Leukopenia News and Research

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Leukopenia is a decrease in the number of white blood cells (leukocytes) found in the blood, which places individuals at increased risk of infection.

ARIAD discontinues Phase 3 EPIC trial of Iclusig in patients with chronic myeloid leukemia

ARIAD Pharmaceuticals, Inc. today announced that it is discontinuing the Phase 3 EPIC (Evaluation of Ponatinib versus Imatinib in Chronic Myeloid Leukemia) trial of Iclusig (ponatinib) in patients with newly diagnosed chronic myeloid leukemia.

18 Oct 2013

FDA approves Cimzia for treatment of adults with active ankylosing spondylitis

UCB announced today that the U.S. Food and Drug Administration has approved Cimzia (certolizumab pegol) for the treatment of adults with active ankylosing spondylitis.

18 Oct 2013

ARIAD announces changes in Iclusig product labeling to reflect updated safety information

ARIAD Pharmaceuticals, Inc. today announced results of its review of updated clinical data from the pivotal PACE trial of Iclusig® (ponatinib) and actions that it is taking following consultations with the U.S. Food and Drug Administration (FDA).

9 Oct 2013

FDA grants accelerated approval of Perjeta for people with HER2-positive early stage breast cancer

The U.S. Food and Drug Administration granted accelerated approval of a Perjeta- (pertuzumab) regimen for neoadjuvant treatment (use before surgery) in people with high-risk, HER2-positive early stage breast cancer.

2 Oct 2013

FDA approves Cimzia (certolizumab pegol) for active psoriatic arthritis

UCB announced today that the U.S. Food and Drug Administration has approved Cimzia (certolizumab pegol) for the treatment of adult patients with active psoriatic arthritis.

30 Sep 2013

CHMP recommends approval of Xofigo for CRPC, symptomatic bone and visceral metastases

Bayer HealthCare announced today that the the European Committee for Medicinal Products for Human Use recommended Xofigo (radium Ra 223 dichloride) for approval with a proposed indication for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.

20 Sep 2013

Boehringer Ingelheim completes patient enrolment for interferon-free hepatitis C treatment

Boehringer Ingelheim today announced the completion of patient enrolment for a Phase IIa clinical trial investigating a new interferon-free, all-oral, direct-acting antiviral combination treatment for patients with genotype-1a chronic hepatitis C virus infection.

10 Sep 2013

Celgene to discontinue treatment with REVLIMID in phase III ORIGIN trial

Celgene Corporation today announced that after consultation with the U.S. Food and Drug Administration Celgene will discontinue treatment with REVLIMID (lenalidomide) in the open-label, phase III ORIGIN trial, which enrolled 450 patients in over 100 sites in 26 countries.

18 Jul 2013

Phase III study: REVLIMID meets primary endpoint in patients newly diagnosed with multiple myeloma

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, today announced that its phase III study (MM-020/IFM 07-01) of REVLIMID (lenalidomide) in combination with dexamethasone in patients newly diagnosed with multiple myeloma met its primary endpoint of progression-free survival.

11 Jul 2013

New study evaluates effectiveness of radioimmunotherapy in lymphoma patients

A new treatment option for patients with relapsing follicular, mantle cell and other indolent B-cell lymphomas has been determined safe and feasible by researchers exploring the potential of a low energy beta-emitter radiopharmaceutical.

11 Jul 2013

Genentech's Perjeta regimen gets FDA Priority Review for HER2-positive early stage breast cancer

Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration has accepted the company's supplemental Biologics License Application for the use of a Perjeta (pertuzumab) regimen before surgery (neoadjuvant treatment) in people with HER2-positive early stage breast cancer.

2 Jul 2013

European Commission amends marketing authorisation for Celgene's REVLIMID

Celgene International Sàrl was today notified that the European Commission has amended the marketing authorisation for REVLIMID. This decision means that REVLIMID is now approved to treat patients with transfusion-dependent anaemia due to low or intermediate-1 risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

17 Jun 2013

Bayer HealthCare to present new data on oncology portfolio at ASCO meeting

Bayer HealthCare announced today that new data on the oncology portfolio, including Nexavar (sorafenib) tablets, Stivarga (regorafenib) tablets and the recently U.S. Food and Drug Administration approved product Xofigo (radium Ra 223 dichloride) injection will be presented at the 49th Annual Meeting of the American Society of Clinical Oncology, May 31 – June 4, in Chicago, IL (USA).

16 May 2013

Prostate cancer drug Xofigo gets FDA approval

The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs.

16 May 2013

Sanofi, Regeneron enroll patients in two sarilumab Phase 3 trials for treatment of RA

Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the COMPARE and ASCERTAIN trials of sarilumab, the first fully human monoclonal antibody directed against the IL-6 receptor, which is delivered by subcutaneous injection every other week, have enrolled their first patients.

15 May 2013

Otsuka receives FDA approval for ABILIFY MAINTENA to treat schizophrenia

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced the U.S. Food and Drug Administration (FDA) has approved ABILIFY MAINTENA (aripiprazole) for extended- release injectable suspension, an intramuscular (IM) depot formulation indicated for the treatment of schizophrenia.

1 Mar 2013

UCB seeks FDA and EMA marketing authorization for Cimzia to treat active psoriatic arthritis

UCB announced today two new regulatory filings with the US Food and Drug Administration (FDA) and with the European Medicines Agency (EMA) to extend the marketing authorization for Cimzia (certolizumab pegol) for the treatment of adult patients with active psoriatic arthritis (PsA) and for adult patients with active axial spondyloarthritis (axSpA).

20 Feb 2013

FDA approves Novartis’ Zortress to prevent organ rejection after liver transplantation in adults

Novartis announced today that the US Food and Drug Administration (FDA) has approved Zortress (everolimus) for the prophylaxis of organ rejection in adult patients receiving a liver transplant.

16 Feb 2013

Boehringer Ingelheim initiates enrollment in Phase III IFN-free HCV trial

Today, Boehringer Ingelheim announced that the first patients have been enrolled in the company's pivotal Phase III interferon (IFN)-free hepatitis C (HCV) clinical trial programme, HCVerso.

18 Jan 2013

FDA grants accelerated approval to ARIAD’s Iclusig for treatment of CML, Ph+ ALL

ARIAD Pharmaceuticals, Inc. today announced that following a priority review, the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Iclusig (ponatinib) for the treatment of adult patients with chronic, accelerated or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior TKI therapy.

14 Dec 2012