"Biosimilars" are copied versions of biologics that offer a 20-50% reduction in cost compared with innovative biologic products. "Biosimilars" are getting the world wide attention as the cost of the innovative biologics are enormously high and even minimal reduction in price will reduce the healthcare spending substantially. All the countries are
SAINT HELIER- Shares of Galectin Therapeutics Inc. were down nearly 50% in extended trading on Tuesday as its phase IIa trial of GR-MD-02 in nonalcoholic steatohepatitis patients with advanced fibrosis failed to meet the study goals. Actinium Pharmaceuticals Inc. has initiated a phase II clinical trial of Actimab-A in elderly patients newly diagnos
The global contract manufacturing organization market is transforming to leverage changes in the pharmaceutical industry. Global Pharmaceutical Contract Manufacturing Organization Market is part of Frost& Sullivan's Life Sciences Growth Partnership Service program, which also includes insights on contract research, biosimilars, orphan drugs,...
Contract notice: Provision of Amgros. Contract number includes the following products: Invitation to tender: 1, ATC code: L04AX04, Generic Name: Lenalidomide, Pharmaceutical form: capsules, Strength: 2.5 to 5 mg, Unit Value: 10 mg, Quantity of units: the 368th Invitation to tender: 1, ATC code: L04AX04, Generic Name: Lenalidomide, Pharmaceutical fo
ANI Pharmaceuticals, Inc. today announced the launch of Erythromycin Ethylsuccinate for Oral Suspension 200 mg/5mL indicated as a treatment for various infections. Arthur S. Przybyl, ANI's President and CEO stated, "This is the first product that we are launching from the basket of 22 previously marketed generic products that we acquired in July
Apotex Inc. is the 7th largest generic pharmaceutical company globally with over 10,500 employees and estimated sales of approximately $2 billion. The company's US headquarters is based in Weston, Florida. The majority of Apotex sites, including manufacturing, are in North America.
"Get key Market Research Reports and Insightful Company Profiles" "Biosimilars" are copied versions of biologics that offer a 20-50% reduction in cost compared with innovative biologic products. Summary. "Biosimilars" are getting the world wide attention as the cost of the innovative biologics are enormously high and even minimal reduction in pric
Biosimilar drugs are used in prevention and treatment of various severe diseases such as cancer, diabetes, autoimmune diseases, heart attacks, rheumatoid arthritis, oncology, growth hormone deficiency, chronic kidney failure, hematological disease and infectious disease.New York City, NY 09/27/2016 Biosimilars or follow-on biologics are...
A recent survey of clinical trials in China has revealed fraudulent practice on a massive scale, according to a government investigation.China' s food and drug regulator recently carried out a one-year review of clinical trials, concluding that more than 80 percent of clinical data is "fabricated," state media reported.The scandal is the result of
Makers of the drug Suboxone- which is used to help wean addicts from heroine and other opioids- are being sued by the attorneys general of 36 states, including Hawaii Attorney General Doug Chin. The lawsuit alleges Indivior and MonoSol RX conspired to "switch Suboxone from a tablet version to a film" with the intent of making a slight change in the
Momenta Pharmaceuticals, Inc., a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that Shire has exercised its right to terminate its collaboration agreement with the Company to develop and commercialize M923, a proposed biosimilar of HUMIRA, based on a comprehensive portfolio assessment
Morrison& Foerster`s Hong Kong capital markets team has today successfully completed the HK $650 million initial public offering by Jacobson Pharma Corporation Limited on the Hong Kong Stock Exchange. Ven Tan, managing partner of Morrison& Foerster`s Hong Kong office and head of the Hong Kong capital markets team, led the deal team, which also incl
Release date- 26092016- Part of what makes my job very exciting is attending conferences. These events provide great opportunities to share, learn, network, and have fun. Apart from taking part in numerous interactive presentations and roundtables, I had the opportunity to host a luncheon alongside my colleague, Bill Dubois, for a packed room of ph
Omeprazole and Sodium Bicarbonate Powder for Oral Suspension is part of an ever-growing portfolio of products that Ajanta has developed for the US market. In total, Ajanta has 26 Abbreviated New Drug Applications of which it has 14 final ANDA approvals; 2 tentative approvals; and 10 ANDAs under review with the United States Food& Drug Administratio
Alter Pharma CEO Pieter Van Rompay was joined by Minister for Jobs, Enterprise and Innovation Mary Mitchell OConnor and staff from its sister site in Belgium to officiate at the opening ceremony. Founded in 2010, Alter Pharma has 5 companies based in Ireland including Generic Specialty Pharma Ltd, Generic Pharma International Ltd, Steac Pharmaceuti
Since Congress likes nothing more than to jump on the bandwagon of public outrage, the House of Representatives has entered the conversation of "outrageous" prescription drug pricing. The recently introduced "Fair Accountability and Innovative Research Drug Pricing Act of 2016," otherwise known as the "FAIR Drug Pricing Act," seeks to force drug-ma
DGAP-News: Cinfa Biotech, S.L./ Key word: Study Cinfa Biotech starts second clinical study of pegfilgrastim biosimilar candidate B12019 26.09. 2016/ 09:30 The issuer is solely responsible for the content of this announcement.- Cinfa Biotech starts second clinical study of peg
BASEL- The FDA on Friday approved Amgen's AMJEVITA, a biosimilar to AbbVie's Humira, across all eligible indications. AMJEVITA, which is Amgen's first biosimilar to receive the FDA nod, has been approved for the treatment of seven inflammatory diseases, including moderate-to-severe rheumatoid arthritis, moderate-to-severe polyarticular juvenile...
Release date- 23092016- The U.S. Food and Drug Administration today approved Amjevita as a biosimilar to Humira for multiple inflammatory diseases. 'This is the fourth FDA- approved biosimilar. The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions,' said J
SUMMARY: The Food and Drug Administration is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments of 2012, which authorizes FDA to collect fees and use them for the review of certain generic human drug applications and associated Type II active pharmaceutical ingredient drug
EVENT: Health and Human Services Department; Food and Drug Administration holds a meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act for fiscal years 2018 through 2022.. LOCATION: FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31 Conference Center, the Great Room, Room 1503, Section A, Sil
EVENT: Health and Human Services Department; Food and Drug Administration holds a meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments of 2012.. LOCATION: FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31 Conference Center, the Great Room, Room 1503, Silver Spring, Md.. CONTACT: Der
ZIMBABWE, among other HIV and AIDS hit countries, is staring at a potential dilemma in accessing anti-retroviral drugs as indications are that the drug will be back on patent where it will cost more than $10 000 per year per patient as India will soon stop making generic ARVs that are cheaper. Zimbabwe was accessing most of its ARVs, for example th
The generic equivalents of branded drugs being supplied through Jan Aushadhi Stores are procured from major public sector pharma units and WHO-GMP-certified manufacturing plants, Biplab Chatterjee, CEO of Bureau of Pharma Public Sector Undertakings of India, said here on Friday. Mr. Chatterjee was here to sign an MoU with the Pharmaceutical Society
Decision Resources Group finds that prescribing of biosimilars is more widespread in France and Germany than in the United States, even though nearly one year after the launch of the first biosimilar, almost half of surveyed U.S. physicians, nearly all of which being oncologists, reported some level of biosimilar use. Indicative of their desire,