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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New Phase of Mab biosimilar knocks the door Biosimilar Opportunities In Japan

The launch of Remicade biosimilar in Dec-2014 in the Japan pharma market demonstrated its changing regulatory environment; it is faster than the U.S. in adapting to biosimilar use. After nine years of continuous efforts by the JP government to promote increased use of generics (started in 2006 by launching various benefits for GE use at Pharmacy, hospital level) – now in 2014, Generic penetration of small molecules is changing the trend line and moving towards faster market penetration. While for…

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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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Emergence of Biogenerics Era in Japan – It’s Time To Welcome Antibody Biosimilars of Foreign Origins Soon

With three products and eight players already in market – Japan biosimilar market will enter new phase of biosimilars with first ‘mab’ approval expected in 2014. This approval (Remicade- FY03/13A sales ¥73.5, infiximab from Nippon Kayaku by YE 14) will be marked as a milestone development because – 1.) it will open antibody biosimilar market in Japan, and 2.) the approval will be based largely from overseas data. ~ ¥200b worth of biologic products is going off patent by 2015…

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Moderate to Severe Pain: Novel Abuse Deterrent Formulation Technologies and Emergence of Novel Mechanisms in the Management of Pain

Pain is the leading cause of disability in the US, affecting more than cancer, diabetes and heart disease combined. Current analgesics for persistent pain are relatively ineffective, are associated with significant adverse effects or abuse liability, and do not reduce pain in all treated individuals. Opioids (e.g., morphine, codeine, oxycodone) are currently one of the most potent groups of analgesics used clinically, with prescriptions increasing by 50% over the past 10 years for chronic, non-cancer pain. However, there is clear…

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New Avatars of Microbes Super Bugs A Growing Threat Worldwide

Novel approaches to treat infection is growing as the need is urgent! Misuse/overuse of antibiotics accelerated antimicrobial resistance (AMR) and has resulted in the emergence of “super bugs” which are posing life threatening challenges world wide. Many of the advances in medical treatment like cancer therapy; organ transplants etc. would go waste if the ability to fight infections during the treatment were not available. If that fails, the gains made in life-improving modern medical advantages will be lost creating a…

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Dietary Supplements: World of Opportunities In the Indian Healthcare Market

The increasing rate of chronic diseases has emphasized the need for Prevention over Intervention. These proactive health solutions include nutritional supplements which promise medical or health benefits and fall between the food and pharma chain – ‘Nutraceuticals’. Over the years, the nutraceutical market has experienced robust growth fueled by high consumer demand, product innovation, and low regulatory hurdles. The nutraceutical industry is already facing intense competitive pressure wherein companies are seeking new opportunities or geography expansion in functional food, beverage,…

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Global Pharmaceutical and Biotechnology Outlook 2014: Rising Stars

Innovations have contributed to the availability of a range of new treatments for diseases resulting in improvement in the length and quality of life and reduced disease burden for individuals and society. However, the need for innovative therapies for unmet needs /challenging diseases continues to grow, accelerating the pace of drug development directly or through partnership/ in-licensing. We expect innovation and improved drugs therapies through novel target discovery and technology platforms to continue to flow from the backyards of small…

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Global Pharmaceutical and Biotechnology Outlook 2014: India Pharma

Indian companies are taking center stage in Complex Generics at US and EU markets. In Bio-similars, Indian companies will have perhaps the largest basket aimed at Emerging Countries in 2014-16 and later for Developed countries. Though few but is the beginning of NCE/mAb development by Indian companies is a sign of Indian Generics moving up in the chain. The uncertainty of clinical and regulatory pathways in the US helps Asian biopharma and biotech companies to be in the forefront of…

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