AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for a Phase 1 B clinical trial investigating the Company`s ROOT OF CANCER technology in patients with metastatic melanoma. AIVITA`s ROOT OF CANCER...
California, January 19: After Apple, Google' s parent company Alphabet is working its way towards bringing health at the center of its products. Now, the company's health division Verily has reportedly received FDA 510 clearance for its Study smartwatch for an on-demand ECG feature. The feature is increasingly becoming a standard for a lot of manuf
Waltham-based AMAG Pharmaceuticals said it has completed a previously announced acquisition of Perosphere Pharmaceuticals, a private biopharmaceutical company. Through this acquisition, AMAG adds ciraparantag to its development portfolio. Ciraparantag has been granted fast track review designation by the U.S. Food and Drug Administration and has...
Cala Health last month launched a clinical trial of the latest version of its wearable neurostimulator for treating essential tremor, eyeing extended use of the wrist-worn device. The Burlingame, Calif.- based company won de novo clearance from the FDA last April for the Cala One device for transient relief in adults with essential tremor.
The American Society of Clinical Oncology, Friends of Cancer Research, and the US Food and Drug Administration recently recommended modernizing criteria related to comorbidities routinely used to exclude patients from cancer clinical trials. The goal was to design clinical trial eligibility such that trial results better reflect real-world cancer..
Cellular Biomedicine Group, Inc., a biopharmaceutical firm engaged in the development of immunotherapies for cancer and stem cell therapies for degenerative diseases, today announced that its off-the-shelf allogeneic adipose-derived mesenchymal progenitor cell AlloJoin therapy for Knee Osteoarthritis has been approved as the first stem cell KOA...
Albany, NY 01/19/2019 Transparency Market Research has published a new report titled, "Contact Lens Market- Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2018 2026". According to the report, the global contact lens market was valued at US$ 11,155.7 Mn in 2017 and is anticipated to expand at a CAGR of 7.4% during fore
The Cystinosis Research Foundation, the largest provider of grants for cystinosis research in the world, today announced that the Federal Drug Administration granted approval for the first human clinical trial for stem cell and gene therapy treatment for cystinosis. Over the last 12 years, CRF has provided more than $4.3 million in research funding
By Jun Ji- hye The ongoing US government shutdown has left Korean drug companies hanging, including Daewoong Pharmaceutical and SK Biopharmaceuticals, as the closed Food and Drug Administration has been unable to review and approve medicines. Daewoong Pharmaceutical has been waiting for FDA approval for its botulinum toxin product, called Nabota Th
The University of Science and Technology issued the following news release:. -Researchers from The Hong Kong University of Science and Technology credited with important translational science and early discovery work. SAN DIEGO AND HONG KONG- aTyr Pharma, Inc., a biotherapeutics company engaged in the discovery and development of innovative medicin
-Kitov Pharma Ltd., an innovative pharmaceutical company, today announced the closing of its previously announced registered direct offering of 3,428,572 American Depositary Shares at a purchase price of $1.75 per ADS, for gross proceeds of $6 million. Copies of the final prospectus supplement and the accompanying prospectus relating to the registe
-Kura Oncology, Inc., a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported new findings identifying a potential association between CXCL12 expression and clinical benefit in patients with pancreatic cancer treated with tipifarnib. These findings are being presented today at the 2019...
aTyr Pharma, Inc., a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel immunological pathways, today recognized the collaboration between its Hong Kong subsidiary, Pangu BioPharma, and The Hong Kong University of Science and Technology for contributions leading to the discovery of aTyrs lead...
The FDA approved Teva`s generic for Sabril, the first generic for the drug, as the agency continues to focus its efforts to approve generics that face little competition. The US Food and Drug Administration has expressed its efforts to carve a path for generic drug development, even in the case of limited distribution programs for brand name drugs,
SMi Group are delighted to have industry expert Tom Parke to lead the post-conference workshop during Adaptive Designs in Clinical Trials 2019.. The 11th Annual Adaptive Designs in Clinical Trials conference, taking place in London on the 1st 2nd April 2019, is a significant change from the 2010 version of the draft guidance. SMi is delighted to ho
The Food and Drug Administration and the Central Ethics Committee in the United States have accepted Xbranes IND application for initiation of the Xplore trial, a phase III trial with Xlucane, a ranibizumab biosimilar candidate. "It is with great satisfaction we can announce acceptance from the FDA and the Central Ethics Committee to initiate the
Zydus Cadila Thursday said it has received the final approval from the USFDA to market Acetazolamide ER capsules that are used to treat certain types of glaucoma. The capsules will be manufactured at the group`s formulations manufacturing facility at Moraiya, Ahmedabad, the company said in a regulatory filing. "Zydus aspires to be a research-based
AbbVie, a research-based global biopharmaceutical company, today announced an update on the Phase 3 RESOLVE trial of ibrutinib in combination with chemotherapy agents nab-paclitaxel and gemcitabine versus placebo in combination with these chemotherapy agents in patients with metastatic pancreatic adenocarcinoma. IMBRUVICA is a first-in-class...
Acorda Therapeutics,Inc. (NASDAQ:ACOR) Files An 8-K Other EventsItem 8.01Other Events On January 17, 2019, Acorda Therapeutics, Inc. issued a press release announcing that The Lancet Neurology published results from SPANSM-PD, the Phase 3 pivotal efficacy trial of INBRIJA? (levodopa inhalation powder), also referred to as CVT-301. A copy of the p
DURHAM- Aerie Pharmaceuticals, Inc., an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, retina diseases and other diseases of the eye today announced that the U.S. Food and Drug Administration has reviewed the...
CINCINNATI- Aerpio Pharmaceuticals, Inc., a biopharmaceutical company focused on developing compounds that activate Tie2 to treat ocular diseases and diabetic complications, today announced the completion of patient dosing in the Company's TIME-2b study, a Phase 2 b clinical trial designed to assess the efficacy and safety of Aerpio's lead candidat
AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, announced today the U.S. Food and Drug Administration has cleared its Investigational New Drug application for a Phase 1 B clinical trial investigating the Company`s ROOT OF CANCER technology in patients with metastatic melanoma. The trial marks the first
BOTHELL- Alder BioPharmaceuticals, Inc., a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, today announced the appointment of Paul Streck, M.D., as chief medical officer, effective January 21, 2019. Prior to Insmed, Dr. Streck was GlaxoSmithKline plc's group vice president and global medic
Prior to Insmed, Dr. Streck was GlaxoSmithKline plcs group vice president and global medical lead of the Immuno-inflammation division responsible for the immunology portfolio strategy, including Benlysta and sirukumab. Before GSK, Dr. Streck spent eight years at Shire plc, culminating in his role as group vice president, clinical development for he
WALTHAM- AMAG Pharmaceuticals, Inc. announced today that it has completed the previously announced acquisition of Perosphere Pharmaceuticals Inc., a private biopharmaceutical company. Ciraparantag has been granted Fast Track review designation by the U.S. Food and Drug Administration and has composition of matter patent protection until 2034..