On August 2015, TiGenix received the FDA endorsement of a Special Protocol Assessment for a pivotal Phase III study for Biologics License Application in the U.S. Since the granting of the SPA, further confirmatory positive results have been obtained from the European Phase III study of Cx601 , the largest randomized study performed so far in Crohn’s disease patients with complex perianal fistulas. Subsequently, TiGenix submitted a Marketing Authorization Application to the European Medicines Agency in March 2016.
Category: Food and Drug Administration
Press release distribution, EDGAR filing, XBRL, regulatory filings
For the fourth quarter of 2016, Green Dot reported GA… )–Cloud Peak Energy Inc. announced that it has commenced a registered underwritten public offering of 13,500,000 shares of its common stock.
FDA explores Listeria growth and detection in ice cream
Resphera Insight and CosmosID tools were used for high-resolution profiling of 16S rRNA amplicons and whole genome shotgun data. Picture: iStock Culture independent next generation sequencing has been used to characterize the microbiome for recovery of Listeria monocytogenes from naturally contaminated ice cream.
Watchdog revises standards, begins regulatory process for online sales
Beijing was a hive of activity last week as regulators revised standards on an extensive range of food lines, and released draft regulations on online food services for public comment. First, the national food and drug watchdog announced its course of action after the State Council’s recently issued a national strategy on food safety as part of its the 13th Five-year plan, which will last until 2020.
Chigurupati Technologies Launches First Globally Disruptive Tech Out…
Harsha Chigurupati knows the meaning of hard work and determination. After what took over 10 years of research, development and clinical trials, the founder of Chigurupati Technologies has invented India’s first globally disruptive technology, NTX Technologya .
Web-connected medical devices are great. Unless . . .
Web-connected medical devices are great. Unless . . . There are many benefits to having Internet-connected medical devices.
FDA Advice on Hacking Threat to Cardiac Device
The U.S. Food and Drug Administration has issued new advice about how to safeguard implantable cardiac devices against hackers. A wireless transmitter used to transmit data from cardiac devices to medical providers, the Merlin@home Transmitter made by St. Jude Medical was found to be vulnerable to online hacking, the FDA said.
FDA: Cardiac device info vulnerable to hackers
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St. Jude says it’s working to protect pacemakers from hackers :0
Nearly five months after ending up in the crosshairs of a short seller, St. Jude Medical said Monday it’s upgrading its cybersecurity to enhance the safety of its implantable heart devices. The updates come after the Food and Drug Administration found that St. Jude’s heart devices have “vulnerabilities” that could allow hackers to break into pacemakers, resulting in battery depletion or “inappropriate pacing or shocks.”
Arterys Receives FDA Clearance For The First Zero-Footprint Medical…
Arterys Cardio DLTM is the first technology to be cleared by the FDA that leverages cloud computing and deep learning in a clinical setting. Arterys Cardio DLTM provides automated, editable ventricle segmentations based on conventional cardiac MRI images that are as accurate as segmentations performed manually by experienced physicians.
OncoMed Announces Year-End Cash Balance and 2017 Outlook
OncoMed Pharmaceuticals Inc. , a clinical-stage company focused on discovering and developing novel anti-cancer stem cell and immuno-oncology therapeutics, today pre-announced its 2016 year-end cash balance and reviewed key anticipated events for 2017. OncoMed ended 2016 with approximately $184.6 million in cash.
LG Chem chief renews pledge to boost biopharma business
South Korea’s leading chemicals maker LG Chem is out to boost its newly merged pharmaceutical unit LG Life Sciences, with aims to drive up its competitiveness in the global red biotechnology, or medical biotech, sector. LG Chem Vice Chairman and CEO Park Jin-soo visited LG Life Sciences’ production plant in Iksan, North Jeolla Province on Thursday, marking his first official on-site visit for 2017.
Opening the FDAa s History Vault
Welcome to the FDA’s History Vault, which contains more than 10,000 artifacts that provide a journey through American history and document the critical role played by one of the nation’s oldest public health agencies in support of its mission to promote and protect American health. The items featured in this new series of short videos reflect the constant changes in science and society.
Jaguar Animal Health Appoints Dr. Ari Azhir To Board Of Directors
Jaguar Animal Health, Inc. , an animal health company focused on developing and commercializing first-in-class gastrointestinal products for companion and production animals, foals, and high value horses, today announced that it has appointed Dr. Ari Azhir, a highly accomplished pharmaceutical and biotechnology executive with extensive operational, fundraising, execution, and strategy development experience, to the Company’s board of directors. Dr. Azhir has also been appointed to Jaguar’s Audit Committee and Compensation Committee.
Shionogi And Purdue Pharma L.P. Establish Alliance For Joint U.S. Commercialization Of Naldemedine
OSAKA, Japan & STAMFORD, Conn.– — Shionogi & Co., Ltd. , a drug-discovery based pharmaceutical company dedicated to developing medicines that protect the health and well-being of patients, and its wholly-owned U.S. subsidiary, Shionogi Inc. , and Purdue Pharma L.P. , a privately-held pharmaceutical company founded by physicians over 60 years ago, distinguished by its pioneering research, products and medical programs directed toward alleviating pain, today announced the establishment of an alliance for the joint U.S. launch and commercialization of SymproicA .