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Watson Pharmaceuticals obtains FTC approval to acquire Arrow Group

Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that the Federal Trade Commission (FTC) has accepted a proposed consent order for public comment relating to Watson's pending acquisition of privately held Arrow Group and has granted early termination of the Hart Scott Rodino waiting period, thereby permitting the parties to close the transaction.

3 Dec 2009

Cephalon's lawsuit against Teva Pharmaceuticals for patent infringement of NUVIGIL tablets

Cephalon, Inc. today announced that it has filed a lawsuit in U.S. District Court in Delaware against Teva Pharmaceuticals USA, Inc. for infringement of U.S. Patent Nos. 7,132,570 (the "'570 Patent"), 7,297,346 (the "'346 Patent") and RE37,516 (the "'516 Patent") for the Cephalon product NUVIGIL® (armodafinil) Tablets [C-IV].

3 Dec 2009

FDA grants Fast Track designation for Keryx Biopharmaceuticals' KRX-0401

Keryx Biopharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits the phosphoinositide 3-kinase (PI3K)/Akt pathway, for the treatment of relapsed/refractory multiple myeloma.

3 Dec 2009

Javelin Pharmaceuticals submits an NDA for Dyloject Injection

Javelin Pharmaceuticals, Inc., a leading developer and marketer of specialty pharmaceutical products for pain management, today announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its investigational product candidate, Dyloject™ (diclofenac sodium) Injection, for the management of acute moderate-to-severe pain in adults.

2 Dec 2009

Sepracor to present clinical study data of STEDESA at the 2009 AES meeting

Sepracor Inc. today announced that clinical study data for STEDESA™ (eslicarbazepine acetate) will be presented at the 2009 annual meeting of the American Epilepsy Society (AES) in Boston. Seven posters describing new safety analyses will be presented at the Hynes Convention Center during the formal poster session on Saturday, December 5, 2009 between 1:00 pm and 8:00 pm EST.

2 Dec 2009

FDA approves Schering-Plough's New Drug Application for ZEGERID OTC capsules

Santarus, Inc., a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Schering-Plough HealthCare Products, Inc.’s, New Drug Application (NDA) for ZEGERID OTC™ Capsules (omeprazole/sodium bicarbonate) with a dosage strength of 20 mg of omeprazole for over-the-counter (OTC) treatment of frequent heartburn.

2 Dec 2009

J&JPRD submits an NDA for tapentadol ER tablets

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tapentadol extended release (ER) tablets, an investigational oral analgesic for the management of moderate to severe chronic pain in patients 18 years of age or older.

2 Dec 2009

Pfizer, Protalix team up to develop and market plant-based enzyme for Gaucher’s disease treatment

Pfizer and Protalix (NYSE-Amex: PLX) today announced that they have entered into an agreement to develop and commercialize taliglucerase alfa, a plant-cell expressed form of glucocerebrosidase (GCD) in development for the potential treatment of Gaucher’s disease.

1 Dec 2009

Refuse to file letter on NDA for Cladribine Tablets issued to EMD Serono

EMD Serono, an affiliate of Merck KGaA, Darmstadt, Germany, announced today that it received a refuse to file letter from the US Food and Drug Administration (FDA) on the New Drug Application (NDA) for Cladribine Tablets, EMD Serono's proprietary investigational oral formulation of cladribine, as a therapy for relapsing forms of multiple sclerosis (MS).

1 Dec 2009

ChemGenex Pharmaceuticals to present updated clinical data from its clinical trials with Omapro

ChemGenex Pharmaceuticals Limited announced today that updated clinical data from several of its clinical trials with Omapro™ (omacetaxine mepesuccinate) will be presented at the upcoming 51st American Society of Hematology Annual Meeting in New Orleans, Louisiana.

1 Dec 2009

GLUMETZA patent infringement lawsuit against Lupin

Depomed, Inc. today announced that it has filed a lawsuit in the United States District Court for the Northern District of California against Lupin Limited and its wholly-owned subsidiary, Lupin Pharmaceuticals, Inc., for infringement of the patents listed in the Orange Book for GLUMETZA® (metformin hydrochloride extended release tablets).

30 Nov 2009

QRxPharma commences Phase 3 pivotal trial of MoxDuo IR

QRxPharma Limited announced today, as part of its Phase 3 program, the initiation of a registration (also called pivotal) trial (Study 008) comparing efficacy and safety profiles of MoxDuo(TM)IR against component doses of morphine and oxycodone alone for the management of moderate to severe post-operative pain following bunionectomy surgery. The Company expects to complete dosing by close of Q2 2010.

