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ORGANIC SPECTROSCOPY

Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL 

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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

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Indian Pharma Market Needs Strong Regulatory Set-up: Kiran Mazumdar-Shaw


Kiran Mazumdar Shaw

Kiran Mazumdar-Shaw, MD, BIOCON

Indian Pharma Market Needs Strong Regulatory Set-up:   Kiran Mazumdar-Shaw, MD, BIOCON

Biocon is looking at gaining market share and improving its margins with a greater focus on its product mixes and organizational efficiencies. Biocon Chairman and Managing Director Kiran Mazumdar-Shaw tells Financial Express that the company has outpaced the market, despite various challenges and that the pharmaceutical market needs to have a more robust regulatory set-up. Edited excerpts:

READ ALL AT

http://kiranmazumdarshaw.blogspot.in/2013/07/indian-pharma-market-needs-strong.html

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Serum Institute of India acquires rights to TB vaccine


Serum Institute of India acquires rights to TB vaccine

Serum Institute of India, a Pune-based manufacturer of vaccines, is planning on taking a promising vaccine – originally developed in Germany – and introducing it into the clinic. Studies have shown that the new vaccine is more effective and better tolerated than currently available options.

By signing a contract with Hannover-based Vakzine Projekt Management (VPM), Serum has secured the licence to the various patents and technologies related to the…

Click here to read more

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UK regulator approves access to Revolade drug after three-year process


25 July 2013

The National Institute for Health and Care Excellence (NICE) in the UK has recommended immune disorder drug Revolade for use on the NHS after a process of three and a half years.

The GSK once-daily oral treatment is now available to adult patients in England and Wales living with chronic immune (idiopathic) thrombocytopenic purpura (cITP), an immune disorder associated with low-blood platelet counts.

In patients with cITP, the immune system prematurely destroys platelets or impairs their production so that platelets are lost from the circulation faster than they can be replaced from the bone marrow, where they are made.

This results in patients developing mild bruising or serious bleeding, which affects their quality of life and, in some instances, may be fatal.

It is estimated that cITP currently affects 50 in 100,000 people in the UK.

The only other licensed TPO-RA recommended by NICE is romiplostim, which is given in the form of a weekly injection.

The Royal London Hospital’s clinical director for pathology Prof Adrian Newland said: “I was very pleased to see that NICE has recognised the clinical value and cost-effectiveness of eltrombopag in their guidance.

“We now have an important addition to the treatment options for patients with severe or refractory disease.”

“With eltrombopag, we hope to ultimately make a meaningful difference in the quality of life of cITP patients and contribute to potential savings for the NHS.”

Revolade is an oral thrombopoietin receptor agonist (TPO-RA) that stimulates the growth and maturation of cells in the bone marrow (megakaryocytes) that produce platelets, increasing platelet production.

When added to conventional immunosuppressive therapy, Revolade, also known as eltrombopag, increases response rates compared with placebo and in some patients.

GlaxoSmithKline UK general manager Erik Van Snippenberg said: “This has been a lengthy three and a half year long appraisal process. We are pleased that NICE has recommended eltrombopag and that the small number of cITP patients in England and Wales are granted access to an alternative treatment option offering the benefit of oral convenience.

“With eltrombopag, we hope to ultimately make a meaningful difference in the quality of life of cITP patients and contribute to potential savings for the NHS.”

 

Hepatitis B


Hepatitis B


Key facts

  • Hepatitis B is a viral infection that attacks the liver and can cause both acute and chronic disease.
  • The virus is transmitted through contact with the blood or other body fluids of an infected person.
  • About 600 000 people die every year due to the consequences of hepatitis B.
  • Hepatitis B is an important occupational hazard for health workers.
  • Hepatitis B is preventable with the currently available safe and effective vaccine.


Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus. It is a major global health problem. It can cause chronic liver disease and chronic infection and puts people at high risk of death from cirrhosis of the liver and liver cancer.

More than 240 million people have chronic (long-term) liver infections. About 600 000 people die every year due to the acute or chronic consequences of hepatitis B.

A vaccine against hepatitis B has been available since 1982. Hepatitis B vaccine is 95% effective in preventing infection and its chronic consequences, and was the first vaccine against a major human cancer.

Geographical distribution

Hepatitis B virus can cause an acute illness with symptoms that last several weeks, including yellowing of the skin and eyes (jaundice), dark urine, extreme fatigue, nausea, vomiting and abdominal pain. Hepatitis B prevalence is highest in sub-Saharan Africa and East Asia. Most people in these regions become infected with the hepatitis B virus during childhood and between 5–10% of the adult population is chronically infected.

