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FDA approves NULOJIX

Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) approved NULOJIX, the first selective T-cell costimulation blocker indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant, in combination with basiliximab induction, mycophenolate mofetil (MMF), and corticosteroids.

18 Jun 2011

GE Healthcare announces results of Optison heart ultrasound contrast agent presented at ASE

Today, GE Healthcare Medical Diagnostics announced results of a study that evaluated the cardiopulmonary safety of Optison- (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), a diagnostic ultrasound contrast agent for use in improving suboptimal echocardiograms.

14 Jun 2011

Five guidelines for avoiding ventilators improve pediatric outcomes, reduce costs of care

Guidelines that reduce the use of mechanical ventilation with premature infants in favor of a gentler form of respiratory support can profoundly affect those children's outcomes while reducing the cost of care, according to a team of researchers at Children's Hospital Boston.

13 Jun 2011

Independent investigators report Lymphoseek meets all endpoints in NEO3-09 Phase 3 study

Independent investigators reported today full results from the NEO3-09 study, reaffirming earlier top-line results that showed Lymphoseek met all primary and secondary endpoints and exhibited superior performance to vital blue dye in intraoperative lymphatic mapping (ILM) procedures.

7 Jun 2011

Initial positive results from ZIOPHARM's ZIN-CTI-001 Phase Ib study against advanced melanoma

ZIOPHARM Oncology, Inc. announced today that Douglas J. Schwartzentruber, MD, FACS, of the Indiana University Health Goshen Center for Cancer Care, presented initial positive clinical results from the first-ever treatment demonstrating control over transgene encoding of a therapeutic anticancer protein in humans using a small molecule activator ligand.

7 Jun 2011

United Therapeutics completes oral treprostinil Phase 3 trial on pulmonary arterial hypertension

United Therapeutics Corporation announced today the completion of its FREEDOM-M Phase 3 trial of treprostinil diethanolamine, an investigational sustained release oral formulation of treprostinil, a stable synthetic form of prostacyclin, in patients with pulmonary arterial hypertension (PAH).

6 Jun 2011

Bristol-Myers Squibb's second YERVOY Phase 3 trial on metastatic melanoma meets primary endpoint

Bristol-Myers Squibb Company today announced results from a second Phase 3 randomized, double blind study demonstrating that YERVOY (ipilimumab) prolonged the lives of patients with metastatic melanoma.

6 Jun 2011

Roche, Bristol-Myers Squibb to evaluate YERVOY and vemurafenib treatment for metastatic melanoma

Bristol-Myers Squibb Company announced today it has entered in to a clinical collaboration agreement with Roche to evaluate the utility of Bristol-Myers Squibb's CTLA-4 inhibitor, YERVOY (ipilimumab), in combination with Roche's investigational oral BRAF inhibitor, vemurafenib, in treating patients with a specific type of metastatic melanoma.

4 Jun 2011

New positive Cimzia phase IIIb study data on rheumatoid arthritis presented at EULAR meeting

UCB today announced data which showed that the addition of Cimzia to current therapy was associated with a rapid and consistent clinical response in a diverse group of rheumatoid arthritis (RA) patients.

30 May 2011

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.