30 Nov 2009

Spectrum Pharmaceuticals completes enrollment in apaziquone Phase 3 trial

Spectrum Pharmaceuticals today announced that one of the two Phase 3 pivotal clinical trials of apaziquone has achieved its enrollment target, having enrolled approximately 800 patients with non-invasive bladder cancer. The second Phase 3 clinical trial of apaziquone is expected to complete enrollment by the end of the year.

30 Nov 2009

EMEA determines MAA for omacetaxine mepesuccinate for treatment of CML patients

ChemGenex Pharmaceuticals Limited announced today that the European Medicines Agency ("EMEA") has determined that the Marketing Authorization Application ("MAA") for omacetaxine mepesuccinate for the treatment of chronic myeloid leukemia (CML) patients who have failed treatment with imatinib and who have developed the Bcr-Abl T315I mutation is valid.

28 Nov 2009

Novartis to terminate its research collaboration agreement with Idera Pharmaceuticals

Idera Pharmaceuticals, Inc., today announced that Novartis will terminate its research collaboration agreement with the Company, effective as of February 21, 2010.

25 Nov 2009

Eisai's NDA for Aricept tablets for treatment of Alzheimer's disease accepted for review

Eisai Inc. and Pfizer Inc announced today that the U.S. Food and Drug Administration (FDA) has accepted for review Eisai's New Drug Application (NDA) for once daily 23 mg Aricept® (donepezil HCl extended release) tablets for the treatment of moderate to severe Alzheimer's disease (AD).

25 Nov 2009

Shanghai Biolaxy receives IND approval for insulin formulation to treat diabetes

Shanghai Biolaxy announced the Chinese State Food & Drug Administration (SFDA) has approved the investigational new drug application (IND) for its oral insulin project (Nodlin), an innovative insulin formulation to treat diabetes. This IND approval allows Biolaxy to initiate its first phase I clinical study.

24 Nov 2009

First-quarter fiscal 2010 results announced by China Aoxing Pharmaceutical

China Aoxing Pharmaceutical Company, Inc., a China-based pharmaceutical company specializing in research, development, manufacturing and distribution of narcotic and pain-management products, today announced financial and operational results for the three month ended September 30, 2009, or the first quarter of fiscal year 2010.

24 Nov 2009

Transcept Pharmaceuticals to discuss the Complete Response Letter for Intermezzo NDA

Transcept Pharmaceuticals, Inc. today announced that it is scheduled to meet with the U.S. Food and Drug Administration (FDA) on January 20, 2010 to discuss the Complete Response Letter regarding the New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet). As previously announced, the Complete Response Letter, received by Transcept on October 28, 2009, indicated that the FDA could not approve the NDA in its present form.

24 Nov 2009

Neuromed discusses Exalgo NDA application with the FDA

Covidien today announced that on November 13, 2009, representatives of Neuromed discussed the pending New Drug Application (NDA) for the product candidate ExalgoTM (hydromorphone HCl extended release) tablets with staff from the United States Food and Drug Administration (FDA). Mallinckrodt Inc., a Covidien company, obtained the commercial rights to Exalgo in the United States from Neuromed Development Inc., a subsidiary of Neuromed Pharmaceuticals Ltd., in June 2009.

24 Nov 2009

New Drug Application News and Research

Watson Pharmaceuticals obtains FTC approval to acquire Arrow Group

Cephalon's lawsuit against Teva Pharmaceuticals for patent infringement of NUVIGIL tablets

FDA grants Fast Track designation for Keryx Biopharmaceuticals' KRX-0401

Javelin Pharmaceuticals submits an NDA for Dyloject Injection

Sepracor to present clinical study data of STEDESA at the 2009 AES meeting

FDA approves Schering-Plough's New Drug Application for ZEGERID OTC capsules

J&JPRD submits an NDA for tapentadol ER tablets

Pfizer, Protalix team up to develop and market plant-based enzyme for Gaucher’s disease treatment

Refuse to file letter on NDA for Cladribine Tablets issued to EMD Serono

ChemGenex Pharmaceuticals to present updated clinical data from its clinical trials with Omapro

GLUMETZA patent infringement lawsuit against Lupin

QRxPharma commences Phase 3 pivotal trial of MoxDuo IR

Spectrum Pharmaceuticals completes enrollment in apaziquone Phase 3 trial

EMEA determines MAA for omacetaxine mepesuccinate for treatment of CML patients

Novartis to terminate its research collaboration agreement with Idera Pharmaceuticals

Eisai's NDA for Aricept tablets for treatment of Alzheimer's disease accepted for review

Shanghai Biolaxy receives IND approval for insulin formulation to treat diabetes

First-quarter fiscal 2010 results announced by China Aoxing Pharmaceutical

Transcept Pharmaceuticals to discuss the Complete Response Letter for Intermezzo NDA

Neuromed discusses Exalgo NDA application with the FDA

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