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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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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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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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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Psoriasis – Plaque Psoriasis & Psoriatic Arthritis: Novel Oral Drugs and Biologics to Change Future Treatment Paradigm

Over the last decades, therapeutic options for Plaque Psoriasis (PsO) and Psoriatic Arthritis (PsA) have expanded considerably and improved patients’ pain, function, and quality of life. Approved biologics fill in a critical unmet need of limited efficacy of DMARDs; however, as in most cases one drug does not fit the bill for all the patients. The lack of targeted immune therapies other than TNF-α inhibitors in Psoriasis signals opportunities for drug developers to bring agents to market that offer treatment…

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Treating Refractory Hematological Malignancies

Targeting unmet needs in the treatment of cancer/ hematological malignancies through innovative drug development strategies have witnessed favorable outcomes. Over the past decade, Proteasome inhibitor, Velcade (bortezomib) and the immunomodulatory drugs – Thalomid (thalidomide) and Revlimid (lenalidomide) have become the cornerstone of treatment for patients with Multiple Myeloma (MM) resulting in improved survival. However, eventually all patients relapse and new treatment options for Relapsed/ Refractory Multiple Myeloma (RRMM) are required to further improve survival and quality of life of this…

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Newer Oral Anti Androgens – Expanding Role in the Treatment Paradigm of Prostate Cancer

XTANDI (Enzalutamide) – Does it have potential to compete against ARN-509 in earlier setting?Zytiga (Abiraterone Acetate) – Ongoing Combination trials creates potential beyond Patent Expiry In recent past approval and launch of various newer treatment options like Xtandi (Enzalutamide, Astellas/Medivation), Zytiga (Abiraterone acetate, JNJ), Jevtana (Cabazitaxel, Sanofi), & Xofigo (radium Ra 223, Boehringer Ingelheim) has evolved the treatment paradigm of treating late stage prostate cancer. In coming years, we expect this to repeat in early stage prostate cancer treatment (nmCRPC,…

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