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Supernus SPN-812 Phase IIa U.S. clinical trial in ADHD meets primary endpoints

Supernus Pharmaceuticals, Inc. today announced that its Phase IIa U.S. clinical trial of SPN-812 in adults for the treatment of attention deficit hyperactivity disorder (ADHD) met the primary endpoints of safety and tolerability, and showed statistically significant median reduction versus placebo in both investigator-rated and patient-rated ADHD symptom scores.

11 Mar 2011

FDA approves Lantheus Medical Imaging's SPA for flurpiridaz F-18 Phase 3 trial in coronary artery disease

Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic imaging, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design and planned analysis of a Phase 3 clinical trial for the assessment of myocardial perfusion using Positron Emission Tomography (PET) imaging of flurpiridaz F-18 in patients with suspected or known coronary artery disease (CAD).

11 Mar 2011

CytRx reports $0.4M net income for 2010 vs. $4.8M net loss for 2009

CytRx Corporation, a biopharmaceutical company specializing in oncology, today reported financial results for the 12 months ended December 31, 2010, and provided a business update.

11 Mar 2011

Updated NCCN Guidelines for Breast Cancer outline expanded treatment options

Women with metastatic breast cancer have expanded treatment options for treating the disease and in the prevention of skeletal-related events as outlined in the recently updated NCCN Guidelines™ for Breast Cancer. Robert W. Carlson, MD, of Stanford Comprehensive Cancer Center and chair of the NCCN Guidelines Panel for Breast Cancer, presented these and other notable updates to the NCCN Guidelines at the NCCN 16th Annual Conference on March 10, 2011.

11 Mar 2011

Arena fourth quarter net loss decreases to $28.2 million

Arena Pharmaceuticals, Inc. today reported financial results for the fourth quarter and full year ended December 31, 2010, and reviewed recent developments.

11 Mar 2011

Inhibitex fourth quarter net loss increases to $7.0 million

Inhibitex, Inc. today announced its financial results for the fourth quarter and year ended December 31, 2010, and provided an update on recent clinical and corporate developments.

11 Mar 2011

Majority of men on ADT after prostatectomy gain weight during first year of therapy

Seventy per cent of men who received androgen-deprivation therapy (ADT) after surgery to remove their prostate gland gained significant weight in the first year, putting on an average of 4.2kg, according to a paper in the March issue of the urology journal BJUI.

11 Mar 2011

Simcere files IND with SFDA of China for APX003 to treat cancer

Apexigen, Inc., an emerging biopharmaceutical company focusing on the development of monoclonal antibody therapeutics, announced today that its partner, Simcere Pharmaceutical Group, a leading pharmaceutical company in China, filed an Investigational New Drug application with the State Food and Drug Administration of China to evaluate APX003 as a potential cancer therapy.

11 Mar 2011

Discovery: VPS4A enzyme plays a key role in release of HIV particles

Human Immunodeficiency Virus - which causes AIDS - invades human immune cells and causes them to produce new copies of the virus, which can then infect new cells.

11 Mar 2011

Sanofi-aventis, Regeneron announce results of VEGF Trap Phase III trial in second-line NSCLC

Sanofi-aventis and Regeneron Pharmaceuticals, Inc. announced results from the Phase III VITAL trial evaluating the investigational agent aflibercept (VEGF Trap) for the second-line treatment of non-small cell lung cancer (NSCLC).

11 Mar 2011

FDA approves Matrix NDA for Zidovudine Tablets

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration under the President's Emergency Plan for AIDS Relief for its New Drug Application for Zidovudine Tablets, 100 mg.

10 Mar 2011

Novartis new MS treatment receives Notice of Compliance in Canada

Novartis Pharmaceuticals Canada Inc. announced today that its new MS treatment, Gilenya, has received Notice of Compliance in Canada.

10 Mar 2011

Preliminary phase I trial results show safety of bone marrow stem cells in children with TBI

Stem cells derived from a patient's own bone marrow were safely used in pediatric patients with traumatic brain injury, according to results of a Phase I clinical trial at The University of Texas Health Science Center at Houston.

