ROCKVILLE, Md., Nov. 21, 2017/ PRNewswire/ Some of the world's largest biopharmaceutical products, among the highest revenue generators in the pharmaceutical industry, may face competition from so-called "biosimilars," according to a new report from healthcare market research firm Kalorama Information. These close copies of biodrugs are coming to
India, Mumbai- Cipla Ltd, a global pharmaceutical company, today announced that it has received final approval for its Abbreviated New Drug Application for Budesonide Inhalation Suspension, 0.25 mg/2mL, 0.5 mg/2mL, and 1 mg/2mL from the United States Food and Drug Administration to market a generic version of Astrazeneca's Pulmicort Respules.
This determination will allow FDA to approve abbreviated new drug applications for vortioxetine hydrobromide oral tablet, 15 mg base, if all other legal and regulatory requirements are met. The 1984 amendments include what is now section 505 of the Federal Food, Drug, and Cosmetic Act, which requires FDA to publish a list of all approved drugs.
East Brunswick, NJ- Heritage Pharmaceuticals Inc. has moved their corporate headquarters from Eatontown, New Jersey to the Tower Center complex in East Brunswick, New Jersey. The location offers easy access to Northern New Jersey, New York and Philadelphia by auto, rail and bus. Heritage Pharmaceuticals Inc. is a specialty pharmaceutical company en
Albany, NY 11/20/2017 According to a new market report published by Persistence Market Research "Global Market Study on Next-Generation Antibody Therapeutics: Biosimilar Antibody Products to Witness Highest Growth by 2022", the global next-generation antibody therapeutics market is project to be valued at US$ 2,250.0 Mn by the end of 2015 and
Teligent, Inc., a New Jersey- based specialty generic pharmaceutical company, today announced it has received approval of the Company s abbreviated new drug application from the U.S. Food and Drug Administration of Erythromycin Topical Solution USP, 2%. Erythromycin Topical Solution USP, 2% is Teligent s eighth FDA approval in 2017,?
By a News Reporter-Staff News Editor at Biotech Business Week Amgen and Allergan plc. announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for the Marketing Authorization of ABP 215, a biosimilar to Avastin . "ABP 215 has the potential to provide healthcare profession
The 10 new Kosdaq-listed firms include biosimilar drug marketer Celltrion Healthcare and antirheumatic drugmaker TissueGene, which made their market debuts in July and earlier this month, respectively, according to data from the Korea Exchange. The firms market cap came to 11 trillion won and 3.6 trillion won, respectively, as of Friday.
Generic Dacogen vial is indicated for treatment of patients with myelodysplastic syndromes Cipla has announced that it has received final approval for its Abbreviated New Drug Application for Decitabine Injection 50 mg single-use sterile vial from the United States Food and Drug Administration to market a generic version of Otsuka America...
By a News Reporter-Staff News Editor at Pharma Business Week Boehringer Ingelheim announced one-year data from VOLTAIRE - RA, a pivotal Phase III clinical trial comparing Cyltezo and reference product Humira *. "In addition to the 48- week efficacy results, the adalimumab biosimilar Cyltezo showed equivalent safety and immunogenicity to H
Findings from University of Szeged Provides New Data about Biosimilars. The news correspondents obtained a quote from the research from the University of Szeged, "CT-P13 was the first IFX biosimilar approved in the same indications as the reference product; however, the approval was based on randomized clinical trials conducted in patients with rhe
The company received USFDA approval for HAILEY 24 Fe Glenmark Pharmaceuticals Inc., USA, a subsidiary of Glenmark Pharmaceuticals Ltd has received ANDA approval by USFDA for HAILEY 24 Fe. The product HAILEY 24 Fe, 1 mg/20 mcg, is the generic version of Loestrin 24 Fe Tablets of Allergan Pharmaceuticals International Ltd.. As per IQVIA sales data fo
SUMMARY: The Food and Drug Administration is publishing notice that an applicant for a proposed biosimilar product notified FDA that a patent infringement action was filed in connection with the applicant's biologics license application. Under the Public Health Service Act, an applicant for a proposed biosimilar product or interchangeable product m
Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to improve FDA review of shared Risk Evaluation and Mitigation Strategies to improve generic drug access. By a News Reporter-Staff News Editor at Pharma Business Week To manage the risks associated with drugs, the FDA employs a range of tools. For drugs that are associated with ser
ONTRUZANT is the industry s first biosimilar referencing Herceptin i to receive marketing authorization from the European Commission Samsung Bioepis sets an industry record by obtaining European regulatory approval for four biosimilars in just two years. INCHEON, Korea Samsung Bioepis Co., Ltd. today announced the European Commission?
Contract notice: Generic drugs injections/infusions 1.. time limit for receipt of tenders or requests to participate: Date: 15/12/2017 local time: 10:00. conditions for opening tenders date: 15/12/2017 Major organization: VELINDRE NHS TRUST, NHS WALES SHARED SERVICES PARTNERSHIP PROCUREMENT SERVICES Address: Procurement Services 4 Th Floor Companie
The "Competitor Analysis: Anti-VEGF and Anti-VEGF-R Biosimilars and Biosuperiors of Avastin, Cyramza, Eylea and Lucentis- a 2017 Update" report has been added to Research and Markets' offering. Therapeutic antibodies targeting vascular endothelial growth factor or VEGF receptor are a highly successful class of products as evidenced by total sales o
SUMMARY: The Food and Drug Administration is correcting a notice entitled "Controlled Correspondence Related to Generic Drug Development; Draft Guidance for Industry; Availability" that appeared in the Federal Register of November 3, 2017. FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy, Food and Drug Administration, 10903 New Hamps
The Food and Drug Administration announced the availability of a draft guidance for industry entitled "Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.". According to a notice in the Federal Register, this draft guidance concerns FDA's implementation of the Biosimilar User Fee Amendments of 2017 and certain intended changes in.
Findings in the Area of Adverse Drug Reactions Reported from Auburn University. According to news reporting originating in Auburn, Alabama, by NewsRx journalists, research stated, "Some public scepticism exists about generics in terms of whether brand and generic drugs produce identical outcomes. The news reporters obtained a quote from the researc
Albany, NY 11/17/2017 This report on the oncology biosimilars market analyzes the current and future scenario of the global market. Increasing prevalence of cancer, innovation in the development of new drugs, pipeline analysis, and drug class sales during the forecast period. The global oncology biosimilars market report contain an elaborate
New Remicade Therapy Study Findings Recently Were Reported by Researchers at Radboud University. According to news reporting originating in Nijmegen, Netherlands, by NewsRx journalists, research stated, "Limited data are available on long-term clinical outcomes regarding the switch from Remicade to the infliximab biosimilar CT-P13 in inflammatory..
Recent Findings in Biosimilars Described by S. Gran-Ruaz and Colleagues. This article defines biosimilars and subsequent entry NBCDs and provides an overview of how these products have been introduced in Europe, the United States, and Canada from a regulatory, health technology, and reimbursement perspective. For more information on this research s
Mumbai- Sun Pharmaceutical Industries Ltd. reported financials for the second quarter& first half ending September 30th, 2017. Post the implementation of Goods and Service Tax with effect from 01- July-2017, India sales are now reported net of GST while sales in Q2 and H1 last year included excise duty which is now subsumed in GST. India sales at R
Request for Proposal are invited for in the areas of: Supply of Biotherapeutics-Support for development of biosimilars for cancer, rheumatoid arthritis and diabetes Support for establishment of: Process Development Laboratory, CMC Facility, GLP Validation Facility, Cell Line Repository Major organization: BIOTECHNOLOGY INDUSTRY REARCH ASSISTANCE...