Research and Markets has announced the addition of the "Advanced Drug Delivery Market Analysis& Trends- Technology, Route Of Administration, End User- Forecast to 2025" report to their offering. The Global Advanced Drug Delivery Market is poised to grow at a CAGR of around 7.8% over the next decade to reach approximately $330.70 billion by 2025..
"Biosimilars are must-have weaponry in financially sustaining healthcare systems on a global scale and significantly improving outcomes for an increasing number of patients throughout Europe and the rest of the world," said ESMO President Professor Fortunato Ciardiello. In Europe, price reductions for biosimilars are expected to range from 20-40%:.
By a News Reporter-Staff News Editor at Drug Week HYPERLINK " http://www.custopharm.com/"\ nCustopharm, Inc., a U.S. leader in generic injectable products, announced that it has acquired two paragraph IV abbreviated new drug application products from HYPERLINK " http://www.perrigo.com/"\ nPerrigo Company plc. William Larkins, chief executive offi
Dublin- Research and Markets has announced the addition of the "Global Biosimilar Monoclonal Antibodies Market: Trend Analysis and Forecast to 2022" report to their offering. Europe is the largest biosimilar monoclonal antibodies market globally. Due to favorable regulatory policies designed by the European Medical Association and since Europe was
Research and Markets has announced the addition of the "Global Biosimilar Monoclonal Antibodies Market: Trend Analysis and Forecast to 2022" report to their offering. Due to favorable regulatory policies designed by the European Medical Association and since Europe was the first region to draft guidelines for approval of biosimilar products, the Eu
By a News Reporter-Staff News Editor at Drug Week- Lannett Company, Inc. announced that it received approval last week from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for Lopinavir and Ritonavir Oral Solution USP, 80 mg/20 mg per mL, the therapeutic equivalent to the reference listed drug, Kaletra Oral Soluti
According to news originating from Bergen, Norway, by NewsRx correspondents, research stated, "Reference pricing intends to reduce pharmaceutical expenditures by increasing demand elasticity and stimulating generic competition. For more information on this research see: Reference pricing with endogenous generic entry. Journal of Health Economics, 2
Our news editors obtained a quote from the research from the Department of Biomedical Sciences, "Importantly for patients with IBD, CT-P13 was the first biosimilar to infliximab that obtained regulatory approval by the European Medicines Agency in September 2013 and by the FDA in April 2016. In May 2016, SB2 was the second biosimilar to infliximab
Aside from the updates and recent developments, they will further discuss 2017 strategies which will be helpful for both innovators and biosimilar applicants. Key issues that will be covered in this course are: Supreme Court to hear the Amgen-Sandoz Fight Case Background The Neupogen // Zarxio? Biosimilar Dispute Questions the Supreme Court wil
Biologics and Biosimilars Market report biologic defined as proteins, peptides, hormones or antibodies drugs production by bio-engineered technology, but does not include a vaccine. Biosimilars are officially approved versions of original innovator products, and can be manufactured when the original product's patent expires.Pune, Maharashtra-
LUGANO, Switzerland, January 19, 2017/ PRNewswire/. "Biosimilars are must-have weaponry in financially sustaining healthcare systems on a global scale and significantly improving outcomes for an increasing number of patients throughout Europe and the rest of the world," said ESMO President Professor Fortunato Ciardiello. In Europe, price reducti
Release date- 18012017- London- Hikma Pharmaceuticals PLC,, the fast growing multinational pharmaceutical group, announces that its wholly owned US subsidiary, Roxane Laboratories, Inc., has received an approval from the US Food and Drug Administration for its Sodium Oxybate Oral Solution, 500 mg/mL, the generic equivalent to Xyrem. Roxane is curre
Multinational London-based pharmaceutical group Hikma Pharmaceuticals PLC's wholly owned US subsidiary Roxane Laboratories Inc has received an approval from the US Food and Drug Administration (FDA) for its Sodium Oxybate Oral Solution, 500 mg/mL, the generic equivalent to Xyrem by Jazz Pharmaceuticals.
"The ACR is pleased to see the FDA issue draft guidance on biosimilar interchangeability," expressed Dr. While the ACR is still reviewing the document and will provide detailed comments to the FDA in the coming weeks, our initial reaction is that the draft guidance strikes a good balance between ensuring safety and efficacy while also getting biosi
Boehringer Ingelheim announced today that BI 695501, its adalimumab biosimilar candidate to Humira *, has been accepted for regulatory review by the European Medicines Agency and the U.S. Food and Drug Administration. "The acceptance of our regulatory filings by the FDA and EMA is a critical milestone as we explore innovative ways for biosimil
Nissan Chemical Industries Limited, and Kowa Pharmaceuticals America Inc. Zydus Cadila, the parent company of Cadila Healthcare, has received the license to market its generic version of Livalo from 2 May 2023 or earlier under certain circumstances.
SUMMARY: The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled "Considerations in Demonstrating Interchangeability With a Reference Product." This guidance is one in a series of guidances that FDA has developed to implement the Biologics Price Competition and Innovation Act of 2009.
This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications that refer to SYMMETREL, and it will allow FDA to continue to approve ANDAs that reference SYMMETREL if all other legal and regulatory requirements are met. The 1984 amendments include what is now section 505 of the Federal Food, Dr
-Elite Pharmaceuticals, Inc. today reported positive topline results from a pivotal bioequivalence fed study initiated in November 2016. Following our recent announcement regarding a successful FDA meeting for our immediate release Oxycodone HCl product SequestOx, I am now very pleased to announce these positive topline study results for an...
Findings in Inflammatory Bowel Disease Reported from J. Jahnsen and Co-Researchers. By a News Reporter-Staff News Editor at Biotech Week Current study results on Digestive System Diseases and Conditions- Inflammatory Bowel Disease have been published. According to news originating from Lorenskog, Norway, by NewsRx editors, the research stated, "M
-Research and Markets has announced the addition of the "Active Pharmaceutical Ingredients/API Market by Type, Manufacturer, Synthesis, Product Drug, Therapy- Global Forecast to 2021" report to their offering. The Active Pharmaceutical Ingredients Market in Terms of Value is Expected to Reach USD 213.97 Billion by 2021 from USD 157.95 Billion in 20
LONDON- Drugmaker Hikma Pharmceuticals PLC on Wednesday said its Roxane Laboratories Inc subsidiary in the US has received approval for its sodium oxybate oral product. Xyrem's owner, Jazz Pharmaceuticals PLC, reported net sales of the drug of USD955.0 million in 2015.. Hikma shares were up 1.9% to 1,950.00 pence on the news.
LONDON- Hikma Pharmaceuticals Plc announced Wednesday that its unit Roxane Laboratories, Inc. has received an approval from the US Food and Drug Administration for its Sodium Oxybate Oral Solution, 500 mg/mL, the generic equivalent to Xyrem. Roxane is currently involved in patent litigation concerning this product in the US District Court for the D
This acquisition represents yet another important strategic move for the Group to realize its strategy of building a family of well-known and trusted household proprietary brands with a wide geographical presence in Asia spanning from Hong Kong, China to Malaysia and Indonesia, etc. With the successful completion of the acquisition of Ho Chai Kung