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Novo Nordisk Files for Regulatory Approval of Ideglira in the EU
May 31, 2013) – Novo Nordisk today announced the submission to the European Medicines Agency of the marketing authorisation application for the approval of IDegLira, the combination product of insulin degludec (Tresiba®), the once-daily new-generation basal insulin analogue, with an ultra-long duration of action, and liraglutide (Victoza®), the once-daily human GLP-1 analogue. IDegLira has been developed for the treatment of people with type 2 diabetes.
Incivo (Telaprevir) Receives European Commission Approval for Twice Daily Dosing for Treatment of Genotype-1 Chronic Hepatitis C Virus (HCV)
TELAPREVIR
may 31, 2013
Incivo (Telaprevir) Receives European Commission Approval for Twice Daily Dosing for Treatment of Genotype-1 Chronic Hepatitis C Virus (HCV)
Janssen Infectious Diseases-Diagnostics BVBA (Janssen) announced today that the European Commission (EC) has approved a new twice daily (BID) dosing of INCIVO(R) (telaprevir), a direct acting antiviral (DAA) protease inhibitor, in combination with pegylated-interferon and ribavirin (PR) for naive and previous treatment experienced patients. The newly approved dosing regimen for INCIVO(R) is now 1,125 mg twice daily in combination with PR, which aligns a morning and evening dose to the already twice daily dosing schedule for ribavirin versus 750 mg every 8 hours in combination with PR.
Telaprevir (VX-950), marketed under the brand names Incivek and Incivo, is a pharmaceutical drug for the treatment of hepatitis C co-developed by Vertex Pharmaceuticals and Johnson & Johnson. It is a member of a class of antiviral drugsknown as protease inhibitors. Specifically, telaprevir inhibits the hepatitis C viral enzymeNS3.4A serine protease. Telaprevir is only indicated for use against hepatitis c genotype1 viral infections and hasn´t been proven to have an effect on or being safe when used for other genotypes of the virus. The standard therapy of pegylated interferon and ribavirin is less effective on genotype 1 and telaprevir offers a welcome addition to the treatment of this genotype.
PROCESS FOR MANUFACTURE OF TELMISARTAN PATENT US2013137878 (A1)30 MAY 2013
A process for preparing telmisartan by reacting 2-n-propyl-4-methyl-6-(1′-methylbenzimidazol-2′-yl)benzimidazole with a compound of formula (IV) wherein Z is a leaving group, to obtain the compound 2-cyano-4′-[2”-n-propyl-4”-methyl-6”-(1”’-methylbenzimidazol-2”’-yl)benzimidazol-1”-ylmethyl]biphenyl, and subsequently hydrolyzing the nitrile function to obtain the acid function.
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.
Top 10 experimental cancer drugs – 2013
Top 10 experimental cancer drugs – 2013
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
DR ANTHONY MELVIN CRASTO
ORGANIC SPECTROSCOPY
New Drug Approvals 