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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Lucentis rival one step away from NHS approval
Bayer’s Eylea (aflibercept),
lucentis, novartis
http://www.pharmatimes.com/Article/13-05-31/Lucentis_rival_one_step_away_from_NHS_approval.aspx
http://www.bioportfolio.com/news/article/1484477/Lucentis-rival-one-step-away-from-NHS-approval.html
Aflibercept is a fusion protein approved in the United States for the treatment of wet macular degeneration and metastatic colorectal cancer.
It is an inhibitor of vascular endothelial growth factor.It is designed to bind to VEGF-A, VEGF-B, and placental growth factor (a.k.a PIGF, gene symbol PGF)
Aflibercept is being co-developed by Sanofi-Aventis and Regeneron Pharmaceuticals.
Ranibizumab (trade name Lucentis) is a monoclonal antibody fragment (Fab) derived from the same parent mouse antibody as bevacizumab (Avastin). It is much smaller than the parent molecule and has been affinity matured to provide stronger binding to VEGF-A. It is an anti-angiogenic that has been approved to treat the “wet” type of age-related macular degeneration (AMD, also ARMD), a common form of age-related vision loss.
Ranibizumab sells for $1,593 per dose, compared to bevacizumab, which can be prepared for macular degeneration treatment in doses that cost $42. Clinical trials have shown both to be equally effective; however there were some reports of infection after dividing bevacizumab into smaller doses.
Ranibizumab was developed by Genentech and is marketed in the United States by Genentech and elsewhere by Novartis,under the brand name Lucentis.
BioMarin gets US priority review for rare disease drug
31 may 2013
BioMarin will be celebrating news that regulators on both sides of the Atlantic have agreed to review Vimzin under accelerated review processes.
Vimzin is an enzyme replacement therapy for which the drugmaker is seeking approval as a treatment for the rare lysosomal storage disorder Mucopolysaccharidosis Type IVA (MPS IVA), also known as Morquio A Syndrome.
During an initial review of the Biologics License Application the US Food and Drug Administration requested extra Chemistry, Manufacturing and Controls information, and following receipt of this from BioMarin it has extended the PDUFA action date by three months to February 28 next year.
In the EU, assuming the marketing application remains on the accelerated assessment timeline, a CHMP opinion is anticipated in December this year, which means a decision from the European Commission could be handed down in the first quarter of 2014, the firm said.
The estimated prevalence of MPS IVA is around 3,000 patients in the developed world, and it is believed that around 20% or patients are in North America and 50% in Europe.
FDA Accepts sNDA for Higher Concentration Dose of Copaxone
Teva Announces FDA Acceptance of sNDA for a Higher Concentration Dose of COPAXONE® Given Three Times a Week
http://www.pharmalive.com/fda-accepts-snda-for-higher-concentration-dose-of-copaxone
Glatiramer acetate (also known as Copolymer 1, Cop-1, or Copaxone – as marketed by Teva Pharmaceuticals) is an immunomodulator drug currently used to treat multiple sclerosis. It is a random polymer of four amino acids found in myelin basic protein, namelyglutamic acid, lysine, alanine, and tyrosine, and may work as a decoy for the immune system. Glatiramer acetate is approved by the Food and Drug Administration (FDA) for reducing the frequency of relapses, but not for reducing the progression of disability. Observational studies, but not randomized controlled trials, suggest that it may reduce progression of disability.
Although the clinical definition of multiple sclerosis requires two or more episodes of symptoms and signs, glatiramer acetate is approved for treatment after single episodes. It is also used to treat relapsing-remitting multiple sclerosis. It is administered bysubcutaneous injection.
Inspection Management – How to Pass EU and FDA Inspections
Inspection Management – How to Pass EU and FDA Inspections
Gaseous Sterilization – New USP General Chapter
Gaseous Sterilization – New USP General Chapter <1229.7>
Generic Licensing News –NAPHAZOLINE NITRATE, featured product
NAPHOZALINE
PRODUCT USED AS
NAPHAZOLINE NITRATE
Naphazoline Nitrate is a rapid acting sympathomimetic vasoconstrictor of occular artierioles. It acts to decrease congestion of the conjunctiva and is found in many over-the-counter eye drops.
Naphazoline is primarily indicated in conditions like Corneal vascularity, Hyperaemia, Itching, Nasal congestion, and can also be given in adjunctive therapy as an alternative drug of choice in Sinusitis.
http://www.leadformix.com/ef1/preview_campaign.php?lf1=933470130c201312625317b456273
Click here to contact Farmak about this product.
more info
It is a sympathomimetic agent with marked alpha adrenergicactivity. It is a vasoconstrictor with a rapid action in reducing swelling when applied tomucous membrane. It acts on alpha-receptors in the arterioles of the conjunctiva to produce constriction, resulting in decreased congestion. It is an active ingredient in several over-the-counter formulations including Clear Eyes and Naphcon eye drops.
Naphazoline, 2-(1-naphthylmethyl)-2-imidazoline, is synthesized from (1-naphthyl)acetonitrile, which upon reaction with ethanol transforms into iminoester, and undergoes further heterocyclization into the desired imidazoline derivative upon reaction with ethylene diamine 
- A. Sonn, U.S. Patent 2,161,938 (1939).
New Drug Approvals 