Thalidomide News and Research

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Thalidomide is a drug that is used to treat multiple myeloma in patients who have just been diagnosed, and a painful skin disease related to leprosy. It is also being studied in the treatment of other types of cancer. Thalidomide belongs to the family of drugs called angiogenesis inhibitors. Also called Thalomid.

Study: REVLIMID and dexamethasone for high-risk smoldering multiple myeloma reduce risk of disease progression

Celgene International Sàrl (NASDAQ: CELG) announced that data evaluating combination therapy REVLIMID® (lenalidomide) and dexamethasone in patients with high-risk asymptomatic smoldering multiple myeloma were presented during the American Society of Hematology's annual meeting. The study reported REVLIMID and dexamethasone prolonged time to progression.

6 Dec 2010

New studies answer questions related to stem cell transplant procedures in treating hematologic malignancies

Results from four innovative studies help answer outstanding questions about stem cell transplant procedures in treating various hematologic malignancies. Research that will be presented today at the 52nd Annual Meeting of the American Society of Hematology reveals that there is no increase in overall cancer risk in people who donate stem cells and that the utilization of a double cord blood stem cell transplant is associated with better overall outcomes when used early in the treatment of acute leukemias.

6 Dec 2010

Investigational study data of REVLIMID with rituximab or rituximab-containing regimen in CLL patients presented at ASH

Celgene International Sàrl announced that clinical data from two investigational studies evaluating the use of REVLIMID (lenalidomide) either with rituximab or following a rituximab-containing regimen in patients with chronic lymphocytic leukaemia were presented at the 52nd American Society of Hematology annual meeting.

6 Dec 2010

Celgene third quarter non-GAAP total revenue increases 31% to $908 million

Celgene Corporation announced non-GAAP net income of $349.9 million, or non-GAAP diluted earnings per share of $0.75 for the quarter ended September 30, 2010.

28 Oct 2010

Incyte Corporation enters SPA agreement with FDA for INCB18424 inhibitor

Incyte Corporation announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase III trial for its JAK1 and JAK2 inhibitor, INCB18424 in patients with polycythemia vera (PV), a blood cancer that belongs to a group of diseases known as myeloproliferative neoplasms (MPNs).

13 Sep 2010

Morning sickness treatment still elusive: Review

According to experts we are nowhere near establishing safe and effective ways to treat morning sickness. Since the Thalidomide disaster in 1960’s that led to severe birth defects in the infants, this area of research is scary and less explored by many researchers. Despite its name, the vomiting and nausea of morning sickness can occur at any time of the day and affect about half of pregnant women. Between 70% and 85% of women will experience nausea during pregnancy, with about half suffering vomiting. Around 2% will experience it so badly they need to be hospitalised.

7 Sep 2010

Celgene receives Paragraph IV Certification Letter on submission of ANDA for REVLIMID

Celgene Corporation today announced it has received a Paragraph IV Certification Letter advising that Natco Pharma Limited of Hyderabad, India, submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration. The application requests authorization to manufacture and market generic versions of REVLIMID (lenalidomide) 5, 10, 15 and 25 mg capsules in the United States.

3 Sep 2010

NICE suggests bortezomib, thalidomide for multiple myeloma patients

The National Institute for Health and Clinical Excellence (NICE) has released draft guidance which recommends the drugs bortezomib and thalidomide as first-line therapies for some patients with multiple myeloma, a type of cancer that affects cells in the bone marrow.

27 Aug 2010

Celgene to enforce REVLIMID intellectual property rights following receipt of Paragraph IV notification letter

Celgene Corporation today announced that information was posted on the FDA Web site indicating that an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a "Paragraph IV" patent certification, for REVLIMID (lenalidomide) 25 mg capsules. Celgene has not yet received the Paragraph IV notification letter identifying the filer.

25 Aug 2010

Celgene receives Japan's MHLW approval for REVLIMID in deletion 5q myelodysplastic syndrome patients

Celgene International Sàrl announced that REVLIMID (lenalidomide) has been granted full marketing authorization by Japan's Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenic abnormality. REVLIMID was also approved in June 2010 in combination with dexamethasone, for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior standard therapy.

20 Aug 2010

Celgene second-quarter non-GAAP total revenue increases 36% to $850 million

Celgene Corporation announced non-GAAP net income of $323.3 million, or non-GAAP diluted earnings per share of $0.69 for the quarter ended June 30, 2010. Non-GAAP net income for the second quarter of 2009 was $216.0 million or non-GAAP diluted earnings per share of $0.46.

29 Jul 2010

Aging thalidomide victims to receive $50 million in compensation

Thalidomide was sold in a number of countries across the world from 1957 until 1961 when it was withdrawn from the market after being found to be a cause of birth defects in what has been called "one of the biggest medical tragedies of modern times".

