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FDA accepts to review Aricept NDA for Alzheimer's disease

Teikoku Pharma USA, Inc., an international specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for a new weekly transdermal patch of Aricept, a leading medication for the treatment of Alzheimer's disease.

18 Sep 2010

Arena, Eisai provide update on lorcaserin NDA

Arena Pharmaceuticals, Inc. and Eisai Inc. announced today that the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted 9 to 5 that the available data do not adequately demonstrate that the potential benefits of lorcaserin outweigh the potential risks, when used long-term in a population of overweight and obese individuals to allow marketing approval.

17 Sep 2010

Elite Pharmaceuticals signs agreements with Precision Dose for four generic products

Elite Pharmaceuticals, Inc. announced today the signing of a license agreement and a manufacturing and supply agreement with Precision Dose, Inc. which has a wholly owned subsidiary, TAGI Pharma, Inc. which will distribute the products covered by the agreement. Pursuant to the License Agreement, TAGI Pharma will market and sell four Elite generic products in the United States, Puerto Rico and Canada.

17 Sep 2010

FDA Advisory Committee recommends approval of Alkermes' VIVITROL for opioid dependence

Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted 12 to 1 that VIVITROL® (naltrexone for extended-release injectable suspension) should be approved for the treatment of opioid dependence.

17 Sep 2010

FDA approves Akorn's Erythromycin Ophthalmic Ointment USP 1 g

Akorn, Inc. a niche generic pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted approval of the Company's Erythromycin Ophthalmic Ointment USP 1 g as a supplement to the Company's already approved Abbreviated New Drug Application (ANDA) for Erythromycin Ophthalmic Ointment USP 3.5 g. The company has begun shipping the product to its customers.

17 Sep 2010

Forest Pharmaceuticals to pay $300 million as penalty for criminal actions

The U.S. Food and Drug Administration (FDA), working in close coordination with the U.S. Department of Justice (USDOJ), today announced that Forest Pharmaceuticals, Inc. entered into a plea agreement in which the company accepted responsibility for criminal actions including distribution of an unapproved new drug, distribution of a misbranded drug, and obstruction of an FDA inspection.

16 Sep 2010

ADVENTRX announces Exelbine 12-month stability test results

ADVENTRX Pharmaceuticals, Inc. today announced the results of stability tests performed on samples of ANX-530 (vinorelbine injectable emulsion), or Exelbine™, manufactured at the Company's intended commercial manufacturing site.

15 Sep 2010

FDA extends PDUFA date for AstraZeneca's ticagrelor NDA

AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has extended the time to complete its review of the New Drug Application (NDA) for ticagrelor (BRILINTA).

15 Sep 2010

AMRI selects compound for advanced preclinical testing in treatment of IBS

AMRI today announced the selection of a compound from its proprietary research program for the treatment of irritable bowel syndrome (IBS) for advanced preclinical testing, with the goal of submitting an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) in 2011.

15 Sep 2010

Stemedica Cell Technologies completes master bank of mesenchymal bone marrow-derived stem cells

Stemedica Cell Technologies, Inc., a world leader in adult stem cell manufacturing and research, announced today that it has completed its proprietary master bank of mesenchymal bone marrow-derived stem cells.

14 Sep 2010

Neoprobe Corporation presents information on Lymphoseek at TERACHEM Symposium

Neoprobe Corporation a diversified developer of innovative oncology surgical and diagnostic products, today announced that Senior Vice President of Pharmaceutical Research and Clinical Development, Dr. Frederick O. Cope, presented information on the Company's lead pipeline initiative, Lymphoseek, at the International Symposium on Technetium and Other Radiometals in Chemistry and Medicine (TERACHEM), held September 8-11, 2010 in Bressanone (Bolzano), Italy.

14 Sep 2010

$Cell Therapeutics to appeal FDA decision on pixantrone NDA for relapsed/refractory aggressive NHL$

Cell Therapeutics to appeal FDA decision on pixantrone NDA for relapsed/refractory aggressive NHL

Cell Therapeutics, Inc. today announced that it intends to appeal the U.S. Food and Drug Administration's previously disclosed decision regarding the pixantrone New Drug Application ("NDA") to treat patients with relapsed/refractory aggressive non-Hodgkin's lymphoma ("NHL").

