Novotech Awarded Asia-Pacific Biotech CRO of the Year - Announced at ASCO
Novotech, the Asia-Pacific CRO, has again won the prestigious Asia-Pacific CRO of the year awarded by leading analyst firm Frost & Sullivan. This is the fifth year Novotech has been awarded the top CRO for the region which focusses on best practices in clinical research for biotechs.The announcement was made at the ASCO Annual Meeting (May 31 - June 4, 2019 McCormick Place, Chicago, IL)Dinesh Sampath Rangaraj, Vice President Healthcare, Frost & S...
Seodong Medical Launches Globally Recognized Innovative Device for Treating Dry Eye Syndrome
Innovative products of Seodong Medical Co., a leading dry eye syndrome treatment devices developer, are gaining significant popularity in Korea and other countries as they enhance health of eyeballs. Seodong Medical’s NURIEYE-5800, a medical vibrator, is an innovative device that treats dry eye syndrome known as a core factor of hampering health of eyeballs. NURIEYE-5800 was approved by the Korea’s Ministry of Food and Drug Safety as its safe...
Boehringer Ingelheim announces FDA and EMA regulatory submission for nintedanib in systemic sclerosis associated ILD
Boehringer Ingelheim has filed for regulatory approval of nintedanib in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) with the FDA and EMA. Nintedanib as an anti-fibrotic medicine is already approved in more than 70 countries for the treatment of patients living with idiopathic pulmonary fibrosis (IPF). Systemic sclerosis, also known as scleroderma, is a rare disease characterised by thickening and scarring of co...
Solasia Files New Medical Device Application for episil® in South Korea
Solasia Pharma K.K. (TOKYO:4597, Headquarters:Tokyo, Japan, President & CEO:Yoshihiro Arai, hereinafter “Solasia”), a specialty pharmaceutical company based in Asia, today officially announced that the Company has filed a New Medical Device Application for episil® oral liquid (SP-03, hereinafter “episil®”) to the Regulatory Authority in South Korea. episil® has a mechanical action indicated for the management of pain and relief of pain...
Octapharma Group Reports Strong Results for 2018
Commenting on the Group’s results, Octapharma CEO and Chairman Wolfgang Marguerre said: “In 2018, we continued to drive growth in many of our products. I am particularly pleased with the important regulatory approvals for our new fibrinogen concentrate, fibryga®, which received regulatory approval in Switzerland, our new 10% IVIG product, panzyga®, approved for the US market, and our new SCIG product, cutaquig®, which was approved by both ...
Celgene Submits Application to EMA for Ozanimod for the Treatment of Relapsing-Remitting Multiple Sclerosis
Celgene Corporation (NASDAQ:CELG) today announced that the Company has submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for ozanimod for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS). Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator, which binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5). The pivotal efficacy and safety data provided ...
Masimo Announces CE Marking of Pediatric Indication for Next Generation SedLine® Brain Function Monitoring
Masimo (NASDAQ: MASI) announced today the CE marking of Next Generation SedLine® brain function monitoring for pediatric patients (1-18 years of age). With this clearance, the benefits of Next Generation SedLine are available for all patients one year old and above in CE mark countries. SedLine helps clinicians monitor the state of the brain under anesthesia with bilateral data acquisition and processing of four leads of electroencephalogram (EE...
Boehringer Ingelheim and GNA Biosolutions partner on emergency veterinary diagnostics development
Boehringer Ingelheim and GNA Biosolutions announce that they have entered into a research collaboration focused on the development of a rapid African swine fever (ASF) diagnostic test. The test would be used in combination with GNA's portable molecular diagnostic platform, and is aimed at supporting the fight against the worldwide spread of this deadly disease. ASF is a devastating viral infection of swine causing severe clinical disease and hig...
LMD’s Smartphone-Integrated e-Checkup™ System Makes Medically-Accurate Personal Health Monitoring a Reality
Leman Micro Devices (LMD), the developer of regulated consumer healthcare products that is backed by major players within the mobile device industry, has announced that e-Checkup™ is now poised to be integrated into the new generation of smartphones. Medically-accurate health monitoring becomes free for everyone, bundled with your new smartphone. e-Checkup™ needs no external devices to measure a person’s five vital signs: blood pressure, bo...
Mundipharma EDO GmbH: US FDA grants Orphan Drug Designation for etoposide toniribate in relapsed/refractory biliary tract cancer
Mundipharma EDO GmbH, part of the Mundipharma network of independent associated companies, and Imbrium Therapeutics L.P., an operating subsidiary of Purdue Pharma L.P., today announced that the US FDA has granted Orphan Drug Designation (ODD) to etoposide toniribate for the treatment of relapsed/refractory biliary tract cancer, also known as cholangiocarcinoma. Biliary tract cancer is a rare tumour with approximately 8,000 patients diagnosed i...