The following discussion should be read in conjunction with the condensed consolidated financial statements and accompanying notes included in this report. Factors that could cause or contribute to these differences include, but are not limited to, those discussed in our "Risk Factors", including those previously disseminated in our Annual Report o
Aerie Pharmaceuticals, Inc., a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye, today announced that Vicente Anido, Jr., Ph.D., Chief Executive Officer and Chairman of the Board, will present at the
Angiochem, a biotechnology company developing ANG1005 for the treatment of Leptomeningeal Carcinomatosis in patients with breast cancer and brain metastases, announced today that the U.S. Food and Drug Administration has scheduled an End-of-Phase 2 meeting to discuss clinical study results of the compound. Angiochem submitted a meeting request to t
Audentes Therapeutics, Inc., a biotechnology company focused on developing and commercializing gene therapy products for patients suffering from serious, life-threatening rare diseases, today announced a collaboration with the Orphan Disease Center at the Perelman School of Medicine at the University of Pennsylvania to develop AT342, an AAV gene...
Bovie Medical Corporation, a maker of medical devices and supplies and the developer of J-Plasma , a patented new surgical product, announced today that Robert L. Gershon, Chief Executive Officer of the Company, and Jay Ewers, Chief Financial Officer, will participate in the Drexel Hamilton Micro Cap Investor Forum on May 12, 2016. Bovie Medical
DESCO Medical Service, also known as Diagnostic Equipment Service Corporation, today announced that they acquired Pocono Sterilizer, an equipment sterilization service and sales company located in Pennsylvania. The acquisition will help DESCO Medical Service expand their sterilizer installations, equipment sales and service capabilities in the mid-
INDIANAPOLIS- Eli Lilly and Company announced the U.S. FDA has granted Priority Review for the biologics license application for olaratumab, a PDGFR? The company has received additional designations for olaratumab from the FDA, including Breakthrough Therapy, Fast Track and Orphan Drug, for this indication. Lilly also submitted olaratumab to the Eu
Endocyte, Inc., a leader in developing targeted small molecule drug conjugates and companion imaging agents for personalized therapy, today announced financial results for the first quarter ending March 31, 2016, and provided a clinical update. Endocyte recently announced promising data at the American Association for Cancer Research annual meeti
Epizyme, Inc., a clinical stage biopharmaceutical company creating novel epigenetic therapies for people with cancer, today announced that the U.S. Food and Drug Administration has accepted the company s Investigational New Drug application for tazemetostat for the treatment of adults with mesothelioma characterized by BAP1 loss-of-function.
DUBLIN- BioMarin Pharmaceutical Inc. expects to submit EU and U.S. Marketing Application for Cerliponase alfa, intended for the treatment of children with CLN2 disease, a form of Batten disease, by mid-2016. In just another two months, Corcept Therapeutics Inc. will be reporting results from a phase 1/ 2 trial of mifepristone in combination with an
Eli Lilly and Company announced today that the U.S. Food and Drug Administration has granted Priority Review for the biologics license application for olaratumab, a PDGFR antagonist, in combination with doxorubicin, for the potential treatment of people with advanced soft tissue sarcoma not amenable to curative treatment with radiotherapy or su
FREDERICK, Md., May 4 MSGI Corp., Tampa, Florida, was awarded a share of a $49,399,990 federal contract set aside for small business by the U.S. Army Medical Research for medical, surgical, pharmaceutical, dental, laboratory, veterinary equipment and materiel sets for the U.S. Army medical units, non-medical and medical support programs. PATUXENT
FREDERICK, Md., May 4 TQM Inc. dba Two Rivers Medical, St. Charles, Missouri, was awarded a share of a $49,399,990 federal contract set aside for small business by the U.S. Army Medical Research for medical, surgical, pharmaceutical, dental, laboratory, veterinary equipment and materiel sets for the U.S. Army medical units, non-medical and medica
The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Middle East& Africa, and Latin America. The report profiles 73 companies including many key and niche players such as- Asahi Kasei Medical Co., Ltd. Baxter International, Inc. B. Braun Melsungen AG DaVita Kidney Diaverum Download the full report:..
AIM Laboratories a clinical, toxicology, and molecular lab based in St. Louis. Circulogene Theranostics a genetic lab in Birmingham, Ala. specializing in next-generation sequencing to monitor tumor mutant DNA within well-characterized, well-documented, cancer-associated genes. Interpath a fully integrated clinical laboratory corporation in bu
EVENT: Health and Human Services Department; Food and Drug Administration holds a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss new drug application 208653, benzhydrocodone/acetaminophen oral tablets, submitted by KemPharm, Inc., with the proposed...
Horizon Pharma plc, a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, today announced it received three additional Notice of Allowances from the United States Patent and Trademark Office for U.S. patent.
Shares of Marksans Pharma ended 9.84% lower at Rs. 50.25 on BSE after the company announced that it has received USFDA nod for a type 2 diabetes drug. The company announced that USFDA has granted approval for an Abbreviated New Drug Application for Metformin Hydrochloride Extended Release Tablets USP 500 mg and 750 mg. Metformin Hydrochloride ER
SUMMARY: The Food and Drug Administration is announcing that it has received a petition requesting exemption from the premarket notification requirements for a method, metallic reduction, glucose test system in a reagent tablet format that is intended to measure glucosuria. FDA is publishing this notice to obtain comments in accordance with procedu
SUMMARY: The Food and Drug Administration is announcing the availability of grant funds for the support of FDA's Office of Orphan Products Development Natural History Grants Program. FDA provides grants for natural history studies that will either assist or substantially contribute to market approval of these products. Applicants must include in th
Previously, he was Vice President& Business Unit Head for Genentech's Tissue Growth and Repair Business, which generated over $2.1 billion in annual sales. During his tenure at Genentech, Mr. Oswald also oversaw the highly successful commercial launch of Lucentis for the treatment of wet AMD. Prior to Genentech, Mr. Oswald led the North American
By a News Reporter-Staff News Editor at Biotech Week From Alexandria, Virginia, NewsRx journalists report that a patent by the inventors Baroni, Sergio; Bellinvia, Salvatore; Viti, Francesca, filed on December 15, 2014, was published online on April 19, 2016. The patent's assignee for patent number 9314434 is Nogra Pharma Limited. News editors ob
Rockwell Medical, Inc., a fully-integrated biopharmaceutical company targeting end-stage renal disease and chronic kidney disease with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, today provided an update on preparations for the commercial launch of Calcitriol, its FDA...
TRACON Pharmaceuticals, a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration and fibrotic diseases, announced today that the European Medicines Agency has granted TRC105 orphan drug designation for the treatment of patients with.
By a News Reporter-Staff News Editor at Biotech Week Biologics, Inc. is pleased to announce the company has been selected by AbbVie Inc. to be a specialty pharmacy provider for VenclextaTM. Approved by the U.S. Food and Drug Administration on April 11, 2016, Venclexta is indicated for the treatment of patients with chronic lymphocytic leukemia wi