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Bavarian Nordic receives SPA for Phase 3 study of PROSTVAC for advanced prostate cancer

Bavarian Nordic A/S announced today that the company has received a letter of concurrence from the U.S. Food and Drug Administration on a Special Protocol Assessment for a Phase 3 study required for product registration for its product candidate, PROSTVAC, for the treatment of patients with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.

8 Dec 2010

TOS, OAC call on FDA to address urgent need for obesity treatments

The Obesity Society (TOS) and the Obesity Action Coalition (OAC) today called on the Food and Drug Administration (FDA) to consider the urgent need for more tools to address the obesity epidemic facing more than 93 million Americans as they convene an advisory panel to review a new treatment for obesity.

8 Dec 2010

Alexza Pharmaceuticals to meet with FDA to discuss CRL regarding its NDA for AZ-004

Alexza Pharmaceuticals, Inc. announced today that the Company has scheduled an End-of Review meeting with the U.S. Food and Drug Administration in December to discuss the Complete Response Letter regarding the Company's New Drug Application for AZ-004 (Staccato loxapine).

8 Dec 2010

FDA Advisory Committee votes in favor of Orexigen's Contrave for treatment of obesity

Orexigen® Therapeutics, Inc. and Takeda Pharmaceutical Company Limited announced today that the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted 13 to 7 that the available data adequately demonstrate that the potential benefits of Contrave® (naltrexone sustained release (SR)/bupropion SR) outweigh the potential risks when used long-term in a population of overweight and obese individuals and support approval.

8 Dec 2010

MP receives FDA IND approval for clinical trial with HTLV-I/II ELISA 4.0 and HTLV Blot.2.4

MP Biomedicals LLC announced today that it has received approval of its investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) to start pivotal clinical trials in the USA with the MP Diagnostics™ HTLV-I/II ELISA 4.0 and HTLV Blot.2.4. Studies will be conducted within the American Red Cross, the California Department of Public Health, and LABS, Inc. The company is working closely with the principal investigator of the American Red Cross sites, Dr. Susan Stramer, Executive Scientific Officer.

From MP Biomedicals, LLC 7 Dec 2010

Matrix's NDA for Abacavir Sulfate receives tentative FDA approval under PEPFAR

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Abacavir Sulfate Tablets, 60 mg. The NDA is based on the reference listed drug Ziagen® by ViiV Healthcare.

7 Dec 2010

Watson, Natco confirm development agreement for generic Revlimid

Watson Pharmaceuticals, Inc. and Natco Pharma Limited today confirmed an exclusive, U.S. development and license agreement, to develop and commercialize lenalidomide 5, 10, 15 and 25 mg tablets. The companies also confirmed that Natco has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its lenalidomide 5, 10, 15 and 25 mg product. Natco's lenalidomide tablets are generic versions of Celgene's Revlimid ® Tablets.

7 Dec 2010

Intellipharmaceutics files generic 30 mg Focalin XR ANDA with FDA

Intellipharmaceutics International Inc., today announced that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for approval to market a generic of the 30 mg strength of Focalin XR® (dexmethylphenidate hydrochloride). The application for the 30 mg strength is filed as an amendment to the ANDA that Intellipharmaceutics had previously filed for the 5, 10, 15 and 20 mg strengths of the drug.

7 Dec 2010

Fraunhofer USA CMB receives FDA approval to initiate Phase I clinical trial of H5N1 influenza vaccine

Fraunhofer USA Center for Molecular Biotechnology announced today it has received approval from the Food and Drug Administration to proceed with the first human clinical trial of plant-produced H5N1 influenza vaccine.

6 Dec 2010

QRxPharma completes patient enrolment of pivotal MoxDuo IR phase 3 study

QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today it has completed patient enrolment for a pivotal Phase 3 registration trial (Study 009) for MoxDuo IR. The comparative study was designed to evaluate analgesic efficacy and safety of MoxDuo IR, a patented 3:2 ratio fixed dose combination of morphine plus oxycodone, for managing moderate to severe pain in patients who have undergone total knee replacement surgery.

5 Dec 2010

Impax confirms challenge of patents in connection with INTUNIV

Impax Laboratories, Inc. today confirms that it has initiated a challenge of patents listed by Shire Development Inc. in connection with INTUNIVTM (guanfacine hydrochloride), 4 mg.

3 Dec 2010

Cell Therapeutics submits pixantrone NDA application to treat non-Hodgkin's lymphoma

Cell Therapeutics, Inc. today announced that it has submitted a formal appeal to the Office of New Drugs in the U.S. Food and Drug Administration's Center for Drug Evaluation and Research regarding the agency's decision from earlier this year on the pixantrone New Drug Application to treat relapsed/refractory aggressive non-Hodgkin's lymphoma.

