Japan Pharma Outlook 2015: 2015 –Year to Watch out for Authorized Generics (AGs), Biosimilars and Overseas Strategic Initiatives

The new pricing system adopted in Japan from April -2014 (Annexure 1) is a game changer initiative. It pains most of the companies - whether generic or innovator. The most of the companies are revalidating their domestic (and thus overseas) strategies to adopt with new regulations. For the innovators – testing Authorized Generics (AGs) phenomenon for protecting their long-listed sales against generic could be one of new choice in Japan. The format and regulations for AG’s are still not clear…

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Mature Biotech Outlook 2015: New Therapy Ventures Pave the Way for Success

All biotech companies - Gilead (GILD), Amgen (AMGN), Biogen Idec (BIIB) and Celgene (CELG), in past year, have given a positive return and hence increased the interest of biotech investors. These companies have been able to select therapy/niche indication where the high treatment cost justifies the need. While large pharma companies are active in M&A deals, the Mature biotech companies are sticking to its core expertise and venturing into unexplored/new therapy; e.g., GILD in anti-cancer and BIIB for hemophilia. Alike…

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Global Pharma US & EU Outlook 2015: First –In- Class Innovations and Cost Optimization Plays Major Role In Shaping Up Business for Large Cap Pharmaceutical Companies

Strategy Diversification Divested: Productivity measurements, Divestment of non-core assets resulting in healthy Cash position- Will accelerate Next wave of targeted acquisition In the recent years' several new therapies have been approved in the area of diabetes (SGLT-2, GLP-1 agonists), Multiple Sclerosis, HCV, melanoma, and breast cancer from major pharmaceutical companies. Many of them are expected to reach multibillion dollars peak sales in the near-term which is likely to compensate the patent expiry loss in top-line revenue. Novel mechanisms like anti-PD1,…

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Sri Lanka Pharma Market Outlook 2015: More beyond Importers & Distributors

With the recent development, Sri Lanka’s aim of developing a pharma industry should be to penetrate the global market since the internal market is not sufficient for any big firm to operate at optimum levels. According to a report published by Indian Council on International Relations in Dec. ‘14, the global market of pharma is about $1trillion, and India’s export of pharma products in 2013 amounted to $13bn, where as Sri Lanka was nil. Hence, pharma industry offers a very…

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Global Rising Stars Outlook 2015: Innovative Therapies for treating diseases are being sought after with fresh vigor as new targets.

Innovative Therapies for treating diseases are being sought after with fresh vigor as new targets, approaches and biology is discovered. One field which is poised to bring a paradigm change in the way diseases are treated in the next decades is the Stem cell therapy/Regenerative Medicine space. The number of companies and products in the clinic have reached a critical mass warranting a close watch for those interested in keeping pace with the development of new medicines. The Regenerative medicine…

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Non-Alcoholic SteatoHepatitis (NASH): An Analysis of Disease Prevalence, Drugs in development, Regulatory guidelines and Market opportunity in Various Geographies

Sales of Hepatitis C drugs crossed ~$10bn in 2014 proving that treatments for liver disease could become mega-blockbusters and Non-Alcoholic SteatoHepatitis (NASH) is expected to be equally lucrative. Improved diagnosis rate and change in treatment guidelines along with defined clinical trials endpoint are the concerns for the emerging therapy. US FDA is expected to release guidelines for the clinical trial in CY16 and this should accelerate the development of the drugs targeting NASH. NASH is the progressive form of Non-Alcoholic…

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Buccal Drug Delivery Systems: Opportunities and Challenges in Buccal, Sublingual Films, Tablets & Sprays – Detailed analysis on Technologies and Pipeline Development

Within the oral mucosal cavity, the buccal region offers an attractive route of administration for systemic drug delivery. The mucosa has a rich blood supply and it is relatively permeable. The buccal mucosa offers several advantages for controlled drug delivery for extended periods of time. The mucosa is well supplied with both vascular and lymphatic drainage and the first-pass metabolism in the liver and pre-systemic elimination in the gastrointestinal tract are avoided. The area is well suited for a retentive…

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