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MSD announces EC approval of SIMPONI (golimumab) for treatment of adult patients with nr-axial SpA

MSD announces EC approval of SIMPONI (golimumab) for treatment of adult patients with nr-axial SpA

MSD (Merck & Co., Inc., Kenilworth, New Jersey, USA) today announced that on 22 June the European Commission approved SIMPONI (golimumab) for the treatment of adult patients with severe, active non-radiographic axial spondyloarthritis (nr-axial SpA). [More]
GSK welcomes U.S. CDC's vote on use of meningococcal group B vaccines

GSK welcomes U.S. CDC's vote on use of meningococcal group B vaccines

GlaxoSmithKline announced today that the U.S. Centers for Disease Control (CDC) Advisory Committee on Immunization Practices (ACIP) voted for a Category B recommendation for meningococcal group B vaccination, including BEXSERO (Meningococcal Group B Vaccine), in individuals aged 16 to 23 (with a preferred age of 16-18). [More]
Phase 3 study shows Vectibix meets primary endpoint in patients with chemorefractory wild-type KRAS mCRC

Phase 3 study shows Vectibix meets primary endpoint in patients with chemorefractory wild-type KRAS mCRC

Amgen today announced that a Phase 3 study evaluating Vectibix (panitumumab) and best supportive care (BSC) met its primary endpoint, demonstrating a statistically significant improvement in overall survival (OS) in patients with chemorefractory wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC) compared to those patients treated with BSC alone. [More]
Allergan agrees to acquire KYTHERA Biopharmaceuticals for $2.1 billion

Allergan agrees to acquire KYTHERA Biopharmaceuticals for $2.1 billion

Allergan plc, a leading global pharmaceutical company, and KYTHERA Biopharmaceuticals, Inc., a biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market, today announced that they have entered into a definitive agreement under which Allergan has agreed to acquire KYTHERA in a cash and equity transaction valued at $75 per KYTHERA share, or approximately $2.1 billion. [More]
Boehringer announces LUX-Lung 8 data that compares efficacy of afatinib, erlotinib in patients with advanced SCC

Boehringer announces LUX-Lung 8 data that compares efficacy of afatinib, erlotinib in patients with advanced SCC

Boehringer Ingelheim today announced overall survival (OS) results from the LUX-Lung 8 trial (NCT01523587) that directly compared the efficacy and safety of two EGFR-directed treatments, afatinib and erlotinib, in patients with advanced squamous cell carcinoma (SCC) of the lung, progressing after treatment with first-line chemotherapy. Treatment with afatinib significantly reduced the risk of death by 19%, extending the survival of patients to a median of 7.9 months compared to 6.8 months on erlotinib. [More]
Pharmacyclics’ Ibrutinib Phase Ib/II data show ibrutinib may be safe and effective in patients with cGVHD

Pharmacyclics’ Ibrutinib Phase Ib/II data show ibrutinib may be safe and effective in patients with cGVHD

Pharmacyclics LLC today announced interim results from the ongoing Phase Ib/II PCYC-1129 study suggesting that ibrutinib (IMBRUVICA) may be a safe and effective treatment for patients with chronic graft-versus-host-disease (cGVHD) who were either refractory to steroid treatment or were steroid-dependent. [More]
Orexigen Therapeutics provides update on business and financial results for Q1 2015

Orexigen Therapeutics provides update on business and financial results for Q1 2015

Orexigen Therapeutics, Inc. today announced business and financial results for the first quarter ended March 31, 2015. [More]
New simeprevir clinical data to be presented at EASL's International Liver Congress 2015

New simeprevir clinical data to be presented at EASL's International Liver Congress 2015

Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, today announced that clinical data for simeprevir, its NS3/4A protease inhibitor for the treatment of hepatitis C virus (HCV) infection, will be presented at The International Liver Congress 2015 of the European Association for the Study of the Liver taking place in Vienna from April 22-26. [More]
Merck announces availability of GARDASIL 9 HPV vaccine in Canada

Merck announces availability of GARDASIL 9 HPV vaccine in Canada

Merck, known as MSD outside the United States and Canada, announced today that GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), Merck's 9-valent human papillomavirus (HPV) vaccine, is now available in Canada. [More]
Elusys presents positive results of obiltoxaximab for treating inhalational anthrax, post-exposure prophylaxis

Elusys presents positive results of obiltoxaximab for treating inhalational anthrax, post-exposure prophylaxis

Elusys Therapeutics, Inc. (Elusys), a biopharmaceutical company developing antibody therapies to treat infectious disease, presented data demonstrating that obiltoxaximab (ETI-204) demonstrated a statistically significant survival benefit across a range of disease severity in animal model studies assessing treatment of inhalational anthrax, as well as effectiveness in post-exposure prophylaxis. [More]
Sebacia reports positive clinical results from two independent studies in people with acne

Sebacia reports positive clinical results from two independent studies in people with acne

Sebacia, Inc., a company dedicated to delivering breakthrough topical treatments to advance dermatology, has announced the presentation of positive clinical results from two independent studies conducted in Europeinvestigating the use of Sebacia gold microparticles to treat acne. [More]
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]
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