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Hyperion's HPN-100 granted FDA Fast Track Designation for urea cycle disorders

Hyperion Therapeutics, Inc. announced today that its investigational compound glycerol phenylbutyrate (HPN-100) has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) as adjunctive therapy for the chronic management of urea cycle disorders. Hyperion recently completed its phase III trial which was conducted under a Special Protocol Assessment (SPA) agreement with the FDA. The Company plans to announce results from that trial later this year.

18 Oct 2010

BioSante enrolls 2,500th woman in LibiGel Phase III cardiovascular and breast cancer safety study

BioSante Pharmaceuticals, Inc. today announced enrollment of the 2,500th woman in the LibiGel (testosterone gel) Phase III cardiovascular and breast cancer safety study. This important enrollment milestone triggers the first unblinded statistical analysis of cardiovascular events by the independent Data Monitoring Committee (DMC), which coincides with their fourth unblinded review of all adverse events.

18 Oct 2010

Intellipharmaceutics announces FDA acceptance to file ANDA for Protonix generic version

Intellipharmaceutics International Inc. today announced that the Food and Drug Administration (FDA) has accepted for filing its abbreviated new drug application (ANDA) for a generic version of Protonix (delayed release pantoprazole sodium).

18 Oct 2010

FDA approves ISTA's sNDA for BROMDAY ophthalmic anti-inflammatory drug

ISTA Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental New Drug Application (sNDA) for BROMDAY (bromfenac ophthalmic solution) 0.09% as a once-daily prescription eye drop for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction.

18 Oct 2010

Questcor's H.P. Acthar Gel sNDA for infantile spasms receives FDA approval

Questcor Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved Questcor's supplemental new drug application (sNDA) for H.P. Acthar® Gel (repository corticotropin injection) in the treatment of infantile spasms (IS), an ultra-rare orphan disorder affecting approximately 2,000 American children annually. IS is a devastating and potentially life-threatening form of epilepsy seen in infancy and early childhood.

15 Oct 2010

Watson Laboratories receives FDA approval for Amlodipine capsules

Watson Pharmaceuticals, Inc. today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Amlodipine Besylate/Benazepril 5/20mg, 10/20mg, 2.5/10mg, and 5/10mg capsules, the generic equivalent to Novartis' Lotrel capsules.

15 Oct 2010

Delcath executes melphalan supply agreement with Synerx and Bioniche Teoranta

Delcath Systems, Inc. announced today that it has executed a multi-year supply agreement with Synerx Pharma, LLC and Bioniche Teoranta, an affiliate of Mylan, Inc., for the supply of Delcath's branded melphalan hydrochloride for injection ("melphalan"). Melphalan is the chemotherapeutic drug used with Delcath's Chemosaturation system in its Phase III clinical study for the treatment of patients with hepatic metastases from ocular or cutaneous melanoma.

15 Oct 2010

Moores Cancer Center files IND application for topical NexACT-based formulation

Apricus Biosciences, backed by a revenue generating CRO business and seeking to leverage its multi-route NexACT drug delivery technology and internal pipeline through out-licensing partnerships, today announced that the Moores Cancer Center at the University of California San Diego (UCSD) has filed an Investigational New Drug Application with the U.S. Food & Drug Administration ("FDA") for approval to test Nupen, Apricus Bio's proprietary, topical NexACT-based formulation of filgrastim (Neupogen).

15 Oct 2010

EFNS recommends use of DaTSCAN injection with SPECT imaging for AD diagnosis

GE Healthcare, a unit of General Electric Company, today announced that DaTSCAN (ioflupane I 123 injection), a radiopharmaceutical agent intended for use with single photon emission computed tomography (SPECT) imaging of the brain, has been recommended in updated European Federation of the Neurological Societies (EFNS) guidelines for the diagnosis and management of Alzheimer's disease (AD). The guidelines appear in the October issue of the European Journal of Neurology.

14 Oct 2010

Alimera to present Iluvien Phase 3 clinical trial data at AAO annual meeting

Alimera Sciences, Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that data from its Phase 3 (FAME) clinical trials for Iluvien will be presented this month at the annual meeting of the American Academy of Ophthalmology (AAO) in Chicago.

12 Oct 2010

ArQule announces SPA with FDA for ARQ 197 Phase 3 trial design for NSCLC

ArQule, Inc. today announced a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for the design of a Phase 3 trial of ARQ 197 in patients with non-small cell lung cancer (NSCLC) of non-squamous histology.

11 Oct 2010

Valeant announces Alexza's receipt of FDA CRL for AZ-004 NDA

Valeant Pharmaceuticals International, Inc. announced today that Alexza Pharmaceuticals, Inc. has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding Alexza's New Drug Application (NDA) for AZ-004 (Staccato® loxapine) submitted as Adusuve™ Staccato® (loxapine) inhalation aerosol, 5 mg and 10 mg.

11 Oct 2010

BioSante presents update on LibiGel clinical study at NAMS Annual Meeting

BioSante Pharmaceuticals, Inc. presented a LibiGel clinical study update at the 21st Annual Meeting of The North American Menopause Society (NAMS) on October 8, 2010, with more than 1,000 experts and practitioners in menopause and women's health in attendance.

11 Oct 2010

FDA issues CRL for AZ-004 NDA application

Alexza Pharmaceuticals, Inc. announced today that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA or Agency) regarding its New Drug Application (NDA) for AZ-004 (Staccato loxapine), submitted as Adusuve Staccato (loxapine) inhalation aerosol, 5 mg and 10 mg.

11 Oct 2010

FDA issues CRL to Jazz for JZP-6 NDA for fibromyalgia

Jazz Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has sent the company a complete response letter (CRL) regarding the company's New Drug Application (NDA) for JZP-6 (sodium oxybate) for the treatment of fibromyalgia. The CRL states that the FDA cannot approve the NDA in its present form.

11 Oct 2010

Endo grants Watson royalty-free license to U.S. patents

Watson Pharmaceuticals, Inc. today announced that its subsidiary, Watson Laboratories, Inc. has reached a settlement with Endo Pharmaceuticals, Inc. on outstanding patent litigation related to Endo's Opana ER (Oxymorphone ER) product.

8 Oct 2010

NIAID announces three new contracts to fund research on dengue, anthrax vaccines

The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, today announced three new contracts to fund research on vaccines to protect against emerging infectious diseases and biological threats that could be used in a terror attack. Each project focuses on simple and efficient vaccine delivery approaches that could be deployed quickly. The total funding for the three contracts could reach $68 million, depending on the successful completion of defined project milestones.

8 Oct 2010

USPTO issues Patent Notice of Allowance for CIP-TRAMADOL ER drug

Cipher Pharmaceuticals Inc. today announced that the U.S. Patent and Trademark Office has issued a Patent Notice of Allowance for CIP-TRAMADOL ER, the Company's extended-release tramadol product for the treatment of moderate to moderately severe chronic pain in adults.

8 Oct 2010

ARCA receives European Patent for bucindolol based treatment for heart failure

ARCA biopharma, Inc. a biopharmaceutical company developing genetically-targeted therapies for heart failure and other cardiovascular diseases, today announced that the European Patent Office has issued a patent on methods of treating heart failure patients with bucindolol based on genetic targeting.

8 Oct 2010

Onyx Pharmaceuticals announces delay in NDA filing for carfilzomib

Onyx Pharmaceuticals, Inc. today announced that it will delay its New Drug Application (NDA) filing for carfilzomib based on a recent meeting with the Chemistry, Manufacturing and Controls (CMC) review division of the U.S. Food and Drug Administration (FDA).

7 Oct 2010