High rates of chronic infections are also found in the Amazon and the southern parts of eastern and central Europe. In the Middle East and the Indian subcontinent, an estimated 2–5% of the general population is chronically infected. Less than 1% of the population in western Europe and North America is chronically infected.

Transmission

In highly endemic areas, HBV is most commonly spread from mother to child at birth, or from person to person in early childhood.

Perinatal or early childhood transmission may also account for more than one third of chronic infections in areas of low endemicity, although in those settings, sexual transmission and the use of contaminated needles, especially among injecting drug users, are the major routes of infection.

The hepatitis B virus can survive outside the body for at least seven days. During this time, the virus can still cause infection if it enters the body of a person who is not protected by the vaccine.

The hepatitis B virus is not spread by contaminated food or water, and cannot be spread casually in the workplace.

The incubation period of the hepatitis B virus is 75 days on average, but can vary from 30 to 180 days. The virus may be detected 30 to 60 days after infection and persists for variable periods of time.

Symptoms

Most people do not experience any symptoms during the acute infection phase. However, some people have acute illness with symptoms that last several weeks, including yellowing of the skin and eyes (jaundice), dark urine, extreme fatigue, nausea, vomiting and abdominal pain.

In some people, the hepatitis B virus can also cause a chronic liver infection that can later develop into cirrhosis of the liver or liver cancer.

More than 90% of healthy adults who are infected with the hepatitis B virus will recover and be completely rid of the virus within six months.

Who is at risk for chronic disease?

The likelihood that infection with the hepatitis B virus becomes chronic depends upon the age at which a person becomes infected. Children less than 6 years of age who become infected with the hepatitis B virus are the most likely to develop chronic infections:

  • 80–90% of infants infected during the first year of life develop chronic infections;
  • 30–50%% of children infected before the age of 6 years develop chronic infections.

In adults:

  • <5% of otherwise healthy adults who are infected will develop chronic infection;
  • 15–25% of adults who become chronically infected during childhood die from hepatitis B-related liver cancer or cirrhosis.

Diagnosis

It is not possible, on clinical grounds, to differentiate hepatitis B from hepatitis caused by other viral agents and, hence, laboratory confirmation of the diagnosis is essential. A number of blood tests are available to diagnose and monitor people with hepatitis B. They can be used to distinguish acute and chronic infections.

Laboratory diagnosis of hepatitis B infection centres on the detection of the hepatitis B surface antigen HBsAg. WHO recommends that all blood donations are tested for this marker to avoid transmission to recipients.

  • Acute HBV infection is characterized by the presence of HBsAg and immunoglobulin M (IgM) antibody to the core antigen, HBcAg. During the initial phase of infection, patients are also seropositive for HBeAg.
  • Chronic infection is characterized by the persistence (>6 months) of HBsAg (with or without concurrent HBeAg). Persistence of HBsAg is the principal marker of risk for developing chronic liver disease and hepatocellullar carcinoma (HCC) later in life.
  • The presence of HBeAg indicates that the blood and body fluids of the infected individual are highly contagious

Treatment

There is no specific treatment for acute hepatitis B. Care is aimed at maintaining comfort and adequate nutritional balance, including replacement of fluids that are lost from vomiting and diarrhoea.

Some people with chronic hepatitis B can be treated with drugs, including interferon and antiviral agents. Treatment can slow the progression of cirrhosis, reduce incidence of HCC and improve long term survival. Treatment, however, is not readily accessible in many resource-constrained settings.

Liver cancer is almost always fatal and often develops in people at an age when they are most productive and have family responsibilities. In developing countries, most people with liver cancer die within months of diagnosis. In high-income countries, surgery and chemotherapy can prolong life for up to a few years.

People with cirrhosis are sometimes given liver transplants, with varying success.

Prevention

The hepatitis B vaccine is the mainstay of hepatitis B prevention. WHO recommends that all infants receive the hepatitis B vaccine as soon as possible after birth, preferably within 24 hours.

The birth dose should be followed by 2 or 3 doses to complete the primary series. In most cases, 1 of the following 2 options is considered appropriate:

  • a 3-dose schedule of hepatitis B vaccine, with the first dose (monovalent) being given at birth and the second and third (monovalent or combined vaccine) given at the same time as the first and third doses of DTP vaccine; or
  • 4 doses, where a monovalent birth dose is followed by 3 monovalent or combined vaccine doses, usually given with other routine infant vaccines.

