Legal/Regulatory

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.

Five things for pharma marketers to know: Tuesday, March 15, 2016

Five things for pharma marketers to know: Tuesday, March 15, 2016

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The FDA will prioritize certain generic drug applications; Valeant posts fourth-quarter loss; medical marijuana drug shines in Phase-III trial

The FDA wants to study DTC tactics

The FDA wants to study DTC tactics

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The agency has proposed two studies to investigate the use of superimposed text and the use of animated characters.

Five things for pharma marketers to know: Wednesday, March 9, 2016

Five things for pharma marketers to know: Wednesday, March 9, 2016

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Amarin settles with the FDA over off-label promotion suit; mobile apps often share medical information with third parties; drug spending rose 12% in 2014

Five things for pharma marketers to know: Monday, March 7, 2016

Five things for pharma marketers to know: Monday, March 7, 2016

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European regulators launch speedier drug approval process: AbbVie and Boehringer Ingelheim to partner on psoriasis drug; the FDA approves hemophilia B drug

Senators propose an end to pharma ad tax deduction

Senators propose an end to pharma ad tax deduction

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The proposed legislation would forbid drugmakers from writing off advertising as a tax deduction.

Five things for pharma marketers to know: Friday, March 4, 2016

Five things for pharma marketers to know: Friday, March 4, 2016

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New PhRMA CEO issues policy strategy; study assess patient response to immuno-oncology drugs; Twitter may be an effective way to talk about clinical trials

Five things for pharma marketers to know: Thursday, February 25, 2016

Five things for pharma marketers to know: Thursday, February 25, 2016

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Senate approves Califf as FDA commissioner; one-fifth of published trial data is used for "marketing trials;" Valeant CEO Pearson is on the mend

Omnicom formalizes health group led by CDM's Wise

Omnicom formalizes health group led by CDM's Wise

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The division, dubbed Omnicom Health Group, claims to serve 70% of the top 100 pharma brands.

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

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

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The Senate clears Califf; Sanofi files new drug application for Lantus/Lyxumia combination; the FDA approves UCB's new epilepsy drug

Five things for pharma marketers to know: Thursday, February 18, 2016

Five things for pharma marketers to know: Thursday, February 18, 2016

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Lawmaker seeks to stop DTC ads for newly approved drugs; testosterone therapy helps sexual function; the FDA requests more data about Catalyst's rare drug

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