The following should be read in conjunction with our consolidated financial statements and related notes beginning on page F 1 of this Annual Report. We earn revenue on net sales of VIVITROL, ARISTADA and ARISTADA INITIO, which are proprietary products that we manufacture, market and sell in the U.S., and manufacturing and/or royalty revenues on
About two years ago, Astellas licensed a novel pneumococcal vaccine technology from Affinivax with eyes on Pfizers Prevnar 13. The first patient has been dosed with the investigational vaccine, dubbed ASP3772, in a phase 1/ 2 study that aims to evaluate the vaccines safety, tolerability and immunogenicity, Affinivax said on Wednesday. We believe th
The US Food and Drug Administration has accepted for priority review a supplemental Biologics License Application for Mercks Bavencio in combination with Inlyta for patients with advanced renal cell carcinoma. "Our alliance is focused on the development of potential new treatment options for patients with cancers that have high unmet medical needs
Bio-Rad Laboratories, Inc., a global leader of life science research and clinical diagnostic products, today announced that its QXDx AutoDG ddPCR System, which uses Bio-Rad s Droplet Digital PCR technology, and the QXDx BCR-ABL% IS Kit are the industry s first digital PCR products to receive U.S. Food and Drug Administration clearance. Used t
Bioblast Pharma Ltd., a clinical-stage, orphan disease-focused biotechnology company, and Team Sanfilippo, a nonprofit medical research foundation founded by parents of children with Sanfilippo Syndrome today announced a clinical collaboration to evaluate the safety and efficacy of Bioblast s proprietary Trehalose solution for the treatment of
Cerecor Inc., a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments in rare and orphan diseases in pediatrics and neurology, announced that the U.S. Patent and Trademark Office issued U.S. Patent No. 10,202,363 on Feb. 12, 2019, which is directed to CERC 301, an oral, NR2B-specific, NMDA re
The Clinical Trial Supplies studies spreads fantastic statistics that makes the document a handy asset for managers, industry professionals and different key individuals alongside charts and tables to help recognize Clinical Trial Supplies market patterns, drivers and challenges. The development rate is based on the instructional exam of the facts
Harrisburg, NC 02/15/2019 Global Contract Research Organization Market Size, Status And Forecast 2025. This report studies the Global Contract Research Organization market size, industry status and forecast, competition landscape and growth opportunity. Food Service Market Segment by Region: North America, United States, Canada, Mexico, Asia-
CymaBay Therapeutics, Inc., today announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for seladelpar for the treatment of early stage primary biliary cholangitis in combination with ursodeoxycholic acid in adult patients with an inadequate response to UDCA, or as monotherapy in adults unable to tolera
Denali Therapeutics Inc., a biopharmaceutical company developing a broad portfolio of therapeutic candidates for neurodegenerative diseases, today announced initiation of dosing in a Phase 1 b clinical study of DNL747 in patients with Alzheimer s disease, in collaboration with its partner Sanofi.. We are excited to advance DNL747 in a secon
Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has accepted and granted priority review for a new supplemental Biologics License Application for KEYTRUDA, Merck s anti-PD-1 therapy, in combination with Inlyta, a tyrosine kinase inhibitor, for the first-line treatment of patien
Growing number of clinical trial studies in Germany is expected to keep the market buoyant over the coming years. Rising need for supply chain planning, software for inventory management, and ancillary supply chain management is also likely to contribute towards the growth of the Germany clinical trial supplies market. Germany clinical trial suppli
According to Coherent Market Insights, the global nanopharmaceuticals market was valued at US$ 28,434.3 million in 2017, and is projected to exhibit a CAGR of 22.1% over the forecast period. For example, in August 2017, Jazz Pharmaceuticals received FDA approval for Vyxeos, used for the treatment of acute myeloid leukemia. For instance, in March 20
The University of Texas MD Anderson Cancer Center issued the following news release:. Some patients with metastatic prostate cancer respond to a combination of immune checkpoint inhibitors after hormonal therapy and chemotherapy have failed, according to early results from a clinical trial led by investigators at The University of Texas MD Anderson
Albany, NY 02/15/2019 Biosimilars are biological products that are similar to FDA- approved drug known as branded drug. Biosimilars are drugs licensed by the European Medicines Agency and the U.S. FDA. Infliximab is a monoclonal antibody first manufactured by Janssen Biotech, Inc. in collaboration with Merck& Co. The U.S. Food and Drug Admini
La Jolla Pharmaceutical Company today announced that there will be multiple presentations on GIAPREZA at the Society of Critical Care Medicine s 48th Critical Care Congress to be held February 17- 20, 2019 in San Diego, CA. Abstracts for the oral presentations are publicly available and can be found on the SCCM website and by clicking the titl
The FDA has started a speedy review of Merck KGaA and Pfizers new combination regimen for advanced kidney cancer, setting up a possible approval in June and piling more pressure on Bristol-Myers Squibb. This week, Merck& Co/ MSD reported new results from the phase 3 KEYNOTE-426 study which showed that the combination of its PD-1 inhibitor Keytruda
A new phase I/II open-label, dose-escalation trial has recently tested the effectiveness of a "Trojan horse" drug in treating multiple types of otherwise treatment-resistant cancer in its late stages. Recently, a team of experts from The Institute of Cancer Research in London and The Royal Marsden NHS Foundation Trust both in the United Kingdom has
New Wave Endo-Surgery Inc. announced today that it completed the acquisition of the Acacia Inc. FDA cleared Nerve Block Needle and anesthesia kit product line. New Wave Endo-Surgery Inc. was founded in 2014 to design, and manufacture proprietary medical devices for laparoscopic and robotic surgery. New Wave Endo-Surgery Inc. will be presenting thei
Rainier Therapeutics, Inc., a privately-held clinical stage drug development company, today announced the presentation of preliminary data from its Phase 2 trial of vofatamab, a fibroblast-growth-factor-receptor 3 targeted antibody, at the 2019 ASCO Genitourinary Cancers Symposium in San Francisco. FGFR3 inhibitors have the potential to...
Pharmaceutical firm ReGenTree has initiated a Phase III ARISE-3 clinical trial to evaluate drug candidate RGN-259 to treat patients with dry eye syndrome. ReGenTree was established in 2015 as a joint venture between RegeneRx Biopharmaceuticals and G-treeBNT to develop RGN-259 for dry eye syndrome and neurotrophic keratitis in the US.
Senzime AB today announces the intent to re-submit the existing 510 application to the US Food and Drug Administration. Based on an updated version of the TetraGraph, the existing 510 application will be re-submitted and Senzime thereby seeks to decrease the overall time to FDA approval. The FDA application is part of Senzime's strategic launch pla
The US Food and Drug Administration Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee jointly voted in favour of Spravato nasal spray CIII for adults living with treatment-resistant depression. The decision came down to 14 yes votes, two no votes and one abstain, basing their support on the safety an
We've been taking new policy steps at the FDA to support downward pressure on drug prices by helping to clear a path for more efficient generic development. We're working to reduce barriers to generic development and to lower the cost of generic entry so that more of the generic medicines that the FDA approves are launched and reach patients.