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 Label

FDA gut-checks DTC clarity

May 14, 2013

The new survey will study whether patients understand how efficacy is calculated and experiment with ways to make communications clearer.
 

Journal article targets FDA misstep on Aricept

March 22, 2012

The FDA approval of 23-mg donepezil (Aricept) conflicted with the opinions of its own reviewers and breached the agency's own regulatory standard, authors write in a BMJ article, leading to misleading consumer and physician ad campaigns that put patients at risk.
 

Company news: J&J, Bayer and Siemens Healthcare

November 08, 2011

Johnson & Johnson/Bayer's Xarelto (rivaroxaban) received FDA approval for stroke prevention in atrial fibrillation (SPAF), the second novel anticoagulant to gain US marketing approval for SPAF.
 

Supremes deny Wyeth in pre-emption bid

March 04, 2009

The Supreme Court struck a blow to FDA pre-emption of state laws with a 6-3 decision in Wyeth v. Levine finding the company liable for a failure-to-warn claim under Vermont state law.
 

MPR rolls out revamped website

January 20, 2009

Monthly Prescribing Reference (MPR) has relaunched its website with a number of enhancements to functionality and design, as well as a new, easier-to-remember URL, www.eMPR.com.
 

Waxman: FDA career staff objected to preemption policies

October 31, 2008

Career staffers at the FDA objected to new drug labeling regulations that favor pre-emption of state liability lawsuits, according to a report from Rep. Henry Waxman's Committee on Oversight and Government Reform.
 

FDA to launch drug name review pilot project

October 08, 2008

FDA will initiate a pilot project to help manufacturers choose safer proprietary drug names.
 

FDA proposes Rx label revisions for moms

May 29, 2008

The FDA on Wednesday announced it is proposing revisions to physician labeling for Rx drugs to include more info about their use by pregnant and/or breast-feeding mothers.
 

King reduces workforce by 20%, cuts mostly sales jobs

October 22, 2007

King Pharmaceuticals will cut 20% of its 2,600 employee workforce after a federal appeals court judge ruled against a patent extension on the company's blood pressure treatment Altace.
 

Amgen seeks to ease investor concerns as staff cuts loom

August 21, 2007

With reimbursement limits the latest threat to its anemia franchise, Amgen moved to shore up investor confidence yesterday.
 

New approval for drug gives Novartis excuse to up promotion

August 20, 2007

The newest indication for Reclast -- postmenopausal osteoporosis -- ups its market potential considerably, analysts said.
 

Warfarin label change advises on genetic factors

August 16, 2007

FDA rang in the era of personalized medicine with a labeling change on blood thinner warfarin cautioning that patients with either of two genetic variations might respond differently to the drug, which is sold by BMS under the Coumadin brand.
 

Timing of FDA notice on diabetes meds leads to confusion

August 15, 2007

Yesterdays FDA notice of black-box warnings for GlaxoSmithKlines Avandia, and drugs like it, for congestive heart failure came as a surprise to many.
 

Avoiding the DDMAC letter: Advice from a Pfizer counselor

August 15, 2007

As the FDA keeps up the pressure on marketers for making unsubstantiated claims in their professional promotions, a Pfizer legal expert says companies may be able to avoid such notices by supporting all advertising claims with substantial evidence.
 

Panel votes to keep Avandia on the market with tougher label

July 31, 2007

Federal advisors recommended keeping GlaxoSmithKlines embattled type 2 diabetes drug Avandia on the market but said its label should include strict warnings on use.
 

Avandia meeting could be rough one for GSK

July 27, 2007

An advisory group is set to meet Monday to discuss the cardiovascular safety of GlaxoSmithKline’s type 2 diabetes drug Avandia, and the drug may be in for a rough time.
 

New indication could see Pfizer expand Lyrica ads

June 25, 2007

Pfizers ability to reach what may be an untapped population of people suffering from fibromyalgia got a boost last week when Lyrica became the first FDA-approved therapy for the condition.
 

Avandia hearings: FDA black-boxes TZD drugs

, June 06, 2007

FDA has asked GSK and Takeda to place boxed warnings of congestive heart failure risks on the labeling for their type 2 diabetes drugs, Avandia and Actos.
 

GSK again on defensive with Avandia

May 31, 2007

The war of words between GlaxoSmithKline and critics of the firm’s oral diabetes drug escalated yesterday, as the marketer took additional steps to shore up confidence in Avandia.
 

Promo piece for Provigil lists unapproved uses

May 01, 2007

A promotional piece distributed on behalf of Cephalon to the Maryland Department of Health and Mental Hygiene Pharmacy and Therapeutics Committee suggested uses for the company’s Provigil (modafinil) tablets that have not been approved by FDA, creating new intended uses for which the product lacks adequate directions.
 

Turning Dialogue into Data

Carolyn Choh Fleming April 01, 2007

Cracking the patient-physician interaction has long proved elusive for pharma. But by combining patient chart data with actual audio conversations, marketers can better understand how to impact the exchange, says Carolyn Choh Fleming
 
  

Web Exclusive

Angelina Jolie's fearless but flawed message

Paul Oestreicher, Ph.D. May 17, 2013

Angelina Jolie's story raises important questions about education, outreach and access—but her nod to holistic treatments is less helpful
 

Podcasts

How to engage even the busiest physicians

March 04, 2013

Sponsored by TRUE Health + Wellness. The increasingly demanding schedules of healthcare professionals continue to narrow the window of opportunity for pharma sales teams, and, as a result, marketers are focusing more on non-personal promotion. However, there's a lot more to it than simply bombarding physicians with brand messages, as Anne Stroup, Managing Director at TRUE Health + Wellness, explains to MM&M's James Chase in this special podcast presentation.
 

2013 Hall of Fame Inductees

An entertaining look at the extraordinary lives and careers of the Medical Advertising Hall of Fame's 2013 inductees: Peter Frishauf, Dorothy Philips and David Labson. Clips produced by JUICE Pharma. 

Slideshows

MAHF 2013: Honors Class

A gallery of images from the 2013 Medical Advertising Hall of Fame induction dinner
 
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