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Trius Therapeutics reaches agreement with FDA under SPA for Phase 3 study of torezolid phosphate for ABSSSI

Trius Therapeutics, Inc. announced today that it has reached agreement with the United States Food and Drug Administration (FDA), under the Special Protocol Assessment (SPA) process, on the design of its planned Phase 3 study for the oral dosage form of torezolid phosphate for treatment of acute bacterial skin and skin structure infections (ABSSSI).

16 Jun 2010

Relypsa commences enrollment for RLY5016 Phase 2 study in heart failure patients with chronic kidney disease

Relypsa, Inc., today announced the initiation of patient enrollment in a Phase 2, open-label titration clinical study of the company's lead drug candidate, RLY5016, in heart failure patients with chronic kidney disease. RLY5016 is a novel non-absorbed oral potassium binder intended to prevent and treat hyperkalemia, a serious condition characterized by elevated serum potassium levels.

16 Jun 2010

VIVUS to present data on Qnexa at ENDO meeting

VIVUS, Inc. today announced that data on Qnexa, an investigational drug candidate, will be presented at the Endocrine Society's 92nd Annual Meeting and Expo in San Diego, California. Timothy Garvey, M.D., professor of medicine and chair of the department of nutrition sciences at the University of Alabama at Birmingham and a Qnexa investigator, will deliver an oral presentation at the Clinical Trials Symposium on Saturday, June 19, entitled: "Once-Daily, Low-Dose, Controlled-Release Phentermine/Topiramate Demonstrates Significant Improvement in Weight, Related Risk in Overweight/Obese Patients with Comorbidities."

16 Jun 2010

Abbott, Neurocrine enter collaboration to develop, commercialize elagolix for endometriosis-related pain

Abbott and Neurocrine Biosciences, Inc. today announced that they have entered into a collaboration agreement to develop and commercialize elagolix for the treatment of endometriosis-related pain. Elagolix is a novel, first-in-class oral gonadotropin-releasing hormone (GnRH) antagonist, which has recently completed a phase IIb study in endometriosis. In addition to endometriosis, elagolix will be evaluated for the treatment of uterine fibroids.

16 Jun 2010

Topical NSAIDs are safe and effective for acute pain: Researchers

Gels, creams and sprays containing painkillers such as ibuprofen, diclofenac, ketoprofen, and piroxicam are safe and effective treatments for local pain, according to Cochrane Researchers. A new systematic review they have conducted shows that topical non-steroidal anti-inflammatory drugs are more effective than placebos for treating short-term pain and have few side effects.

16 Jun 2010

UT Southwestern head and neck cancer surgeons perform area's first transoral robotic surgery

Head and neck cancer surgeons at UT Southwestern Medical Center performed the area's first transoral robotic surgery (TORS), a recently approved minimally invasive no-scar procedure to remove tumors in the throat.

16 Jun 2010

Bayer sues Teva, Barr in connection with oral contraceptive Gianvi

Today, Bayer HealthCare Pharmaceuticals Inc. and Bayer Schering Pharma AG sued Teva Pharmaceuticals USA, Inc., Barr Pharmaceuticals LLC, and Barr Laboratories, Inc. in the Northern District of Illinois (Chicago) for false advertising and patent infringement in connection with Teva's generic oral contraceptive, Gianvi™. Teva's product is sold as a generic version of Bayer HealthCare's leading oral contraceptive YAZ®.

16 Jun 2010

Galera Therapeutics completes Series 1 financing

Galera Therapeutics, a drug development company focused on novel therapeutics to protect against the side effects and increase the effectiveness of cancer treatment, today announced it has completed a Series 1 financing led by BioGenerator. Also participating in the round is Galera Angels, LLC, an angel investment group, and Analytical Bio-Chemistry Laboratories, Inc., of Columbia Missouri.

16 Jun 2010

Biogen Idec initiates enrollment in Phase II BG-12 combination trial for relapsing-remitting multiple sclerosis

Biogen Idec today announced enrollment of the first patient in a multicenter Phase II clinical trial designed to evaluate its investigational oral therapy BG-12 (dimethyl fumarate) in combination with commonly used first-line treatments in patients with relapsing-remitting multiple sclerosis (RRMS).

15 Jun 2010

EMA COMP grants orphan medicinal product designation for Raptor's DR Cysteamine for cystinosis

Raptor Pharmaceutical Corp., announced that the European Medicines Agency's ("EMA") Committee for Orphan Medicinal Products ("COMP") has issued a positive opinion recommending orphan medicinal product designation for DR Cysteamine for the potential treatment of cystinosis.

15 Jun 2010

Comprehensive source for treatment information of atrial fibrillation in the European market

Arlington Medical Resources, a provider of premier market intelligence for the pharmaceutical and diagnostic imaging industries, finds that electrical cardioversion usage patterns in Europe differed dramatically by country in the fourth quarter of 2009. While ECV represented almost half of all cardioversion attempts in Germany, in Spain ECV accounted for only 13% of cardioversion attempts.

15 Jun 2010

Aeterna Zentaris to present poster on AEZS-130 growth hormone secretagogue/ghrelin receptor agonist at 92nd ENDO

Aeterna Zentaris Inc. a late-stage drug development company specialized in oncology and endocrine therapy, today announced that a poster on its oral synthetic growth hormone secretagogue/ghrelin receptor agonist, AEZS-130, will be presented at the upcoming 92nd Annual Endocrine Society (ENDO) Meeting and Expo, which will be held June 19 through 22, 2010 at the San Diego Convention Center in San Diego, California.

