Home » Posts tagged 'GMP' (Page 7)
Tag Archives: GMP
DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
.....FOR BLOG HOME CLICK HEREFlag and hits
ORGANIC SPECTROSCOPY
SUBSCRIBE
Subscribe in a reader
Enter your email address:
Delivered by FeedBurner
Subscribe to New Drug Approvals by Email
Recent Comments
 | shivkr2 on SPSR Excellence Award 2025 – S… |
 | Bonkasaurus on Infigratinib phosphate |
 | PALOVAROTENE | ORGAN… on Palovarotene |
| Pfizer just purchase… on Temanogrel | |
| Pfizer To Cash In On… on Temanogrel |
SAMIDIRECT -Healthy, Wealthy & Wise, FREE OF COST CONSULTATION on Diabetes, Cancer, Arthritis, Osteoporosis, Heart- Liver -Lung & Kidney problems, Low Immunity, Alzheimer, Weight Management, Weak Memory, Neutritional Deficiency, UTI problems
Healthy, Wealthy & Wise
For over 25 years the Sami Group has been unlocking the mystery of herbs, extracting the goodness, and gifting the world with good health.
Now the Sami Group provides YOU an opportunity to unlock the mystery of Success, Wealth & Better living.
FREE OF COST CONSULTATION on Diabetes, Cancer, Arthritis, Osteoporosis, Heart- Liver -Lung & Kidney problems, Low Immunity, Alzheimer, Weight Management, Weak Memory, Neutritional Deficiency, UTI problems etc.
(REVOLUTIONARY AYURVEDIC SOLUTIONS with ISO 22000 Certified Indian MNC after 25 years of R & D by 120 Scientists.
Numberless Testimonials.)
http://www.samidirect.com/products/
Do visit the website www.samidirect.com & have the study in detail. Have a look at the Sami Direct Corporate Video on you tube. If you get the wonderful potential of the brightest future…do call me for ‘How to get started?’
…..
DISTRIBUTOR ENQUIRY WELCOME
CONTACT MR JAY DESAI
REGARDS
+91 9699952526
Mumbai, INDIA
email-jaydesai1502@gmail.com
 |
Bussines Sami Direct Seminar ppt.ppt1.pdf 9204K View Download |
samidirect corporate video
DR MAJID, FOUNDER , SAMIDIRECT
Dr. Muhammed Majeed
Dear Friend, Congratulations on your decision!
A little over three decades ago I went from a small town in South India to the United States Of America seeking fulfillment of my dreams. Today with a business conglomerate spread across the globe, I can confidently say that the future belongs to those who believe in the beauty of their dreams.
The aspiration to dream and the conviction to follow their dreams is what sets apart the extraordinary from the ordinary. Congratulations for choosing to be among the extraordinary. Now we are in it together. You have chosen the right place and the right means. The awesome combination of extensively researched products and a revolutionary business plan is a definite formula for success. We are with you at every step to help you fulfill your dreams and reach greater heights.
Dr. Muhammed Majeed
Welcome home again!
– See more at: http://www.samidirect.com/about/founder-desk/#sthash.rrOCRiJ1.dpuf
Sami Direct, as a part of the Sami Group, is the culmination of relentless Research and Development for more than two decades. We at Sami Direct are committed to offer you an unrivalled range of nutraceuticals, soon to be followed by cosmeceutical products, which have been acknowledged by the world over for its highest quality and safety standards.
Sami Direct is supported by its very own R&D facility- SAMI LABS LTD., located in Bangalore. This state-of-the-art, multi-disciplinary division pursues diverse fields of research with over 120 scientists focusing all efforts towards creating effective and safe products. With six highly advanced cutting-edge manufacturing units adhering to the strictest quality and safety standards, Sami Direct ensures that the highest quality of products are being produced.
Today the Sami Group holds a strong intellectual property portfolio with over 70 US and International Patents to its credit including awards and recognitions worldwide.
With the perfect blend of world class products and a revolutionary business plan, it is a lifetime opportunity not just to enhance your health, but also a fruitful and lasting career heightening your income.
