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FDA approves Sirion's Zirgan for treating acute herpetic keratitis

Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced today that the US Food and Drug Administration (FDA) has approved its New Drug Application for Zirgan(TM) (ganciclovir ophthalmic gel) 0.15% as a treatment for acute herpetic keratitis (dendritic ulcers). The FDA granted orphan drug designation to Zirgan for this indication in April 2007.

17 Sep 2009

FDA provides Orphan-Drug designation for Keryx' KRX-0401 to treat multiple myeloma

Keryx Biopharmaceuticals, Inc. today announced that KRX-0401 (perifosine) has received Orphan-Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma. In August, the Company announced that it had reached an agreement with the FDA regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial in relapsed/refractory multiple myeloma and that the study is expected to start by year-end.

16 Sep 2009

Matrix Laboratories receives tentative FDA approval for its NDA

Mylan Inc. today announced that its privately held Indian subsidiary, Matrix Laboratories Limited, has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 600 mg/300 mg/300 mg.

16 Sep 2009

KemPharm announces nomination of its second pipeline candidate

KemPharm, Inc. today announced the nomination of its second pipeline candidate, KP201, based on its proprietary ligand activated therapy (LAT) platform. KP201 is a new chemical entity (NCE) for the treatment of pain with the possibility of reduced abuse potential. KP201 joins lead candidate KP106, which is a novel prodrug candidate in development for ADHD.

16 Sep 2009

Extension study data on Fampridine-SR drug

Data from two long-term open-label extension studies of Fampridine-SR show that 86.0% of participants remained on therapy after a maximum treatment time of 15 months in study MS-F204EXT, and 69.5% remained on therapy after a maximum treatment time of 36 months in study MS-F203EXT.

15 Sep 2009

Cell Therapeutics submits Pediatric Investigation Plan to EMEA for pixantrone

Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that it has submitted a Pediatric Investigation Plan (PIP) to the European Medicines Agency (EMEA) as part of the required filing process for approval of pixantrone for treating relapsed or refractory, aggressive non-Hodgkin's Lymphoma (NHL) in Europe. The PIP outlines how the company proposes to study the drug in children in order to benefit child health.

15 Sep 2009

FDA provides a complete response letter for Digestive Care's PANCRECARB

Digestive Care, Inc. (DCI) announced today that the company has received a complete response letter from the U.S. Food and Drug Administration (FDA) and has moved closer to obtaining approval of its New Drug Application (NDA) for PANCRECARB((R) )(pancrelipase) used for the treatment of Exocrine Pancreatic Insufficiency.

15 Sep 2009

Clinical studies reveal treatment with pirfenidone is safe and well-tolerated

InterMune, Inc. (Nasdaq: ITMN) today announced that the results of a comprehensive review of safety data from four clinical studies were presented at the 2009 European Respiratory Society Annual Congress in Vienna, Austria by Dr. Ulrich Costabel of the Ruhrlandklinik, Essen, Germany.

14 Sep 2009

Protalix Biotherapeutics reports completion of its Phase III trial of prGCD

Protalix Biotherapeutics, Inc. (NYSE-Amex: PLX), announced the completion of its pivotal Phase III trial for prGCD, the Company’s proprietary plant-cell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of Gaucher disease. The trial enrolled a total of 31 patients across Europe, North America, South America, Israel and South Africa. No serious adverse events were reported in this trial.

14 Sep 2009

Preliminary results of Phase 2b clinical trial of AZ-104 announced by Alexza Pharmaceuticals

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today announced preliminary results from its 366 patient Phase 2b clinical trial of AZ-104 (Staccato(R) loxapine) in patients with migraine headache.

14 Sep 2009

Mylan Pharmaceutical's ANDA for Teva's Copaxone accepted by FDA (Correction)

Mylan Inc. (Nasdaq: MYL) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Mylan Pharmaceutical Inc.'s abbreviated new drug application (ANDA) for Glatiramer Acetate Injection (20 mg/mL), a generic version of Teva's Copaxone(R), a product indicated for the treatment of multiple sclerosis.

14 Sep 2009

GTx to continue its toremifene Phase III high grade PIN clinical trial for prevention of prostate cancer

GTx, Inc. (Nasdaq: GTXI), today announced that following a planned safety review, an independent Data Safety Monitoring Board (DSMB) has recommended that the company continue as planned the pivotal Phase III clinical trial evaluating toremifene 20 mg for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia (PIN), a precancerous lesion of the prostate.

14 Sep 2009

Phase 3 results of TARGET 1 and TARGET 2 clinical trials released

Salix Pharmaceuticals, Ltd. today announced the successful outcome of two Phase 3, randomized, double-blind, placebo-controlled, multicenter trials, TARGET 1 and TARGET 2, designed to evaluate the efficacy and safety of rifaximin 550 mg TID in the treatment of patients with non-constipation irritable bowel syndrome (non-C IBS).

14 Sep 2009

FOCUS 1 and FOCUS 2 clinical trial results released

Forest Laboratories, Inc today presented at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco new data from a complete analysis of FOCUS 1 and FOCUS 2, two global multicenter Phase III studies of ceftaroline for the treatment of community-acquired pneumonia (CAP) in hospitalized patients.

14 Sep 2009

Abbreviated New Drug Application for nateglinide tablets approved

Par Pharmaceutical Companies, Inc. today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for nateglinide tablets.

11 Sep 2009

New Drug Application for trabectedin approved by the FDA

Centocor Ortho Biotech Products, L.P. today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for trabectedin when administered in combination with DOXIL(R) (doxorubicin HCI liposome injection) for the treatment of women with relapsed ovarian cancer.

11 Sep 2009

FDA approves Supplemental New Drug Application for DOXIL

Centocor Ortho Biotech Products, L.P. today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its Supplemental New Drug Application (sNDA) for DOXIL (doxorubicin HCI liposome injection) in combination with docetaxel for the treatment of women with locally advanced and metastatic breast cancer.

10 Sep 2009

Quatrx' second phase 3 study of ospemifene tablets provides positive results

QuatRx Pharmaceuticals Company, a privately-held biopharmaceutical company, today announced positive efficacy results from the second of two patient cohorts in the second pivotal Phase 3 study for Ophena(TM) (ospemifene tablets), the company's investigational compound in development for the treatment of postmenopausal vulvovaginal atrophy (VVA).

10 Sep 2009

Acorda Therapeutics announces Phase 3 Fampridine-SR trial findings

Data from a long-term open-label extension study from the first Phase 3 Fampridine-SR trial, known as MS-F203, showed that 24.9% of extension study participants with multiple sclerosis (MS) met the criteria as Extension Timed Walk Responders (ETWRs) after one year of treatment and demonstrated improved walking speed over a two year period.

10 Sep 2009

Affymax to complete Hematide Phase 3 clinical study by the end of 2009

Affymax, Inc. today announced that it has notified clinical trial sites to complete treatment of patients in the Phase 3 clinical program for the investigational drug, Hematide, by the end of 2009.

10 Sep 2009