10 Mar 2011

Avinger completes patient enrollment in CONNECT trial to treat CTOs linked with PAD

Avinger, Inc., medical device manufacturer of innovative, multi-functional catheters for treating patients with peripheral artery disease, announced that it has successfully completed enrollment in its CONNECT clinical trial.

10 Mar 2011

Positive results from exenatide phase 2 study in patients with type 2 diabetes

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced positive results from a phase 2 study evaluating the effects of a once-monthly injectable suspension formulation of exenatide on glycemic control in patients with type 2 diabetes.

10 Mar 2011

Positive results from Creabilis CT327 Phase IIa study in patients with psoriasis vulgaris

Creabilis SA, a clinical stage European biotechnology company addressing unmet medical needs in dermatology, today announced positive results from its Phase IIa study of its lead product CT327 in psoriasis vulgaris.

10 Mar 2011

Scientists identify chemical compound that may lead to cancer-fighting drugs

Researchers at UT Southwestern Medical Center have identified a chemical compound that may eventually lead to a drug that fights cancers that are dependent on a particular anti-viral enzyme for growth.

10 Mar 2011

Ohio officials seek federal permission for use of propoxur to halt bedbug infestations

Mom's comforting tuck-them-in-words - "Sleep tight, don't let the bedbugs bite"- is becoming an impossible dream for millions of people as the world experiences a resurgence of an ancient scourge that is fostering human misery, financial burdens and the risk of exposure to potentially toxic materials. That's the message from the cover story of the current edition of Chemical & Engineering News (C&EN), ACS' weekly newsmagazine.

10 Mar 2011

FDA accepts Tris' Extended Release Carbinoxamine Oral Suspension NDA for allergies in kids

Tris Pharma, a specialty pharmaceutical company that develops innovative drug delivery technologies, announced today that the US Food and Drug Administration (FDA) has accepted its Extended Release Carbinoxamine Oral Suspension NDA for the treatment of allergies in kids two years and older. If approved, Tris Pharma's Extended Release Suspension will provide an alternative to the currently available immediate release formulations.

10 Mar 2011

Stemline's SL-401 receives FDA Orphan Drug designation for treatment of acute myeloid leukemia

Stemline Therapeutics, Inc. today announced that SL-401, the Company's lead compound, has received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML).

10 Mar 2011

Efficacy News and Research

Supernus SPN-812 Phase IIa U.S. clinical trial in ADHD meets primary endpoints

FDA approves Lantheus Medical Imaging's SPA for flurpiridaz F-18 Phase 3 trial in coronary artery disease

CytRx reports $0.4M net income for 2010 vs. $4.8M net loss for 2009

Updated NCCN Guidelines for Breast Cancer outline expanded treatment options

Arena fourth quarter net loss decreases to $28.2 million

Inhibitex fourth quarter net loss increases to $7.0 million

Majority of men on ADT after prostatectomy gain weight during first year of therapy

Simcere files IND with SFDA of China for APX003 to treat cancer

Discovery: VPS4A enzyme plays a key role in release of HIV particles

Sanofi-aventis, Regeneron announce results of VEGF Trap Phase III trial in second-line NSCLC

FDA approves Matrix NDA for Zidovudine Tablets

Novartis new MS treatment receives Notice of Compliance in Canada

Preliminary phase I trial results show safety of bone marrow stem cells in children with TBI

Avinger completes patient enrollment in CONNECT trial to treat CTOs linked with PAD

Positive results from exenatide phase 2 study in patients with type 2 diabetes

Positive results from Creabilis CT327 Phase IIa study in patients with psoriasis vulgaris

Scientists identify chemical compound that may lead to cancer-fighting drugs

Ohio officials seek federal permission for use of propoxur to halt bedbug infestations

FDA accepts Tris' Extended Release Carbinoxamine Oral Suspension NDA for allergies in kids

Stemline's SL-401 receives FDA Orphan Drug designation for treatment of acute myeloid leukemia

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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