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Cubist enters license agreement with Teva to dismiss CUBICIN patent lawsuit

Cubist Pharmaceuticals, Inc. today announced that it has entered into a license agreement with Teva Parenteral Medicines, Inc., Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd., which includes a stipulation by the parties requesting dismissal of the lawsuit filed by Cubist in the U.S. District Court for the District of Delaware relating to the Abbreviated New Drug Application filed by TPM with the U.S. Food and Drug Administration for a generic version of CUBICIN.

5 Apr 2011

Pfizer receives FDA Refusal to File letter for tafamidis to treat Transthyretin Familial Amyloid Polyneuropathy

Pfizer Inc. announced today that it has received a Refusal to File letter from the United States Food and Drug Administration (FDA) for tafamidis, the company's novel, oral investigational compound for patients with Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP).

4 Apr 2011

Mylan receives FDA approval for generic Xalatan Ophthalmic Solution

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Latanoprost Ophthalmic Solution, 0.005%, the generic version of Pharmacia and Upjohn's Xalatan® Ophthalmic Solution, an eyedrop that lowers pressure in the eye.

4 Apr 2011

Oncothyreon's ONT-10, PX-866 preclinical data presented at AACR meeting

Oncothyreon Inc. today announced the presentation of preclinical data for ONT-10, a therapeutic vaccine directed at cancers expressing MUC1, and PX-866, its irreversible inhibitor of phosphatidylinositol 3-kinase, at the American Association of Cancer Research meeting in Orlando, Florida.

4 Apr 2011

Leukemia & Lymphoma publishes CTI's CPOP phase I/II trial results against NHL

Cell Therapeutics, Inc. announced today that the April 2011 edition of the peer reviewed journal, Leukemia & Lymphoma published results of a phase I/II clinical trial evaluating the effect of cyclophosphamide, pixantrone, vincristine, and prednisone in treating patients with aggressive non-Hodgkin's lymphoma who relapsed following initial therapy with cyclophosphamide, doxorubicin, vincristine, and prednisone.

4 Apr 2011

Biota receives US$231 million BARDA contract to advance laninamivir development

Biota Holdings Limited advises that the Office of Biomedical Advanced Research and Development Authority within the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services has awarded up to an estimated US$231 million contract to its wholly owned subsidiary, Biota Scientific Management Pty Ltd, for the advanced development of laninamivir.

1 Apr 2011

Vertex announces final results from Phase 3 REALIZE study against HCV

Vertex Pharmaceuticals Incorporated today announced final results from its pivotal Phase 3 REALIZE study that evaluated people with genotype 1 chronic hepatitis C whose prior treatment with pegylated-interferon and ribavirin was unsuccessful either because they relapsed, had a partial response or had a null response.

1 Apr 2011

Watson, GeneraMedix receive FDA approval for Nulecit to treat iron deficiency anemia

Watson Pharmaceuticals, Inc. today announced that it is initiating launch activities of Nulecit, following FDA approval of GeneraMedix Inc.'s, Abbreviated New Drug Application.

1 Apr 2011

FDA grants Nile Fast Track designation for cenderitide post-acute development program

Nile Therapeutics, Inc., a biopharmaceutical company that develops novel therapeutics for heart failure patients, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Nile's post-acute development program for cenderitide, which has the goal of reducing cardiovascular mortality and cardiovascular re-hospitalization in the post-acute period in patients with acute decompensated heart failure.

31 Mar 2011

Vertex announces interim results from VX-222 ongoing Phase 2 study against hepatitis C

Vertex Pharmaceuticals Incorporated today announced interim results from an ongoing Phase 2 study designed to assess the safety and tolerability of 12-week response-guided treatment regimens with its polymerase inhibitor, VX-222, and its protease inhibitor, telaprevir, in combination with pegylated-interferon and ribavirin in people with genotype 1 chronic hepatitis C who were new to treatment.

31 Mar 2011

Pacira reports net loss of $7.0 million for quarter ended December 31, 2010

Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, today announced financial results for the fourth quarter and full-year ended December 31, 2010, provided an update on the execution of its pre-commercial and launch strategies for EXPAREL and established 2011 financial guidance.

31 Mar 2011

NEJM publishes MSD's VICTRELIS two pivotal Phase III studies against HCV

MSD, known as Merck in the United States and Canada, announced today that final results from the two pivotal Phase III studies of VICTRELIS, its investigational oral hepatitis C protease inhibitor, will be published in the March 31st edition of The New England Journal of Medicine.

