New Drug Application News and Research

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Interim safety review of LEVADEX completed by MAP Pharmaceuticals

MAP Pharmaceuticals, Inc. today announced that it has completed a planned interim safety review of the open-label, long-term safety extension of the company's Phase 3 FREEDOM 301 clinical trial with its LEVADEX(TM) orally inhaled migraine therapy.

29 Oct 2009

BioCryst Pharmaceuticals reports fiscal 2009 third-quarter results

BioCryst Pharmaceuticals, Inc. announced financial results for the quarter and nine months ended September 30, 2009 and provided a corporate update regarding clinical programs and potential emergency use of intravenous (i.v.) peramivir.

29 Oct 2009

Fresenius Kabi to license its proprietary HESylation Technology to Octapharma

Octapharma Group and Fresenius Kabi have signed a License, Development and Supply Agreement regarding the use of Fresenius Kabi's HESylation® Technology to develop a HESylated recombinant protein.

29 Oct 2009

Sangamo BioSciences awarded a grant to develop zinc finger nuclease-based stem cell therapy for AIDS

Sangamo BioSciences, Inc. announced today that the California Institute for Regenerative Medicine (CIRM) has granted a $14.5 million Disease Team Research Award to develop an AIDS-related lymphoma therapy based on the application of its zinc finger nuclease (ZFN) gene-editing technology in stem cells.

29 Oct 2009

Repros Therapeutics amends its existing license for Proellex

Repros Therapeutics today announced that the Company has entered into an amendment with the National Institutes of Health (NIH) to its existing exclusive license for Proellex® that revises the existing milestones and dates for performance to provide additional time to lift the current clinical hold on Proellex or select a second generation molecule for further development from the family of anti-progestational agents covered by the license.

29 Oct 2009

FDA issues a Complete Response Letter regarding NDA for Intermezzo

Transcept Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter regarding the New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet).

29 Oct 2009

Third-quarter fiscal 2009 results announced by POZEN

POZEN Inc., today announced results for the third quarter ended September 30, 2009.

28 Oct 2009

Auxilium Pharmaceuticals reports increased net revenues of $42.1 million in third quarter 2009

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced financial results and operational highlights for the quarter ended September 30, 2009. For the third quarter of 2009, Auxilium reported net revenues of $42.1 million compared to net revenues of $32.6 million in the third quarter of 2008.

28 Oct 2009

A.P. Pharma to transfer listing from The Nasdaq Global Market to The Nasdaq Capital Market

A.P. Pharma, a specialty pharmaceutical company, today announced that on October 26, 2009, the Company received notice that the Nasdaq Listing Qualifications Panel (Panel) has granted the Company’s request to transfer the listing of the Company’s common stock from The Nasdaq Global Market to The Nasdaq Capital Market, which will take effect with the opening of the market on Wednesday, October 28, 2009.

28 Oct 2009

Development of VLN cigarettes for use in smoking cessation continues: 22nd Century

22nd Century Limited, LLC is pleased to announce that it is continuing development of a very low nicotine cigarette for use in smoking cessation. Clinical trial results demonstrate that these cigarettes, also referred to as ‘nicotine-free’ and ‘denicotinized,’ may be more effective for quitting than FDA-approved therapies.

28 Oct 2009

Orexigen Therapeutics presents phase 3 trial results of Contrave for treating obesity

Orexigen® Therapeutics, Inc. today announced results from new intent to treat (ITT) analyses from the COR-I and COR-II Phase 3 trials of Contrave® (naltrexone SR/bupropion SR), the first of two late stage Orexigen candidates for the treatment of obesity. These data expand on top-line results announced in July and complement findings from a panel discussion on Saturday where the Company presented data on Contrave patients who completed 56 weeks of therapy.

28 Oct 2009

Isotechnika Pharma reports voclosporin Phase 2/3 clinical trial results at the AAO meeting

Isotechnika Pharma Inc. today announced that results of the international Phase 2/3 clinical trials studying voclosporin, conducted by its partner Lux Biosciences, were the subject of two podium presentations at the American Association of Ophthalmology (AAO) meeting and of a presentation at the satellite meeting of the American Uveitis Society (AUS) in San Francisco, October 24-27.

