United States

Amgen provides testimony to FDA stakeholder hearing on biosimilars

Monday, May 14, 2012 01:40 PM

Joseph P. Miletich, M.D., Ph.D., senior vice president of R&D at Amgen, submitted testimony to the FDA stakeholder hearing on biosimilars, urging members of the FDA panel charged with implementing a pathway for biosimilars to establish approval standards that advance patient safety and promote confidence in biosimilars marketed in the U.S.

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invivodata consults on ClinRO instrument for UCB

Friday, May 11, 2012 12:19 PM

Pittsburgh, Penn.-based invivodata, a fully-integrated clinical outcomes assessments company, has been chosen to deliver regulatory consulting services for a phase III trial that UCB is conducting in the development of a unique biopharmaceutical product to treat Rheumatoid Arthritis (RA).

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FDA issues alert on potential dangers of unproven treatment for MS

Friday, May 11, 2012 11:54 AM

The FDA is alerting health care professionals and patients about injuries and death associated with the use of an experimental procedure sometimes called “liberation therapy” or the “liberation procedure” to treat chronic cerebrospinal venous insufficiency (CCSVI).

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Reed introduces bill to strengthen cancer research reporting requirements

Friday, May 4, 2012 03:23 PM

Congressman Tom Reed has introduced legislation in the U.S. House of Representatives which strengthens the enforcement mechanisms of the requirement to publicly report results of cancer trials and research conducted with federal grant money. The goal of the legislation is greater sharing of cancer research results in the search for a cure to cancer.

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NIH launches collaborative program to spur therapeutic development

Friday, May 4, 2012 08:02 AM

The National Institutes of Health (NIH) has unveiled a collaborative program, Discovering New Therapeutic Uses for Existing Molecules, that will match researchers with a selection of pharmaceutical industry compounds to help scientists explore new treatments for patients.

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Regulus Therapeutics appoints Bruce Carter to board of directors

Wednesday, May 2, 2012 04:38 PM

Regulus Therapeutics, a biopharmaceutical company focused on medicines targeting microRNAs, has appointed Bruce Carter, Ph.D., to its board of directors.

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UH Harrington launches grant program to accelerate drug discovery

Wednesday, May 2, 2012 04:28 PM

UH Harrington Discovery Institute has launched the Harrington Scholar-Innovator grant competition that serves as a nationwide search for physician-scientists seeking support to accelerate their promising drug discoveries into novel treatments for patients.

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Benchmark Research wins ViE Award for best clinical trial site

Tuesday, May 1, 2012 11:03 AM

Benchmark Research’s Austin, Texas location was recognized as Best Clinical Trial Site at the 2012 Vaccine Industry Excellence (ViE) Awards, held during the Annual World Vaccine Congress.

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FDA approves Stendra for ED

Monday, April 30, 2012 03:45 PM

The FDA has approved Stendra (avanafil) tablets for the treatment of erectile dysfunction (ED), marking the first new prescription agent approved in nearly a decade for the condition that afflicts as many as 30 million men in the U.S., according to biopharmaceutical company Vivus.

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Mannkind grants Tolero worldwide rights to BTK inhibitors

Monday, April 30, 2012 09:34 AM

Tolero Pharmaceuticals, a Salt Lake City, Utah-based company focused on cancer, has been granted exclusive worldwide rights to develop and commercialize compounds from Valencia, Calif.-based MannKind’s novel BTK (Bruton’s tyrosine kinase) program, which are currently being developed for the treatment of hematological malignancies and inflammatory diseases.

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