Novel Drug Approvals for 2016

Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process. With its understanding of the science used to create new products, testing and manufacturing procedures, and the diseases and conditions that new products are designed to treat, FDA provides scientific and regulatory advice needed to bring new therapies to market.

The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public. For this reason, CDER supports innovation and plays a key role in helping to advance new drug development.

Each year, CDER approves a wide range of new drugs and biological products. Some of these products are innovative new products that never before have been used in clinical practice. Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace.

Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active moieties that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product; these products frequently provide important new therapies for patients. Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that have previously been approved by FDA. For example, CDER classifies biological products submitted in an application under section 351(a) of the Public Health Service Act as NMEs for purposes of FDA review, regardless of whether the Agency previously has approved a related active moiety in a different product. FDA’s classification of a drug as an “NME” for review purposes is distinct from FDA’s determination of whether a drug product is a “new chemical entity” or “NCE” within the meaning of the Federal Food, Drug, and Cosmetic Act.

No.	Drug  Name	Active Ingredient	Approval Date	FDA-approved use on approval date
9.	Tecentriq	atezolizumab	5/18/2016	To treat urothelial carcinoma, the most common type of bladder cancer Press Release
8.	Nuplazid	pimavanserin	4/29/2016	To treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease Press Release
7.	Venclexta	venetoclax	4/11/2016	For chronic lymphocytic leukemia in patients with a specific chromosomal abnormality Press Release Drug Trials Snapshot
6.	Defitelio	defibrotide sodium	3/30/3016	To treat adults and children who develop hepatic veno-occlusive disease with additional kidney or lung abnormalities after they receive a stem cell transplant from blood or bone marrow called hematopoietic stem cell transplantation Press Release Drug Trials Snapshot
5.	Cinqair	reslizumab	3/23/2016	To treat severe asthma Press Release Drug Trials Snapshot
4.	Taltz	ixekizumab	3/22/2016	To treat adults with moderate-to-severe plaque psoriasis.  Press Release Drug Trials Snapshot
3.	Anthim	obiltoxaximab	3/18/2016	To treat inhalational anthrax in combination with appropriate antibacterial drugs. Press Release Drug Trials Snapshot
2.	Briviact	brivaracetam	2/18/2016	To treat partial onset seizures in patients age 16 years and older with epilepsy. Press Release Drug Trials Snapshot
1.	Zepatier	elbasvir and grazoprevir	1/28/2016	To treat patients with chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients. Press Release Drug Trials Snapshot

8 new Drug molecules from India

• Two decades after Indian Pharma started dabbling in new drug research, eight indigenously developed novel drugs are gearing up for late-stage human trials.While two new molecules are being developed by BioCon and Glenmark each, the others are contributed by Dr.Reddy’s, Sun, Ranbaxy and Primal life sciences.
  Dr Reddy’s anti-diabetic drug, codenamed DRF 2593-307, was the first indigenously developed novel drug to enter phase-III trials, in August 2007. This is the penultimate round of testing on patients before marketing approval can be sought. Last year, two more compounds made it to this stage: Biocon’s oral insulin pill and Ranbaxy’s anti-malaria drug. A fourth drug, from Glenmark, to treat diarrhoea, is concurrently undergoing phase-II and phase-III trials.

  

1) IN-105 (Biocon)

• Therapy area: Diabetes-insulin
• Status: In phase-III human trials
• Target launch: 2011 in India; rest of the world by 2015
• Global market size: $13 billion
• Global players: Novo Nordisk, Eli Lilly

2) T1h (Biocon)

• Therapy area: Psoriasis & rheumatoid arthritis
• Status: Completed phase-II trials
• Target launch: Not yet announced
• Global market size: $15-16 billion
• Global players: Astellas, BMS, Abbot, Amgen

3) DRF 2593-307IN (Dr Reddy’s Lab)

• Therapy area: Diabetes-PPAR agonists
• Status: In phase-III trials
• Target launch: Not announced yet
• Global market size: $7 billion
• Global players: Glaxo, Takeda, Abbot, Solvay

4) Crofelemer (Glenmark Pharma)

• Therapy area: Diarrhoea
• Status: In phase-III trials
• Target launch: 2010-11
• Global market size: $2-3 billion
• Global players: Glaxo

5) Sun-1334H (Sun Pharma)

• Therapy area: Allergy
• Status: Completed phase-II trials
• Target launch: Not Announced Yet
• Global market size: $5.5 billion
• Global players: Sanofi-Aventis, Pfizer

6) GRC 8200 (Glenmark Pharma)

