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Pro-Pharmaceuticals announces financial results for the third quarter and first nine months of fiscal 2009

Pro-Pharmaceuticals, Inc., a developer of galectin-targeted, carbohydrate therapeutic compounds to treat cancer and fibrosis, today reported its financial results for the third quarter and first nine months of fiscal 2009. These results are included in the Company’s Quarterly Report on Form 10-Q for the three- and nine-month periods ended September 30, 2009, which has been filed with the SEC.

13 Nov 2009

Results from first-in-man study of NO-donating HMG-CoA Reductase Inhibitor released

NicOx S.A. today announced that a phase 1b, first-in-man study for NCX 6560, versus placebo and Lipitor® (atorvastatin), has met its primary and secondary objectives. The top-line results demonstrated very good safety and tolerability for all the tested doses of NCX 6560, as well as the expected cholesterol lowering profile.

13 Nov 2009

Transcept Pharmaceuticals reports financial results for the third quarter of 2009

Transcept Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in neuroscience, today announced financial results for the three and nine months ended September 30, 2009.

13 Nov 2009

Cequent Pharmaceuticals proposes the first test of an orally administered RNA interference drug in humans

Cequent Pharmaceuticals, a pioneer in the development of novel products to deliver RNAi-based treatments to prevent and treat human disease, has announced that it has filed its first IND (investigational new drug) application with the U.S. Food and Drug Administration (FDA).

12 Nov 2009

Third-quarter 2009 results announced by Neurologix

Neurologix, Inc., a biotechnology company engaged in the development of innovative gene therapies for the brain and central nervous system, announced today its financial results for the third quarter and nine months ended September 30, 2009.

12 Nov 2009

FDA accepts Sol-Gel’s Investigational New Drug Application for DER45-EV Gel

Sol-Gel Technologies announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of Sol-Gel’s Investigational New Drug Application (IND) for DER45-EV Gel for the topical treatment of rosacea. This IND allows Sol-Gel to initiate Phase II studies with DER45-EV Gel in rosacea patients.

11 Nov 2009

Mylan subsidiary receives FDA approval for its Lansoprazole DR Capsules ANDA

Mylan Inc. today announced that its privately held Indian subsidiary, Matrix Laboratories Limited, has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Lansoprazole Delayed-release (DR) Capsules, 15 mg and 30 mg. This product is shipping immediately and will be sold under the Mylan Pharmaceuticals brand.

11 Nov 2009

Teva Pharmaceutical's generic lansoprazole does not infringe patent No. 5,464,632: U.S. Court

Teva Pharmaceutical Industries Ltd. announced today that the U.S. District Court for the District of Delaware has issued a decision in its litigation over the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Takeda Pharmaceuticals North America, Inc.'s Prevacid® (Lansoprazole) SoluTab.

10 Nov 2009

EpiCept announces third quarter 2009 financial results

EpiCept Corporation today announced operating and financial results for the three and nine months ended September 30, 2009, and provided an update on Ceplene® and several of the Company’s key product candidates.

10 Nov 2009

FDA accepts ChemGenex Pharmaceuticals' NDA for Omapro

ChemGenex Pharmaceuticals Limited announced today that the U.S. Food & Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for Omapro™ (omacetaxine mepesuccinate) for the treatment of patients with chronic myeloid leukemia (CML) who have failed treatment with imatinib and who have developed the Bcr-Abl T315I mutation.

10 Nov 2009

Clinical Data announces financial results for its second fiscal quarter ended September 30, 2009

Clinical Data, Inc. today announced the Company’s operational and financial results for its second fiscal quarter ended September 30, 2009.

9 Nov 2009

GTx reports financial results for the third quarter of 2009

GTx, Inc. today reported financial results for the third quarter of 2009. The net loss for the third quarter and nine months ended September 30, 2009 was $12.8 million and $35.4 million, respectively, compared with a net loss of $11.9 million and $37.9 million for the same periods in 2008. At September 30, 2009 GTx had cash, cash equivalents and short-term investments of $55.5 million.

