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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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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Akorn, Inc. Announces FDA Approval For Hydromorphone Hydrochloride Injection 10mg/ml In 1ml, 5ml And 50ml Doses

Akorn, Inc. Announces FDA Approval For Hydromorphone Hydrochloride Injection 10mg/ml In 1ml, 5ml And 50ml Doses
Akorn, Inc. (NASDAQ: AKRX) a niche generic pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has granted approval of the Company’s Abbreviated New Drug Application (ANDA) for the generic version of Dilaudid-HP® 10mg/ml Injection. The company intends to begin shipping the product next month. In addition, the Company has commenced the manufacturing of Vancomycin …

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