28 Jul 2010

Onyx reports positive results from carfilzomib Phase 2b 003-A1 study in multiple myeloma

Onyx Pharmaceuticals, Inc. today announced positive top-line results from the Phase 2b 003-A1 study of single-agent carfilzomib, a selective, next generation proteasome inhibitor, in patients with relapsed and refractory multiple myeloma.

26 Jul 2010

Japan's MHLW grants full marketing authorization to REVLIMID

Celgene International Sàrl announced that REVLIMID (lenalidomide) has been granted full marketing authorization by Japan's Ministry of Health, Labour and Welfare for use in combination with dexamethasone as a treatment for patients with relapsed or refractory multiple myeloma who have received at least one prior standard therapy. This marketing authorization represents the first regulatory approval of REVLIMID in Japan.

25 Jun 2010

Phase III study of REVLIMID for treating patients with multiple myeloma shows improvement in PFS

Celgene International Sàrl announced that data from the planned second interim analysis (median follow-up of 21 months) of a phase III, randomized, double-blind study of continuous REVLIMID (lenalidomide) for the treatment of elderly patients with newly diagnosed multiple myeloma show improvement in progression-free survival, the primary endpoint of the study.

14 Jun 2010

Clinical data from investigational study of patients with multiple myeloma presented at ASCO

Celgene International Sàrl announced clinical data from an investigational study of patients with multiple myeloma who were younger than 65 years old and received either lenalidomide (REVLIMID), melphalan and prednisone or melphalan plus autologous stem cell transplant (MEL200) following an induction treatment of lenalidomide plus low-dose dexamethasone (Rd) were presented at the American Society of Clinical Oncology annual meeting.

11 Jun 2010

Researchers present data from Phase II study of lenalidomide in patients with untreated CLL at ASCO

Celgene International Sàrl today announced that researchers presented data from an investigator-initiated Phase II study of lenalidomide (REVLIMID) in untreated patients with chronic lymphocytic leukemia at the annual meeting of the American Society of Clinical Oncology.

8 Jun 2010

Millennium reports on data of VELCADE for multiple myeloma from 2010 ASCO oral presentations

Millennium: The Takeda Oncology Company today reported on data from oral presentations of VELCADE® (bortezomib) for Injection based therapy in multiple myeloma presented at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO). These data highlight VELCADE based therapy in both transplant and non-transplant eligible previously untreated multiple myeloma patients, as well as VELCADE used as induction and/or maintenance therapy.

7 Jun 2010

Onyx reports encouraging ORR from ongoing Carfilzomib Phase 2 study for multiple myeloma

Onyx Pharmaceuticals, Inc. today announced interim results from an ongoing Phase 2 study, known as the 004 study. Carfilzomib, a selective, next-generation proteasome inhibitor, demonstrated encouraging overall response rates (ORR), tolerability and durable disease control when administered as a single-agent in patients with relapsed and/or refractory multiple myeloma.

7 Jun 2010

Celgene reports initial data from investigator-initiated study of REVLIMID

Celgene International Sàrl today announced that initial data from an investigator-initiated study of REVLIMID (lenalidomide) plus Rituxan (rituximab) in patients with newly diagnosed indolent B-cell non-Hodgkin's lymphoma (NHL) were presented at the annual meeting of the American Society of Clinical Oncology.

5 Jun 2010

Thalidomide News and Research

Further Reading

Study: REVLIMID and dexamethasone for high-risk smoldering multiple myeloma reduce risk of disease progression

New studies answer questions related to stem cell transplant procedures in treating hematologic malignancies

Investigational study data of REVLIMID with rituximab or rituximab-containing regimen in CLL patients presented at ASH

Celgene third quarter non-GAAP total revenue increases 31% to $908 million

Incyte Corporation enters SPA agreement with FDA for INCB18424 inhibitor

Morning sickness treatment still elusive: Review

Celgene receives Paragraph IV Certification Letter on submission of ANDA for REVLIMID

NICE suggests bortezomib, thalidomide for multiple myeloma patients

Celgene to enforce REVLIMID intellectual property rights following receipt of Paragraph IV notification letter

Celgene receives Japan's MHLW approval for REVLIMID in deletion 5q myelodysplastic syndrome patients

Celgene second-quarter non-GAAP total revenue increases 36% to $850 million

Aging thalidomide victims to receive $50 million in compensation

Onyx reports positive results from carfilzomib Phase 2b 003-A1 study in multiple myeloma

Japan's MHLW grants full marketing authorization to REVLIMID

Phase III study of REVLIMID for treating patients with multiple myeloma shows improvement in PFS

Clinical data from investigational study of patients with multiple myeloma presented at ASCO

Researchers present data from Phase II study of lenalidomide in patients with untreated CLL at ASCO

Millennium reports on data of VELCADE for multiple myeloma from 2010 ASCO oral presentations

Onyx reports encouraging ORR from ongoing Carfilzomib Phase 2 study for multiple myeloma

Celgene reports initial data from investigator-initiated study of REVLIMID

Achieving and maintaining ISO 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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