• Therapy Area: Diabetes-DPP IV inhibitor
• Status: Completed phase-II trials
• Target launch: 2013-14
• Global market size: $1-2 billion
• Global players: Merck

7) P276 (Primal Life sciences)

• Therapy area: Cancer
• Status: Late phase-II trials
• Target launch: To file for marketing approval in 2011
• Global market size: $47.7 billion
• Global players: Roche, Eli Lilly, Pfizer, Glaxo

8) Arterolane Maleate+Piperaquine Phosphate (Ranbaxy)

• Therapy area: Malaria
• Status: Currently in phase-III trials
• Target launch: To apply for marketing approval by late-2010
• Global market size: Less than $1 billion
• Global players: Novartis

Source- Outlook Business 

In spite of lower costs of operating in India, R&D of new drug molecules is a long, tiring and expensive affair. The Indian companies have invested in drug molecules especially required in India ( like drugs for malaria, Diabetes, Diarrhoea). The fate of these 8 molecules may well decide future R&D plans of Indian Pharma companies. 

Related articles;-

• Drug Discovery and Indian Pharma Industry

Psoriasis Diseases

Psoriasis: The Basics
*Psoriasis is a chronic multisystem disease with predominantly skin and joint manifestations

*Affects approximately 2% of the U.S. population

*Age of onset occurs in two peaks: ages 20-30 and ages 50-60, but can be seen at any age

*Waxes and wanes during a patient’s lifetime, is often modified by treatment initiation and cessation and has few spontaneous remissions

*There is a strong genetic component
#Classification of Psoriasis

Classification is based on morphological descriptions

The types of psoriasis are:
•Plaque: scaly, erythematous patches, papules, and plaques that are sometimes pruritic

•Inverse/Flexural: lesions are located in the skin folds

•Erythrodermic: generalized erythema covering nearly the entire body surface area with varying degrees of scaling

•Pustular: clinically apparent pustules

•are, acute generalized variety called "von Zumbuschvariant"

•Palmoplantar–localized involving palms and soles
 •Guttate: presents withdrop lesions, 1-10mm salmon-pink papules with a fine scale

Clinical findings in patients frequently overlap in more than one category

Different types of psoriasis may require different treatment

GuttatePsoriasis
 Acute onset of raindrop-sized lesions on trunk and extremities in young adults, often preceded by streptococcal pharyngitis
Inverse/Flexural Psoriasis
 Erythematous plaques in the axilla, groin, inframammary region, and other flexural areas. May lack scale due to moistness of area. 

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psoriasis

 Psoriasis -- the Basics

What Is Psoriasis?
Unpredictable and irritating, psoriasis is one of the most baffling and persistent of skin disorders. It's characterized by skin cells that multiply up to 10 times faster than normal. As underlying cells reach the skin's surface and die, their sheer volume causes raised, red plaques covered with white scales. Psoriasis typically occurs on the knees, elbows, and scalp, and it can also affect the torso, palms, and soles of the feet.

The symptoms of psoriasis vary depending on the type you have. Some common symptoms for plaque psoriasis -- the most common variety of the condition -- include: Plaques of red skin, often covered with loose, silver-colored scales; these lesions may be itchy and painful, and they sometimes crack and bleed. In severe cases, the plaques of irritated skin will grow and merge into one another, covering large areas.
Disorders of the fingernails and toenails, including discoloration and pitting of the nails; the nails may also begin to crumble or detach from the nail bed.
Plaques of scales or crust on the scalp.

सबसे बड़ा खजाना ! स्वस्थ शरीर है

आधुनिक जीवन शैली की तेज रफ्तार एवं भागदौड़ भरी जिंदगी में सेहत का विषय बहुत पीछे रह गया है और नतीजा यह निकला की आज हम युवावस्था में ही ब्लड प्रेशर,डायबिटीज, ह्रदय रोग, कोलेस्ट्रोल, मोटापा, गठिया, थायरॉइड जैसे रोगों से पीड़ित होने लगे हैं जो कि पहले प्रोढ़ावस्था एवं व्रद्धावस्था में होते थे और इसकी सबसे बड़ी वजह है खान पान और रहन सहन की गलत आदतें, आओ हम सेहत के इन् नियमों का पालन करके खुद भी स्वस्थ रहे तथा परिवार को भी स्वस्थ रखते हुए अन्य लोगों को भी अच्छे स्वास्थय के लिए जागरूक करें ताकि एक स्वस्थ एवं मजबूत समाज और देश का निर्माण हो,क्योंकि कहा भी गया है-पहला सुख निरोगी काया l




