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PolyMedix completes public offering of units for aggregate gross proceeds of $20.7 million

18. November 2009 01:51
PolyMedix Inc. (http://polymedix.com), an emerging biotechnology company developing acute care therapeutic drug products for infectious diseases and cardiovascular disorders, announced today that it has completed a public offering of units for aggregate gross proceeds of $20.7 million. [More]

Posted in: Business / Finance

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Report on the export of Chinese chemical active pharmaceutical ingredients from 2004 to 2009

13. November 2009 05:11
Research and Markets has announced the addition of the "Research Report on Chinese Chemical Active Pharmaceutical Ingredients (API) Export, 2004-2009" report to their offering. [More]

Posted in: Pharmaceutical News

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Study suggests a new improved treatment option for children with Hurler's syndrome

10. November 2009 04:07
Researchers have transplanted genetically modified hematopoietic stem cells into mice so that their developing red blood cells produce a critical lysosomal enzyme - preventing or reducing organ and central nervous system damage from the often-fatal genetic disorder Hurler's syndrome. [More]

GTC Biotherapeutics announces financial results for third quarter 2009

6. November 2009 23:49
GTC Biotherapeutics, Inc.’s total net loss for the third quarter ended September 27, 2009 was $5.1 million, or $0.48 per share, compared with $6.1 million, or $0.59 per share, in the third quarter of 2008. The total net loss for the first nine months of 2009 was $26.2 million, or $2.51 per share, compared to $16.5 million, or $1.71 per share, for the first nine months of 2008. [More]

Posted in: Business / Finance

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Fresenius Medical Care reports financial results for the third quarter and first nine months of 2009

3. November 2009 06:49
Fresenius Medical Care AG & Co. KGaA, the world’s largest provider of dialysis products and services, today announced its results for the third quarter and first nine months of 2009. [More]

Posted in: Business / Finance

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sanofi-aventis reports financial results for the third quarter of 2009

30. October 2009 08:59
In the third quarter of 2009, sanofi-aventis generated net sales of euro 7,400 million, up 8.0% on a reported basis. Exchange rate movements had a favorable effect of 2.0 percentage points, with the appreciation of the U.S. dollar (and to a lesser extent the yen) against the euro more than offsetting the unfavorable effects of some other currencies. [More]

PolyMedix completes second successful clinical study of PMX-60056

27. October 2009 08:10
PolyMedix, Inc. (http://polymedix.com), an emerging biotechnology company developing new therapeutic drug products to treat infectious diseases and acute cardiovascular disorders, has completed a second successful clinical study of its anticoagulant reversing agent, PMX-60056. [More]

CHMP grants positive opinion to extend the use of Angiox to patients undergoing PCI

24. October 2009 04:05
The Medicines Company announced today that the Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion applicable to all Member States of the European Union/European Economic Area that will extend the use of Angiox (bivalirudin) to include patients with heart attacks (so-called ST segment elevation myocardial infarction (STEMI)) undergoing emergency heart procedures called primary percutaneous coronary intervention (PCI). [More]

Posted in: Drug Trial News | Pharmaceutical News

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U.S. Pharmacopeial fellowships awarded to 6 students

21. October 2009 05:11
New research focused on the quality of key medicines and their use as well as increasingly popular botanicals is being sponsored by the U.S. Pharmacopeial (USP) Convention under its 2009� Fellowship Program. [More]

Posted in: Medical Research News | Miscellaneous News

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FDA grants marketing approval for Elitek

19. October 2009 03:44
Sanofi-aventis U.S. announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Elitek (rasburicase) to be used for the initial management of plasma uric acid (PUA) levels in adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis syndrome (TLS) and subsequent elevations of plasma uric acid. [More]

Contaminated pre-filled heparin and saline syringes cause bloodstream infections

13. October 2009 02:29
An outbreak of bloodstream infections appears to have been caused by the contamination of pre-filled heparin and saline syringes made by a single company, according to a report in the October 12 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. The subsequent investigation revealed that the company was not in compliance with safety regulations and identified challenges and areas for improvement in medication monitoring systems. [More]

Posted in: Device / Technology News | Pharmaceutical News

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Second round of revised quality standards for blood thinner heparin released

5. October 2009 04:12
Further helping to secure public health, a second round of revised quality standards for the widely used blood thinner heparin became effective today, the U.S. Pharmacopeial (USP) Convention announced. Working closely with the Food and Drug Administration (FDA), the pharmaceutical industry, and other regulatory and scientific bodies, USP started initial revisions in 2008 after adverse reactions and deaths resulted from heparin intentionally adulterated with over-sulfated chondroitin sulfate (OSCS). [More]

Posted in: Pharmaceutical News

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APP Pharmaceutical continues support of FDA's USP standards for unfractionated heparin

3. October 2009 09:41
APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ:APCVZ), and the leading supplier of heparin sodium to the U.S. market, announced today its continued support of the US Food & Drug Administration (FDA) and medical community for the October 1, 2009 implementation of the new United States Pharmacopeia (USP) monograph change for unfractionated heparin. [More]

Posted in: Pharmaceutical News

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Change in Heparin manufacturing - expected to decrease the potency

1. October 2009 20:20
The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common blood-clotting drug. [More]

Posted in: Pharmaceutical News

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Polymedix commences Phase 1B study of novel anticoagulant reversing agent

30. September 2009 05:36
PolyMedix, Inc., an emerging biotechnology company developing new therapeutic drug products to treat infectious diseases and acute cardiovascular disorders based on biomimetics, has initiated dosing and commenced a second clinical trial, a Phase 1B pilot proof of concept study, in the U.S. with its anticoagulant reversing agent PMX-60056 under an Investigational New Drug application (IND) filed with the U.S. Food and Drug Administration (FDA). [More]

Posted in: Drug Trial News

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