31 Mar 2011

EC grants marketing authorization for GSK, Valeant's Trobalt to treat epilepsy

GlaxoSmithKline and Valeant Pharmaceuticals International, Inc. announced today that the European Commission has granted marketing authorisation for Trobalt as an adjunctive treatment of partial onset seizures, with or without secondary generalisation in adults aged 18 years and above with epilepsy.

30 Mar 2011

SCOLR Pharma total revenue decreases 34% to $618,000 for 2010

SCOLR Pharma, Inc. today reported financial results for the twelve months ended December 31, 2010, and also provided updates on a number of key corporate objectives.

30 Mar 2011

Onyx plans to expand carfilzomib Phase 3 European trial in patients with myeloma

Onyx Pharmaceuticals, Inc. today announced its plans to expand the Phase 3 European clinical trial FOCUS, which is evaluating the efficacy and tolerability of carfilzomib, a selective next-generation proteasome inhibitor.

29 Mar 2011

Cephalon intends to make takeover bid for ChemGenex

Cephalon, Inc. and ChemGenex Pharmaceuticals Limited today jointly announced that Cephalon's wholly-owned subsidiary, Cephalon CXS Holdings Pty Ltd, intends to make a takeover bid for ChemGenex.

29 Mar 2011

MolecularMD and ARIAD collaborate to develop and commercialize CML, ALL diagnostic test

ARIAD Pharmaceuticals, Inc. and MolecularMD Corporation today announced an exclusive collaboration agreement in which MolecularMD will develop and commercialize a companion diagnostic test to identify the T315I mutation of the BCR-ABL gene in patients with chronic myeloid leukemia and Philadelphia positive acute lymphoblastic leukemia.

28 Mar 2011

A.P. Pharma fourth quarter revenue decreases to $1.6 million

A.P. Pharma, Inc., a specialty pharmaceutical company, today reported financial results for its fourth quarter and full year ended December 31, 2010 and provided a corporate update.

28 Mar 2011

U.S. District Court rules in favor of Watson in generic SEASONIQUE patent infringement suit

Watson Pharmaceuticals, Inc., a leading integrated global pharmaceutical company, today confirmed that it has received a favorable decision from the U.S. Court of Appeals for the Federal Circuit related to its ongoing patent challenge in connection with Watson's Abbreviated New Drug Application seeking FDA approval to market a generic version of Teva Women's Health, Inc.'s SEASONIQUE and ethinyl estradiol.

28 Mar 2011

Isotechnika fourth quarter consolidated net loss increases to $2.42 million

Isotechnika Pharma Inc. has released its financial results for the fourth quarter and year ended December 31, 2010 and provided a review of the Company's operational and financial progress for 2010 and to the current date.

25 Mar 2011

New Drug Application News and Research

Cubist enters license agreement with Teva to dismiss CUBICIN patent lawsuit

Pfizer receives FDA Refusal to File letter for tafamidis to treat Transthyretin Familial Amyloid Polyneuropathy

Mylan receives FDA approval for generic Xalatan Ophthalmic Solution

Oncothyreon's ONT-10, PX-866 preclinical data presented at AACR meeting

Leukemia & Lymphoma publishes CTI's CPOP phase I/II trial results against NHL

Biota receives US$231 million BARDA contract to advance laninamivir development

Vertex announces final results from Phase 3 REALIZE study against HCV

Watson, GeneraMedix receive FDA approval for Nulecit to treat iron deficiency anemia

FDA grants Nile Fast Track designation for cenderitide post-acute development program

Vertex announces interim results from VX-222 ongoing Phase 2 study against hepatitis C

Pacira reports net loss of $7.0 million for quarter ended December 31, 2010

NEJM publishes MSD's VICTRELIS two pivotal Phase III studies against HCV

EC grants marketing authorization for GSK, Valeant's Trobalt to treat epilepsy

SCOLR Pharma total revenue decreases 34% to $618,000 for 2010

Onyx plans to expand carfilzomib Phase 3 European trial in patients with myeloma

Cephalon intends to make takeover bid for ChemGenex

MolecularMD and ARIAD collaborate to develop and commercialize CML, ALL diagnostic test

A.P. Pharma fourth quarter revenue decreases to $1.6 million

U.S. District Court rules in favor of Watson in generic SEASONIQUE patent infringement suit

Isotechnika fourth quarter consolidated net loss increases to $2.42 million

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