Pharyngitis News and Research

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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

ACTOS offers safety profile regarding risk of CV events in people with type 2 diabetes: Takeda

The U.S. Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee held a joint meeting primarily focused on reviewing the cardiovascular safety of rosiglitazone, as presented by the FDA and GlaxoSmithKline. Following this two day discussion, Takeda Pharmaceuticals North America, Inc. ("Takeda") underscores its position that ACTOS (pioglitazone HCl) offers an established safety profile regarding the risk of CV events in people living with type 2 diabetes.

16 Jul 2010

Student-led team awarded top honor in 2010 CIMIT Prize in Primary Healthcare competition

Imagine finding out before you leave the pediatrician's office if your child has strep throat, or even something more serious requiring a different treatment. A novel application for applying DNA "nanobarcodes" in a clinical assay could help primary-care physicians quickly and more accurately determine what's causing a patient's acute pharyngitis from an easy throat swab.

9 Jul 2010

Welchol plus metformin combination therapy reduces A1C, LDL-C levels in type 2 diabetes patients

Results of a new study demonstrated that initial combination therapy with Welchol® (colesevelam HCl) 3.75 g/d and metformin (initiated at 850 mg/d; uptitrated to 1700 mg/d thereafter) significantly improved glycemic and lipid control in drug-naive adult type 2 diabetes patients with high LDL cholesterol (LDL-C).

29 Jun 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

Bayer sues Teva, Barr in connection with oral contraceptive Gianvi

Today, Bayer HealthCare Pharmaceuticals Inc. and Bayer Schering Pharma AG sued Teva Pharmaceuticals USA, Inc., Barr Pharmaceuticals LLC, and Barr Laboratories, Inc. in the Northern District of Illinois (Chicago) for false advertising and patent infringement in connection with Teva's generic oral contraceptive, Gianvi™. Teva's product is sold as a generic version of Bayer HealthCare's leading oral contraceptive YAZ®.

16 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