Legal/Regulatory

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.

Five things for pharma marketers to know: Wednesday, April 27, 2016

Five things for pharma marketers to know: Wednesday, April 27, 2016

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Pearson expected to say price hikes were too aggressive; Collegium's painkiller receives full FDA approval; most hospitals stop advertising infant formula

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

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

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FDA panel says Duchenne drug is not effective; Bill Ackman to appear before Senate committee investigating pricing issues; Daiichi Sankyo to open new headquarters

Five things for pharma marketers to know: Wednesday, April 13, 2016

Five things for pharma marketers to know: Wednesday, April 13, 2016

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Sanofi is reportedly interested in buying Medivation; Sean Parker funds $250 million cancer research institute; FDA will review Merck's allergy biologic

FDA committee votes no on Clovis lung-cancer drug

FDA committee votes no on Clovis lung-cancer drug

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The FDA advisory committee voted 12-1 against approving the therapy, citing safety issues and requesting more data.

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

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

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California bill would require price disclosures; AbbVie's and Genentech's blood-cancer drug is approved; FDA expands metformin use

The FDA approves AbbVie's and Roche's blood cancer drug

The FDA approves AbbVie's and Roche's blood cancer drug

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Analysts have estimated the drug could reach $2 billion in sales in the next four years.

The FDA's Actions Open Door to 'Truthful, Non-Misleading' Marketing

The FDA's Actions Open Door to 'Truthful, Non-Misleading' Marketing

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That change is coming about in the wake of a string of First Amendment-based losses for the FDA in federal courts around the country.

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

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

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Analyst survey says docs want outcomes benefit from PCSK9s; Allergan licenses early-stage Alzheimer's drugs; Pfizer and IBM partner in Parkinson's disease

DTC Report 2016: Gut Check

DTC Report 2016: Gut Check

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DTC is facing a new test from physicians and politicians. Here's why critics fear a deluge, and how they're pushing back.

Five things for pharma marketers to know: Thursday, March 31, 2016

Five things for pharma marketers to know: Thursday, March 31, 2016

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The FTC asks for more info about Pfizer-Allergan deal; the FDA loosens guidelines for abortion-inducing drug; startup to deliver Truvada through an app

Another physician group raises concerns about DTC

Another physician group raises concerns about DTC

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The American College of Physicians questioned the role direct-to-consumer advertising plays in contributing to prescription drug costs.

Five things for pharma marketers to know: Tuesday, March 29, 2016

Five things for pharma marketers to know: Tuesday, March 29, 2016

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Lawmakers call out high price of Xtandi; Novo Nordisk breaks ground in North Carolina; Sanofi poaches top research scientist from AstraZeneca

Amgen wins PCSK9 patent case against Sanofi and Regeneron

Amgen wins PCSK9 patent case against Sanofi and Regeneron

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A jury ruled in favor of Amgen, saying its patents for Repatha are valid.

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