Pro-Pharmaceuticals plans to submit Phase III trial design for DAVANAT to FDA

Pro-Pharmaceuticals plans to submit Phase III trial design for DAVANAT to FDA
Pro-Pharmaceuticals, Inc., the leading developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, today announced plans to submit a Phase III trial design for DAVANAT to the U.S. Food and Drug Administration during the second half of 2010. The Company has added the talent of Peter G. Traber, M.D., to its FDA approval strategy and trial design team.

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The World According to Monsanto part 1 of 10

Playlist: www.youtube.com On March 11 2008 a new documentary was aired on French television (ARTE French-German cultural tv channel) by French journalist and film maker Marie-Monique Robin, The World According to Monsanto A documentary that you wont see on American television. The gigantic biotech corporation Monsanto is threatening to destroy the agricultural biodiversity which has served mankind for thousands of years. The story starts in the White House, where Monsanto often got its way by exerting disproportionate influence over policymakers via the revolving door. One example is Michael Taylor, who worked for Monsanto as an attorney before being appointed as deputy commissioner of the US Food and Drug Administration (FDA) in 1991. While at the FDA, the authority that deals with all US food approvals, Taylor made crucial decisions that led to the approval of GE foods and crops. Then he returned to Monsanto, becoming the companys vice president for public policy. Thanks to these intimate links between Monsanto and government agencies, the US adopted GE foods and crops without proper testing, without consumer labeling and in spite of serious questions hanging over their safety. Not coincidentally, Monsanto supplies 90 percent of the GE seeds used by the US market. Monsantos long arm stretched so far that, in the early nineties, the US Food and Drugs Agency even ignored warnings of their own scientists, who were cautioning that GE crops could cause negative health …

JHP Pharmaceuticals Announces Successful Completion of FDA and EMEA GMP Audits

JHP Pharmaceuticals Announces Successful Completion of FDA and EMEA GMP Audits
PARSIPPANY, N.J., May 10 /PRNewswire/ — JHP Pharmaceuticals’ sterile manufacturing site based in Rochester, Michigan completed a successful GMP (Good Manufacturing Practices)/Pre Approval Audit by the U.S. Food and Drug Administration (FDA) drug division (CDER).

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FDA approves prostate cancer vaccine from Seattle company

FDA approves prostate cancer vaccine from Seattle company
The Food and Drug Administration says it has approved a drug by a Seattle biotech company that is designed to stimulate a patient’s immune system to fight prostate cancer.

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D-Pharm Receives Agreement Letter On Special Protocol Assessment For DP-b99 Study – A Pivotal Phase III Trial In Acute …

D-Pharm Receives Agreement Letter On Special Protocol Assessment For DP-b99 Study – A Pivotal Phase III Trial In Acute …
D-Pharm Ltd (DPRM: TASE) announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) procedure for a pivotal phase 3 trial (MACSI) of its neuroprotective agent DP-b99 in acute ischemic stroke patients. The SPA agreement letter indicates that “the design and planned analysis of the study adequately address the objectives …

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