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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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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.
Cheminformatics, scaffolding & tuberculosis: a work in progress
One of the projects that has been keeping me busy lately is a structure data-mining exercise intended to reveal some interesting scaffold hypotheses that can contribute to research into finding new cures for tuberculosis. The process is at an early stage, but if you’re interested in taking a look at some of the preliminary results, you can view them here.
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Guidance on Medicinal Product Registration in Singapore
Singapore Drug Registration Information and Guidelines
Guidance on Medicinal Product Registration in Singapore
– See more at:
http://worlddrugtracker.blogspot.in/2013/09/guidance-on-medicinal-product.html
Cuidado con los remedios naturales que pueden producir cáncer
Uno de los mayores errores actuales dentro de la medicina alternativa es la creencia popular de que los llamados “remedios naturales” a base de plantas son siempre beneficiosos y que nunca tienen ningún efecto secundario dañino.
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Innovative Regulatory Review Practices for Better Efficiencies- The Singapore Experience
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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
SINGAPORE-HSA DRUG APPROVALS
SINGAPORE-HSA DRUG APPROVALS
Nexium Tablet
Active Ingredient: esomeprazole
Licence Holder: AstraZeneca Singapore Pte Ltd
Date of Approval: 28 May 2013
20MG & 40MG Indications: Patients requiring continued low dose aspirin
Galvus Met Tablet
Active Ingredient: vildagliptin/metformin
Licence Holder: Novartis (Singapore) Pte Ltd
Date of Approval: 22 May 2013
50MG/500MG, 50MG/850MG & 50MG/1000MG Indications: For patients with Type 2
Galvustablet
Active Ingredient: vildagliptin
Licence Holder: Novartis (Singapore) Pte Ltd
Date of Approval: 22 May 2013
50MG Indications: Galvus is indicated as an adjunct to diet
Firmagon Powder & Solvent for Solution for Injection
Active Ingredient: degarelix
Licence Holder: Ferring Pharmaceuticals Pte Ltd
Date of Approval: 13 May 2013
120MG & 80MG Indications: FIRMAGON® is a gonadotrophin releasing hormone
Votrient Tablet
Active Ingredient: pazopanib
Licence Holder: GlaxoSmithKline Pte Ltd
Date of Approval: 10 May 2013
200MG & 400MG Indications: Soft tissue sarcoma (STS) VOTRIENT is indicated
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
DR ANTHONY MELVIN CRASTO
ORGANIC SPECTROSCOPY
New Drug Approvals 