Prostate Cancer – Newer Antiandrogens & Emerging Therapies Targeting a “Watchful Waiting” and Resistance Population

Xtandi – Replacing competitor from Zytiga to Casodex (Bicalutamide) for a bigger pie in Prostate cancer & Finding its niche in crowded BC market Xtandi + Zytiga vs. ARN-509 + Zytiga - Who will win the race? Rising star Anti Androgens – Third generation Antiandrogens- What left for AR-V7 mutants after TOK-001 failure? Late Stage Prostate Cancer Pipeline drugs – AKT inhibitors or PARP inhibitors or a new MoA combination with Antiandrogen or IO combo - Competing to Xtandi/Zytiga or…

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Pain Management: New Discoveries and Treatment Options in Abuse Deterrent Era

Rescheduling of Hydrocodone combinations from Class III to Class II, clear-cut regulatory guideline for Abuse-Deterrent drug formulation NDA & ANDA (solid oral) filing and CDC guideline for Prescribing Opioids for Chronic Pain (2016) are definite steps taken by FDA in last two years for creating “Abuse-Deterrent Era” in a short span to stop opioid abuse and reversing opioid epidemic in USA. There were around 18,893deaths involving prescription of opioids in the United States in 2014 which was up 16% from…

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Sun Pharma enters Japanese Prescription Market

Novartis and Sun Pharma agreed to a novel transaction conceptualized by MP team. Sun Pharma acquired 14 long-listed brands in Japan from Novartis for a total cash consideration of $293 million (see Press Release below). MP Advisors, led by Tarun Shah, solved a challenge facing many biopharma companies—how to establish a significant presence in Japan that will create a sustainable and growing infrastructure. MP team is well-positioned to help you solve such challenges in capturing global growth opportunities, from major…

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Large Cap Pharma US & EU Outlook 2016: Maximizing Their Strength on Fewer Therapy Class, Personalized Medicine, Novel Target and Biosimilars For Future Growth

Major pharma companies continue to improve the productivity by taking different approaches like focusing on selected therapy area and markets, merger and acquisition, divestment of non-core brands/segments and consolidation in animal health, vaccines and consumer health care business. Oncology segment has been the key areas of interest for large-cap Pharma companies in 2014/2015. The field of immuno-oncology is currently one of the most explosive fields in biotechnology. Bristol-Myers’s with more concentrated effort in Immuno-Oncology has gained the lead with its…

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India Pharma Outlook 2016: Milestones to Watch – Growth from Exports and Domestic Getting Better, Implementation of Policies under “Make-in-India”, Overture of A New Ministry

2016 will be a crucial for drug makers and consumers. During ‘Make-in-India’ week in Mumbai, Govt. highlighted many amendments or introduction of new policies with an aim to make India as a major hub for end to end drug discovery. To boost drug discovery, to promote manufacturing of certain drugs against life threatening diseases like AIDS, and to reduce our dependence on China, the Govt. has promised to offer many incentives (exemption from excise duty or tax) and also plans…

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JP Giants leaning in for becoming a Speciality Global Pharma Sakigake designation – A Push from government to “Innovate”! “Essential drugs” exemption from Z2 rule- Balancing long listed pricing pressure! Authorized Generics, Biosimilars, and Patent Litigations – Avenues to grow in JP Generic market!

In this report- we analyzed therapy focus, changing Strategies, pipeline and key growth drivers of 12 major Japanese biopharma companies (Pure play innovators/ Innovators+ Generics/Pure play generics) and detailed our view on their strategic action to withstand in domestic market and expand globally with their interest for inlicensing external innovation from the globe for increasing R&D productivity and priorities on M & A side. Japan Pharma Outlook 2016: JP Giants leaning in for becoming a Speciality Global Pharma Sakigake designation…

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Japan Biosimilar- Active Players In Quest of a Specialty & Niche BS space

Filgrastim BS and Lantus BS Approval- Encouraging uptake and a lesson to fast track JP approval based on Ex-Japan data! Remicade biosimilar “NK” – A slow start does not pull back NK in starting PhIII for Herceptin BS in Japan Active companies in Biosimilar Space: Local Japanese Generic Giants- Opening the door for Biosimilars in Japan? - Will go for All or Niche in BS space???- Opportunities beyond 2020? Encouraging Uptake of Filgrastim BS and Lantus BS in 2015 in…

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Rising Stars Outlook 2016 :New Emergence of Potential Tx & Dx Options could transform the Current Landscape for Liver Diseases (NASH)

Non-Alcoholic SteatoHepatitis (NASH) is an unmet medical need and is becoming the leading cause of liver transplant. No FDA-approved therapies and a meager diagnosis, it poses a unique challenge in the design of studies for NASH. Therefore, there is a worldwide need for new therapies to treat the global epidemic of NASH and the cost to society will be huge if it is not addressed in the upcoming years! Besides, scarcity of treatment options, there is also an urgent unmet…

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Innovation Rising

Citizens are increasingly taking responsibility for their health, and convergence of IT and life sciences is accelerating this pace. Value for money from healthcare spending is increasingly the call of the day, which has managed to noticeably stem healthcare inflation in the US. Improving standards in the emerging markets, on the other hand, are accelerating healthcare spending, but largely on generic drugs. For the biopharma industry, biologics helped it come out of the small molecule generic carnage of the last…

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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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