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FDA

FDA undergoes staffing changes in external affairs

Jaimy Lee February 24, 2011

SILVER SPRING, MD: The Food and Drug Administration's office of external affairs is undergoing a number of leadership changes, including the departures of the agency's public affairs and Web chiefs.

Allergan's obesity device approved for broader use

Jaimy Lee February 17, 2011

Allergan said late Wednesday night that the FDA approved Lap-Band, its adjustable gastric banding system, for broader use.

Biotech PR pro Jenkins passes away

Jaimy Lee February 14, 2011

Adriana Jenkins, a longtime biotech PR professional, died last week from breast cancer. She was 41.

Obesity drug fails to win FDA approval

Jaimy Lee February 01, 2011

Federal officials did not approve Contrave, the weight loss drug developed by Orexigen Therapeutics, over concerns about the risks of heart attacks.

3D hires Cox

Jaimy Lee January 25, 2011

WASHINGTON: 3D Communications hired Virginia Cox as an executive in the firm's Washington office, effective February 1.

Sharfstein says he will leave FDA

Jaimy Lee January 05, 2011

Joshua Sharfstein, second-in-command at the Food and Drug Administration, said he is leaving the federal agency to return to Maryland and lead the state's health agency.

Report: Genzyme willing to discuss a deal

Jaimy Lee December 22, 2010

The Wall Street Journal reported that Genzyme is "displaying a new willingness" to discuss a possible deal with Sanofi-Aventis.

Orexigen leads obesity market with FDA backing

Jaimy Lee December 09, 2010

Drugmakers with an eye on the obesity market got some good news this week when an FDA panel issued a positive recommendation for Orexigen Therapeutics' obesity drug Contrave.

Allergan hires GCI Health for Botox account

Chris Daniels October 19, 2010

IRVINE, CA: Allergan has selected GCI Health to support the launch of Botox for the preventative treatment of headaches, which was approved by the FDA on October 15 for use in adults with chronic migraines.

Genzyme taps C&W for pre-launch drug comms

Jaimy Lee August 10, 2010

CAMBRIDGE, MA: Genzyme hired Cohn & Wolfe to provide global pre-launch communications for alemtuzumab, a multiple sclerosis drug that received fast-track status from the Food and Drug Administration in June.

FDA closer to approving Botox for migraines

Jaimy Lee August 02, 2010

Allergan said in its second-quarter earnings statement the FDA had requested information about how the company could safely market Botox to treat migraines.

HRA Pharma works with BallouPR on emergency contraceptive

Jaimy Lee June 24, 2010

HRA Pharma is working with BallouPR on Ella, the emergency contraceptive currently under review by the Food and Drug Administration (FDA).

FDA warns dermatologist about promotion of antiwrinkle drug

Jaimy Lee February 02, 2010

The number of warnings regarding drug promotion has doubled since President Barack Obama came into office, according to a Reuters report.

J&J recall criticized for reacting too slowly to complaints

Erica Morris January 19, 2010

McNeil Consumer Healthcare, a division of Johnson & Johnson, announced a recall on January 15, of several hundred batches of medicine including Benadryl, Motrin, Rolaids, Simply Sleep, St. Joseph Aspirin and Tylenol.

Tylenol expands recall on arthritis drug

Erica Morris December 31, 2009

Johnson & Johnson has recalled all Tylenol Arthritis Pain Caplet 100-count bottles, an extension of an earlier five-lot recall in November.

Journalists demand that FDA media screening end

Jaimy Lee December 02, 2009

Several journalism organizations sent a letter to the Food and Drug Administration (FDA), asking that the federal agency end its policy that requires employees to get permission to do interviews with the media.

FDA hearings focus on need for guidelines

Jaimy Lee November 12, 2009

WASHINGTON: The pharmaceutical industry and healthcare communicators advocated for guidelines that would define the way they use the Web to communicate during the Food and Drug Administration (FDA)'s two-day social media hearings.

GSK issues statements to assure consumers about Alli

Jaimy Lee September 03, 2009

GlaxoSmithKline is seeking to reassure consumers through statements that its weight loss drug Alli is safe and effective, following news reports that the Food and Drug...

Healthcare communicators must steep themselves in social media

June 08, 2009

During the Clinton Administration, the main piece of reform on the table was in healthcare. Multiple plans were introduced with various methods of payment...

FDA warns Cheerios about health claims

Jaimy Lee May 12, 2009

The Food and Drug Administration (FDA) has turned its eye to Cheerios' claim that the cereal is clinically proven to lower cholesterol.

The government...

NYT looks at drug ad confusion among marketers

Jaimy Lee April 17, 2009

The New York Times spoke with drug makers, a consumer watchdog group, the FDA, and Google about how a lack of specified rules...

Health groups form FDA Commissioner Coalition

Jaimy Lee December 18, 2008

Health groups, some supported by pharmaceutical companies, are voicing concerns about the appointment of the next FDA commissioner.

The FDA Commissioner Coalition