NEW BRUNSWICK- Axovant Sciences Ltd. expects results from a phase II study of Nelotanserin in Lewy body dementia subjects experiencing visual hallucinations in the second half of calendar year 2016.. AXON closed Tuesday's trading at $10.07, up 5.89%. Shares of Bellerophon Therapeutics Inc. surged more than 43% on Tuesday, following positive data fr
WASHINGTON, Feb. 9, 2016/ PRNewswire-USNewswire/ On Tuesday, February 9th, the U.S. Food and Drug Administration met with its Arthritis Advisory Committee to discuss Celltrion's Remsima, a proposed biosimilar of Johnson& Johnson's Remicade and most likely the second biosimilar to be approved in the U.S. The Biologics Prescribers Collaborative alo
-EPIRUS Biopharmaceuticals, Inc., a pure-play biosimilar company focused on the development and commercialization of biosimilar monoclonal antibodies, today announced the initiation of its global registration study for BOW015 in active Rheumatoid Arthritis patients. EPIRUS plans to enroll over 500 patients in the UNIFORM Study, which will be conduc
Hikma has dropped 234 p or nearly 12% to 17.61 after the pharmaceutical group revised the terms of its offer for US generic drug group Roxane. Since the publication of the Prospectus on January 22nd, Hikma received new information from BI with regard to the financial performance of Roxane in 2015, leading to a reassessment of the outlook for 2016
Momenta Pharmaceuticals, Inc., a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that the Federal Trade Commission has granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in connection with the global collaboration agreement...
Celltrion's proposed biosimilar infliximab, to which Pfizer holds exclusive U.S. commercialization rights, is the first biosimilar monoclonal antibody therapy to be reviewed by the FDA for licensure in the U.S., and is only the second biosimilar to be recommended for approval by a U.S. FDA Advisory Committee. 'We look forward to the FDA's continued
-Trxade Group, Inc., a web-based pharmaceutical marketplace engaged in promoting and enabling trade among independent pharmacies and large pharmaceutical suppliers nationally, today announced that its wholly-owned subsidiary, Westminster Pharmaceuticals LLC, has launched the generic drug HCTZ as part of an exclusive agreement with ScieGen...
-Depomed, Inc. announced today a favorable Markman claim construction ruling by Judge Claire Cecchi of the United States District Court for the District of New Jersey has been issued in the ongoing patent infringement case against the three filers of Abbreviated New Drug Applications with Depomed prevailing on all disputed claims. Judge Cecchi cons
DGAP-News: Cinfa Biotech, S.L./ Schlagwort: Konferenz Cinfa Biotech prsentiert auf zwei bevorstehenden Biosimilar-Konferenzen, um Strategien der klinischen Entwicklung vorzustellen 09.02. 2016/ 16:45 Fr den Inhalt der Mitteilung ist der Emittent verantwortlich.- Pressemit
DGAP-News: Cinfa Biotech, S.L./ Key word: Conference Cinfa Biotech to present at two upcoming biosimilar conferences to discuss clinical development strategies 09.02. 2016/ 16:45 The issuer is solely responsible for the content of this announcement.- Press Release Cinfa Biote
EPIRUS Biopharmaceuticals, Inc., a pure-play biosimilar company focused on the development and commercialization of biosimilar monoclonal antibodies, today announced the initiation of its global registration study for BOW015 in active Rheumatoid Arthritis patients. EPIRUS plans to enroll over 500 patients in the UNIFORM Study, which will be condu
On February 9, 2016, EPIRUS Biopharmaceuticals, Inc. announced the initiation of its global registration study for its lead product candidate, BOW015, a biosimilar version of Remicade , in active rheumatoid arthritis patients. The full text of the press release issued by the Company on February 9, 2016 is filed as Exhibit 99.1 to this Current Rep
NEW YORK, Feb. 9, 2016/ PRNewswire-USNewswire/ The U.S. Food and Drug Administration convened a meeting of its Arthritis Advisory Committee today to review biologics license application 125544, for CT-P13, a proposed biosimilar to Janssen Biotech Inc.' s REMICADE, submitted by Celltrion, Inc. The Crohn's& Colitis Foundation of America, the leadin
