The pharmaceutical industry is facing a tough road ahead in the future marketplace Though pharmaceuticals remain the most costeffective healthcare intervention they should bring about a significant transformation in their organisations to realise the..
The rise in counterfeit medicines worldwide with concomitant problems of toxicity instability and ineffectiveness is often underestimated It is a hidden risk because counterfeit medicines are largely overlooked in the official public health statistic..
Two questions from patients about drug therapydoes it fix my problem does it cause other problemssuggest three new pharma strategies to address payers priorities for improved results These strategies are affected by payer perspectives as they shape t..
With a decrease in RD productivity increase in the cost of latephase drug development and a greater competition for licensing opportunities the stakes are high for the major players in the pharmaceutical industry..
It has become dogma that the era of genomics will require extensive genotyping of each patient personalised medicine and that this will carve up the pharmaceutical marketplace making blockbuster drugs a thing of the past In the extreme each patient w..
Understanding the solubility behaviour of the drugexcipient complex in a lipidbased drug delivery system will help formulation scientists in rational selection of the appropriate excipients and in the determination of the optimum excipient levels to ..
Vaccines play a central role in health protection and advances in biotechnologies now offers numerous novel approaches for vaccine development The goal of developing new vaccines to immunise people against infectious diseases has long been a key prio..
It is important to show that biogeneric drugs are comparable in structure and function to that of the innovator and any differences have to be supported with data showing no influence on these parameters..
Companies developing biosimilars face a challenge of adopting the right commercial and regulatory strategy as the regulatory environment is not yet harmonized across the major markets Draft guidelines for Japanese biosimilars were published by its re..
The number of new biotechnology therapeutics makeup a significant proportion of all new drug development programmes However some of these new therapies are prohibitively expensive Many toptier generic firms today have developed scientific and technol..
Translating the pharmacoeconomic potential of biosimilars into real improvements in access to expensive cuttingedge medicines remains a challenge that must be urgently addressed by healthcare authorities and policy makers..
This is a case study of how Amgen manages a major electronic Common Technical Document filing It focusses on tools and processes developed and refined from 2005 to present During this time Amgen has filed three original Marketing Applications with an..
Although conventional freeze drying in vials is still the predominant format lyophilisation in alternative formats such as prefilled syringes and alternate technologies such as spray freeze drying are becoming more popular..
In managing Chemistry Manufacturing and Controls documents the larger process is involved for electronic regulatory submissions to health authorities This is a case of an entire process standard providing significant gains in efficiency A solution is..
Indias growing respect and legal regulatory framework for IPR favourable economic policies resulting into attractive investment destination and availability of huge talent pool for sustaining and growing operations is making India an attractive dest..