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FDA approves Fluzone Intradermal Quadrivalent vaccine to prevent four strains of influenza virus

FDA approves Fluzone Intradermal Quadrivalent vaccine to prevent four strains of influenza virus

Sanofi Pasteur, the vaccines division of Sanofi, today announced that the U.S. Food and Drug Administration has approved the supplemental biologics license application (sBLA) for Fluzone Intradermal Quadrivalent vaccine. [More]
FDA approves Fluzone High-Dose vaccine sBLA to include efficacy data in Prescribing Information

FDA approves Fluzone High-Dose vaccine sBLA to include efficacy data in Prescribing Information

Sanofi Pasteur, the vaccines division of Sanofi, today announced that the U.S. Food and Drug Administration has approved the supplemental biologics license application (sBLA) for Fluzone High-Dose (Influenza Vaccine) to include efficacy data in the Prescribing Information. [More]
Eisai, Helsinn Group announce FDA approval of AKYNZEO for prevention of CINV

Eisai, Helsinn Group announce FDA approval of AKYNZEO for prevention of CINV

Helsinn Group and Eisai Inc. announced today that the Food and Drug Administration (FDA) approved AKYNZEO® for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. [More]
New report shows liquid detergent pods can cause eye injuries to children

New report shows liquid detergent pods can cause eye injuries to children

Liquid laundry and dishwasher detergent pods are an emerging source of chemical exposure in children. When squeezed or bitten into, these pods can burst and send detergent into the mouth, nose, and eyes. [More]
Elusys completes phase 3 clinical program of obiltoxaximab in healthy adult volunteers

Elusys completes phase 3 clinical program of obiltoxaximab in healthy adult volunteers

Elusys Therapeutics, Inc., a biopharmaceutical company developing antibody therapies to treat infectious disease, today announced it has completed three phase 3 healthy adult volunteer safety studies of obiltoxaximab (ETI-204). [More]
FDA approves Contrave extended-release tablets for chronic weight management

FDA approves Contrave extended-release tablets for chronic weight management

Takeda Pharmaceuticals U.S.A., Inc. and Orexigen® Therapeutics, Inc. jointly announced today that the U.S. Food and Drug Administration has approved Contrave® extended-release tablets as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. [More]
SYNERA can help prevent needle stick pain associated with superficial IVs

SYNERA can help prevent needle stick pain associated with superficial IVs

Galen US Incorporated today announced that the U.S. Food and Drug Administration (FDA) recently approved a labeling change that allows SYNERA® (lidocaine and tetracaine) topical patch to be used at home. [More]
New data on Gilotrif and investigational compounds to be presented at 50th ASCO annual meeting

New data on Gilotrif and investigational compounds to be presented at 50th ASCO annual meeting

Boehringer Ingelheim today announced that new data will be presented from 7 abstracts for Gilotrif (afatinib) and investigational compounds, including nintedanib and BI 836845, from its oncology pipeline at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL, on May 30 – June 3, 2014. [More]
Bristol-Myers Squibb to present new immunotherapy study data at ASCO Annual Meeting

Bristol-Myers Squibb to present new immunotherapy study data at ASCO Annual Meeting

Bristol-Myers Squibb Company today announced that new data from studies investigating its immunotherapies in adjuvant and advanced melanoma, non-small cell lung cancer (NSCLC) and metastatic renal cell carcinoma (mRCC) will be presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from May 30-June 3. [More]
Scientists lay groundwork for understanding immune responses in Lyme disease patients

Scientists lay groundwork for understanding immune responses in Lyme disease patients

A team of scientists led by Johns Hopkins and Stanford University researchers has laid the groundwork for understanding how variations in immune responses to Lyme disease can contribute to the many different outcomes of this bacterial infection seen in individual patients. A report on the work appears online April 16 in PLOS One. [More]
NICE recommends FIRMAGON for treating advanced hormone-dependent prostate cancer in adults with spinal metastases

NICE recommends FIRMAGON for treating advanced hormone-dependent prostate cancer in adults with spinal metastases