3 Dec 2010

FDA accepts IND application to initiate human clinical trial to evaluate BNC

QR Pharma, Inc., a developer of novel drugs to treat Alzheimer's disease (AD), announced today that the United States Food and Drug Administration (FDA) has accepted the Investigational New Drug application (IND) to begin human clinical trials and evaluate the safety and efficacy of the company's second product, bisnorcymserine (BNC).

3 Dec 2010

AstraZeneca announces FDA Advisory Committee meeting outcome for vandetanib NDA

AstraZeneca today announced the outcome of the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee meeting to discuss the New Drug Application (NDA) for AstraZeneca's investigational drug, vandetanib, for the treatment of patients with unresectable (non-operable) locally advanced or metastatic medullary thyroid cancer (MTC).

2 Dec 2010

Shire reports topline results from FAST-3 Firazyr Phase III trials for acute attacks of hereditary angioedema

Shire plc, the global specialty biopharmaceutical company, today announced topline results from FAST-3 (For Angioedema Subcutaneous Treatment), the largest of the Phase III trials studying the use of Firazyr (icatibant) for treatment of acute attacks of hereditary angioedema (HAE).

2 Dec 2010

FDA advisory committee votes against Avodart sNDA for prostate cancer risk reduction

GlaxoSmithKline today announced the results of a U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the supplemental New Drug Application (sNDA) for Avodart® (dutasteride) for reducing the risk of prostate cancer in men at risk for the disease, defined as those who have had a prior negative biopsy due to clinical concern and have an elevated serum prostate-specific antigen (PSA).

2 Dec 2010

GSK and Valeant receive FDA Complete Response letter for ezogabine

GlaxoSmithKline and Valeant Pharmaceuticals International, Inc. announced receipt of a Complete Response letter from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for ezogabine, an investigational anti-epileptic drug being studied for the adjunctive treatment of adults with partial-onset seizures.

2 Dec 2010

Zogenix completes enrollment in ZX002 Phase 3 study for moderate to severe pain

Zogenix, Inc. today announced completion of enrollment in its open-label Phase 3 safety study (Study 802) of ZX002. ZX002 is a novel, oral, single-entity, controlled-release formulation of hydrocodone for the treatment of moderate to severe pain in patients requiring around-the-clock opioid therapy for an extended period of time.

30 Nov 2010

Keryx announces positive top-line results from Zerenex Phase 3 study for hyperphosphatemia

Keryx Biopharmaceuticals, Inc. today announced positive top-line results from the Phase 3 short-term efficacy study component of its Phase 3 registration program of Zerenex (ferric citrate), the Company's ferric iron-based phosphate binder for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with end-stage renal disease on dialysis.

30 Nov 2010

Cytheris' combinational therapy demonstrates possible therapeutic strategy for PML

Cytheris SA, a clinical-stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced the publication of a case study report based on successful treatment of Progressive Multifocal Leukoencephalopathy (PML) with combination therapy consisting of two investigational agents, Cytheris' recombinant human interleukin-7 (CYT107) and CMX001, an investigational, oral broad-spectrum antiviral drug (Chimerix, Research Triangle Park, NC) in the Journal of Antimicrobial Chemotherapy.

30 Nov 2010

New Drug Application News and Research

Bavarian Nordic receives SPA for Phase 3 study of PROSTVAC for advanced prostate cancer

TOS, OAC call on FDA to address urgent need for obesity treatments

Alexza Pharmaceuticals to meet with FDA to discuss CRL regarding its NDA for AZ-004

FDA Advisory Committee votes in favor of Orexigen's Contrave for treatment of obesity

MP receives FDA IND approval for clinical trial with HTLV-I/II ELISA 4.0 and HTLV Blot.2.4

Matrix's NDA for Abacavir Sulfate receives tentative FDA approval under PEPFAR

Watson, Natco confirm development agreement for generic Revlimid

Intellipharmaceutics files generic 30 mg Focalin XR ANDA with FDA

Fraunhofer USA CMB receives FDA approval to initiate Phase I clinical trial of H5N1 influenza vaccine

QRxPharma completes patient enrolment of pivotal MoxDuo IR phase 3 study

Impax confirms challenge of patents in connection with INTUNIV

Cell Therapeutics submits pixantrone NDA application to treat non-Hodgkin's lymphoma

FDA accepts IND application to initiate human clinical trial to evaluate BNC

AstraZeneca announces FDA Advisory Committee meeting outcome for vandetanib NDA

Shire reports topline results from FAST-3 Firazyr Phase III trials for acute attacks of hereditary angioedema

FDA advisory committee votes against Avodart sNDA for prostate cancer risk reduction

GSK and Valeant receive FDA Complete Response letter for ezogabine

Zogenix completes enrollment in ZX002 Phase 3 study for moderate to severe pain

Keryx announces positive top-line results from Zerenex Phase 3 study for hyperphosphatemia

Cytheris' combinational therapy demonstrates possible therapeutic strategy for PML

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