14 Sep 2010

IGI submits first ANDA to FDA

IGI Laboratories, Inc., a New Jersey based formulation and manufacturing company, today announced that it has submitted its first abbreviated new drug application (ANDA) to the US FDA. IGI President and CEO Charlie Moore commented "This is a significant step forward in validating IGI's commitment to pharmaceutical product development.

14 Sep 2010

Ironwood, Forest Laboratories announce positive results for linaclotide Phase 3 clinical trials in IBS-C patients

Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. (NYSE: FRX) today announced positive top-line results from the first of two Phase 3 clinical trials assessing the efficacy and safety of the investigational drug, linaclotide, in patients with irritable bowel syndrome with constipation (IBS-C).

14 Sep 2010

InterMune's development program for pirfenidone, IPF to be presented at Annual Congress of ERS

InterMune, Inc. today announced that four oral presentations related to the company's development program for pirfenidone and idiopathic pulmonary fibrosis will be presented at the Annual Congress of the European Respiratory Society, to be held September 18-22 in Barcelona, Spain.

13 Sep 2010

Forest files response to FDA Complete Response Letter for roflumilast NDA

Forest Laboratories, Inc. today announced that it has filed a response to the U.S. Food & Drug Administration (FDA) addressing topics raised in the complete response letter regarding the New Drug Application (NDA) for roflumilast. Forest licenses roflumilast from Nycomed, which submitted the original NDA.

13 Sep 2010

Pro-Pharmaceuticals engages Numoda Corporation to optimize DAVANAT Phase III clinical trial

Pro-Pharmaceuticals, Inc., the leading developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, today announced that it has engaged the Numoda Corporation, a leading information, process and logistics management company, to oversee the Phase III clinical trial of DAVANAT and 5-FU compared with the standard of care in the treatment of patients with advanced, metastatic colorectal cancer.

13 Sep 2010

Incyte Corporation enters SPA agreement with FDA for INCB18424 inhibitor

Incyte Corporation announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase III trial for its JAK1 and JAK2 inhibitor, INCB18424 in patients with polycythemia vera (PV), a blood cancer that belongs to a group of diseases known as myeloproliferative neoplasms (MPNs).

13 Sep 2010

XenoPort intends to initiate Phase 3 XP19986 trial for multiple sclerosis

XenoPort, Inc. announced today that it plans to move arbaclofen placarbil (AP), also known as XP19986, into Phase 3 development as a potential treatment of spasticity in multiple sclerosis (MS) patients.

13 Sep 2010

Cyclacel reaches SPA agreement with FDA for sapacitabine Phase 3 trial in AML

Cyclacel Pharmaceuticals, Inc., a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious diseases, today announced 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 pivotal Phase 3 trial for the Company's sapacitabine oral capsules as a front-line treatment in elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy.

13 Sep 2010

New Drug Application News and Research

FDA accepts to review Aricept NDA for Alzheimer's disease

Arena, Eisai provide update on lorcaserin NDA

Elite Pharmaceuticals signs agreements with Precision Dose for four generic products

FDA Advisory Committee recommends approval of Alkermes' VIVITROL for opioid dependence

FDA approves Akorn's Erythromycin Ophthalmic Ointment USP 1 g

Forest Pharmaceuticals to pay $300 million as penalty for criminal actions

ADVENTRX announces Exelbine 12-month stability test results

FDA extends PDUFA date for AstraZeneca's ticagrelor NDA

AMRI selects compound for advanced preclinical testing in treatment of IBS

Stemedica Cell Technologies completes master bank of mesenchymal bone marrow-derived stem cells

Neoprobe Corporation presents information on Lymphoseek at TERACHEM Symposium

Cell Therapeutics to appeal FDA decision on pixantrone NDA for relapsed/refractory aggressive NHL

IGI submits first ANDA to FDA

Ironwood, Forest Laboratories announce positive results for linaclotide Phase 3 clinical trials in IBS-C patients

InterMune's development program for pirfenidone, IPF to be presented at Annual Congress of ERS

Forest files response to FDA Complete Response Letter for roflumilast NDA

Pro-Pharmaceuticals engages Numoda Corporation to optimize DAVANAT Phase III clinical trial

Incyte Corporation enters SPA agreement with FDA for INCB18424 inhibitor

XenoPort intends to initiate Phase 3 XP19986 trial for multiple sclerosis

Cyclacel reaches SPA agreement with FDA for sapacitabine Phase 3 trial in AML

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