The complete vaccine series induces protective antibody levels in more than 95% of infants, children and young adults. Protection lasts at least 20 years and is possibly lifelong.

All children and adolescents younger than 18 years old and not previously vaccinated should receive the vaccine if they live in countries where there is low or intermediate endemicity. In those settings it is possible that more people in high risk groups may acquire the infection and they should also be vaccinated. They include:

  • people who frequently require blood or blood products, dialysis patients, recipients of solid organ transplantations;
  • people interned in prisons;
  • injecting drug users;
  • household and sexual contacts of people with chronic HBV infection;
  • people with multiple sexual partners, as well as health-care workers and others who may be exposed to blood and blood products through their work; and
  • travellers who have not completed their hepatitis B vaccination series should be offered the vaccine before leaving for endemic areas.

The vaccine has an excellent record of safety and effectiveness. Since 1982, over one billion doses of hepatitis B vaccine have been used worldwide. In many countries, where 8–15% of children used to become chronically infected with the hepatitis B virus, vaccination has reduced the rate of chronic infection to less than 1% among immunized children.

As of July 2011, 179 Member States vaccinate infants against hepatitis B as part of their vaccination schedules. This is a major increase compared with 31 countries in 1992, the year that the World Health Assembly passed a resolution to recommend global vaccination against hepatitis B. Furthermore, as of July 2011, 93 Member States have introduced the hepatitis B birth dose.

In addition, implementation of blood safety strategies, including quality-assured screening of all donated blood and blood components used for transfusion can prevent transmission of HBV. Safe injection – unnecessary as well as unsafe injections – practices can protect against HBV transmission. Furthermore, safer sex practices, including minimizing the number of partners and using barrier protective measures (condoms), protect against transmission.

WHO response

WHO is working in the following areas to prevent and control viral hepatitis:

  • raising awareness, promoting partnerships and mobilizing resources;
  • formulating evidence-based policy and data for action;
  • preventing of transmission; and
  • executing screening, care and treatment.

WHO also organizes World Hepatitis Day on July 28 every year to increase awareness and understanding of viral hepatitis.

 

Antibody Effective Against Norovirus


 

Antibody Effective Against Norovirus
Researchers have released data showing that a monoclonal antibody can neutralize human norovirus. Norovirus causes roughly 20 million cases of acute diarrhea and vomiting annually in the United States, alone. It is also responsible for roughly 800 deaths annually.

FULL STORY

http://www.dddmag.com/news/2013/07/antibody-effective-against-norovirus?et_cid=3387991&et_rid=523035093&type=headline

 

What is Norovirus?

Norovirus is a stomach bug that sets in within 10 hours of transmission and usually lasts up to three days. It is completely different from the flu in that only your stomach is affected. While most people recover completely after three days, norovirus is more serious for young children, the elderly and people with other serious health conditions. Every year 70,000 people are hospitalized and 800 deaths are caused by the virus.

What are the symptoms?

The most common symptoms of norovirus include stomach pain, vomiting, diarrhea and nausea. Some people also experience a low-grade fever, headache and body ache. Because it is common to have continued vomiting and diarrhea during the three days of illness, dehydration is another concern for those affected.

How do you get it?

Norovirus is spread through direct contact with an infected person’s vomit or feces. Most commonly, unwashed hands can be attributed to spreading the virus through surfaces or food. The virus spreads quickly in enclosed spaces like cruise ships, nursing homes and schools.

What is the treatment?

Unfortunately, there are no medications to treat norovirus. Health care providers say the best thing to do is try to stay hydrated, rest and wait for the virus to run its course. People who are unable to keep fluids down may need to receive fluids intravenously.

How can you protect yourself?

Hand washing is the best defense against the norovirus, since no one is immune to the always-changing strains of the virus. However, new research has found hand sanitizers are not affective in killing the virus. Avoid direct contact with anyone who is infected and pay close attention to cleaning and preparing food. Also, anyone who is infected should not prepare food. Use disinfectants to wipe down all surfaces that have come in contact with someone who is infected. Also, launder infected clothes immediately on the longest wash cycle to help from spreading the virus.