DISTRIBUTOR ENQUIRY WELCOME
CONTACT MR JAY DESAI
REGARDS
+91 9699952526
Mumbai, INDIA
email; jaydesai1502@gmail.com
Comparing China’s And India’s Pharmaceutical Manufacturing
By Jim Zhang, Ph.D., JZMed, Inc.
The pharmaceutical markets of China and India have been experiencing such rapid growth in the past decade that they are widely recognized as two of the world’s most dynamic emerging markets. Consequently, they have attracted many drug companies around the world…………FULL ARTICLE
READ ALL AT
Jim Zhang, Ph.D., is president and managing director of JZMed, Inc., a market research company specializing in research on the Chinese pharmaceutical outsourcing industry. The company also provides consulting services for pharmaceutical outsourcing in China.
http://www.allfordrugs.com/2013/09/11/comparing-chinas-and-indias-pharmaceutical-manufacturing/
Novel Drug Shows Promise for Early Stage Breast Cancer
pertuzumab
TUESDAY Sept. 10, 2013 — A drug already used to treat advanced breast cancer also appears to shrink early stage breast tumors, potentially offering women a first-of-its-kind treatment option, U.S. health regulators say.
read all at
http://www.drugs.com/news/novel-shows-promise-early-stage-breast-cancer-47311.html
FDA Advisory Committee Recommends Approval in U.S. of Umeclidinium/Vilanterol for the Treatment of COPD
umeclidinium
vilanterol
09/10/13 — GlaxoSmithKline plc (LSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to the US Food and Drug Administration (FDA) voted 11 yes to 2 no that the efficacy and safety data provide substantial evidence to support approval of umeclidinium/vilanterolumeclidinium (UMEC/VI, 62.5/25mcg dose) for the long-term, once-daily, maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
Anoro Ellipta is the proposed proprietary name for UMEC/VI, a combination of two investigational bronchodilator molecules — GSK573719 or umeclidinium bromide (UMEC), a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta2 agonist (LABA), administered using the Ellipta inhaler.
The FDA Advisory Committee also voted that the safety of the investigational medicine has been adequately demonstrated at the 62.5/25mcg dose for the proposed indication (10 yes, 3 no), and the efficacy data provided substantial evidence of a clinically meaningful benefit for UMEC/VI 62.5/25mcg once daily for the long-term, maintenance treatment of airflow obstruction in COPD (13 yes, 0 no).
Patrick Vallance, GSK’s President of Pharmaceuticals R&D, said: “Today’s recommendation is good news and a reflection of our commitment to giving an alternative treatment option for patients living with COPD — a disease that affects millions of Americans. If approved, Anoro Ellipta will be the first, once-daily dual bronchodilator available in the US, marking another significant milestone for GSK’s portfolio of medicines to treat respiratory disease. We will continue to work with the FDA as they complete their review.”
“We are pleased with the Advisory Committee’s support of UMEC/VI,” said Rick E Winningham, Chief Executive Officer of Theravance. “This is a transformative year for Theravance and today’s positive recommendation brings the second major respiratory medicine in our GSK collaboration closer to approval and becoming an important therapeutic option for COPD patients.”
In December 2012, a New Drug Application (NDA) was submitted to the FDA for the use of UMEC/VI administered by the Ellipta™ inhaler for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. UMEC/VI is not proposed for the relief of acute bronchospasm or for the treatment of asthma in any of the regulatory applications.
The FDA Advisory Committee provides non-binding recommendations for consideration by the FDA, with the final decision on approval made by the FDA. The Prescription Drug User Fee Act (PDUFA) goal date for UMEC/VI is 18 December 2013.
UMEC/VI is an investigational medicine and is not currently approved anywhere in the world.
Safety Information
Across the four pivotal COPD studies for UMEC/VI, the most frequently reported adverse events across all treatment arms, including placebo, were headache, nasopharyngitis, cough, upper respiratory tract infection, and back pain. COPD exacerbation was the most common serious adverse event reported. In addition, in the four pivotal COPD studies, a small imbalance was observed in cardiac ischemia which was not observed in the long term safety study.
