All About Pharmaceuticals

The future of clinical trial design The costs of clinical trials have grown substantially in recent years, and as a result, clinical trials are now one of the most expensive elements of drug development. Considering this, many companies are exploring how they can reduce the financial burden through effective trial design, improved efficiency, and changing the strategy for recruitment and retention. Although clinical sites have the potential to partner with sponsors to improve all aspects of clinical trials, sites are often excluded from the conversation. To find out more about reducing clinical trial costs, we spoke to  Ravi Thadhani, MD, MPH , Vice Dean of Research and Education at Cedars-Sinai and  Teri A. Grieb , Ph.D., Chief Scientific Officer, Senior Director for Research at the University of Michigan, about the coming changes in trial design. According to Ravi, the growing focus on reducing costs and improving enrolment for clinical trials has the potential to ...

Many folks outside of this industry don’t realize that the FDA sends inspectors to drug manufacturing facilities in other countries. That might sound a bit odd, but agreeing to such inspections is in fact a condition of being able to sell pharmaceutical substances in the US (or to supply other companies that do). It’s a big job, and one feels sure that there are things that slip through the many possible cracks in the system – but still, it is good to see   inspection reports   like this once in a while that let you know that the system is catching clowns like this bunch (a facility in Gujarat state, India): On October 24, 2018, our investigator observed torn documents of stability study data, analytical testing sheets, analysis calculations, and release forms that were placed into clear trash bags. Stability study documents for three batches of  (b)(4)  mg tablets were salvaged from the trash and compared to the official and approved records. Out-of-specif...

I   wrote here   about a new company (Homology Medicine) that claimed to have a viral method for gene editing that did not involve any sort of double-strand DNA breaking enzyme (as you need during the CRISPR, TALENs, or zinc-finger nuclease methods). That’s a pretty interesting claim, because double-strand breaks (DSBs) are powerful but can be hard to control. But as is always the case, interesting claims need interesting evidence to back them up. As I said at the time: This is a testable hypothesis, of course. The company will be working very hard to produce convincing results, and if they do, they can expect to see a lot more than $127 million. I’d be a little jumpy about investing at this point, though, because it’s certainly true that a lot of neat stuff doesn’t quite pan out. (The current research boom, looked at from that perspective, is due to a slightly higher-than-normal run of neat stuff actually working). Even at the time (as a link in that post shows) there...

Truth is one, perceived and expressed differently by different sages. Ashtavakra, the great mystic philosopher, is addressing King Janaka who, at that moment, had one foot in the saddle while mounting his horse, telling him that following his instructions, Janaka could attain liberation by the time he sat on his horse. Liberation means shattering all chains of bondage and becoming one with the Creator.  Ashtavakra and Shankaracharya have both insisted that it is possible to realise this great Truth and become jivanmukta. The other school says that this is possible only when the body perishes, which is in one way, videhmukta. The firm conviction of Ashtavakra about the possibility of attaining freedom from bondage in this body forms the teachings contained in Ashtavakra Gita.                                   ...

Introduction India is the largest provider of generic drugs globally. Indian pharmaceutical sector industry supplies over 50 per cent of global demand for various vaccines, 40 per cent of generic demand in the US and 25 per cent of all medicine in UK. India enjoys an important position in the global pharmaceuticals sector. The country also has a large pool of scientists and engineers who have the potential to steer the industry ahead to an even higher level. Presently over 80 per cent of the antiretroviral drugs used globally to combat AIDS (Acquired Immune Deficiency Syndrome) are supplied by Indian pharmaceutical firms. Market Size The pharmaceutical sector was valued at US$ 33 billion in 2017. The country’s pharmaceutical industry is expected to expand at a CAGR of 22.4 per cent over 2015–20 to reach US$ 55 billion. India’s pharmaceutical exports stood at US$ 17.27 billion in FY18 and have reached US$ 19.14 billion in FY19. Pharmaceutical exports include bulk drugs, interm...