FDA

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

Five things for pharma marketers to know: Monday, February 22, 2016

Five things for pharma marketers to know: Monday, February 22, 2016

Merck CEO says industry needs to better communicate value; procedural vote could clear Califf as FDA chief; HPV vaccine lowers virus' prevalence

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

With support of FDA committee, Remicade biosimilar edges closer to market

With support of FDA committee, Remicade biosimilar edges closer to market

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The FDA is set to announce its decision on the drug in April.

Five things for pharma marketers to know: Tuesday, February 9, 2016

Five things for pharma marketers to know: Tuesday, February 9, 2016

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The FDA to review biosimilar Remicade; lawmaker looks at panelists' ties to painkiller manufacturers; Novartis signs risk-sharing contracts for Entresto

Five things for pharma marketers to know: Wednesday, February 3, 2016

Five things for pharma marketers to know: Wednesday, February 3, 2016

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Seven potential blockbusters set to launch in 2016; Amarin case may lead to 'misleading' marketing; Valeant, Turing raised prices to meet preset targets

Speeding up FDA Approvals Calls for Pause

Speeding up FDA Approvals Calls for Pause

The idea that 30 days is enough time for the FDA to evaluate anything is, of course, quite silly. But Sen. Cruz takes it one step further.

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

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

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The FDA accepts bid for new label for Jardiance; Markey puts on a hold on Califf's FDA nomination; GSK is studying the Zika virus

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

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

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The FDA declines to approve two drugs for Duchenne muscular dystrophy; government watchdog questions FDA's post-market drug tracking; WebMD denies acquisition talks

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

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

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HCPs sound off on CMS opioid proposal; Senate committee to decide if Califf gets FDA commissioner nod; Celgene names new CEO

2016 May Bring More Warning Letters, Guidance from FDA

2016 May Bring More Warning Letters, Guidance from FDA

It is worth noting that the FDA sent only nine warning letters last year, all focused on well-recognized violations, such as minimization of risk information and unsubstantiated claims.

Five things for pharma marketers to know: Monday, January 4, 2016

Five things for pharma marketers to know: Monday, January 4, 2016

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The FDA approved 45 new drugs in 2015; Baxalta signs immuno-oncology deal; pharma M&A activity may slow this year

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