Author: Navin

This author has written 9 articles

Mehta Analysis: China, A Populist Pharma Power

With money pouring into biopharma in China, and regulatory reforms favoring market growth and R&D speed, western firms should watch their backs, warns Viren Mehta, founding partner of Mehta Partners LLC. The dollars and renminbi are adding up, as are structural and regulatory changes in China. With the modified IPO listing rules in Hong Kong, China’s momentum as a biopharma leader is accelerating. Even the Trump trade tirade seems to bypass many bold biopharma initiatives in China that have brought…

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Mehta Analysis: Takeda and Alliance Bernstein Moves Contain A Message For Pharma

Buying Shire gives Takeda the chance to exploit global tax benefits and gain other profit-promoting advantages through integrating with Shire's differently focused business. Outside of pharma, business model rationales are changing rapidly, and old certainties cannot be taken for granted. Pharma would ignore the wider revolution at its peril, and Takeda's move is a step in the right direction, argues Viren Mehta, founding partner of Mehta Partners LLC. Three examples capture the pace of change all around us: the largest…

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Mehta Analysis: Trump Pricing Tempest In A Teapot Is An Opportunity For Bio-pharma Leaders

President Trump's much anticipated pronouncements on drug pricing reform leave a lot to be clarified. Biopharma companies and their leaders should grasp the opportunity to lead from the front and propose tangible and transformative actions that deliver benefits for all stakeholders. This may be one of the few letdowns that the biopharma industry should embrace, if not relish. Shrill propaganda by so many in the government, starting with President Trump himself soon after entering the US presidential race, had escalated…

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Next Decade Generic String Of Pearls Opportunities: Sustainability Assessment With Respect To Therapeutic Positioning

The rapid growth of the generic industry has come with a number of challenges, such as heavy competition, including from authorized generics and government-mandated price cuts. All contribute to diminishing prices and ever decreasing margins. In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns. Diversification of product…

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The Future of the U.S. Biologics and Biosimilars Treatment Market for Psoriasis

The U.S. psoriasis treatment market for Biologics and Biosimilars was estimated at $6.6bn in 2016 is projected to almost double during the forecast period to reach $12.9bn in 2021 driven by safety and efficacy improvements of the new generation biologics. The psoriasis treatment market is dominated by topical agents and phototherapy for the non-severe forms (mainly corticosteroids), but mild to severe forms are treated with systemic agents. The psoriasis treatment market is dominated by topical agents and phototherapy for the…

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Japan Biosimilars – A start of Authorized Biosimilar Era? Biosimilar/BioPharma CMO opportunities – JP Conglomerates – A definite role to play for Global Market! Major JP Innovator vs. Early entrant Mid size Japanese companies- TA focus approach – A Win Win Game!

In 2016, encouraging uptake of Lantus BS in Japan confirms strong foothold of the marketer, product mix targeted to DPC hospitals (Diagnostic Procedure Combination hospitals- ~4000) and early entry of the player are critical factors to decide biosimilar penetration and market share dynamics of Japan Biosimilar Market. While ongoing discussion of local originators to launch authorized generic BS in a way indicate cost pressure & threat on the originators by payers(Chuikyo), but put pause on attractiveness of developing BS for…

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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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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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