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.

Genzyme gets FDA Complete Response Letter for Lemtrada sBLA

Genzyme, a Sanofi company, announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration for its supplemental Biologics License Application seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis.

30 Dec 2013

Australian Therapeutic Goods Administration approves Genzyme's Lemtrada for multiple sclerosis

Genzyme, a Sanofi company, announced today that the Australian Therapeutic Goods Administration has approved Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis for patients with active disease defined by clinical or imaging features to slow the accumulation of physical disability and reduce the frequency of clinical relapses.

19 Dec 2013

Celgene subsidiary presents REVLIMID study results on lymphoma at ASH annual meeting

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ:CELG) today announced that results from two studies of REVLIMID (lenalidomide) combinations in patients with diffuse large B-cell lymphoma (DLBCL) were presented at the American Society of Hematology annual meeting in New Orleans, La.

11 Dec 2013

Investigational c-Met inhibitor shows early promise in NSCLC

A first-in-class drug that inhibits c-Met, a receptor tyrosine kinase, has demonstrated good tolerability when combined with erlotinib in the treatment of Japanese patients with advanced/metastatic non-small-cell lung cancer.

3 Dec 2013

Forest Laboratories to acquire exclusive rights in the U.S. for Saphris sublingual tablets

Forest Laboratories Holdings Limited, a wholly owned subsidiary of Forest Laboratories, Inc. today announced that the company is acquiring exclusive rights in the United States for Saphris (asenapine) sublingual tablets, a treatment for adult patients with schizophrenia or acute bipolar mania, from Merck Sharp & Dohme B.V., a wholly owned subsidiary of Merck & Co., Inc.

3 Dec 2013

CHMP adopts positive opinion for ABRAXANE with gemcitabine for treatment of metastatic pancreas

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, today announced that the European Medicines Agency's: Committee for Medicinal Products for Human Use has adopted a positive opinion for ABRAXANE (paclitaxel formulated as albumin bound nanoparticles, or nab-paclitaxel) in combination with gemcitabine for first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.

25 Nov 2013

European Commission grants marketing authorization for Bayer HealthCare's Xofigo injection

Bayer HealthCare announced today that the European Commission has granted marketing authorization for Xofigo (radium Ra 223 dichloride) solution for injection for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. This decision follows a positive recommendation from the European Committee for Medicinal Products for Human Use in September of this year.

15 Nov 2013

ARIAD temporarily suspends commercial distribution of Iclusig drug in US

ARIAD Pharmaceuticals, Inc. today announced that it is temporarily suspending the marketing and commercial distribution of Iclusig® (ponatinib), a treatment for patients with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL), in the United States, while it continues to negotiate updates to the U.S. prescribing information for Iclusig and implementation of a risk mitigation strategy.

31 Oct 2013

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