भोजन हो संतुलित- घी,तैल से बनी चीजें जैसे पूड़ी,पराँठे,छोले भठूरे,समोसे कचौड़ी,जंक फ़ूड,चाय,कॉफी ,कोल्ड ड्रिंक का ज्यादा सेवन सेहत के लिए घातक है इनका अधिक मात्रा में नियमित सेवन ब्लड प्रेशर ,कोलेस्ट्रोल,मधुमेह,मोटापा एवं हार्ट डिजीज का कारण बनता है तथा पेट में गैस,अल्सर,ऐसीडिटी,बार बार दस्त लगना,लीवर ख़राब होना जैसी तकलीफें होने लगती हैं इनकी बजाय खाने में हरी सब्जियां,मौसमी फल,दूध,दही,छाछ,अंकुरित अनाज और सलाद को शामिल करना चाहिए जो की विटामिन,खनिज लवण,फाइबर,एव जीवनीय तत्वों से भरपूर होते हैं और शरीर के लिए बहुत फायदेमंद होते हैं l

चीनी एवं नमक का अधिक मात्रा में सेवन ना करें,ये डायबिटीज,ब्लड प्रेशर,ह्रदय रोगों का कारण हैं l

बादाम,किशमिश,अंजीर,अखरोट आदि मेवा सेहत के लिए बहुत लाभकारी होते हैं इनका सेवन अवश्य करें

पानी एवं अन्य लिक्विड जैसे फलों का ताजा जूस,दूध,दही,छाछ,नींबू पानी,नारियल पानी का खूब सेवन करें,इनसे शरीर में पानी की कमी नहीं हो पाती,शरीर की त्वचा एवं चेहरे पर चमक आती है,तथा शरीर की गंदगी पसीने और पेशाब के दवारा बाहर निकल जाती है l

व्यायाम का करें नियमित अभ्यास– सूर्योदय से पहले उठकर पार्क जाएं,हरी घास पर नंगे पैर घूमें,दौड़ लगाएं,वाक करें,योगा,प्राणायाम करें,इन उपायों से शरीर से पसीना निकलता है,माँस पेशियों को ताकत मिलती है,शरीर में रक्त का संचार बढ़ता है,अनेक शारीरिक एवं मानसिक रोगों से बचाव होता है,पूरे दिन भर बदन में चुस्ती फुर्ती रहती है,भूख अच्छी लगती है इसलिए नियमित रूप से व्यायाम अवश्य करें l

गहरी नींद भी है जरुरी -शरीर एवं मन को स्वस्थ रखने के लिए प्रतिदिन लगभग 7 घंटे की गहरी नींद एक वयस्क के लिए जरुरी है,लगातार नींद पूरी ना होना तथा बार बार नींद खुलना,अनेक बीमारियों का कारण बनता हैl

अच्छी नींद के लिए ये उपाय करें- सोने का कमरा साफ सुथरा,शांत एवं एकांत में होना चाहिए,रात को अधिकतम 10-11 बजे तक सो जाना और सुबह 5-6 बजे तक उठ जाना स्वास्थ्य के लिए अच्छा माना जाता है,सोने से पहले शवासन करने से अच्छी नींद आती है,खाना सोने से 2-3 घंटे पहले कर लेना चाहिए एवं शाम को खाना खाने के बाद 20-25 मिनट अवश्य घूमें l

टेंशन को कहें बाय बाय – रोज मर्रा की जिंदगी में आने वाली समस्यों के लिए चिंतन करना सही है चिंता करना नहीं,चिता तो फिर भी मरने के बाद शरीर को जलाती है किन्तु लगातार अनावश्यक चिंता जीते जी शरीर को जला देती है इसलिए तनाव होने पर भाई,बंधू एवं विश्वास पात्र मित्रों से सलाह मश्वरा करें यदि समस्या फिर भी ना सुलझे तो विशेषज्ञ से राय लें l

नशे से रहें बच के- यूवा पीढ़ी के लिए कोई सबसे खतरनाक बीमारी है तो वो है नशे के जाल में फँसना,शराब,धूम्रपान,तम्बाकू ये सब सेहत के दुश्मन हैं,किसी भी स्थिति में नशे की लत से बचें,यदि नशे से बचे हुए हैं तो बहुत अच्छा किन्तु,यदि कोई नशा करते हैं तो जितनी जल्दी नशे से दुरी बना लें उतना ही अच्छा है,ये ऐसी बीमारी है जो कैंसर और एड्स से भी ज्यादा खतरनाक है और एकसाथ कई परिवारों को बर्बाद करती है तथा शारीरिक,मानसिक,आर्थिक एवं सामाजिक प्रतिष्ठा के नाश का कारण बनती है,इसलिए नशे से बचना ही बेहतर उपाय है l

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