The UMEC/VI clinical development programme involved over 6,000 COPD patients.
About COPD
Chronic obstructive pulmonary disease (COPD) is a term referring to two lung diseases, chronic bronchitis and emphysema, that are characterized by obstruction to airflow that interferes with normal breathing. COPD is the third most common cause of death in the US and The National Heart, Lung and Blood Institute (NHLBI) estimates that nearly 15 million US adults have COPD and another 12 million are undiagnosed or developing COPD(1).
According to the NHLI, long-term exposure to lung irritants that damage the lungs and the airways are usually the cause of COPD and in the United States, the most common irritant that causes COPD is cigarette smoke. Breathing in second hand smoke, air pollution, or chemical fumes or dust from the environment or workplace also can contribute to COPD. Most people who have COPD are at least 40 years old when symptoms begin.
Innovative Regulatory Review Practices for Better Efficiencies- The Singapore Experience
| Republic of Singapore | ||||||
|---|---|---|---|---|---|---|
|
||||||
| Motto: “Majulah Singapura” (Malay) “Onward, Singapore” |
||||||
.svg)
Innovative Regulatory Review Practices for Better Efficiencies- The Singapore Experience
by
Dr Daniel Tan
Director
Health Products Regulation Group
Health Sciences Authority
read all this at
http://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/WH-1_2Dec.pdf
overview
Mission
Background
Regulatory Principles
Evaluation Routes
Data Requirements
Regulatory Process
Application Statistics
Pre-market Evaluation
Depth of evaluation varies following a risk-
& confidence-based approach
Three evaluation routes allowing flexibility
yet ensuring robustness in the registration
system
In-house capabilities complemented by
external experts and advisory committee
Conclusion
Resources are always limited in most regulatory agencies
Adopting a risk based approach to triage drug applications
Titrate the evaluation workload by levaraging on reference agencies
assessment reports
Managing Access to important medicines without prolonging
timelines
For small markets like Singapore, this unique system of drug evaluation,
ensures that market entry of drug products is vetted in an efficient manner
without compromising on stringent standards for safety and efficacy.
Bayer seeks EMA approval for marketing of regorafenib to treat GIST
Bayer seeks EMA approval for marketing of regorafenib to treat GIST
Bayer HealthCare has submitted an application to the European Medicines Agency (EMA) for marketing authorisation regarding the oral multi-kinase inhibitor, regorafenib.
read all at
Merck Announces FDA Acceptance of New Drug Application for Investigational Fertility Treatment
corifollitropin alfa
WHITEHOUSE STATION, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the New Drug Application (NDA) for its investigational fertility treatment, corifollitropin alfa, has been accepted for standard review by the U.S. Food and Drug Administration (FDA). Merck is seeking FDA approval of corifollitropin alfa for Controlled Ovarian Stimulation (COS) in women participating in assisted reproductive technology.
If approved, corifollitropin alfa would be the first sustained follicular stimulant for use in a fertility treatment regimen.
read all at
http://www.pharmalive.com/fda-accepts-mercks-fertility-treatment-nda
Corifollitropin alfa
Merck received approval on February 15, 2010 from the European Commission for ELONVA (corifollitropin alfa) a long lasting single injection fusion protein lacking LH activity. Only one injection is required for the first seven days, replacing the first seven daily injections of conventional FSH. Initial results demonstrates similar pregnancy rates as daily recombinant FSH injections.[7][8]
- ref 7 N. P. Koper, R. Boostanfar, P. Devroey, B. C. Fauser, P. C. IJzerman-Boon, B. M. J. L. Mannaerts. Global ClinicalDevelopment, Organon, Part of Schering-Plough Corporation, Oss, Netherlands; Huntington Reproductive Center, Tarzana, CA; Center of Reproductive Medicine, Dutch-speaking Free University, Brussels, Belgium; University Medical Center Utrecht, Utrecht, Netherlands; Biometrics, NV Organon, Part of Schering-Plough Corporation, Oss, Netherlands. “Corifollitropin alfa demonstrates similar pregnancy rates as compared to daily recombinant FSH treatment in a controlled ovarian stimulation regimen for IVF/ICSI.” Fertility and Sterility, 90:page S75.
