Mike Topper, President of the American Veterinary Medical Association. A drug that is approved by the FDA has been shown through rigorous studies to be safe and effective for its labeled indication. Unfortunately, there simply are not enough FDA approved drugs for use in animals.
By a News Reporter-Staff News Editor at Biotech Week The "3rd Peptide Drug Design& Delivery Conference" conference has been added to ResearchAndMarkets.com' s offering. It is estimated that by 2018, the global Peptide therapeutics market is expected to pass $25 billion. June's 3rd Peptide Drug Design& Delivery Conference will bring together key d
Aimmune Therapeutics to Host Analyst and Investor Event Following Oral Late-Breaking Presentation of Phase 3 PALISADE Results on Sunday, March 4, at the AAAAI-WAO Joint Congress in Orlando. By a News Reporter-Staff News Editor at Biotech Week Aimmune Therapeutics, Inc., a biopharmaceutical company developing treatments for life-threatening food..
The additions to the executive leadership team include: Katalin Kauser, M.D., Ph.D, D.Sc., vice president of biology, joins Alucent Biomedical after 20 years of experience in the biotechnology and pharmaceutical industry with such firms as Global Blood Therapeutics, Boehringer Ingelheim, Actelion, and Bayer, specializing in cardiovascular biology,.
By a News Reporter-Staff News Editor at Biotech Week Antibe Therapeutics Inc. would like to confirm the previously announced timing for its Phase 2 B double-blind clinical trial of ATB-346. The CRO conducting the study, Topstone Research Inc., is currently performing data validation and analysis. The study was conducted in 240 healthy volunteers
"Following the US approval, we are very proud of the approval to deliver the first-in-class product HEMLIBRA to people with hemophilia A with inhibitors in the EU as well," said Chugai's President& COO, Tatsuro Kosaka. "By having HEMLIBRA- an additional Chugai originated medicine to the existing product lineup currently marketed in the EU, such as
By a News Reporter-Staff News Editor at Biotech Week Intensity Therapeutics, Inc., a privately held biotechnology company developing proprietary cancer immune-based drug products for direct intratumoral injection, announced completion of the first safety cohort of the Company's Phase 1/ 2 international clinical study evaluating lead product,...
MabVax Therapeutics Reports Positive Safety Results from Initial Cohort of MVT-1075 Radioimmunotherapy Phase 1 Trial for the Treatment of Pancreatic, Colon and Lung Cancers. By a News Reporter-Staff News Editor at Biotech Week MabVax Therapeutics Holdings, Inc., a clinical-stage biotechnology company focused on the development of antibody-based..
I was convinced that Cara Therapeutics had a winning drug. You weren't necessarily wrong to invest in Cara Therapeutics, either. In February 2016, the Food and Drug Administration put a "clinical hold" on a late-stage clinical trial of CR845, sending the stock down, but the hold was lifted a few months later.
Photo: Courtesy of Novo Nordisk. Danish pharmaceutical company Novo Nordisk has announced that Tresiba, a new insulin degludec, has been approved by China Food and Drug Administration and is now available in China. According to Novo Nordisk, there are about 114 million people in China with diabetes, among whom only 46.4 percent are diagnosed and on
By a News Reporter-Staff News Editor at Biotech Week Pharmaceutical Product Development, LLC, a global contract research organization, and Acurian, the leading full-service provider of global patient enrollment and retention solutions and a subsidiary of PPD, announced a new patient concierge service designed to make it easier for patients and th
By a News Reporter-Staff News Editor at Computer Weekly News Investigators publish new report on Immune System Diseases and Conditions- HIV/AIDS. However, it seems the emergence of new HIV-1 PR mutations enhances drug resistance, hence, the available FDA approved drugs show less activity towards the protease. " Our news journalists obtained a quo
FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945, Trang.Tran@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The holders of the applications listed in the table have informed FDA that these drug product
By a News Reporter-Staff News Editor at Biotech Week TP Therapeutics, Inc., a privately held, clinical-stage biopharmaceutical company focusing on addressing oncology drug resistance, announced the appointment of Lewis "Lew" Shuster to the Company's Board of Directors. Mr. Shuster is presently the Chief Executive Officer of Shuster Capital, a str
By a News Reporter-Staff News Editor at Biotech Week Zymeworks Inc., a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, announced the addition of new clinical sites in Canada and the United States for its ongoing adaptive Phase 1 study of the company's lead clinical candidate, ZW25. "We are pleased to announce
By a News Reporter-Staff News Editor at Life Science Weekly A patent application by the inventors Gunning, Kerry; Ackley, Donald; Shieh, Chan-Long, filed on August 17, 2016, was made available online on March 1, 2018, according to news reporting originating from Washington, D.C., by NewsRx correspondents. This patent application has not been assi
AbbVie, a global research and development-based biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc., announced that the Phase 3 ELARIS UF-II study of elagolix met its primary endpoint. Uterine fibroids are the most common type of abnormal growth in a woman's pelvis and can affect up to 80 percent of women by age 50. 2 Fibr
Actinium Pharmaceuticals, Inc. announced today that the Medical College of Wisconsin received clearance from the U.S. Food and Drug Administration for the previously announced Investigational New Drug application for the Phase 1 trial of Actimab-A in combination with CLAG-M for relapsed or refractory Acute Myeloid Leukemia patients.
On March 13, 2018, the U.S. Food and Drug Administration's New Paragraph IV Certifications list was updated to reflect that an abbreviated new drug application seeking authorization from the FDA to manufacture, use, or sell a generic version of GOCOVRI? extended release capsules, containing one or more certifications pursuant to 21 U.S.C. 355,
AHP- Adult diaper sales are expected to plummet as results from a clinical trial on a new, patented bladder control pill have finally been released. Sold under the brand name UriVarx?, the new pill contains key ingredients that keeps the bladder from releasing voluntarily, which reduces accidents and frequent bathroom trips. Bassam Damaj of Innov
Aeglea BioTherapeutics, Inc., a clinical-stage biotechnology company that designs and develops innovative human enzyme therapeutics for patients with rare genetic diseases and cancer, today reported new repeat dose data from its Phase 1/ 2 open-label trial of pegzilarginase in patients with Arginase 1 Deficiency. The Company also reported financi
Aerpio Pharmaceuticals, Inc., a biopharmaceutical company focused on advancing first-in-class treatments for ocular diseases, today reported financial results for the fourth quarter and full year ended December 31, 2017. Completed enrollment in the TIME-2b study, a Phase 2 b clinical trial designed to assess the efficacy and safety of the Company?
Wendelsheim, Germany/ Oakland, California March 13, 2018. "Laboratories have continued to return to IFA testing ever since the 2009 ACR position statement, which asserts that IFA is the Gold Standard for systemic autoimmune disease screening. "Laboratories performing IFA will be able to screen for ANA's and then reflex to a very specific anti-dsD
The following discussion and analysis of our financial condition and results of operations should be read together with our financial statements and related notes appearing elsewhere in this Annual Report on Form 10- K. Overview We are a clinical stage biopharmaceutical company with an emphasis on identifying the genetic drivers of disease and appl
The American Liver Foundation, the nation's largest patient advocacy organization for people with liver disease, announced today the launch of an online search tool to match liver disease patients with clinical trials that are appropriate for them. "In the last few years, we have continued to see a rise in the number of people affected by liver di