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Enrollment stopped in one of two global necitumumab Phase III studies in NSCLC

Eli Lilly and Company and Bristol-Myers Squibb Company announced today that they have stopped enrollment in one of their two global Phase III studies evaluating necitumumab, an investigational anti-cancer agent, as a first-line treatment for advanced non-small cell lung cancer (NSCLC).

3 Feb 2011

Celgene announces regulatory submissions for blood cancer therapies REVLIMID and ISTODAX

Celgene International Sàrl announced regulatory submissions for its blood cancer therapies REVLIMID (lenalidomide) and ISTODAX (romidepsin).

5 Jan 2011

New guideline provides evidence-based recommendation for children undergoing tonsillectomy

A multidisciplinary clinical practice guideline, "Tonsillectomy in Children" will be published in the January issue of Otolaryngology-Head and Neck Surgery.

3 Jan 2011

New report indicates that struggling economy may have reduced use of preventive care

A new report released by non-profit health care organization MN Community Measurement, indicates that the struggling economy may have reduced the use of preventive care, including breast cancer screenings and childhood immunizations, as well as the on-going care needed for chronic diseases like diabetes and vascular disease.

9 Dec 2010

Data from comparative REVLIMID study in multiple myeloma presented at 52nd ASH

Celgene International Sàrl today announced that data from a randomised clinical study conducted by the Eastern Cooperative Oncology Group (ECOG) were presented at the 52nd Annual Meeting of the American Society of Hematology comparing REVLIMID® (lenalidomide) plus low-dose dexamethasone (Rd) to lenalidomide plus high-dose dexamethasone (RD) in both younger and older newly-diagnosed multiple myeloma patients (NDMM).

7 Dec 2010

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

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

Teva presents QNAZE Phase III study results for SAR at ACAAI Meeting

Teva Pharmaceutical Industries Ltd. today announced results from a Phase III study of QNAZE (beclomethasone dipropionate [BDP]) HFA, a nasal aerosol corticosteroid in development for the treatment of seasonal allergic rhinitis (SAR), that demonstrated significantly greater symptom relief compared with placebo.

15 Nov 2010

Acton submits Manufacturing Supplement to FDA for AEROSPAN Inhalation Aerosol

Acton Pharmaceuticals, Inc. today announced that it has submitted to the U.S. Food and Drug Administration (FDA), a Manufacturing Supplement to the previously approved AEROSPAN Inhalation Aerosol NDA.

4 Nov 2010

FDA approves Gamunex-C for primary immunodeficiency treatment

Talecris Biotherapeutics announced today that the U.S. Food and Drug Administration (FDA) approved Gamunex-C (Immune Globulin Injection [Human], 10% Caprylate/Chromatography Purified) for subcutaneous administration in the treatment of primary immunodeficiency (PI).

15 Oct 2010

Eli Lilly presents ALIMTA Phase III trial results at ESMO Annual Meeting

Eli Lilly and Company announced today that its global Phase III trial evaluating ALIMTA (pemetrexed for injection) in combination with cisplatin in patients with recurrent or metastatic squamous cell cancer of the head and neck (SCCHN) did not meet its primary endpoint for overall survival. Data were presented for the first time today at the 35th Annual Meeting of the European Society for Medical Oncology (ESMO).

11 Oct 2010

Data shows Take Care Clinics’ quality of care exceeds national benchmarks

Take Care Health Systems, a wholly-owned subsidiary of Walgreens and the nation's largest and most comprehensive manager of convenient care clinics and worksite health and wellness centers, today announced that an analysis of de-identified data collected through the company's electronic medical record (EMR) system by the Jefferson School of Population Health showed that the quality of care delivered in Take Care Clinics for treatment of pharyngitis (inflammation of the throat) and upper respiratory infections (URI) meets or exceeds the quality of the care delivered in other settings.

5 Oct 2010

Takeda underscores commitment to ACTOS following FDA and EMA announcements for rosiglitazone

Following today’s announcements by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for rosiglitazone in the U.S. and Europe, Takeda Pharmaceuticals North America, Inc. and Takeda Pharmaceuticals Europe Limited underscore the company’s commitment to ACTOS® (pioglitazone HCl) and ACTOS-containing medications, and to the millions of people living with type 2 diabetes.

24 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

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

Education, changes in reimbursement practices can reduce inappropriate antibiotic usage: Study

Improved drug coverage under Medicare Part D has led to an increase in the use of antibiotics by seniors, particularly of brand-name and more expensive drugs, according to a University of Pittsburgh Graduate School of Public Health study. Published in the Aug. 23 issue of Archives of Internal Medicine and the first to explore spending on antibiotics under Medicare Part D, the study suggests recent changes in drug coverage improved the use of antibiotics for pneumonia, but could lead to unnecessary spending on expensive broad-spectrum antibiotics and the overuse of inappropriate antibiotics.

11 Aug 2010

Study suggests reimbursements can address inappropriate antibiotic usage

Antibiotic use appears to have increased among older adults whose prescription drug coverage improved as a result of enrolling in Medicare Part D, with the largest increases for broad-spectrum, newer and more expensive drugs, according to a report in the August 9/23 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

10 Aug 2010

Victory Pharma acquires assets of MiddleBrook Pharmaceuticals

Victory Pharma, Inc. today announced that it has completed the acquisition of substantially all of the assets of MiddleBrook Pharmaceuticals, Inc..

4 Aug 2010

Teva Respiratory reports positive results from BDP HFA Nasal Aerosol Phase III trial in seasonal allergic rhinitis

Teva Respiratory today announced positive results from a Phase III trial evaluating the efficacy and safety of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) Nasal Aerosol in the treatment of seasonal allergic rhinitis (SAR). The study met all efficacy endpoints, demonstrating a statistically significant benefit as compared to placebo. Furthermore, the safety profile of BDP HFA Nasal Aerosol was similar to placebo.

29 Jul 2010