bill; broad Entresto adoption could prevent more than 28,000 deaths

Five things for pharma marketers to know: Thursday, June 23, 2016

Five things for pharma marketers to know: Thursday, June 23, 2016

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Medicare cost-cutting panel will not be activated this year; more Americans are abusing opioids; BIO blasts ICER

Five things for pharma marketers to know: Tuesday, June 21, 2016

Five things for pharma marketers to know: Tuesday, June 21, 2016

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Cancer docs push HPV vaccine; GSK says experimental lung combo trumps Symbicort; Google rolls out new symptom search feature

Pharma's complexity calls for a closer look at creativity

Pharma's complexity calls for a closer look at creativity

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The discontinuation of the Take It From a Fish campaign can serve as an example of the common ups-and-downs of pharma marketing.

Five things for pharma marketers to know: Tuesday, May 31, 2016

Five things for pharma marketers to know: Tuesday, May 31, 2016

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Lawmaker calls for investigation of Purdue; Jazz to acquire Celator; Intercept's liver drug is approved

Five things for pharma marketers to know: Tuesday, May 24, 2016

Five things for pharma marketers to know: Tuesday, May 24, 2016

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The FDA accepts Samsung's biosimilar for review; Sanofi retools executive committee; Entresto may get a boost from updated care guidelines

Five things for pharma marketers to know: Monday, May 23, 2016

Five things for pharma marketers to know: Monday, May 23, 2016

E.U. lifts warning on Pfizer's Chantix; Obama's Medicare Part B proposal panned by lawmakers; France to propose stricter rules for clinical trials

Industry criticizes FDA's proposed DTC studies

Industry criticizes FDA's proposed DTC studies

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Pharma companies took issue with the methodology for the FDA's proposed studies of advertising tactics.

Lobbyists argue DTC ad tax deduction may be a casualty of reform

Lobbyists argue DTC ad tax deduction may be a casualty of reform

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Advertising lobbyist said eliminating the DTC ad tax deduction is a real threat to the industry.

Five things for pharma marketers to know: Thursday, May 12, 2016

Five things for pharma marketers to know: Thursday, May 12, 2016

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Valeant has not delivered promised price breaks on heart drugs; AstraZeneca drug receives orphan status; Allergan promotes Meury and Stewart

Five things for pharma marketers to know: Thursday, April 28, 2016

Five things for pharma marketers to know: Thursday, April 28, 2016

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Pfizer settles rebate suit; Sanofi moves to acquire Medivation; AstraZeneca sells US rights to gout drug

Senate committee condemns Valeant's business model

Senate committee condemns Valeant's business model

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The Senate committee on Aging said Valeant's missteps go beyond price hikes and that its business model is fundamentally to blame.

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