CStone Pharmaceuticals today announced that a first patient has been enrolled and dosed in a Phase I clinical trial in China for the recombinant humanized anti-programmed death-1 monoclonal antibody CS1003. Frank Jiang, Chairman and CEO of CStone, "We are happy to see Phase I trial get under way in China. We plan to carry out global development f
FOSTER CITY- Gilead Sciences, Inc. announced that the China National Medical Products Administration has approved Vemlidy 25 mg, for chronic hepatitis B Virus Infection in adults and adolescents. Jinlin Hou, Nanfang Hospital of Southern Medical University. Vemlidy received marketing approval from the U.S. Food and Drug Administration and the Japane
The Abdominal Aortic Junctional Tourniquet that treats both pelvic hemorrhage and severe bilateral lower junctional hemorrhage has been approved for use by paramedics and other first-responders in Alabama. The AAJT, approved for military use in 2012 by the Federal Drug Administration, has saved many lives on the battlefield. His company, Compressio
Amid the growing opioid crisis, the U.S. Food and Drug Administration has attracted criticism for approving a new kind of opioid that's five to 10 times more powerful than fentanyl, the deadliest drug in Virginia. Under the FDA' s approval guidelines, the drug, known as Dsuvia, can be distributed only by a health care professional in a certified me
Amid the growing opioid crisis, the U.S. Food and Drug Administration has attracted criticism for approving a new kind of opioid that's five to 10 times more powerful than fentanyl, the deadliest drug in Virginia. Under the FDA's approval guidelines, the drug, known as Dsuvia, can be distributed only by a health care professional in a certified med
SEONGNAM, South Korea, Nov. 18, 2018/ PRNewswire/ Bridge Biotherapeutics Inc., a clinical stage biotech company headquartered in Seongnam, South Korea and a tenant company of JLABS@ TMC in Houston, Texas, announced that the company filed an Investigational New Drug application to the U.S. Food and Drug Administration to initiate phase I study of
Aimmune Therapeutics, Inc., a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced that the New England Journal of Medicine has published the full results of the landmark phase 3 PALISADE clinical trial of AR101, Aimmune s investigational biologic oral immunotherapy for desensitization
4 D Molecular Therapeutics, a world-leader in Therapeutic Vector Evolution for adeno-associated virus gene therapy vector discovery and product development today announced that the U.S. Food and Drug Administration has granted orphan drug designation to 4 D-110 for the treatment of choroideremia. The FDAs Office of Orphan Drug Products grants orpha
-Agios Pharmaceuticals, Inc., a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today presented updated data from the ongoing Phase 1 study evaluating single agent AG-881 in advanced glioma. The data were featured in an oral presentation at the Society for Neuro-Oncology Annual Meeting in New Orleans.
AstraZeneca has announced its Phase III MYSTIC trial of Imfinzi alone and Imfinzi combined with tremelimumab in untreated non-small cell lung cancer patients failed to meet its primary endpoint. AstraZeneca executive vice-president of global medicines eevelopment and chief medical officer Sean Bohen said: We are disappointed that these results...
The Baylor College of Medicine issued the following news release:. Led by researchers at Baylor College of Medicine and the National Taiwan University College of Medicine, the team shows in the journal Scientific Reports proof of concept that this approach can potentially lead to the discovery of drugs in a way that is quicker and less expensive th
BeiGene, Ltd., a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced the presentation of preliminary clinical data from an ongoing Phase 1/ 2 trial of its investigational PARP inhibitor, pamiparib, in combination..
Boehringer Ingelheim and Epizyme, Inc. today announced a new global collaboration focused on the research, development and commercialization of novel small molecule inhibitors directed toward two previously unaddressed epigenetic targets as potential therapies for people with cancer. "Boehringer Ingelheim's collaboration with Epizyme furthers...
Pune, India 11/16/2018 In 2017, the global Clinical Trial Management System market size was xx million US$ and it is expected to reach xx million US$ by the end of 2025, with a CAGR of xx% during 2018-2025.. This report focuses on the global Clinical Trial Management System status, future forecast, growth opportunity, key market and key playe
The numbers are staggering- 233 confirmed drug overdose deaths this year in Milwaukee, Wisconsin, with 188 because of opioids, according to Karen Domagalski, operations manager for the Milwaukee County medical examiner's office. In Wisconsin last year, there were 829 deaths from drug overdoses- many involving the injection of heroin and fentanyl, A
*The positive opinion is the result of a 10- year partnership between the Drugs for Neglected Diseases initiative, Sanofi, and African partners. The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive scientific opinion of fexinidazole, the first all-oral treatment that has been shown to be efficacious
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release:. The U.S. Food and Drug Administration today expanded the approved use of Adcetris injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma. "The Real-Time Oncology Review program a
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release:. "Travelers' diarrhea affects millions of people each year and having treatment options for this condition can help reduce symptoms of the condition," said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in t
*Promacta is the first new treatment in decades for newly diagnosed SAA patients in the US; a decision by the European Medicines Agency is expected in 2019. "Severe aplastic anemia can be a fatal diagnosis if left untreated, and many patients fail to respond to current initial treatment options," said Liz Barrett, CEO, Novartis Oncology. The FDA's
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following statement by Commissioner Scott Gottlieb to hold industry accountable for fulfilling critical post-marketing studies of the benefits and safety of drugs:. "The FDA remains committed to ensuring that FDA- approved drugs are safe and effective for Ame
Genzada Pharmaceuticals USA Inc., a subsidiary of Ionics Life Sciences Limited, announced today that the U.S. Food and Drug Administration has approved its Investigational New Drug application for a Phase 1 human clinical trial of the companys flagship molecule GZ17-6.02 for patients with advanced solid organ tumors or lymphoma. We are excited to b
Husband-and-wife doctors at the University of Virginia Cancer Center have been awarded more than $1.8 million from the National Institutes of Health for their effort to improve radiation therapy and breast surgery for patients with early-stage breast cancer. Radiation oncologist Timothy Showalter, MD, and breast cancer surgeon Shayna L. Showalter,
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