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U.S. FDA accepts Pfizer's tafamidis NDA for treatment of TTR-FAP

Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for tafamidis meglumine, the company's investigational, novel, oral therapy for the treatment of Transthyretin Familial Amyloid Polyneuropathy.

16 Feb 2012

Valeant receives FDA approval for secondary supplier of Methoxsalen

The FDA has approved the addition of a secondary supplier of Methoxsalen USP, an integral component of a treatment for the relief of moderate to severe psoriasis prescribed under the brand name Oxsoralen-Ultra (methoxsalen) Capsules, USP, 10mg.

15 Feb 2012

Genzyme announces four-year data from eliglustat tartrate phase 2 trial on Gaucher disease type 1

Genzyme, a Sanofi company, announced today four-year follow-up data from patients enrolled in the phase 2 clinical trial for its investigational oral therapy for Gaucher disease type 1 known as eliglustat tartrate.

8 Feb 2012

Takeda launches EDARBYCLOR in the U.S. for treatment of hypertension

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., announced EDARBYCLOR (azilsartan medoxomil and chlorthalidone) is now available by prescription in U.S. pharmacies for the treatment of hypertension to lower blood pressure in adults.

6 Feb 2012

AMAG completes enrollment in Feraheme Phase III program for iron-deficiency anemia

AMAG Pharmaceuticals, Inc. today announced the completion of patient enrollment in the second of the company's two phase III studies that comprise its global registrational program for Feraheme (ferumoxytol) in patients with iron-deficiency anemia (IDA) who are not candidates for oral iron, regardless of the underlying cause.

30 Jan 2012

Voraxaze receives FDA approval for treatment of toxic methotrexate levels

The U.S. Food and Drug Administration today approved Voraxaze (glucarpidase) to treat patients with toxic levels of methotrexate in their blood due to kidney failure.

18 Jan 2012

UCB initiates EXXELERATE study in rheumatoid arthritis

UCB today announced the start of the EXXELERATE study which will evaluate the short- and long-term efficacy of Cimzia (certolizumab pegol) plus methotrexate (MTX) compared with that of Humira(adalimumab) plus MTX in the treatment of moderate to severe rheumatoid arthritis (RA). The start of this study confirms previously announced plans.

21 Dec 2011

Takeda receives FDA approval for EDARBYCLOR to treat hypertension

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., announced that the U.S. Food and Drug Administration (FDA) approved EDARBYCLOR (azilsartan medoxomil and chlorthalidone) for the treatment of hypertension to lower blood pressure in adults.

21 Dec 2011

CDER, Shire enter agreement for ProAmatine clinical trial to treat symptomatic orthostatic hypotension

Shire plc, the global specialty biopharmaceutical company, announces that it has reached an agreement with the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration to conduct additional clinical trials to confirm the clinical benefit of ProAmatine (midodrine HCl), a medicine approved in 1996 under Subpart H for the treatment of symptomatic orthostatic hypotension (SOH).

3 Dec 2011

Study reveals classification scheme for treatment of blunt aortic injury

New research at the University of Washington's (UW) Harborview Medical Center in Seattle reveals a classification scheme for the treatment of blunt aortic injury.

1 Dec 2011

NYU Langone cardiovascular experts present new research findings at AHA 2011

Experts from the Cardiac & Vascular Institute at NYU Langone Medical Center presented new research findings at the American Heart Association Scientific Sessions 2011 held November 12-16, 2011 in Orlando, Florida.

18 Nov 2011

EC approves Pfizer's Vyndaqel to treat Transthyretin Familial Amyloid Polyneuropathy

Pfizer announced today that the European Commission has approved Vyndaqel (tafamidis) for the treatment of Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP) in adult patients with stage 1 symptomatic polyneuropathy.

17 Nov 2011

Feraheme as safe and effective as iron sucrose in patients with anemia, CKD

AMAG Pharmaceuticals, Inc. today announced positive new data from the FIRST head-to-head trial comparing Feraheme (ferumoxytol) Injection for intravenous (IV) use to iron sucrose in patients with iron deficiency anemia and chronic kidney disease.

14 Nov 2011

UCB to sponsor several key sets of Cimzia data on RA at ACR 2011 meeting

UCB, a leading biopharmaceutical company at the forefront of immunology treatment and research, is proud to sponsor several key sets of Cimzia (certolizumab pegol) data at the American College of Rheumatology's 2011 Annual Scientific Meeting in Chicago, November 5-9.

7 Nov 2011

Human Genome Sciences to present abstracts regarding BENLYSTA, SLE at ACR/ARHP meeting

Human Genome Sciences, Inc. announced today that several abstracts related to BENLYSTA (belimumab) and systemic lupus erythematosus will be presented at the annual meeting of the American College of Rheumatology/ Association of Rheumatology Health Professionals, being held in Chicago, IL from November 4 to November 9, 2011.

5 Nov 2011

AMAG reports third quarter total revenues of $17.6 million

AMAG Pharmaceuticals, Inc. today reported unaudited consolidated financial results for the third quarter ended September 30, 2011.

4 Nov 2011

Takeda receives FDA approval for VELCADE sNDA to treat MM

Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VELCADE (bortezomib) for Injection, which updates the label to include additional long-term overall survival (OS) data from the VISTA trial.

2 Nov 2011

UCB to present new data on Cimzia at ACG annual scientific meeting

UCB, a leading biopharmaceutical company at the forefront of immunology treatment and research, will present new data on Cimzia at the American College of Gastroenterology (ACG) Annual Scientific Meeting, taking place in Washington D.C. from October 28 to November 2.

1 Nov 2011

J&JPRD submits NUCYNTA ER sNDA to FDA for DPN associated neuropathic pain

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. announced today that it has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration for NUCYNTA ER (tapentadol) extended-release tablets, an oral analgesic, for the management of neuropathic pain associated with diabetic peripheral neuropathy in adults.

31 Oct 2011

Pfizer releases Phase III study results comparing VFEND-ERAXIS combination to VFEND for IA

Pfizer Inc. today reported the top-line results of an international Phase III clinical trial which compared the combination of VFEND (voriconazole) and ERAXISTM (anidulafungin) to VFEND monotherapy for primary therapy of invasive aspergillosis, a life-threatening invasive fungal infection that can develop as a complication in patients with compromised immune systems.

1 Oct 2011