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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Mitsubishi Tanabe, Outperform – Invokana: Nice to Have A Clean Label, Yet A Long Way To Go Before Gaining Full Confidence!

Invokana clean label thrills many on the street rising hopes that Invokana sales could cross $2.5b+ at peak. However we think that CV issues (dose dependent increase in LDL, CV events observed in first 30 days in CANVAS study), associated genital/UTI infections, compromised efficacy in renally impaired patients and long term safety study requirements by FDA (Table 1), should be seen in conjunction with the ‘clean label’. These issues will limit the initial uptake of Invokana to a small segment…

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Regenerative Medicine and Stem cell based Cell therapies-Drugs of the Future Offering Hope for Cure

Innovative Therapies for treating diseases are being sought after with fresh vigor as new targets, approaches and biology is discovered. Improved health care, nutrition and preventive medicine in the last few decades have all helped in increasing the life expectancy WW. However, this has not translated into any reduction in the incidence or prevalence of chronic or critical illnesses! On the contrary the incidence of chronic diseases like diabetes, obesity, arthritis etc. as well as cancer and the maladies associated…

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Hematological Malignancies: Multiple Myeloma (MM) – Early and Robust Diagnosis along with New Treatment Options can have Considerable Impact on Management of the Disease

While targeting unmet needs in the treatment of hematological malignancies/ cancer through innovative drug development strategies have witnessed favorable outcomes, the specific choice of the therapies is dependent on the identification of important genomic alterations in cancerous cells that allow for the tumor’s sub classification. Over the past decade, Proteasome inhibitor and the immunomodulatory drugs have become the cornerstone of treatment for pts with Multiple Myeloma (MM) resulting in improved survival. However, eventually, all pts relapse and use of modern…

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