The non-binding recommendation could clear the way for the cheaper medication from Celltrion, which would only be the second in a new class of quasi-generic biotech drugs to reach the U.S. market. After nine hours of discussion the FDA panel of outside experts voted 21-3 in favor of approval for all the diseases currently indicated on Remicade's la
INCHEON, South Korea Celltrion, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration Arthritis Advisory Committee recommended approval of all indications for CT-P13, a proposed biosimilar to Janssen Biotech Inc.' s Remicade , by a vote of 21-3. CT-P13 is the first biosimilar monoclonal antibody medica
Lannett is under no obligation to, and expressly disclaims any such obligation to, update or alter its forward-looking statements, whether as a result of new information, future events or otherwise. All references to "Fiscal 2016" or "Fiscal Year 2016" shall mean the fiscal year ended June 30, 2016, and all references to "Fiscal 2015" or "Fiscal Ye
Growth in biopharmaceuticals and new therapeutics markets is leading the growth of this market in North America and Europe. The drivers of the medical membranes market in North America and Europe are the rising cost of product development and manufacturing, pharmaceutical price control and competition with generics, more severe clinical trial hurdl
The global pharmaceutical filtration market is expected to reach USD 20,190.1 Million by 2020 from USD 12,451.3 Million in 2015, growing at a CAGR of 10.2%. Growth of biopharmaceutical industry, advancements in nanofiber technology, rapid expansion in generic drug production, increasing incidence of airborne disease, and strong biologics product...
PCI Synthesis, Inc., a drug substance manufacturer of new chemical entities, generic active pharmaceutical ingredients, today announced that it has been recognized as a Life Science Leader CMO Leadership Award recipient in the categories of Reliability and Compatibility. The awards will be presented at the CMO Leadership Awards Ceremony and Recepti
Pfizer Inc. commends today s recommendation by the United States Food and Drug Administration s Arthritis Advisory Committee to approve the investigational biosimilar infliximab across all eligible indications by a vote of 21 to three. Celltrion's proposed biosimilar infliximab, to which Pfizer holds exclusive U.S. commercialization rights, i
Entitled Generics360, this comprehensive report compares generic drug prices in Canada with those of up to eleven other industrialized countries. Provincial generic pricing policies, including those initiated by the pan- Canadian Pharmaceutical Alliance, achieved significant price reductions in Canada. Most of this reduction was realized by the end
Contract notice: Purchase with the delivery of cancer drugs, generic drugs, narcotic drugs and supplements for hospital pharmacies holy cross cancer center in kielce. Time limit for receipt of tenders or requests to participate: 17.3. 2016- 10:00 Conditions for opening tenders Date: 03.17. 2016- 10:30 Language in which tenders or requests to partic
Sanofi has said it expects stable earnings this year after reporting lower profit for the final three months of 2015.. The division is a major revenue and profit driver, but Sanofi's best-selling insulin drug Lantus is losing ground to rivals. Chief Executive Olivier Brandicourt said Sanofi was still exploring options for its generic drugs business
Trxade Group, Inc., a web-based pharmaceutical marketplace engaged in promoting and enabling trade among independent pharmacies and large pharmaceutical suppliers nationally, today announced that its wholly-owned subsidiary, Westminster Pharmaceuticals LLC, has launched the generic drug HCTZ as part of an exclusive agreement with ScieGen...
-Research and Markets has announced the addition of the "US Biosimilars Market Opportunity& Clinical Pipeline Analysis" report to their offering. Biosimilars in US has been approved after a long-time while they have been introduced in other places over a decade ago. Late entry in US market has prevented the patients from getting benefit of biosimil