New Drug Approvals

Home » Uncategorized (Page 209)

Category Archives: Uncategorized

DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO .....FOR BLOG HOME CLICK HERE

Blog Stats

  • 4,928,727 hits

Flag and hits

Flag Counter

Enter your email address to follow this blog and receive notifications of new posts by email.

Join 37.8K other subscribers
Follow New Drug Approvals on WordPress.com

Archives

Categories

Recent Posts

Flag Counter

ORGANIC SPECTROSCOPY

Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL 

Enter your email address to follow this blog and receive notifications of new posts by email.

Join 37.8K other subscribers
DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with AFRICURE PHARMA, ROW2TECH, NIPER-G, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Govt. of India as ADVISOR, earlier assignment was with GLENMARK LIFE SCIENCES LTD, as CONSUlTANT, Retired from GLENMARK in Jan2022 Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 32 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 32 PLUS year tenure till date Feb 2023, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 100 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 100 Lakh plus views on dozen plus blogs, 227 countries, 7 continents, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 38 lakh plus views on New Drug Approvals Blog in 227 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc He has total of 32 International and Indian awards

Verified Services

View Full Profile →

Archives

Categories

Flag Counter

Avanir said the FDA agreed to a faster development process for its experimental drug AVP-786 and will allow the company to use some data from studies of Nuedexta in its applications for AVP-786

6/may/2013

Avanir Pharmaceuticals Inc. announced that the Food and Drug Administration will allow it to speed research on a newer version of its drug Nuedexta.

Avanir said the FDA agreed to a faster development process for its experimental drug AVP-786 and will allow the company to use some data from studies of Nuedexta in its applications for AVP-786.

Avanir plans to start human clinical trials of the drug after it completes some limited preclinical testing. The company said the FDA’s decision could reduce the cost of developing the drug and allow it to win marketing approval sooner.

Nuedexta is a treatment for pseudobulbar affect, a condition that involves involuntary emotional outbursts like laughing or crying. It is associated with brain disease or injury. Net revenue from the drug more than doubled to $31.4 million over the first six months of the company’s current fiscal year. That was almost all of the Aliso Viejo, Calif., company’s revenue.

Nuedexta was approved in February 2011. The drug combines two ingredients: dextromethorphan, a common ingredient in cough and cold medicines that can suppress coughing, and quinidine, which is used to treat abnormal heart rhythms.

Avanir is also studying Nuedexta as a treatment for diabetic nerve pain, agitation in patients with Alzheimer’s disease, central nerve pain in multiple sclerosis, and levodopa-induced dyskinesia in Parkinson’s disease. Dyskinesias are involuntary movements tied to most treatments used to manage Parkinson’s.

Canaccord Genuity analyst Ritu Baral said Avanir considers AVP-786 to be a safer version of Nuedexta because it contains less quinidine. The drug also has stronger patent protection and is patent protected until 2030, a few years longer than Nuedexta.

In a telephone interview, Baral said the FDA’s decision could speed approval of AVP-786 by two to four years. She said Avanir may start late-stage testing of the drug in the second half of 2014 depending on the results of current studies of Nuedexta.

OPRD PAPER-An Improved Manufacturing Process for the Antimalaria Drug artemether

Abstract Image

Novartis Pharma AG, Chemical and Analytical Development and Chemical Operations, CH-4002 Basel, Switzerland.
Org. Process Res. Dev., 2007, 11 (3), pp 336–340
DOI: 10.1021/op0602425
Artemisinin and its derivatives, such as artemether, are highly sensitive compounds, which require careful optimized production processes for their manufacture. Due to robustness issues, the manufacturing procedure of the reduction of artemisinin with potassium borohydride to dihydroartemisinin was reinvestigated. The most important factor for obtaining optimal yields is to ensure low levels of contamination of potassium hydroxide in potassium borohydride. Application of a lower reaction temperature, fast addition rate of potassium borohydride, and careful control of the pH during the quench with acid are further important parameters in guaranteeing a robust process. In the redesign of the conversion of dihydroartemisinin to artemether, the yield was increased, and dichloromethane was replaced by the ecologically friendlier methyl acetate. A robust manufacturing process forartemether is now at hand, allowing the production of this important medicine reliably and in good quality and yield.

