12. December 2011 15:57
A scientific investigation team headed by Cleveland Clinic’s Stephen J. Nicholls, M.B.B.S., Ph.D., has found that the use of the drug Evacetrapib is associated with a large increase in “good cholesterol”, i.e., high-density lipoprotein cholesterol, or HDL-C, a substance that is known to be associated with a lower incidence of cardiovascular disease. Evacetrapib acted also to decrease“bad cholesterol” or low-density lipoprotein cholesterol, also known as LDL-C. 398 individuals who had sub-optimal levels of cholesterol – either abnormally low HDL-C or abnormally high LDL-C, were the subjects of the investigation.
Evacetrapib belongs to a class of substances that act to increase HDL-C and in some cases, reduce LDL-C, by means of inhibiting Cholesterol Ester Transfer Proteins, or CTEPs. The Nicholls study found that over the course of twelve weeks of treatment, HDL-C levels in the test subjects who were given doses of Evacetrapib shot up by dramatically, from 53.6% to 128.8% (from 30 mg/dL to 66 mg/dL). LDL-C levels dropped by -13.6% to -35.9%. The HDL-C boost was even more impressive in the test subjects who had lowerlevels of HDL-C to begin with. Placebos were found todecrease HDL-C by -3% in test subjects, and to either reduce LDL-C by -3.0% or increase it by 3.9%.
The study also looked at the effect of Evacetrapib when taken in conjunction with statins (cholesterol reducing drugs). When 100 mg/d of Evaceptrapib was taken along with statins, HDL-C levels increased by 78.5% to 88.5%, and LDL-C got reduced by -11.2% to -13.9%. Compared to exclusive statin therapy, (i) Evaceptrapib plus statins resulted in greater decrease of LDL-C and (ii) Evaceptrapib plus statins did not produce greater increase in HDL-C. These results are consistent with well known findings from other studies.
To put the Nicholls study in perspective: Evaceptrapib therapy is only one among many approaches to treating patients with low HDL-C. Christopher P. Cannon, M.D., of Brigham and Women's Hospital, Boston, notes that while lifestyle change with respect to diet, exercise, and cigarette smoking are known to deliver the desired result, i.e., higher HDL-C, existing guidelines counsel lowering LDL-C. This has benefits regardless of HDL levels. The use of Niacin to increase HDL-C is yet another approach, though the jury is still out on this one. Meanwhile, trials involving Niacin and CTEP inhibitors like Dalcetrapib, Anacetrapib and Evacetrapib are on the anvil.
28. November 2011 16:45
Russia, France, Germany and other European countries signed the first ever international treaty to combat the counterfeit medicine industry.
Developed in 2010, the Council of Europe created a binding international instrument based upon the Right to Life provision in the European Convention on Human Rights and Fundamental Freedoms. Signatories of the treaty agree to criminalize activities that produce or promote the sale of counterfeit drugs that are harmful to patients. Said Tatyana Golkova, Health and Social Development Minister of Russia, "The global trend has been that these crimes were often not considered as serious enough to merit criminal law measures," she said. "In some countries, these activities have already been criminalized. In others, the governments will have to introduce new measures." Austria, Finland, Italy, Israel, Iceland, Portugal, Switzerland, Ukraine, Russia, France and Germany have signed the treaty.
SOURCE: Safe Medicines
13. November 2011 23:06
Over 28 pharmaceutical manufacturing facilities in India are in the process of complying with the bar coding requirement for exports which came into effect from Oct 1, 2011 in partnership with PharmaSecure, Inc.
The most difficult challenge in implementing the DGFT serialization is putting unique numbers on packages in high speed, high volume and sterile pharmaceutical manufacturing facilities in a way that does not disrupt production.
PharmaSecure -- a global innovator in drug authentication technologies and software, had deployed a specialized team of engineers from the United States and India to help Indian companies meet the regulatory requirement.
As per the notification of Directorate General of Foreign Trade, every tertiary package (or shipping package) of drugs exported from India need to be serialized uniquely beginning October 1st 2011. All secondary packages (the box typically in the chemist's shop) need to be serialized uniquely beginning January 1st, 2012, and primary packages (blister packs and vials) need to be uniquely serialized by July 1st 2012.
The regulation allows pharmaceutical companies to track and ensure that their drugs are reaching the destination without the influx of counterfeits and diversion of valuable, life-saving products.
“This serialization to comply with DGFT mandate is just the beginning. We look forward to working with our clients to activate SMS authentication and data analytics in the over 60 different countries to which these drugs are being exported.” – Kishore Kar, VP Sales and Marketing for India and Southeast Asia, PharmaSecure.
PharmaSecure's DGFT serialization not only conforms to the regulations, but also allows consumers to confirm the authenticity of their medicines by sending the serial number by SMS and receiving confirmation of authenticity.
“India is leading the way in a global movement toward serialization which has the potential to transform the way drugs are distributed globally. I believe we will see other countries follow. We're seeing our focus on service excellence and cost effectiveness resonate with the Indian market right now. We plan to invest in more applications that can ride on the serialization to increase the reach and distribution of our clients' products.” - Nathan Sigworth, CEO PharmaSecure Inc.
India, which accounts for the 3rd Largest Drug production globally by volume and 14th by value, has increasingly witnessed Spurious and Counterfeit Drugs made in China for African Countries, under the brand name of Indian drug companies. The $20 Billion (Rs 90,000 Crore) Indian pharmaceutical industry constitutes 40% exports.