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FDA grants approval for CSI to complete enrollment in ORBIT II IDE coronary clinical trial

Cardiovascular Systems, Inc. has received FDA approval to complete enrollment of 429 patients in its ORBIT II Investigational Device Exemption clinical trial for a coronary application for its Diamondback 360 System.

25 May 2011

YM BioSciences announces updated interim results from CYT387 Phase I/II trial in myelofibrosis

YM BioSciences Inc., today reported updated interim results for the first 60 patients with high/intermediate-risk myelofibrosis who have completed a minimum of three cycles of treatment (12 weeks) in its ongoing Phase I/II multi-center study.

19 May 2011

Journal of Rheumatology publishes positive results from Cimzia Phase III trial in RA

UCB announced today results from a post hoc analysis of the RAPID 1 study published in the Journal of Rheumatology. The results suggest moderate to severe rheumatoid arthritis patients treated with Cimzia, the only approved PEGylated anti-TNF, together with methotrexate, achieved a rapid response associated with improved long-term outcomes one year after treatment began.

11 May 2011

Abiomed presents PROTECT II study data in percutaneous coronary intervention at SCAI 2011

Abiomed, Inc., a leading provider of breakthrough heart support technologies, today announced results from further 90 day clinical and economic analyses, based on data from the PROTECT II study.

7 May 2011

PolyMedix Phase 1B/2 clinical study data presented at ATVB meeting

PolyMedix, Inc., an emerging biotechnology company focused on developing new therapeutic drugs to treat life-threatening infectious diseases and acute cardiovascular disorders, announced that clinical data with PMX-60056 were presented at the American Heart Association's Arteriosclerosis, Thrombosis, and Vascular Biology Meeting in Chicago on April 28, 2011.

4 May 2011

Millennium submits two VELCADE sNDAs to FDA

Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited today announced that it has submitted two supplemental new drug applications (sNDAs) for VELCADE® (bortezomib) for Injection to the U.S. Food and Drug Administration. The first application seeks to add a subcutaneous route of administration for VELCADE. The second application is for the use of VELCADE in combination with rituximab in patients with relapsed follicular non-Hodgkin lymphoma (NHL).

26 Apr 2011

Baxter enters definitive agreement to acquire Prism

Baxter International Inc. announced today that it has entered into a definitive agreement to acquire privately-held Prism Pharmaceuticals, Inc., a specialty pharmaceutical company based in King of Prussia, PA. Prism Pharmaceuticals has developed and received U.S. Food and Drug Administration (FDA) approval for multiple presentations of NEXTERONE® (amiodarone HCl), an antiarrhythmic agent.

From Baxter International Inc. 18 Apr 2011

Takeda announces EDARBI availability in U.S. pharmacies for hypertension treatment

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., today announced that EDARBI, an angiotensin II receptor blocker approved for the treatment of hypertension, or high blood pressure, is now available by prescription for adults in U.S. pharmacies.

15 Apr 2011

Baxter's ARTISS phase III study results in face lift surgery presented at AAPS meeting

Baxter International Inc. announced today the results of a phase III study evaluating the safety and efficacy of ARTISS in 75 patients.

From Baxter International Inc. 12 Apr 2011

RE-LY trial results suggest Pradaxa capsule reduces risk of stroke in AF patients

Two new retrospective subanalyses of the RE-LY trial, involving Pradaxa capsules, suggested that the reduction in stroke risk achieved with PRADAXA 150mg over warfarin occurred irrespective of CHA2DS2-VASc risk score and the type of non-valvular atrial fibrillation.

5 Apr 2011

Cardioxyl's CXL-1020 preclinical data against heart failure presented at ACC meeting

Cardioxyl Pharmaceuticals, Inc. announced today that it is presenting two abstracts from studies of its lead clinical candidate, CXL-1020, at the American College of Cardiology's 60th Annual Scientific Session & Expo in New Orleans, Louisiana.

5 Apr 2011

Abiomed presents Impella PROTECT II study final results in PCI at ACC and i2 Summit

Abiomed, Inc., a leading provider of breakthrough heart support technologies, today announced the final results from the PROTECT II study, presented by William O'Neill, M.D., Dean of University of Miami and Principal Investigator of PROTECT II, at the American College of Cardiology's 60th Annual Scientific Session and i2 Summit 2011 in New Orleans.

4 Apr 2011

Merck's VICTRELIS phase III study results against HCV presented at EASL annual meeting

Merck, known as MSD outside of the United States and Canada, announced results from several new data analyses from the pivotal Phase III studies evaluating the addition of its investigational oral protease inhibitor VICTRELIS to peginterferon alfa-2b and ribavirin in adult patients with chronic hepatitis C virus genotype 1 infection.

1 Apr 2011

Watson, GeneraMedix receive FDA approval for Nulecit to treat iron deficiency anemia

Watson Pharmaceuticals, Inc. today announced that it is initiating launch activities of Nulecit, following FDA approval of GeneraMedix Inc.'s, Abbreviated New Drug Application.

1 Apr 2011

PHOENIX phase III trial of PHP for distributive shock to continue after positive midpoint recommendation from DMB

The PHOENIX trial is a European, placebo-controlled, Phase III study treating catecholamine-resistant patients in distributive shock with the Nitric Oxide (NO) scavenger Pyridoxalated Haemoglobin Polyoxyethylene Conjugate (PHP). The study was launched by Curacyte AG in Austria, Belgium, Germany, Spain, The Netherlands and in the United Kingdom in 2009.

28 Mar 2011

BMY receives FDA approval for YERVOY to treat metastatic melanoma

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration approved YERVOY 3 mg/kg for the treatment of patients with unresectable or metastatic melanoma.

28 Mar 2011

FDA grants CSI marketing clearance for Stealth 360° Orbital PAD System

Cardiovascular Systems, Inc. has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA), and has begun a limited market release for the Stealth 360°™ Orbital PAD System. The Stealth 360° propels CSI into the forefront of treating peripheral arterial disease (PAD) with a simpler design that gives physicians complete control of device operation.

17 Mar 2011

Chelsea uses PHT's LogPad, SitePad Tablet for clinical study to treat Parkinson's patients with NOH

PHT Corporation announced that Chelsea Therapeutics is using PHT's LogPad System and SitePad Tablet for its ongoing clinical study in Parkinson's disease patients with symptomatic neurogenic orthostatic hypotension.

15 Mar 2011

FDA approves BENLYSTA for active, autoantibody-positive systemic lupus erythematosus

Human Genome Sciences, Inc. and GlaxoSmithKline PLC today announced that the U.S. Food and Drug Administration has approved BENLYSTA® (belimumab) for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy.

10 Mar 2011

Merck to present VICTRELIS phase III study data against HCV at EASL annual meeting

Merck, known as MSD outside of the United States and Canada, announced that several new data analyses from Phase III studies of VICTRELIS, its investigational oral hepatitis C protease inhibitor, will be presented at The International Liver CongressTM / 46th European Association for the Study of the Liver annual meeting.

9 Mar 2011