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

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

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.

The FDA warns drugmakers over promotion of experimental opioid

The FDA warns drugmakers over promotion of experimental opioid

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

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

The FDA sends untitled letter to Jazz subsidiary over ASCO display

The FDA sends untitled letter to Jazz subsidiary over ASCO display

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

The FDA asks for input on off-label comms

The FDA asks for input on off-label comms

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

Lobbyists create off-label principles following FDA lawsuits

Lobbyists create off-label principles following FDA lawsuits

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

Five things for pharma marketers to know: Thursday, July 14, 2016

Five things for pharma marketers to know: Thursday, July 14, 2016

The FDA expands use for Pfizer's Prevnar 13 vaccine; an FDA panel votes in support of Novartis biosimilar; U.S. healthcare spending rises 5.5% in 2015

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

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

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

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

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

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

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: Thursday, June 16, 2016

Five things for pharma marketers to know: Thursday, June 16, 2016

A government watchdog criticizes the FDA; the FDA strengthens kidney warnings for Invokana and Farxiga; people with diabetes are living longer

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

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

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

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