EU approves Takeda’s bowel drug Entyvio

New Drug Approvals

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

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

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

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

New Drug Approvals

SOME LINKS ON VIDEOS

CLICK TO VIEW

India business robust in terms of growth: Glenmark on Q1 …

► 4:33► 4:33

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 …

• FY14 looks solid, though local market has slowed: Glenmark …

  ► 8:24► 8:24

  http://www.ndtv.com › Video

  May 8, 2013

  

  Glenn Saldanha, chairman and MD, Glenmark Pharmaceuticals, says that FY14 will bring in solid growth for …

• Outperformed peers in domestic market: Glenmark …

  ►►

  profit.ndtv.com/…/news/video-outperformed-peers-in-…

  Jan 30, 2013

  Visit NDTVProfit.com to Watch Outperformed peers in domestic market: Glenmark Pharmaceuticals Video …

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

New Drug Approvals

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

Using 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 Dificid, Dificlir, 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

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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EMA: new guidance for pharma on early HTA dialogue

The European Medicines Agency (EMA) has published draft best-practice guidance for industry on parallel scientific advice with health technology assessment (HTA) agencies, aimed at facilitating early dialogue between regulators, HTA bodies and drug developers.

Read more at: http://www.pharmatimes.com/Article/14-05-11/EMA_new_guidance_for_pharma_on_early_HTA_dialogue.aspx#ixzz31Z1LsEH1
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How to become a QP for Europe

How to become a QP for Europe
Both the ECA and the European QP Association are often contacted by people who would like to become a Qualified Person in a Member State of the European Union or outside the EU to release products for the EU market. Read more.

Read more.

 

GDP Question: When to use Mean Kinetic Temperature Calculation (MKT)?

GDP Question: When to use Mean Kinetic Temperature Calculation (MKT)?
The British Medicines Authority MHRA is performing GMP and GDP Inspections on a risk based strategy. Based on the experience the MHRA answers frequent asked questions. One very interesting Q&A refers to Mean Kinetic Temperature Calculations (MKT). Read more about MKT here

Read more about MKT here

 

EMA publishes Guideline Draft on Validation of biotechnology-derived Products

For the EMA, it was necessary to develop an independent guideline on the topic as – despite the existence of harmonised ICH documents – specific aspects of the validation of biotechnology-derived products have been missing. A draft is now available.

A draft is now available.

EMA publishes Guideline Draft on Validation of biotechnology-derived Products

 

 

Top 15 Drug Launch Superstars

Jayan Rappai

October 2, 2013

A year ago, FiercePharma published a list of drugs that missed when stepping on the up escalator. A heel got caught, or a sleeve. Bystanders hit the emergency stop button. For whatever reason, escalate they did not. We called it “Top 10 Drug Launch Disasters.” It’s still one of our most popular special reports.

This year, we wanted to take a more positive approach. So, herewith we bring you our Top 15 Drug Launch Superstars. Some of them will be obvious to anyone who follows the pharma business. They certainly were obvious to us. But choosing the rest was a challenge–one we weren’t exactly expecting, based on previous experience. Turns out, as tough as it may be to identify disasters before they happen, it’s not so difficult after the fact. To go back to the escalator analogy, it’s like trying…

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