New Drug Application News and Research

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A.P. Pharma reports net loss of $1.9M for fourth-quarter of 2009

A.P. Pharma, Inc., a specialty pharmaceutical company, today reported financial results for its fourth quarter and full year ended December 31, 2009.

15 Mar 2010

FDA accepts proposed proprietary name Exelbine for ADVENTRX Pharmaceuticals' ANX-530

ADVENTRX Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has accepted the proposed proprietary name "Exelbine™" for the Company's product candidate ANX-530 (vinorelbine injectable emulsion).

12 Mar 2010

Arena Pharmaceuticals reports lower net loss allocable to common stockholders in fourth-quarter 2009

Arena Pharmaceuticals, Inc. today reported financial results for the fourth quarter and full year ended December 31, 2009.

12 Mar 2010

Neoprobe meets with FDA to review Phase 3 clinical trial results of Lymphoseek drug

Neoprobe Corporation, a diversified developer of innovative oncology and surgical diagnostic and treatment products, today announced that it recently met with the United States Food and Drug Administration to review the clinical trial results of a Phase 3 investigational new drug, Lymphoseek®.

12 Mar 2010

Abbott's sNDA for new six-month 45-mg formulation of Lupron Depot: FDA accepts for review

The U.S. Food and Drug Administration has accepted for review the supplemental new drug application (sNDA) of a new six-month 45-mg formulation of Lupron® Depot (leuprolide acetate for depot suspension) for use in the palliative treatment of advanced prostate cancer. Palliative treatment helps to relieve symptoms associated with advanced prostate cancer.

12 Mar 2010

FDA provides guidance on Restanza clinical program in treatment of CABP

Advanced Life Sciences Holdings, Inc., a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, announced today that the U.S. Food and Drug Administration has provided guidance on the clinical program required to assess the approvability of Restanza™ (cethromycin), a novel oral once-a-day antibiotic, in the treatment of outpatient community acquired bacterial pneumonia (CABP) as well as biodefense indications including anthrax, plague and tularemia.

11 Mar 2010

USPTO issues patent related to Seattle Genetics' ADC technology

Seattle Genetics, Inc. announced today that the U.S. Patent and Trademark Office has issued a patent related to its antibody-drug conjugate (ADC) technology. U.S. Patent No. 7,659,241 covers cleavable linkers and potent auristatin drug payloads used in certain of Seattle Genetics’ ADC programs, most notably brentuximab vedotin (SGN-35), as well as many ADC programs in development by its collaborators.

11 Mar 2010

Great Point and Deerfield invest in BioSante Pharmaceuticals

BioSante Pharmaceuticals, Inc. today announced the closing of the sale, directly to funds affiliated with two institutional investors, of an aggregate of approximately 10.4 million shares of BioSante’s common stock and warrants to purchase up to approximately 5.2 million shares of its common stock, resulting in gross cash proceeds to BioSante of $18 million.

11 Mar 2010

DSPA's lurasidone NDA accepted for FDA review

Dainippon Sumitomo Pharma America, Inc., a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd., today announced that the U.S. Food and Drug Administration recently accepted for review the lurasidone New Drug Application (NDA) for the treatment of patients with acute schizophrenia. The NDA was submitted to FDA on December 30, 2009 and will receive a standard review.

10 Mar 2010

FDA's Advisory Committee votes 9-3 to recommend approval of Esbriet for treatment of patients with IPF

InterMune, Inc. announced today that the U.S. Food and Drug Administration's Pulmonary-Allergy Drugs Advisory Committee voted 9-3 to recommend approval of Esbriet® (pirfenidone) for the treatment of patients with idiopathic pulmonary fibrosis (IPF) to reduce decline in lung function.

9 Mar 2010

NASDAQ halts trading of InterMune's common stock, FDA PADAC to discuss pirfenidone NDA

InterMune, Inc. announced that NASDAQ has today halted trading of InterMune's common stock. The Pulmonary-Allergy Drugs Advisory Committee to the U.S. Food and Drug Administration meets today to review and discuss the company's New Drug Application for pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis.

9 Mar 2010

Orexigen Therapeutics reports net loss of $15.0M for three months ended December 31, 2009

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced financial results for the three months and year ended December 31, 2009.

9 Mar 2010

Fenwal receives FDA marketing clearance for Amicus blood cell separator

Fenwal, Inc., a global medical technology company focused on improving blood collection, separation, safety and availability, announced today that the U.S. Food and Drug Administration has granted Fenwal 510(k) clearance to market its Amicus® blood cell separator for collecting human platelets stored in InterSol® platelet additive solution (PAS 3). Fenwal's InterSol® solution was approved by the FDA in December 2009 under a new drug application. It is the first and only platelet additive solution now available in America.

