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USPTO awards Transcept Pharmaceuticals patent covering Intermezzo's composition and usage method

Transcept Pharmaceuticals, Inc. today announced that the first patent covering the composition and method of use of Intermezzo® (zolpidem tartrate sublingual tablet), the lead Transcept product candidate, has been issued by the United States Patent and Trademark Office.

10 Feb 2010

Third-quarter fiscal 2010 results announced by Clinical Data

Clinical Data, Inc. (NASDAQ: CLDA) today announced the Company’s operational and financial results for its third fiscal quarter ended December 31, 2009, confirming its plans to submit a new drug application (NDA) for vilazodone for the treatment of depression this quarter.

9 Feb 2010

Cell Therapeutics' pixantrone NDA: FDA postpones ODAC meeting due to severe weather conditions

Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that the United States Food and Drug Administration informed CTI that due to severe weather conditions in the Washington, D.C. area, the FDA is postponing the Oncologic Drugs Advisory Committee ("ODAC") meeting that was to be held on Wednesday, February 10, 2010 to discuss the pixantrone New Drug Application ("NDA"). The FDA indicated that it intends to reschedule the meeting as soon as the FDA can determine a schedule that will allow them to reconvene the advisory panel.

9 Feb 2010

FDA accepts Psyadon Pharmaceuticals' ecopipam IND for treatment of LND

Psyadon Pharmaceuticals, Inc. today announced that the United States Food and Drug Administration (FDA) has accepted its Investigational New Drug Application (IND) to study ecopipam in patients with Lesch-Nyhan Disease (LND). The first center at which the drug will be evaluated is Emory University under the direction of Dr. Hyder A. Jinnah, MD, PhD. The study is designed to evaluate the safety and tolerability of different doses of ecopipam in adults (group 1), adolescents (group 2) and children (group 3) with LND.

9 Feb 2010

GeoVax Labs provides updates on HIV-1 vaccine trials

GeoVax Labs, Inc., an Atlanta-based, biopharmaceutical company developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents, today provided an update on its vaccine trials progress.

9 Feb 2010

AMRI announces fourth-quarter and full-year 2009 results

AMRI today reported financial and operating results for the fourth quarter and full year ending December 31, 2009.

8 Feb 2010

Strativa Pharmaceuticals' Zuplenz NDA: FDA issues complete response letter

Strativa Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the new drug application (NDA) for Zuplenz® (ondansetron) oral soluble film for the prevention of nausea and vomiting associated with highly- and moderately-emetogenic chemotherapy, radiotherapy and surgery.

6 Feb 2010

Mylan first to file ANDA patent for Caduet Tablets

Mylan Inc. today confirmed that it was sued by Pfizer in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Amlodipine Besylate and Atorvastatin Calcium Tablets 2.5/10 mg, 2.5/20 mg, 2.5/40 mg, 5/10 mg, 5/20 mg, 5/40 mg, 5/80 mg, 10/10 mg, 10/20 mg, 10/40 and 10/80 mg.

5 Feb 2010

Top-line results from Optimer Pharmaceuticals' second fidaxomicin Phase 3 trial in CDI patients

Optimer Pharmaceuticals, Inc. today announced positive top-line results from the second of two pivotal Phase 3 trials evaluating the safety and efficacy of fidaxomicin (OPT-80) in patients with Clostridium difficile Infection (CDI). This study was conducted in approximately 100 clinical sites throughout North America and Europe. The Company plans to use data from this study to support submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2010.

5 Feb 2010

Lux Biosciences seeks US and European marketing approval for LUVENIQ

Lux Biosciences, Inc. today announced its submission of simultaneous regulatory filings to both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking marketing approval for its investigational drug LUVENIQ™ (LX211; oral voclosporin) for the treatment of noninfectious uveitis involving the intermediate or posterior segments of the eye.

5 Feb 2010

Lux Biosciences files NDA with FDA and MAA with EMA for approval of voclosporin

Isotechnika Pharma Inc. today announced that its partner, Lux Biosciences, Inc., has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) and a Market Authorization Application (MAA) with the European Medicines Agency (EMA) for voclosporin, under the proposed brand name, LUVENIQ(TM).

4 Feb 2010

BioCryst Pharmaceuticals announces fourth-quarter and full-year 2009 financial results

BioCryst Pharmaceuticals, Inc. today announced financial results for the fourth quarter and year ended December 31, 2009.

