FDA

Five things for pharma marketers to know: Thursday, July 21, 2016

Five things for pharma marketers to know: Thursday, July 21, 2016

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The FDA approves generic versions of AstraZeneca's Crestor; Biogen CEO steps down; drugmakers race to develop smart inhalers

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: Tuesday, July 19, 2016

Five things for pharma marketers to know: Tuesday, July 19, 2016

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The FDA declines to approve Novartis biosimilar; GSK partners with Apple's ResearchKit; drugmakers partner with Lyft for clinical trial participants

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

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

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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: 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

Clinton or Trump? Either Way, Change Is Coming

Clinton or Trump? Either Way, Change Is Coming

Donald Trump and Hillary Clinton offer clear contrasts on the issues of the Affordable Care Act, entitlement reform, and drug pricing.

Five things for pharma marketers to know: Wednesday, June 29, 2016

Five things for pharma marketers to know: Wednesday, June 29, 2016

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GIlead Sciences' new HCV treatment receives approval; FDA adcomm votes in favor of Jardiance health-outcomes' claims; FDA names head of new oncology center

Five things for pharma marketers to know: Tuesday, June 28, 2016

Five things for pharma marketers to know: Tuesday, June 28, 2016

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Opdivo nets sixth Breakthrough Therapy designation; AstraZeneca seeks rare indication to block Crestor generics; Endo mulls sale to reduce debt

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

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

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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: Friday, June 10, 2016

Five things for pharma marketers to know: Friday, June 10, 2016

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FDA leader says drugmakers should develop more novel drugs; Merck to acquire Afferent for $1.25 billion; Colombia demands lower prices for Gleevec

Five things for pharma marketers to know: Thursday, June 9, 2016

Five things for pharma marketers to know: Thursday, June 9, 2016

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Industry lobbying group plans counteroffensive; the FDA rejected a record high amount generic drug applications; adcomm recommends Pfizer painkiller

Merck educates doctors about biosimilars, long before it will sell one in the U.S.

Merck educates doctors about biosimilars, long before it will sell one in the U.S.

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Drugmakers like Merck are making a big education push as they lay the groundwork for future biosimilars.

Five things for pharma marketers to know: Tuesday, May 10, 2016

Five things for pharma marketers to know: Tuesday, May 10, 2016

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U.S. investors want lobbyists to make a better case on drug pricing; pancreatic vaccine failed in Phase-III trial; Epirus cuts 40% of its workforce

Five things for pharma marketers to know: Wednesday, May 4, 2016

Five things for pharma marketers to know: Wednesday, May 4, 2016

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The FDA issues warning for certain antipsychotics; Shkreli may face more securities charges; Genentech and Stand Up to Cancer launch campaign

Five things for pharma marketers to know: Tuesday, May 3, 2016

Five things for pharma marketers to know: Tuesday, May 3, 2016

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IMS and Quintiles to merge and create $17 billion firm; Biogen spins off hemophilia company; Google partners with the National Health Service

Infographic: the growing biosimilar market in the U.S.

Infographic: the growing biosimilar market in the U.S.

The FDA has approved two biosimilars, but questions remain about how quickly providers and patients in the U.S. will adopt them.

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

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

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Valeant names new CEO; Novartis weighs sales of stake in Roche; FDA ad panel to recommend DMD drug

Five things for pharma marketers to know: Friday, April 15, 2016

Five things for pharma marketers to know: Friday, April 15, 2016

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Bristol-Myers Squibb seeks new indication for Opdivo; Clinton received $2.8 million from the healthcare industry; Quest creates tests for hep.-C drugs

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.

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

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

Five things for pharma marketers to know: Wednesday, March 30, 2016

Five things for pharma marketers to know: Wednesday, March 30, 2016

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There are 23 biosimilars ready to file with the FDA; an FDA committee votes in favor of Parkinson's disease drug; Bloomberg funds new immunotherapy center

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

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

Right-to-Try Laws Take Sensible Approach to Reforming FDA Rules

Right-to-Try Laws Take Sensible Approach to Reforming FDA Rules

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The regulator's reliance on double-blind, placebo-controlled trials with exhaustive inclusion and exclusion criteria is incompatible with today's precision medicine.

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

Five things for pharma marketers to know: Wednesday, February 24, 2016

Five things for pharma marketers to know: Wednesday, February 24, 2016

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Analysts worry about government intervention in Pfizer-Allergan deal; FDA said PTC drug application is incomplete; J&J baby campaign features sleep-tracking app

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

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