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and Drug Administration is correcting a notice entitled "Controlled Correspondence Related to Generic Drug Development; Draft Guidance for Industry; Availability" that appeared in the Federal Register of November 3, 2017.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
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
The US Food and Drug Administration has approved 763 generic drug applications during Jan- Oct 2017 compared to 651 in 2016. Indian firms received approvals for 203 applications during Apr- Oct 2017, including tentative approvals. The US FDA also approved 101 drug applications in Oct 2017 alone, including 14 tentative approvals.
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
The University of Nebraska Medical Center issued the following news release:. It wasn't too long ago that people meeting Beth Conover thought she was a "generic" counselor. Conover is actually a member of the Munroe-Meyer Institute's team of genetic counselors at the University of Nebraska Medical Center.
Lewes, DE 11/16/2017 The Competitive Intelligence Report "Anti-VEGF& Anti-VEGF-R Biosimilars and Biosuperiors of Avastin, Cyramza, Eylea and Lucentis a 2017 Update" provides a competitor evaluation in the field of recombinant antibodies, proteins and vaccines targeting vascular endothelial growth factor or its receptors for treatment of a
SUMMARY: The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled "Assessing User Fees Under the Biosimilar User Fee Amendments of 2017." This draft guidance concerns FDA's implementation of the Biosimilar User Fee Amendments of 2017 and certain intended changes in policies and procedures surrounding
Boehringer Ingelheim has announced that Cyltezo, its new biosimilar version of adalimumab, has been approved by the European Commission. The regulator has granted marketing authorisation to Cyltezo for the treatment of multiple chronic inflammatory diseases in adults and children, including rheumatoid arthritis, psoriatic arthritis, Crohn`s disease
-British Columbia and Prince Edward Island are the first provinces to add Erelzi TM to their public drug plans for the treatment of multiple inflammatory diseases, respectively on November 14 and November 27. The two provincial listings follow the conclusion of an agreement between the pan- Canadian Pharmaceutical Alliance and Sandoz Canada, allowi
Hyderabad, India and Princeton, NJ, USA- Dr. Reddy's Laboratories Ltd announced today that it has launched Clofarabine Injection, a therapeutic equivalent generic version of Clolar Injection in the United States market, approved by the U.S. Food& Drug Administration. Dr. Reddy's Laboratories' Clofarabine Injection is available in single-dose, 20 mL
By a News Reporter-Staff News Editor at Women's Health Weekly Investigators discuss new findings in Oncology- Breast Cancer. According to news reporting out of Durham, North Carolina, by NewsRx editors, research stated, "In 2015, the biosimilar filgrastim EP2006 became the first biosimilar approved by the US Food and Drug Administration for comme
If you want a Stock Review on CPRX, FLXN, SUPN, or AGN then come over to http://dailystocktracker.com/register/ and sign up for your free customized report. DailyStockTracker.com shifts focus on Catalyst Pharmaceuticals Inc., Flexion Therapeutics Inc., Supernus Pharmaceuticals Inc., and Allergan PLC. The Generic Drugs market can be segmented into..
Generic pharmaceutical major Hetero Healthcare Limited has launched the first-ever generic fixed-dose combination anti- retroviral drug, Darunavir+ Ritanovair, in India. The drug was granted approval by the Drug Controller General of India and will be marketed and distributed under the brand name Danavir-R, in India, by Hetero Healthcare Limited.
Hetero, one of India's leading generic pharmaceutical companies and one of the world's largest producer of anti-retroviral drugs, today announced that it has received the approval from Drug Controller General of India to launch the first-ever generic fixed-dose combination drug' Darunavir+ Ritonavir' in India. The product will be marketed and distr
Holzkirchen- Sandoz, a Novartis division and the global leader in biosimilars, today announces data from four clinical studies comparing its proposed biosimilar adalimumab and biosimilar rituximab with their reference medicines, Humira and MabThera/Rituxan respectively-. Further the impact of switching between Sandoz biosimilar adalimumab and its..
Brokerages expect Indian pharmaceutical companies to show a better growth in Oct 2017- Mar 2018 after a very poor first half due to gradual reduction in pricing pressure in the US market. Revenues of some of the top generic pharmaceutical companies had fallen year-by-year by seven-46 percent in Jul- Sep 2017 on account of 11-12 percent price erosio
-PCI Synthesis, Inc., a pharmaceutical manufacturer of new chemical entities, generic active pharmaceutical ingredients, and other specialty chemical products, announced that industry veteran Scott VanderWel has joined the company as Business Development Manager, and is based in San Diego, the companys first office outside Massachusetts.
Biosimilars Market Size and Forecast, By Indication, And Trend Analysis, 2014- 2024 Download the full report: https://www.reportbuyer.com/product/5205101 The global biosimilars market is expected to reach USD 13.1 billion by 2024 on account of increase in the prevalence of chronic diseases such as cancer, diabetics, cardiac disorders and autoimmune
Boehringer Ingelheim has won its first biosimilar approval in Europe with authorisation of Cyltezo for a range of chronic inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, Crohns disease and ulcerative colitis. Cyltezo is the first biosimilar from Boehringer Ingelheim approved in Europe, and marks a significant step...
Already locked in a legal tussle with AbbVie over intellectual property for adalimumab in the US, the German drugmaker has already indicated it does not intend to launch the biosimilar in Europe until October 2018- after AbbVies patent protection for the drug expires. Cyltezo was approved by the FDA in August, and a launch there will depend on the
Vicente Gonzalez, D- Texas, issued the following news release:. Congressman Vicente Gonzalez recently announced that the Centers for Medicare and Medicaid Services issued a finalized 2018 Quality Payment Program and Physician Fee Schedule, which includes a provision that modernizes the Medicare payment system to increase competition and opportunity
Pharmaceutical major Dr Reddy's Laboratories Limited announced that it. has launched Clofarabine injection, a therapeutic and generic equivalent of Clolar injection of Genzyme Corporation, in the US market. As per IMS Health, Clolar brand and generic had the US sales of about $53 million for the most recent 12 months ended Sep 2017.