9 Nov 2009

Health Canada accepts for review the EpiCept’s New Drug Submission for Ceplene

EpiCept Corporation today announced that Health Canada has accepted for review the Company’s New Drug Submission (NDS) for Ceplene® (histamine dihydrochloride) for the remission maintenance of acute myeloid leukemia (AML) patients in first complete remission.

9 Nov 2009

FDA extends review date of New Drug Application for GSK1838262/XP13512

GlaxoSmithKline and XenoPort, Inc. (Nasdaq: XNPT) today announced that the U.S. Food and Drug Administration (FDA) has extended the original Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) for GSK1838262/XP13512 (gabapentin enacarbil) to February 9, 2010. The original PDUFA date for this NDA review was November 9, 2009.

7 Nov 2009

Positive interim data from the multicenter randomized Phase II trial of palifosfamide presented

ZIOPHARM Oncology, Inc. presented today at the 15th Annual Connective Tissue Oncology Society (CTOS) Meeting, positive interim data from the multicenter randomized Phase II trial of palifosfamide (ZymafosTM, ZIO-201) treating patients with unresectable or metastatic soft tissue sarcoma.

6 Nov 2009

Third-quarter 2009 financial results announced by Inhibitex

Inhibitex, Inc., today announced its financial results for the third quarter ended September 30, 2009. The Company held cash, cash equivalents and short-term investments of $21.1 million at September 30, 2009, as compared to $33.1 million at December 31, 2008.

6 Nov 2009

Cadence Pharmaceuticals reports net loss of $11.4 million for three months ended September 30, 2009

Cadence Pharmaceuticals, Inc., a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting, today reported financial results for the three and nine months ended September 30, 2009.

5 Nov 2009

FDA approves the New Drug Application for Pennsaid Topical Solution

Covidien, a leading global provider of healthcare products, and Nuvo Research Inc., a Canadian drug development company, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for Pennsaid(R) Topical Solution (diclofenac sodium topical solution) 1.5% w/w.

5 Nov 2009

Pennsaid Topical Solution approved by FDA

Covidien, a leading global provider of healthcare products, and Nuvo Research Inc. (TSX:NRI), a Canadian drug development company, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for Pennsaid® Topical Solution (diclofenac sodium topical solution) 1.5% w/w.

5 Nov 2009

Cell Therapeutics reports financial results for the third quarter and nine months ended September 30, 2009

Cell Therapeutics, Inc. today reported recent achievements and financial results for the third quarter and nine months ended September 30, 2009, which included a 45% decrease in the net loss attributable to common shareholders for the nine month period in 2009 compared to the same period in 2008.

5 Nov 2009

New Drug Application News and Research

Pro-Pharmaceuticals announces financial results for the third quarter and first nine months of fiscal 2009

Results from first-in-man study of NO-donating HMG-CoA Reductase Inhibitor released

Transcept Pharmaceuticals reports financial results for the third quarter of 2009

Cequent Pharmaceuticals proposes the first test of an orally administered RNA interference drug in humans

Third-quarter 2009 results announced by Neurologix

FDA accepts Sol-Gel’s Investigational New Drug Application for DER45-EV Gel

Mylan subsidiary receives FDA approval for its Lansoprazole DR Capsules ANDA

Teva Pharmaceutical's generic lansoprazole does not infringe patent No. 5,464,632: U.S. Court

EpiCept announces third quarter 2009 financial results

FDA accepts ChemGenex Pharmaceuticals' NDA for Omapro

Clinical Data announces financial results for its second fiscal quarter ended September 30, 2009

GTx reports financial results for the third quarter of 2009

Health Canada accepts for review the EpiCept’s New Drug Submission for Ceplene

FDA extends review date of New Drug Application for GSK1838262/XP13512

Positive interim data from the multicenter randomized Phase II trial of palifosfamide presented

Third-quarter 2009 financial results announced by Inhibitex

Cadence Pharmaceuticals reports net loss of $11.4 million for three months ended September 30, 2009

FDA approves the New Drug Application for Pennsaid Topical Solution

Pennsaid Topical Solution approved by FDA

Cell Therapeutics reports financial results for the third quarter and nine months ended September 30, 2009

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