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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Innovative Regulatory Review Practices for Better Efficiencies- The Singapore Experience
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| Motto: “Majulah Singapura” (Malay) “Onward, Singapore” |
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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
Research Perspective in Academia and Generic Pharmaceutical Industry
Rakeshwar Bandichhor
Director at Dr. Reddy’s Laboratories
Research Perspective in Academia and Generic Pharmaceutical Industry
Research per say is an exploratory endeavor that allows us to discover or invent not only medicine and material but how to make them in sustainable manner. In particular, research primarily involves identification of the target and its significance in terms of applicability to meet the societal needs ranging from education to commercial production of the goods.
| Research Perspective in Academia and Generic Pharmaceutical Industry | ||
| Rakeshwar Bandichhor* | ||
|
Research Perspective in Academia and Generic Pharmaceutical Industry
Research Perspective in Academia and Generic Pharmaceutical Industry
| Research Perspective in Academia and Generic Pharmaceutical Industry | ||
| Rakeshwar Bandichhor* | ||
| Associate Director, API, R&D, Dr. Reddy′s Laboratories, Hyderabad 500072, AP, India | ||
|
FDA OKs Abraxane With Gemcitabine for Pancreatic Cancer
U.S. FOOD AND DRUG ADMINISTRATION APPROVES ABRAXANE® IN COMBINATION WITH GEMCITABINE AS FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC PANCREATIC CANCER
-Approval Based on MPACT Study of ABRAXANE in Combination with Gemcitabine Demonstrating a Clinically Meaningful Increase in Overall Survival-
-First New Treatment Approved for Metastatic Adenocarcinoma of the Pancreas in Nearly 8 Years-
SUMMIT, New Jersey– (September 6, 2013) – Celgene Corporation (NASDAQ: CELG) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental New Drug Application (sNDA) of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) as first–line treatment for patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine. Adenocarcinoma, a sub-type of exocrine tumors, accounts for about 95% of cancers of the pancreas.
read all at
http://www.pharmalive.com/fda-oks-abraxane-with-gemcitabine-for-pancreatic-cancer
Abraxane, a microtubule inhibitor, is an albumin-bound form of paclitaxel with a mean particle size of approximately 130 nanometers. Paclitaxel exists in the particles in a non-crystalline, amorphous state. Abraxane is supplied as a white to yellow, sterile, lyophilized powder for reconstitution with 20 mL of 0.9% Sodium Chloride Injection, USP prior to intravenous infusion. Each single-use vial contains 100 mg of paclitaxel (bound to human albumin) and approximately 900 mg of human albumin (containing sodium caprylate and sodium acetyltryptophanate). Each milliliter (mL) of reconstituted suspension contains 5 mg paclitaxel. Abraxane is free of solvents.
The active agent in Abraxane is paclitaxel. The chemical name for paclitaxel is 5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine.
Paclitaxel has the following structural formula:
Paclitaxel is a white to off-white crystalline powder with the empirical formula C47H51NO14 and a molecular weight of 853.91. It is highly lipophilic, insoluble in water, and melts at approximately 216°C to 217°C.
Five herbs your liver will love – detox, boost function and more
Friday, September 06, 2013 by: PF Louis
(NaturalNews) The liver is the largest solid organ in our bodies. It can be adversely affected by poor diet and lifestyle choices, alcohol consumption, acetaminophen, non-prescription pain killers, and the myriad of toxins in our environment.
It is responsible for filtering blood from toxins and converts waste products from metabolic functions into urea to be eliminated by urine. It creates bile to help digest fats and carbohydrates.
It also filters out toxins from the blood stream and synthesizes glutathione, the master antioxidant that also helps recycle other spent antioxidants. It also helps balance blood sugars and creates red blood cells.
Learn more: http://www.naturalnews.com/041944_liver_function_detox_medicinal_herbs.html#ixzz2eIaDescq
pic coutesy presenter media
New Drug Approvals 