9 Mar 2010

Watson Laboratories sued over ANDA filing for generic Opana ER

Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc., has been sued by Endo Pharmaceuticals Inc. and Penwest Pharmaceuticals Co. in connection with the filing of Watson's Abbreviated New Drug Application (ANDA) for Oxymorphone Hydrochloride Extended-Release Tablets, 40mg.

9 Mar 2010

ISTA Pharmaceuticals' sNDA for once-daily XiDay: FDA assigns PDUFA action date

ISTA Pharmaceuticals, Inc., today announced the Company's supplemental New Drug Application (sNDA) for once-daily XiDay™ (bromfenac ophthalmic solution) has been accepted for review by the U.S. Food and Drug Administration (FDA).

8 Mar 2010

FDA approves Taro Pharmaceutical Industries' Fluorouracil Topical Cream ANDA

Taro Pharmaceutical Industries Ltd. today reported that it received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Fluorouracil Topical Cream USP, 5%.

8 Mar 2010

NerPharMa facility receives FDA approval to manufacture CTI's drug pixantrone

Cell Therapeutics, Inc. today announced that the U.S. Food and Drug Administration has completed its inspection of the facility at NerPharMa (a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences Srl, in Nerviano, Italy), which manufactures the CTI's drug pixantrone and has found the site in compliance and acceptable for continued manufacturing of the drug product.

8 Mar 2010

FDA's PADAC meeting to review pirfenidone NDA: InterMune posts briefing documents

InterMune, Inc. announced today that the U.S. Food and Drug Administration (FDA) has posted briefing documents for the March 9 Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting to review the New Drug Application (NDA) for pirfenidone, InterMune's investigational drug candidate for the treatment of patients with idiopathic pulmonary fibrosis (IPF) to reduce decline in lung function. The proposed trade name for pirfenidone is Esbriet®.

5 Mar 2010

FDA's 5-year NCE exclusivity grant to VYVANSE: Court upholds decision

Shire plc, the global specialty biopharmaceutical company, announces that the United States District Court for the District of Columbia ("Court"), following extensive briefing by the parties and an oral hearing, has upheld the decision of the U.S. Food and Drug Administration ("FDA") to grant 5-year New Chemical Entity ("NCE") exclusivity to lisdexamfetamine dimesylate-currently marketed by Shire U.S. Inc. for the treatment of attention-deficit hyperactivity disorder under the name VYVANSE(R).

5 Mar 2010

BioSante Pharmaceuticals enters into securities purchase agreements with Great Point and Deerfield Management

BioSante Pharmaceuticals, Inc. today announced that it has received commitments from two institutional investors to purchase $18 million of securities in a registered direct offering. The investors are Great Point Partners, LLC and Deerfield Management Company. BioSante expects to receive net proceeds of approximately $17.5 million after deducting placement agent fees and other offering expenses.

4 Mar 2010

New Drug Application News and Research

A.P. Pharma reports net loss of $1.9M for fourth-quarter of 2009

FDA accepts proposed proprietary name Exelbine for ADVENTRX Pharmaceuticals' ANX-530

Arena Pharmaceuticals reports lower net loss allocable to common stockholders in fourth-quarter 2009

Neoprobe meets with FDA to review Phase 3 clinical trial results of Lymphoseek drug

Abbott's sNDA for new six-month 45-mg formulation of Lupron Depot: FDA accepts for review

FDA provides guidance on Restanza clinical program in treatment of CABP

USPTO issues patent related to Seattle Genetics' ADC technology

Great Point and Deerfield invest in BioSante Pharmaceuticals

DSPA's lurasidone NDA accepted for FDA review

FDA's Advisory Committee votes 9-3 to recommend approval of Esbriet for treatment of patients with IPF

NASDAQ halts trading of InterMune's common stock, FDA PADAC to discuss pirfenidone NDA

Orexigen Therapeutics reports net loss of $15.0M for three months ended December 31, 2009

Fenwal receives FDA marketing clearance for Amicus blood cell separator

Watson Laboratories sued over ANDA filing for generic Opana ER

ISTA Pharmaceuticals' sNDA for once-daily XiDay: FDA assigns PDUFA action date

FDA approves Taro Pharmaceutical Industries' Fluorouracil Topical Cream ANDA

NerPharMa facility receives FDA approval to manufacture CTI's drug pixantrone

FDA's PADAC meeting to review pirfenidone NDA: InterMune posts briefing documents

FDA's 5-year NCE exclusivity grant to VYVANSE: Court upholds decision

BioSante Pharmaceuticals enters into securities purchase agreements with Great Point and Deerfield Management

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