The National Institute for Health and Care Excellence (NICE) today issued its Final Appraisal Determination (FAD) recommending FIRMAGON (degarelix) as an option for treating advanced hormone-dependent prostate cancer, only in adults with spinal metastases who present with signs or symptoms of spinal cord compression. [More]
Halozyme meets primary endpoint in Hylenex CONSISTENT 1 trial

Halozyme meets primary endpoint in Hylenex CONSISTENT 1 trial

Halozyme Therapeutics, Inc. today announced that the primary endpoint of non-inferiority of A1C levels at six months was met for the CONSISTENT 1 trial. The trial is evaluating Hylenex® recombinant and a new formulation of Hylenex currently under U.S Food and Drug Administration (FDA) review, when used as pretreatment of the insulin infusion site in patients with type 1 diabetes receiving continuous subcutaneous insulin infusion (CSII) in comparison to no pre-treatment. [More]
Bayer enrolls patients for Phase III trial of Stivarga (regorafenib) tablets in colorectal cancer

Bayer enrolls patients for Phase III trial of Stivarga (regorafenib) tablets in colorectal cancer

Bayer HealthCare today announced that the company has begun to enroll patients in the COAST trial studying Stivarga® (regorafenib) tablets in colorectal cancer (CRC) patients with resected liver metastases. [More]
Mallinckrodt announces commercial launch of PENNSAID

Mallinckrodt announces commercial launch of PENNSAID

Mallinckrodt today announced the commercial launch of PENNSAID (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%). PENNSAID 2% is a topical non-steroidal anti-inflammatory drug (NSAID) approved for use in the treatment of the pain of osteoarthritis of the knees. [More]
Erosive GERD treatments: an interview with Professor Joaquim Moraes-Filho, University of São Paulo Medical School

Erosive GERD treatments: an interview with Professor Joaquim Moraes-Filho, University of São Paulo Medical School

Gastroesophageal Reflux Disease (GERD) is a condition that develops when the reflux of stomach contents causes troublesome symptoms and/or complications. [More]
FDA approves New Drug Application for PENNSA 2%

FDA approves New Drug Application for PENNSA 2%

Mallinckrodt today announced that the U.S. Food and Drug Administration has approved the New Drug Application for PENNSAID (diclofenac sodium topical solution) 2% w/w. PENNSAID 2% is a topical non-steroidal anti-inflammatory drug approved for use in the treatment of the pain of osteoarthritis of the knee(s). [More]
GSK receives FDA approval for combination of Mekinist with Tafinlar for treatment of melanoma

GSK receives FDA approval for combination of Mekinist with Tafinlar for treatment of melanoma

GlaxoSmithKline plc announced today that the U.S. Food and Drug Administration (FDA) has approved Mekinist® (trametinib) for use in combination with Tafinlar® (dabrafenib) for the treatment of patients with unresectable melanoma (melanoma that cannot be removed by surgery) or metastatic melanoma (melanoma which has spread to other parts of the body) with BRAF V600E or V600K mutations. [More]
Supraglottic index, teaching program validated

Supraglottic index, teaching program validated

A scoring system known as the supraglottic index is valuable in assessing patients with asthma complicated by laryngopharyngeal reflux, researchers report. [More]
Takeda and Teva announce agreement related to commercialization of glatiramer acetate in Japan

Takeda and Teva announce agreement related to commercialization of glatiramer acetate in Japan

Teva Pharmaceutical Industries Ltd. and Takeda Pharmaceutical Company Limited (Takeda) today announced the signing earlier this year of an agreement in which Teva licensed to Takeda the right to commercialize Teva's innovative glatiramer acetate ( active ingredient) formulation for the treatment of multiple sclerosis, in Japan. [More]
Novartis to present updates on broad cancer portfolio at ASH and SABCS symposiums

Novartis to present updates on broad cancer portfolio at ASH and SABCS symposiums

Novartis will present updates on its broad cancer portfolio with more than 240 abstracts at the upcoming American Society of Hematology (ASH) annual meeting and CTRC-AACR San Antonio Breast Cancer Symposium (SABCS). [More]