Month: March 2015
March 27, 2015 | By Márcio Barra
Kalydeco, a new orphan drug priced at over US$300,000 per year
A new study released today by the WHO Regional Office for Europe provides an in depth look at the challenges faced by European Member States health systems by the introduction of new, costly therapeutic entities, and the troubling economic burden they bring to the Member States.
As an array of new drugs reach Europe, healthcare expenditure with new drugs is increasing at an accelerated pace. Some of new, costlier drugs include Gilead’s Hepatitis C drug Sofosbuvir (Sovaldi), orphan drugs with prohibitive price tags, and new anti-cancer agents costing $6,000-10,000 a month.
The report’s main takeaway message is that European governments need to cooperate and encourage collaboration between payers on standards and criteria for evaluation of benefits and cost–efficiency of new medicines, seeing as some member states do not have mechanisms in place to evaluate…
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ALL ABOUT DRUGS, LIVE, BY DR ANTHONY MELVIN CRASTO, WORLDDRUGTRACKER, HELPING MILLIONS, 7 MILLION HITS ON GOOGLE, PUSHING BOUNDARIES, ONE LAKH PLUS CONNECTIONS WORLDWIDE, 5 LAKHS PLUS VIEWS ON THIS BLOG IN 203 COUNTRIES
DR ANTHONY MELVIN CRASTO
Sri Lanka has its own indigenous scheme of traditional medicine (Ayurveda). This system has been practised for many centuries in the island nation. The Sri Lankan Ayurvedic tradition is a mixture of the Sinhala traditional medicine, Ayurveda and Siddha systems of India, Unani medicine of Greece through the Arabs, and most importantly, theDesheeya Chikitsa, which is the indigenous medicine of Sri Lanka.
Sri Lanka developed its own Ayurvedic system based on a series of prescriptions handed down from generation to generation over a period of 3,000 years. The ancient kings, who were also prominent physicians, sustained its survival and longevity. King Buddhadasa (398 AD), the most influential of these physicians, wrote the Sarartha Sangrahaya, a comprehensive manuscript which Sri Lankan physicians still use today for reference.
- Sri Lanka
Ancient inscriptions on rock surfaces reveal that organized medical services…
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By Sai Chamarthy, Philip Kuehl, and Jayne Hastedt
Since 2000, developers of immediate-release oral drugs have been able to request waivers of in vivo bioequivalence studies based on the Food and Drug Administration’s (FDA’s) Biopharmaceutics Classification System (BCS). Based on the work of University of Michigan professor Gordon Amidon, the BCS has allowed more efficient development and regulatory review of immediate release oral drug products based on in vitro data. The oral BCS was originally published in 1995 and has been revisited several times by Amidon and his team(s): Dahan et al and Amidon et al. For oral products, the BCS approach has provided an effective means to develop high-throughput screening paradigms in early discovery, prioritizing development resources in early development and increasing market access due to generics through the waivers of in vivo bioequivalence studies.
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2-Hydroxy-l-(2-((9-((lr,4r)-4-methylcyclohexyl)-9H- pyrido [4′,3 ‘ :4,5] pyrrolo [2,3-d] pyrimidin-2-yl)amino)-7,8-dihydro-l ,6- naphthyridin-6(5H)-yl)ethanone
2-Hydroxy-1-(2-((9-((1R,4R)-4-methylcyclohexyl)-9H-pyrido[4′,3′:4,5]pyrrolo[2,3-d]pyrimidin-2-yl)amino)-7,8-dihydro-1,6-naphthyridin-6(5H)-yl)ethanone (AMG 925)
FLT3/CDK4 inhibitor,potent and selective
AMG 925 is a dual kinase inhibitor of FLT3 and CDK4 with IC50 value of 1 nM and 3 nM, respectively
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The European Directorate for the Quality of Medicines & Healthcare (EDQM) has published new information about the CEP procedure and its related inspections. Please read more about he latest updates from EDQM.
The European Directorate for the Quality of Medicines & Healthcare (EDQM) has published new information about the CEP procedure and its related inspections.
1) Costs of inspections
The EDQM has published a new document which describes the inspection costs. The EDQM document PA/PH/CEP (12) 28 1R refers to a table of fees and inspection costs. The costs for the inspection as well as for the travel will be invoiced prior to the inspection. For a three day inspection, for example, the fee is 5000,- Euro. If the facility is located in Asia a flat rate of 6000,- Euro will be charged to cover the travel costs, food and accommodation for the inspector. The travel costs are less when the facility is located in Europe (800,- Euro) and elsewhere (4500,- Euro). The CEP inspection fee table can be found here.
2) New Indian State has impact on CEP holders
The Indian government created a new state on 2nd June 2014 which is called Telangana. The EDQM reminds holders of CEPs and applicants for CEPs that it is their responsibility to update their CEP applications. Many of the addresses mentioned on CEPs and in CEP applications which are currently listed as being in Andhra Pradesh are now in this new state of Telangana. The new address details, as well as an updated section 3.2.S.2.1 should be submitted to EDQM. This should be done until 31 August 2015.
At the beginning of each year the FDA always publishes a list of the guidances it plans to publish during that year. It has done so again in 2015. The document is relatively comprehensive, containing five pages. Find out more about the Guidances the FDA plans on publishing in 2015.
At the beginning of each year the FDA always publishes a list of the guidances it plans to publish during that year. It has done so again in 2015. The document is relatively comprehensive, containing five pages. The list is subdivided into different categories. It contains for example also guidances planned in connection with the topics Clinical Pharmacology or Clinical/Statistical.
CGMP is a category of its own for which “only” three new guidances are planned for 2015:
- A questions & answers (Q&A) paper on the topic data integrity
- CGMP rules for outsourced facilities (pharmacy compounding)
- Rules for the repackaging of certain drug products by pharmacies and outsourcing facilities
Especially the Q&A document could be interesting.
The guidances planned for the category “Pharmaceutical Quality/CMC” are also closely related to GMP. The following guidances are examples of the 13 guidances planned altogether in this category:
- A guidance on the development of NIR procedures
- A guidance on microbiological quality considerations in non-sterile drug product manufacturing
- A guidance on quality metrics and risk-based inspections.
Concerning biotechnology specifically there are two separate categories with the topics biopharmaceutics and biosimilarity.
Conclusion: The number of new guidances in the GMP environment planned for 2015 is relatively limited but some of the topics (such as data integrity and quality metrics) could be very interesting. Furthermore, it remains to be seen if all of the planned guidances will really be published in 2015.
Please also see the “New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2015″.
Postscript: If you are interested in the topic quality metrics: In the framework of the 6th European GMP-Conference the ECA offers a Pre-Conference on this topic taking place in Heidelberg on 8 June 2015.