Management of Hepatitis C with Natural and Synthetic Medicine

 Management of Hepatitis C with Natural and Synthetic Medicine by Khan Usmanghani, Asif Iqbal , Department of Basic Clinical Sciences, Faculty of Eastern Medicine , HAMDARD UNIVERSITY, Karachi, Pakistan

during the 6 th International Conference of Infection Control December 19, 2006 Liaquat National Hospital, Karachi

http://www.slideshare.net/icsp/management-of-hepatitis-c-with-natural-and-synthetic-medicine

 

Viral hepatitis is defined as viral infection of hepatocytes that produces necrosis and inflammation of the liver. Viral Hepatitis is a parenchymal disease of liver. This disease is caused by (a) Hepatotropic viruses A, B, C (Non-A-Non B), D,E,F,G,H (b) Other viruses like Epstein-Barr, Cytomegalovirus, and Coxsackie virus etc. Hepatitis C virus (HCV), the major causative agent of non-A and non-B hepatitis, poses a serious worldwide health problem. about 170 million people, 3% of the world’s population, are infected with HCV High prevalence rates Southeast Asian countries WHO

DENGUE FEVER by Prof. D. S. Akram, Dr. Saba Ahmed

Outline of a human torso with arrows indicating the organs affected in the various stages of dengue fever

Dengue fever (DF) and Dengue hemorrhagic fever (DHF) rank high among infectious diseases and are considered to be most important of arthropod born viral diseases

MOSQUITO VECTOR DF is caused by mosquito of genus Aedes ,most important is A.aegypti which is a day biting mosquito, rests indoors and can breed in small collection of water. Rainy season increase risk of DF as it increases larval population ,also ambient temperature and humidity favor viral propagation

Chikungunya an update by Dr.T.V.Rao MD

The Aedes aegypti mosquito biting a person.

WHAT IS CHIKUNGUNYA• Manifest with Crippling Arthritic disease of sudden onset.• Name is derived from Swahili – Chikungunya meaning that which bends up• Virus isolated in 1953 from serum and Aedes mosquitoes and Culex spp

Chikungunya is a virus that is transmitted from human to human mainly by infected Aedes albopictus and Aedes aegypti mosquitoes (later referred to as Aedes mosquitoes) acting as the disease-carrying vector• Chikungunya causes sudden onset of high fever, severe joint pain, muscle pain and headache• As no vaccine or medication is currently available to prevent or cure the infection, control of Chikungunya involves vector control measures and encouraging people to avoid mosquito bites
http://www.slideshare.net/doctorrao/chikungunya-an-update

SEXUAL POWER ; Confirmation of Sexual Power intensity of a Human being by Electro Tridosha Graphy ; ETG AyurvedaScan system

Dr.D.B.Bajpai's avatarELECTRO TRIDOSHA GRAPHY ; ETG AyurvedaScan ; इलेक्‍ट्रो-त्रिदोष-ग्राफ ; ई०टी०जी० आयुर्वेदास्कैन

Many persons are willing to know the intensity of their SEXUAL POWER by any source. Till today no machine and mechanical parameters are available to establish sexual power by any technology.

But it is possible today and sexual power can be measured by mechanical means. By virtue of Electro Tridosha Graphy ; ETG AyurvedaScan system, now it is possible to establish the SEXUAL POWER of any human being in measured intensity.

The ETG system measures many parameters systemwise, sectorwise, traces wise, ayurvedic fundamental-wise and so on . PROSTATE health condition is scanned by ETG system. So is of the SAPTA dhatu. The SAPTA DHATU of Ayurveda is considered , similar to PATHOLOGY of Modern western medicine. Intensity of Prostate value shows the Sexual Power intensity of a human being, how is the person’s sexual drive. One of the Sapta Dhatu SHUKRA is evaluated and this shows the Quality and quantity…

View original post 265 more words

New late-stage data on Boehringer Ingelheim’s lung cancer drug nintedanib and its benefit to overall survival in some patients has caused a stir at the American Society of Clinical Oncology meeting in Chicago.