27 Oct 2009

PolyMedix completes second successful clinical study of PMX-60056

PolyMedix, Inc. (http://polymedix.com), an emerging biotechnology company developing new therapeutic drug products to treat infectious diseases and acute cardiovascular disorders, has completed a second successful clinical study of its anticoagulant reversing agent, PMX-60056.

27 Oct 2009

FDA grants five-year New Chemical Entity exclusivity to VYVANSE

Shire plc, the global specialty biopharmaceutical company, announces that the Food and Drug Administration (FDA), following a thorough administrative review of governing statutory and regulatory standards and public comments, has affirmed its prior decision to grant five-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).

26 Oct 2009

Orexigen Therapeutics announces new data from COR-I, COR-II and COR-Diabetes trials for Contrave

Orexigen® ( )Therapeutics, Inc today announced new data from the COR-I, COR-II and COR-Diabetes trials for Contrave® (bupropion SR/ naltrexone SR) to expand on top-line results announced in July. Contrave is the first of the Company's two late stage candidates for the treatment of obesity.

26 Oct 2009

Schering-Plough announces 2009 third quarter financial results

Schering-Plough Corporation (NYSE: SGP) today reported financial results for the 2009 third quarter.

22 Oct 2009

FDA extends Acorda Therapeutics' Fampridine-SR PDUFA goal date

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the U.S. Food and Drug Administration (FDA) has extended the PDUFA goal date for its review of the New Drug Application (NDA) for Fampridine-SR to January 22, 2010. The original Prescription Drug User Fee Act (PDUFA) date for this priority review application was October 22, 2009.

22 Oct 2009

Cephalon announces receipt of a Paragraph IV Certification Notice Letter regarding ANDA

Cephalon, Inc. (Nasdaq: CEPH) today announced receipt of a Paragraph IV Certification Notice Letter on October 20, 2009 regarding an Abbreviated New Drug Application (ANDA) submitted to the U.S. Food and Drug Administration (FDA) by Teva Pharmaceuticals USA, Inc. requesting approval to market and sell a generic version of the 50 mg, 100 mg, 150 mg, 200 mg and 250 mg strengths of NUVIGIL® (armodafinil) Tablets [C-IV].

22 Oct 2009

NicOx reports financial results for the first nine months of 2009

NicOx S.A. today reported financial results for the nine months ended September 30, 2009.

22 Oct 2009

FDA grants Fast Track designation for MacuSight's Perceiva

MacuSight, a developer of innovative therapeutics for the treatment of severe ocular diseases and conditions, today announced that it has received Fast Track designation from the United States Food and Drug Administration (FDA) for Perceiva, the company's proprietary ocular sirolimus product, for the treatment of diabetic macular edema (DME).

21 Oct 2009

New Drug Application News and Research

Interim safety review of LEVADEX completed by MAP Pharmaceuticals

BioCryst Pharmaceuticals reports fiscal 2009 third-quarter results

Fresenius Kabi to license its proprietary HESylation Technology to Octapharma

Sangamo BioSciences awarded a grant to develop zinc finger nuclease-based stem cell therapy for AIDS

Repros Therapeutics amends its existing license for Proellex

FDA issues a Complete Response Letter regarding NDA for Intermezzo

Third-quarter fiscal 2009 results announced by POZEN

Auxilium Pharmaceuticals reports increased net revenues of $42.1 million in third quarter 2009

A.P. Pharma to transfer listing from The Nasdaq Global Market to The Nasdaq Capital Market

Development of VLN cigarettes for use in smoking cessation continues: 22nd Century

Orexigen Therapeutics presents phase 3 trial results of Contrave for treating obesity

Isotechnika Pharma reports voclosporin Phase 2/3 clinical trial results at the AAO meeting

PolyMedix completes second successful clinical study of PMX-60056

FDA grants five-year New Chemical Entity exclusivity to VYVANSE

Orexigen Therapeutics announces new data from COR-I, COR-II and COR-Diabetes trials for Contrave

Schering-Plough announces 2009 third quarter financial results

FDA extends Acorda Therapeutics' Fampridine-SR PDUFA goal date

Cephalon announces receipt of a Paragraph IV Certification Notice Letter regarding ANDA

NicOx reports financial results for the first nine months of 2009

FDA grants Fast Track designation for MacuSight's Perceiva

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