4 Feb 2010

Keryx Biopharmaceuticals reaches agreement with FDA on SPA for Phase 3 trial of KRX-0401

Keryx Biopharmaceuticals, Inc. announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial for its PI3K/Akt pathway inhibitor, KRX-0401 (perifosine), in patients with refractory metastatic colorectal cancer.

3 Feb 2010

Repros Therapeutics receives FDA confirmation for initiating Androxal IND

Repros Therapeutics Inc. today announced that the Company has received verbal confirmation from the Division of Metabolic and Endocrine Drug Products of the Food and Drug Agency that the Company may initiate its Investigational New Drug Application for the study of oral Androxal® in the treatment of hypogonadal men with Type II Diabetes (T2D) with a Phase IIa trial.

3 Feb 2010

Lannett Company plans to submit NDA for Morphine Sulfate products to FDA

Lannett Company, Inc. today announced plans to submit its New Drug Application (NDA) for its Morphine Sulfate products to the U.S. Food and Drug Administration (FDA) at the end of the month.

2 Feb 2010

Hovione announces filing of new drug application in Japan for the influenza drug CS-8958

Hovione is announcing the filing of a new drug application in Japan by its licensee Daiichi Sankyo Company Ltd. for the influenza drug CS-8958, which is delivered using Hovione's TwinCaps(R) inhaler.

2 Feb 2010

Javelin Pharmaceuticals' NDA for Dyloject Injection accepted for formal review

Javelin Pharmaceuticals, Inc., a leading developer and marketer of specialty pharmaceutical products for pain management, today announced that its New Drug Application (NDA) submitted on December 2, 2009 to the US Food and Drug Administration (FDA) for its investigational product candidate, Dyloject™ (diclofenac sodium) Injection, has been accepted for formal review.

2 Feb 2010

FDA approves INNOPHARMA's ibutilide fumarate injection ANDA

INNOPHARMA LLC announced today FDA approval of the Abbreviated New Drug Application (ANDA) for ibutilide fumarate injection (the generic equivalent of Corvert® from Pfizer Inc).

2 Feb 2010

FDA approves Taro Pharmaceutical Industries' levetiracetam tablets ANDA

Taro Pharmaceutical Industries Ltd. reported today that it has received approval from the U.S. Food and Drug Administration (“FDA”) for its Abbreviated New Drug Application (“ANDA”) for Levetiracetam Tablets, 250 mg, 500 mg, 750 mg and 1000 mg (“levetiracetam tablets”).

2 Feb 2010

FDA requests additional data on CMC section of NDA for taliglucerase alfa from Protalix BioTherapeutics

Protalix BioTherapeutics, Inc. announced today that, in connection with the New Drug Application (NDA) filed by the Company in December 2009 for taliglucerase alfa for the treatment of Gaucher disease, the U.S. Food and Drug Administration (FDA) has requested additional data regarding the Chemistry, Manufacturing and Controls (CMC) section of the NDA.

2 Feb 2010

New Drug Application News and Research

USPTO awards Transcept Pharmaceuticals patent covering Intermezzo's composition and usage method

Third-quarter fiscal 2010 results announced by Clinical Data

Cell Therapeutics' pixantrone NDA: FDA postpones ODAC meeting due to severe weather conditions

FDA accepts Psyadon Pharmaceuticals' ecopipam IND for treatment of LND

GeoVax Labs provides updates on HIV-1 vaccine trials

AMRI announces fourth-quarter and full-year 2009 results

Strativa Pharmaceuticals' Zuplenz NDA: FDA issues complete response letter

Mylan first to file ANDA patent for Caduet Tablets

Top-line results from Optimer Pharmaceuticals' second fidaxomicin Phase 3 trial in CDI patients

Lux Biosciences seeks US and European marketing approval for LUVENIQ

Lux Biosciences files NDA with FDA and MAA with EMA for approval of voclosporin

BioCryst Pharmaceuticals announces fourth-quarter and full-year 2009 financial results

Keryx Biopharmaceuticals reaches agreement with FDA on SPA for Phase 3 trial of KRX-0401

Repros Therapeutics receives FDA confirmation for initiating Androxal IND

Lannett Company plans to submit NDA for Morphine Sulfate products to FDA

Hovione announces filing of new drug application in Japan for the influenza drug CS-8958

Javelin Pharmaceuticals' NDA for Dyloject Injection accepted for formal review

FDA approves INNOPHARMA's ibutilide fumarate injection ANDA

FDA approves Taro Pharmaceutical Industries' levetiracetam tablets ANDA

FDA requests additional data on CMC section of NDA for taliglucerase alfa from Protalix BioTherapeutics

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