New Drug Application News and Research

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Somaxon Pharmaceuticals to meet FDA to discuss the NDA for Silenor for insomnia treatment

Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today stated that it is scheduled to meet with the U.S. Food and Drug Administration (FDA) on January 20, 2010 to discuss the New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia.

18 Dec 2009

ODAC to review Cell Therapeutics' NDA for pixantrone

Cell Therapeutics, Inc. (CTI) announced today that on February 10, 2010 the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) will review the New Drug Application (NDA) for pixantrone for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL).

17 Dec 2009

ODAC to conduct public advisory meeting to review ChemGenex Pharmaceuticals’ NDA for Omapro

ChemGenex Pharmaceuticals Limited announced today the U.S. Food and Drug Administration (FDA) has notified the company that the Oncologic Drugs Advisory Committee (ODAC) will conduct a public advisory meeting on 10 February 2010 to review the Company’s NDA for Omapro™ (omacetaxine mepesuccinate) for injection.

17 Dec 2009

AstraZeneca's CRESTOR receives favorable vote from FDA Advisory Committee

The U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) today voted 12 yes, 4 no, and 1 abstention that AstraZeneca has established sufficient benefit to offset the observed risks to support the use of CRESTOR®

16 Dec 2009

InSite Vision to advance new development candidate ISV-303

InSite Vision Incorporated, a company developing ophthalmic products for unmet eye care needs, today announced plans to advance new development candidate ISV-303, a topical anti-inflammatory product intended to reduce the pain and swelling associated with ocular surgery.

16 Dec 2009

Patheon releases the first commercial shipments of SUMAVEL DosePro to Zogenix

Patheon a global provider of drug development and manufacturing services to the international pharmaceutical industry announced today that it has successfully released the first commercial shipments of SUMAVEL DosePro (sumatriptan injection) to Zogenix in anticipation of the planned U.S. commercial product launch scheduled in January 2010.

15 Dec 2009

Positive results from study comparing exenatide once weekly to BYETTA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced positive results from a head-to-head study comparing exenatide once weekly, an investigational diabetes therapy, to BYETTA® (exenatide) injection taken twice daily, in patients with type 2 diabetes.

15 Dec 2009

Femta Pharmaceuticals, Lonza Group collaborate in cGMP production of FM101 antibody

Femta Pharmaceuticals and Lonza Group Ltd jointly announce the execution of a manufacturing services agreement to facilitate the development and cGMP manufacturing of FM101. FM101 is a high affinity monoclonal antibody in late pre-clinical development for the treatment of Rheumatoid Arthritis.

15 Dec 2009

Jazz Pharmaceuticals announces submission of JZP-6 NDA for treatment of fibromyalgia

Jazz Pharmaceuticals, Inc. announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for JZP-6 (sodium oxybate oral solution) for the treatment of fibromyalgia.

15 Dec 2009

Bend Research makes available Type V DMF for HPMCAS concerning FDA regulatory filings

Bend Research Inc. announced today that its clients may now reference a key safety file for HPMCAS, an excipient used in technologies developed by the firm to enhance the oral bioavailability of clients' low-solubility drugs.

15 Dec 2009

FDA publishes cGMPs for PET drugs

The U.S. Food and Drug Administration (FDA) announced publication of a final regulation on current good manufacturing practices (cGMPs) for the production of positron emission tomography (PET) drugs, as well as a guidance document describing acceptable approaches that would enable PET drug producers to meet the requirements in the proposed regulation.

15 Dec 2009

USPTO issues Notice of Allowance to Transcept Pharmaceuticals for Intermezzo claims

Transcept Pharmaceuticals, Inc. today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for claims under U.S. patent application no. 11/060,641, which covers the composition and use of Intermezzo® (zolpidem tartrate sublingual tablet), the lead Transcept product candidate.

15 Dec 2009

Alexza Pharmaceuticals submits its NDA for Staccato loxapine to FDA

Alexza Pharmaceuticals, Inc. today announced that it has submitted its New Drug Application (NDA) for Staccato® loxapine (AZ-004) to the US Food and Drug Administration (FDA).