Nintedanib

nintedanib

The German drugmaker presented results from the LUME-Lung 1 Phase III trial looking at the addition of nintedanib, to docetaxel as a second-line treatment in patients with advanced non-small cell lung cancer (NSCLC) compared to chemotherapy alone.

New late-stage data on Boehringer Ingelheim’s lung cancer drug nintedanib and its benefit to overall survival in some patients has caused a stir at the American Society of Clinical Oncology meeting inChicago.

read all at

http://www.pharmatimes.com/Article/13-06-04/Boehringer_NSCLC_drug_impresses_at_ASCO.aspx

Nintedanib (also known as BIBF 1120 and Vargatef) is a small molecule inhibitor of vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR) and platelet derived growth factor receptor (PDGFR) being developed by Boehringer Ingelheim for use as an anti-vascular anti-cancer agent.

Impotence: When You Can’t Get It Up is Getting You Down

neilbaum's avatarDr. Neil Baum's Urology Blog

Probably nothing devastates a man more than having a failure in the bedroom. Impotence or erectile dysfunction affects nearly 33 million men in the United States. You are not alone. Help is available for nearly every man who has erectile dysfunction.
Diet
According to the Urology Channel’s “Erectile Dysfunction: Natural/Alternative Treatments,” erectile dysfunction can be treated by eating right, drinking plenty of water and avoiding sugar, dairy and caffeine. They recommend to eat whole, fresh, unrefined and unprocessed foods, including vegetables, whole grains, soy, beans, seeds, nuts, olive oil and cold-water fish such as salmon and tuna.
Taking your vitamins can also help; the Urology Channel suggests supplements such as flaxseed, and in particular vitamins C, E and the mineral zinc. These vitamins and supplements help bolster the vascular system, which is an important part of good sexual health.


Exercise
Since sexual health relies on the vascular system, a strong heart…

View original post 638 more words

Ayurvedic Management of Chronic Colds, Flu, Ear Nose & Throat Problems

Alex Duncan's avatarAlex's Ayurveda & Life Blog

This protocol assumes that you do not have access to Ayurvedic clinical treatments. Please also note that this article may be too complex for the general public. If you have studied Ayurveda, you will be more familiar with the terms and basic concepts.

The main treatments are dietary, lifestyle and herbal. Treatment should begin with Langhana (reducing) then move towards Brimhana (nourishing).

FOUNDATION (DOSHA/AGNI/AMA)

#1 Balance the Doshas

Reduce causal Dosha accumulation in inner pathway + reduce/balance Bodaka/Avalabbaka.

Start with diet & lifestyle.

Dietshould have most offending Kapha aggravating foods removed but also adapt to causal Dosha if it is not Kapha.

  • All animal and dairy foods should be stopped along with wheat and all sweeteners.
  • Any Ama forming food should be avoided.
  • Eat lightly. Fast if possible (if not too weak), otherwise cooked whole grains and steamed vegetables with spices is perfect.
  • Foods that are helpful: Cabbage, Garlic…

View original post 1,673 more words

Joint Pain: Medicine Kit of the Lower Pecos, Part II

Mary S. Black's avatarMary S. Black

Human beings have been plagued with joint pain throughout the history of mankind.  Arthritis, the condition caused by the wearing down of beneficial cartilage in the joints, affects over 27 million people in the United States today, according to the Arthritis Foundation

(www.arthritistoday.org). I don’t know enough about the skeletal evidence from the Lower Pecos of Texas to do more than speculate, but at least some people in the region 4000-6000 years ago must have worn out a knee or two climbing up and down steep canyons and running over rough stone outcroppings in the uplands. In other words, they probably had  their share of  “archaic arthritis.”

Ow! Even that phrase hurts!  Osteoarthritis produces stinging pain and can cause swelling and stiffness in the joints affected. Generally, the older you are, the more wear and tear you have on your joints.  A stiff knee could make a thirty-year-old adult from the archaic period feel…

View original post 703 more words