Month: May 2014

EU approves Takeda’s bowel drug Entyvio

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New Drug Approvals

EU approves Takeda's bowel drug Entyvio

Hot on the heels of an approval in the US, regulators in Europe have now also given Takeda’s Entyvio (vedolizumab) the nod for two inflammatory bowel diseases. The European Commission has granted Marketing Authorisation for use of the gut-selective humanised monoclonal antibody to treat adults with moderately to severely active ulcerative colitis (UC) and adults with moderately to severely active Crohn’s disease (CD).

Read more at: http://www.pharmatimes.com/Article/14-05-27/EU_approves_Takeda_s_bowel_drug_Entyvio.aspx#ixzz334DL7xQJ

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Pharmaceutical Water: Uncertainty caused by the New Biocidal Products Regulation

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Pharmaceutical Water: Uncertainty caused by the New Biocidal Products Regulation
Many pharmaceutical water facility operators are not aware of the Biocidal Product Regulation which came into force on 1st September 2013 which implies a product registration for ozone equipment.Read more here.http://www.gmp-compliance.org/eca_news_4317_n.html

 

 


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WHO publishes Draft on Process Validation

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Dated April 2014 the WHO published a proposal for the revision of appendix 7 (non-sterile process validation) as a supplementary to the Guidelines on Good Manufacturing Practices. The reason given for the revision is compliance with actual GMP requirements. The following is an in-depth analysis.

http://www.gmp-compliance.org/enews_4252_WHO%20publishes%20Draft%20on%20Process%20Validation_8377,8480,8550,8471,Z-VM_n.html

Europe’s May 2014 Products Recommended For Orphan Drug Designation

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Orphan Druganaut Blog

The European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) held a meeting May 13 – 14, 2014. The EMA COMP May 2014 Meeting Report on the review of applications for orphan designation is published May 16.

At this meeting, there are 10 positive opinions recommending the following medicines for designation as orphan medicinal products. COMP’s opinions are then forwarded to the European Commission (EC). The EC will then decide whether to grant an orphan designation for the medicines in question. Public summaries of the opinions will be available on the EMA website following adoption of the respective decisions on orphan designation by the EC :

 Product Name Sponsor Company Indication
1-(2,2-difluoro-1,3-benzodioxol-5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl}cyclopropanecarboxamide Vertex Pharmaceuticals Cystic Fibrosis
Isavuconazonium sulfate Fondazione Telethon Stargardt’s Disease
Mixture of two adeno-associated viral vectors serotype 8 containing the 5’-half sequence of human MYO7A gene and the 3’-half sequence of human MYO7A gene Fondazione Telethon Usher Syndrome
Adeno-associated viral vector…

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India business robust in terms of growth: Glenmark….videos

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New Drug Approvals

SOME LINKS ON VIDEOS

CLICK TO VIEW

India business robust in terms of growth: Glenmark on Q1 

profit.ndtv.com/…/news/video-india-business-robust…
Aug 2, 2013

NDTV Profit News Video Clip on India business robust in terms of growth: … chairman and managing director …

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Astellas’ Dificlir (fidaxomicin) could save NHS thousands of pounds

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New Drug Approvals

Fidaxomicin2DCSD.svg

Fidaxomicin

873857-62-6 3-(((6-Deoxy-4-O-(3,5-dichloro-2-ethyl-4,6-dihydroxybenzoyl)-2-O-methyl-β-D-mannopyranosyl)oxy)-methyl)-12(R)-[(6-deoxy-5-C-methyl-4-O-(2-methyl-1-oxopropyl)-β-D-lyxo-hexopyranosyl)oxy]-11(S)-ethyl-8(S)-hydroxy-18(S)-(1(R)-hydroxyethyl)-9,13,15-trimethyloxacyclooctadeca-3,5,9,13,15-pentaene-2-one

C52H74Cl2O18   Molecular Weight: 1058.03916 

US FDA:link         Launched – 2011   Clostridium difficile-associated diarrhea

OPT-80  
PAR-101

Astellas' Dificlir could save NHS thousands of poundsUsing Astellas’ Dificlir (fidaxomicin) as a first-line treatment for clostridium difficile infection (CDI) is not only clinically effective but could also save the National Health Service thousands of pounds compared to the standard of care, according to data from a late-stage study

Read more at: http://www.pharmatimes.com/Article/14-05-14/Astellas_Dificlir_could_save_NHS_thousands_of_pounds.aspx#ixzz31qrtFXlT

Fidaxomicin (trade names DificidDificlir, and previously OPT-80 and PAR-101) is the first in a new class of narrow spectrummacrocyclic antibiotic drugs.[2] It is a fermentation product obtained from the actinomycete Dactylosporangium aurantiacum subspecies hamdenesis.[3][4] Fidaxomicin is non-systemic, meaning it is minimally…

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For National Women’s Health Week, FDA Resources Help Women Make Informed Health Choices

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New Drug Approvals


For National Women’s Health Week, FDA Resources Help Women Make Informed Health Choices

By: Marsha B. Henderson, M.C.R.P. “Ask your mother.” In households throughout the country, women often make decisions about foods and medical products for themselves and their loved ones. As we celebrate National Women’s Health Week (May 11-17), I want to … Continue reading →http://blogs.fda.gov/fdavoice/index.php/2014/05/for-national-womens-health-week-fda-resources-help-women-make-informed-health-choices/?source=govdelivery&utm_medium=email&utm_source=govdelivery

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