15 Dec 2009

Vion Pharmaceuticals receives complete response letter related to its NDA for Onrigin injection

VION PHARMACEUTICALS, INC. today announced that it had received a complete response letter from the U.S. Food and Drug Administration ("FDA") related to its New Drug Application ("NDA") for Onrigin(TM) (laromustine) injection submitted in February 2009.

14 Dec 2009

Trial date set for patent litigation in the U.S. District Court for the District of Delaware

Cubist Pharmaceuticals, Inc. today announced that a trial date has been set for patent litigation in the U.S. District Court for the District of Delaware against Teva Parenteral Medicines, Inc. (TPM), Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. alleging infringement of Cubist’s US Patent Nos. 6,468,967 and 6,852,689, which expire on September 24, 2019, and US Patent No. RE39,071, which expires on June 15, 2016.

14 Dec 2009

Cubist Pharmaceuticals signs definitive agreement to acquire Calixa Therapeutics

Cubist Pharmaceuticals, Inc. a leading acute care therapeutics company, announced today the signing of a definitive agreement under which Cubist has agreed to acquire privately held Calixa Therapeutics Inc., a biopharmaceutical company focused on the development of novel antibiotics that address the expanding problem of multi-drug resistant Gram-negative pathogens.

14 Dec 2009

ChemGenex Pharmaceuticals and Hospira enter into exclusive agreement

ChemGenex Pharmaceuticals Limited and Hospira, Inc. announced today that they have entered into an exclusive agreement to license, develop and commercialize ChemGenex’s product candidate omacetaxine mepesuccinate, a novel targeted cytotoxic pharmaceutical product, in Europe, the Middle East and parts of Africa (the Territory).

13 Dec 2009

FDA approves Mylan Pharmaceuticals' ANDA for Levetiracetam Tablets

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets, 1000 mg.

12 Dec 2009

Genentech terminates dacetuzumab collaboration agreement with Seattle Genetics

Seattle Genetics, Inc. today reported that it has been notified by Genentech, a wholly owned member of the Roche Group, that Genentech has elected to terminate the companies’ collaboration agreement for dacetuzumab (SGN-40). Dacetuzumab is a monoclonal antibody targeting CD40 that has been investigated in clinical trials for non-Hodgkin lymphoma and multiple myeloma.

11 Dec 2009

Cequent Pharmaceuticals' IND application for CEQ508 approved for clinical trial

Cequent Pharmaceuticals, a pioneer in the development of novel products to deliver RNAi-based treatments to prevent and treat human disease, announced that the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) approved Cequent's first IND (investigational new drug) application yesterday.

10 Dec 2009

New Drug Application News and Research

Somaxon Pharmaceuticals to meet FDA to discuss the NDA for Silenor for insomnia treatment

ODAC to review Cell Therapeutics' NDA for pixantrone

ODAC to conduct public advisory meeting to review ChemGenex Pharmaceuticals’ NDA for Omapro

AstraZeneca's CRESTOR receives favorable vote from FDA Advisory Committee

InSite Vision to advance new development candidate ISV-303

Patheon releases the first commercial shipments of SUMAVEL DosePro to Zogenix

Positive results from study comparing exenatide once weekly to BYETTA

Femta Pharmaceuticals, Lonza Group collaborate in cGMP production of FM101 antibody

Jazz Pharmaceuticals announces submission of JZP-6 NDA for treatment of fibromyalgia

Bend Research makes available Type V DMF for HPMCAS concerning FDA regulatory filings

FDA publishes cGMPs for PET drugs

USPTO issues Notice of Allowance to Transcept Pharmaceuticals for Intermezzo claims

Alexza Pharmaceuticals submits its NDA for Staccato loxapine to FDA

Vion Pharmaceuticals receives complete response letter related to its NDA for Onrigin injection

Trial date set for patent litigation in the U.S. District Court for the District of Delaware

Cubist Pharmaceuticals signs definitive agreement to acquire Calixa Therapeutics

ChemGenex Pharmaceuticals and Hospira enter into exclusive agreement

FDA approves Mylan Pharmaceuticals' ANDA for Levetiracetam Tablets

Genentech terminates dacetuzumab collaboration agreement with Seattle Genetics

Cequent Pharmaceuticals' IND application for CEQ508 approved for clinical trial

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