15 Jun 2010

Micromet's blinatumomab demonstrates potential to change outcome for patients with ALL

Micromet, Inc. today announced the presentation of updated results from a Phase 2 trial of the Company's lead product candidate blinatumomab (MT103) in adult patients with minimal residual disease (MRD) positive acute lymphoblastic leukemia (ALL). Results of the analysis demonstrate that a prolonged hematologic relapse free survival was observed in patients treated with blinatumomab.

15 Jun 2010

UCB announces availability of Vimpat oral solution formulation

UCB today announced the availability of an oral solution formulation of Vimpat- (lacosamide) C-V, an antiepileptic drug (AED) for add-on treatment of partial-onset seizures in people with epilepsy age 17 years and older. Vimpat 10 mg/mL solution is now available in U.S. pharmacies.

14 Jun 2010

Calistoga Pharmaceuticals presents CAL-101 PI3K inhibitor data at European Hematology Association Congress

Calistoga Pharmaceuticals, Inc., the leader in the development of isoform-selective phosphatidylinositol 3 kinase (PI3K) inhibitors for the treatment of cancer and inflammatory diseases, today presented preclinical and clinical data on CAL-101, the Company's oral, delta selective PI3K inhibitor at the 15th Congress of the European Hematology Association in Barcelona, Spain.

14 Jun 2010

Updated Phase 1 trial results of blinatumomab in patients with relapsed NHL presented at EHA 2010

Micromet, Inc. today announced the presentation of updated results from a Phase 1 trial of the Company's lead product candidate blinatumomab (MT103) in patients with relapsed non-Hodgkin's lymphoma. A high objective response rate was maintained among patients treated with blinatumomab using an adapted schedule, comparable to that previously reported in patients receiving constant dosing.

14 Jun 2010

Biodel announces schedule for presentations at 70th Scientific Sessions of American Diabetes Association

Biodel Inc. announced today that the following oral and poster presentations describing results from studies of the company's product candidates will be presented during the 70th Scientific Sessions of the American Diabetes Association this month in Orlando, Florida:

14 Jun 2010

Patients beginning therapy on popular osteoporosis drugs discontinue treatment within 6 months: Report

According to a recent analysis by SDI, a leading healthcare market insight and analytics firm, about half of patients beginning therapy on popular osteoporosis drugs discontinue their treatment within 6 months. Amgen's Prolia, which was recently approved for postmenopausal women with osteoporosis at high risk of fracture, or patients who could not tolerate other osteoporosis therapies, is the newest product to enter the market. Prolia differs from existing therapies as it is given every 6 months via injection.

14 Jun 2010

Chiasma successfully completes Phase I clinical study of Octreolin

Chiasma, Inc., a privately held biopharma company, announced that it has successfully completed a Phase I clinical study evaluating the safety and pharmacokinetics (PK) of its proprietary product Octreolin, which contains the active ingredient octreotide actetate and is administered orally

14 Jun 2010

$Data from Phase 1 study of FOLOTYN in patients with relapsed or refractory CTCL presented at EHA 2010$

Data from Phase 1 study of FOLOTYN in patients with relapsed or refractory CTCL presented at EHA 2010

Allos Therapeutics, Inc. today announced updated data from its ongoing dose finding Phase 1 study of FOLOTYN (pralatrexate injection) in patients with relapsed or refractory cutaneous T-cell lymphoma, a group of often slow-growing non-Hodgkins lymphomas that primarily manifest in the skin. These data were presented during a poster presentation at the European Hematology Association meeting being held June 10-13, 2010 in Barcelona, Spain.

11 Jun 2010

Oral News and Research

Trius Therapeutics reaches agreement with FDA under SPA for Phase 3 study of torezolid phosphate for ABSSSI

Relypsa commences enrollment for RLY5016 Phase 2 study in heart failure patients with chronic kidney disease

VIVUS to present data on Qnexa at ENDO meeting

Abbott, Neurocrine enter collaboration to develop, commercialize elagolix for endometriosis-related pain

Topical NSAIDs are safe and effective for acute pain: Researchers

UT Southwestern head and neck cancer surgeons perform area's first transoral robotic surgery

Bayer sues Teva, Barr in connection with oral contraceptive Gianvi

Galera Therapeutics completes Series 1 financing

Biogen Idec initiates enrollment in Phase II BG-12 combination trial for relapsing-remitting multiple sclerosis

EMA COMP grants orphan medicinal product designation for Raptor's DR Cysteamine for cystinosis

Comprehensive source for treatment information of atrial fibrillation in the European market

Aeterna Zentaris to present poster on AEZS-130 growth hormone secretagogue/ghrelin receptor agonist at 92nd ENDO

Micromet's blinatumomab demonstrates potential to change outcome for patients with ALL

UCB announces availability of Vimpat oral solution formulation

Calistoga Pharmaceuticals presents CAL-101 PI3K inhibitor data at European Hematology Association Congress

Updated Phase 1 trial results of blinatumomab in patients with relapsed NHL presented at EHA 2010

Biodel announces schedule for presentations at 70th Scientific Sessions of American Diabetes Association

Patients beginning therapy on popular osteoporosis drugs discontinue treatment within 6 months: Report

Chiasma successfully completes Phase I clinical study of Octreolin

Data from Phase 1 study of FOLOTYN in patients with relapsed or refractory CTCL presented at EHA 2010

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