- ref 8 ^ Devroey P, Boostanfar R, Koper NP, Mannaerts BM, Ijzerman-Boon PC, Fauser BC, 2009. “A double-blind, non-inferiority RCT comparing corifollitropin alfa and recombinant FSH during the first seven days of ovarian stimulation using a GnRH antagonist protocol.” Human Reproduction, 2009, August 14, [Epub ahead of print]. PMID 19684043.
In May2013, MSD launched ELONVA® (corifollitropin alfa injection) – a new treatment for fertility, – in Singapore. Approved for controlled ovarian stimulation in combination with a GnRH antagonist for the development of multiple follicles, Corifollitropin alfa injection is the first sustained follicle stimulant. A single subcutaneous injection of the recommended dose of corifollitropin alfa injection may replace the first seven injections of any
Findings showed that other failed repeated treatments may lead to depression, anxiety, sexua conventional daily recombinant follicle stimulating hormone (rFSH) preparation in a controlled ovarian stimulation treatment cycle. Simplified fertility treatment with Elonva not only helps to reduce the emotional and physical burden of fertility, it may also reduce dropout rates and potentially improve the overall chances of pregnancy.
l anxiety/difficulty, relationship problems with partner, family and friends, increased sense of self-blame and guilt, particularly for the partner experiencing fertility problem. ”By reducing the number of daily injections, the
availability of corifollitropin alfa injection is a positive step towards helping reduce the burden of fertility treatment for women experiencing difficulty conceiving. Simplifying fertility treatment with new modalities of treatment and new medication may encourage more infertile couple to embark
on treatment earlier when the wife’s age is younger and ovarian reserve better.” said Dr Loh Seong Feei, Medical Director of Thomson Fertility Centre
Novartis Ilaris Approved for SJIA in Europe
Novartis Ilaris Approved for SJIA in Europe
Zacks.com
The EC cleared Ilaris for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and above in the EU, who did not respond adequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and …http://www.zacks.com/stock/news/108513/novartis-ilaris-approved-for-sjia-in-europe
Canakinumab (INN, trade name Ilaris, previously ACZ885)[1] is a human monoclonal antibody targeted at interleukin-1 beta. It has no cross-reactivity with other members of the interleukin-1 family, including interleukin-1 alpha.[2]
Canakinumab was approved for the treatment of cryopyrin-associated periodic syndromes (CAPS) by the U.S. Food and Drug Administration (FDA) on June 2009[3] and by the European Medicines Agency in October 2009.[4] CAPS is a spectrum of autoinflammatory syndromes including familial cold autoinflammatory syndrome, Muckle–Wells syndrome, and neonatal-onset multisystem inflammatory disease.
Canakinumab was being developed by Novartis for the treatment of rheumatoid arthritis but this trial has been discontinued.[5] Canakinumab is also in phase I clinical trials as a possible treatment for chronic obstructive pulmonary disease,[6] gout and coronary artery disease.
Ilaris neutralises IL-1 beta for a sustained period of time, and reduces inflammation. Image courtesy of Novartis.
- Dhimolea, Eugen (2010). “Canakinumab”. MAbs 2 (1): 3–13. doi:10.4161/mabs.2.1.10328. PMC 2828573. PMID 20065636.
- Lachmann, HJ; Kone-Paut I, Kuemmerle-Deschner JB et al. (4 June 2009). “Use of canakinumab in the cryopyrin-associated periodic syndrome”. New Engl J Med 360 (23): 2416–25. doi:10.1056/NEJMoa0810787. PMID 19494217.
- “New biological therapy Ilaris approved in US to treat children and adults with CAPS, a serious life-long auto-inflammatory disease” (Press release). Novartis. 18 June 2009. Retrieved 28 July 2009.
