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Abbott submits SIMCOR sNDA for two new dosage strengths

Abbott has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for two new dosage strengths of SIMCOR®, a cholesterol medication. SIMCOR is a fixed-dose combination of niacin extended-release and simvastatin.

10 Dec 2009

Salix Pharmaceuticals discusses proposed rifaximin NDA with the FDA

Salix Pharmaceuticals, Ltd. today reported that the Company held a pre-NDA meeting on December 8, 2009 with the FDA to discuss the Company’s proposed new drug application (NDA) for rifaximin in the treatment of patients with non-constipation irritable bowel syndrome (non-C IBS).

10 Dec 2009

Fourth-quarter and full year fiscal 2009 results announced by Biodel

Biodel Inc. today reported financial results for the fourth quarter and fiscal year ended September 30, 2009.

10 Dec 2009

Perrigo files Abbreviated New Drug Application for Clobex Spray

Perrigo Company today announced that it has filed an Abbreviated New Drug Application for Clobetasol Propionate Topical Spray, 0.05%, a generic form of Clobex® Spray.

10 Dec 2009

Protalix Biotherapeutics completes NDA submission for taliglucerase alfa

Protalix Biotherapeutics, Inc. today announced the completion of its New Drug Application (NDA) submission with the U.S. Food and Drug Administration (FDA) for taliglucerase alfa, a plant-cell expressed form of glucocerebrosidase (GCD) for the potential treatment of Gaucher’s disease.

9 Dec 2009

Neoprobe completes Phase 3 Lymphoseek clinical trial on breast cancer patients

Neoprobe Corporation (OTCBB: NEOP), a diversified developer of innovative oncology surgical and diagnostic products, has completed a Phase 3 clinical trial of Lymphoseek® (NEO3-05) with positive results.

9 Dec 2009

$Phase 2 study of carfilzomib shows promising results in patients with refractory multiple myeloma$

Phase 2 study of carfilzomib shows promising results in patients with refractory multiple myeloma

Onyx Pharmaceuticals, Inc. today announced results from an ongoing Phase 2 study, known as the 004 study, of the company's lead proteasome inhibitor, carfilzomib.

8 Dec 2009

Novo Nordisk in-licenses intellectual property rights to IL-21 antibodies

Novo Nordisk A/S and ZymoGenetics, Inc. today announced an agreement where Novo Nordisk in-licenses a fully-human anti-IL21 monoclonal antibody (IL-21 mAb) developed by ZymoGenetics, as well as broad intellectual property rights covering IL-21 mAb and the development of other IL-21 antibodies.

From Novo Nordisk 8 Dec 2009

FDA provides a Complete Response Letter for Somaxon Pharmaceuticals' Silenor NDA

Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today announced that the company has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia.

7 Dec 2009

Encouraging data from Seattle Genetics' phase I trial of brentuximab vedotin

Seattle Genetics, Inc. today reported data from a phase I weekly-dosing clinical trial of brentuximab vedotin (SGN-35), an antibody-drug conjugate (ADC), including multiple complete and partial remissions in patients with relapsed or refractory Hodgkin lymphoma or systemic anaplastic large cell lymphoma (ALCL).

7 Dec 2009

Zogenix closes its $35M second tranche of Series B preferred stock financing

Zogenix, Inc., a privately held pharmaceutical company, announced today that it has closed a $35 million second tranche of a Series B preferred stock financing. The Series B round was increased from $51 million, previously announced in September, to $71 million. The additional $20 million investment was made by Chicago Growth Partners, which will now be represented on the Zogenix Board of Directors by Dr. Arda Minocherhomjee.

7 Dec 2009

ChemGenex Pharmaceuticals presents clinical results of Omapro drug at ASH meeting

ChemGenex Pharmaceuticals Limited (ASX:CXS) announced today updated clinical data showing that Omapro™ (omacetaxine mepesuccinate) produced durable hematologic and cytogenetic responses in chronic myeloid leukemia (CML) patients who have failed treatment with imatinib and who have developed the Bcr-Abl T315I mutation.

7 Dec 2009

Updated safety data from Phase 2b 003-A1 study of carfilzomib announced

Onyx Pharmaceuticals, Inc. today announced updated safety data from the pivotal Phase 2b 003-A1 study, known as the 003 trial, demonstrating that carfilzomib is well-tolerated in heavily pre-treated relapsed and refractory multiple myeloma patients.

7 Dec 2009

Positive final data from Phase 2 study of ISTODAX presented

Gloucester Pharmaceuticals announced today the presentation of positive final data from a Phase 2 study of ISTODAX® (romidepsin) in peripheral T-cell lymphoma (PTCL) conducted by the National Cancer Institute (NCI) at the 51st American Society of Hematology (ASH) Annual Meeting being held in New Orleans, LA.

6 Dec 2009

FDA approves Santarus’ NDA for immediate-release prescription tablet product

Santarus, Inc., a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s New Drug Application (NDA) for immediate-release omeprazole/sodium bicarbonate/ magnesium hydroxide tablets in 40 mg and 20 mg dosage strengths of omeprazole.

5 Dec 2009

Watson Laboratories files an ANDA for generic version of Rozerem

Watson Pharmaceuticals, Inc., a leading global specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc.-Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market its 8mg ramelteon tablets prior to the expiration of a patent owned by Takeda Pharmaceutical Company Limited.

4 Dec 2009

FDA approves once-daily SEROQUEL XR Extended Release Tablets

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved once-daily SEROQUEL XR® (quetiapine fumarate) Extended Release Tablets as adjunctive (add-on) treatment to antidepressants in adults with Major Depressive Disorder (MDD).

4 Dec 2009

Alkermes licenses Medifusion technology to develop TNF receptor-Fc fusion protein

Alkermes, Inc. and Acceleron Pharma, Inc. today announced that Alkermes has licensed a proprietary long-acting Fc fusion technology platform, called the Medifusion™ technology, which is designed to extend the circulating half-life of proteins and peptides.

4 Dec 2009

Endo Pharmaceuticals receives FDA complete response letter for AVEED NDA

Endo Pharmaceuticals today announced that it received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for its extended-duration testosterone undecanoate injection, AVEED(TM), for men diagnosed with low testosterone.

3 Dec 2009

AstraZeneca and Targacept enter into agreement to develop and commercialize TC-5214

AstraZeneca and Targacept, Inc. today announced a collaboration and license agreement for the global development and commercialization of TC-5214, Targacept’s late-stage investigational product for major depressive disorder (MDD).

3 Dec 2009