- Wan, Yuet (29 October 2009). “Canakinumab (Ilaris) and rilonacept (Arcalyst) approved in EU for treatment of cryopyrin-associated periodic syndrome”. National electronic Library for Medicines. Retrieved 14 April 2010.
- “clinicaltrials.gov, Identifier NCT00784628: Safety, Tolerability and Efficacy of ACZ885 (Canakinumab) in Patients With Active Rheumatoid Arthritis”. Retrieved 2010-08-21.
- Yasothan U, Kar S (2008). “Therapies for COPD”. Nat Rev Drug Discov 7 (4): 285. doi:10.1038/nrd2533.
Ilaris Approved by FDA to Treat Active Systemic Juvenile Idiopathic Arthritis
Basel, May 10, 2013 – Novartis announced today that the US Food and Drug Administration (FDA) has approved Ilaris (canakinumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older. Ilaris is the first interleukin-1 beta (IL-1 beta) inhibitor approved for SJIA and the only treatment approved specifically for SJIA that is given as a once-monthly subcutaneous injection[1]. SJIA is a rare and disabling form of childhood arthritis characterized by spiking fever, rash and arthritis that can affect children as young as 2 years old and can continue into adulthood[2],[3].
This approval was based on two Phase III trials in SJIA patients, aged 2-19, showing significant improvement in the majority of Ilaris-treated patients[1]. Study 1 showed that 84% of patients treated with one subcutaneous dose of Ilaris achieved the primary endpoint of the adapted pediatric American College of Rheumatology 30 (ACR30), compared to 10% achievement of ACR30 for placebo at Day 15[1]. In the open-label part of Study 2, 92 of 128 patients attempted “corticosteroid tapering”. Of those 92 patients, 62% were able to substantially reduce their use of corticosteroids, and 46% completely discontinued corticosteroids[1]. In the controlled portion of Study 2, there was a 64% relative reduction in the risk of flare for patients in the Ilaris group as compared to those in the placebo group (hazard ratio of 0.36; 95% CI: 0.17 to 0.75).
About Ilaris
Ilaris is a selective, fully human, monoclonal antibody that inhibits IL-1 beta, which is an important part of the body’s immune system defenses[1]. Excessive production of IL-1 beta plays a prominent role in certain inflammatory diseases[8]. Ilaris works by neutralizing IL-1 beta for a sustained period of time, therefore inhibiting inflammation[1].
In addition to its approval for SJIA in the US, Ilaris is approved in the EU for the treatment of refractory gouty arthritis, and in more than 60 countries, including in the EU, US, Switzerland and Japan for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), a rare, lifelong, genetic disorder with debilitating symptoms[1]. The approved indication may vary depending upon the individual country
1 Ilaris [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2013.
2. Woo P. Systemic juvenile idiopathic arthritis: diagnosis, management, and outcome. Nat Clin Pract Rheumatol 2006; 2(1):28-34.
3. Ramanan AV, Grom AA. Does systemic-onset juvenile idiopathic arthritis belong under juvenile idiopathic arthritis? Rheumatology (Oxford) 2005; 44(11):1350-3.
FDA Accepts Endo’s Aveed Application
Endo Health Solutions said that regulators accepted for review new data for its long-acting testosterone injection Aveed and will make a ruling on the drug by Feb. 28. The Food and Drug Administration asked Endo for more information in May.
| FULL STORY |
Niche play, alliances hold promise for Biocon
DR KIRAN SHAW MAXUMDAR
MD BIOCON
Niche play, alliances hold promise for Biocon
While biosimilar opportunity in the regulated markets is likely to play out in the medium term, its existing biopharma and branded portfolio will ensure growth in the short term
Niche play, alliances hold promise for Biocon
Business Standard
Innovator sales for these two drugs are pegged at $10 billion which is slightly over half of the worldwide insulin market of $19 billion.On the monoclonal antibody front, the company is in phase III for the cancer drug Trastuzumab which has a market …
READ ALL THIS AT
New Drug Approvals 