Biosimilars applications under review by EMA – 2013 Q2


The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the EU. A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or ‘reference drug’.

read all at

http://www.gabionline.net/Biosimilars/General/Biosimilars-applications-under-review-by-EMA-2013-Q2

Alkermes unveils three new drug candidates


Alkermes has unveiled three new drug candidates, including: a monomethyl fumarate (MMF) prodrug programme for the treatment of multiple sclerosis; ALKS 7106 for the treatment of pain; and RDB 1419, a cancer immunotherapy candidate based on interleukin-2 (IL-2) and its receptors, Alkermes’ first proprietary biologic.

According to Alkermes, these drug candidates demonstrate the company’s focus on unmet medical needs in specific patient populations and show the productivity of its expanded R&D capabilities.

read all at

http://www.manufacturingchemist.com/news/article_

page/Alkermes_unveils_three_new_drug_candidates/90167

 

 

 

FDA Approves New Drug to Treat Nephropathic Cystinosis


CHICAGO—The U.S. Food and Drug Administration (FDA) has recently approved PROCYSBI(cysteamine bitartrate), a delayed release capsule for treating nephropathic cystinosis in adults and children 6 years and older.

Ann and Robert H. Lurie Children’s Hospital of Chicago served as one of three United States sites for the landmark study and patients came from all over North America to be seen by lead investigator, Craig B Langman, M.D., The Isaac A Abt, M.D. professor of Kidney Diseases at Northwestern University Feinberg School of Medicine and head of Kidney Diseases at Lurie Children’s

http://www.renalbusiness.com/news/2013/07/fda-approves-new-drug-to-treat-nephropathic-cystinosis.aspx

 

Kyowa Hakko Kirin seeks MHLW Approval for Additional Indication for ATL, PTCL and CTCL of Mogamulizumab


Kyowa Hakko Kirin Co., Ltd. has been filed an application to Japan’s Ministry of Health, Labour and Welfare (“MHLW”) seeking approval for additional indication for untreated CCR4-positive adult T-cell leukemia-lymphoma (ATL), relapsed CCR4-positive peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) of Mogamulizumab (brand name: POTELIGEO® Injection 20 mg).

read at…………

http://japan.pharmaintellect.com/2013/07/kyowa-hakko-kirin-seeks-mhlw-approval.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+Pharmainvest+%28PharmaInvest%29

Mogamulizumab (USAN; trade name Poteligeo) is a humanized monoclonal antibodytargeting CC chemokine receptor 4 (CCR4). It has been approved in Japan for the treatment of relapsed or refractory adult T-cell leukemia/lymphoma.[1]

Mogamulizumab was developed by Kyowa Hakko Kirin Co., Ltd.[2] It has also been licensed to Amgen for development as a therapy for Asthma.[3]

 

  1.  Subramaniam, J; Whiteside G, McKeage K, Croxtall J (18). “Mogamulizumab: First Global Approval”Drugs 72 (9): 1293–1298. doi:10.2165/11631090-000000000-00000. Retrieved 10 September 2012.
  2.  “Statement On A Nonproprietary Name Adopted By The USAN Council: Mogamulizumab”American Medical Association.
  3.  “Kyowa Hakko Kirin R&D Pipeline”. Kyowa Hakko Kirin. Retrieved 10 September 2012.

Poteligeo(mogamulizumab)-单克隆抗体

 
简介: 单克隆抗体Poteligeo(mogamulizumab)获得日本厚生劳动省批准治疗白血病-淋巴瘤日本厚生劳动省批准Kyowa Hakko Kirin公司的Poteligeo治疗复发或难治性CC趋化因子受体4(CCR4,CD194)阳性的T细胞性白 …
 单克隆抗体Poteligeo(mogamulizumab)获得日本厚生劳动省批准治疗白血病-淋巴瘤
日本厚生劳动省批准Kyowa Hakko Kirin公司的Poteligeo治疗复发或难治性CC趋化因子受体4(CCR4,CD194)阳性的T细胞性白血病-淋巴瘤。厚生劳动省还批准了Kyowa公司这一抗体的两个诊断方法,用于测试IHC和FCM,从而确定最有可能对治疗有应答的患者亚群。Amgen公司拥有Poteligeo在除日本、韩国、中国大陆和台湾以外地区的所有非癌症适应症的开发和商业化独占权。Amgen公司正在进行本品用于治疗哮喘的Ⅰ期临床研究。

 

 

 

Sihuan Pharma Receives OK from CFDA for Trials of Novel PPI Drug


http://www.telegraphindia.com/pressrelease/prnw/prna_086_1306033.html

Sihuan Pharma Receives OK from CFDA for Trials of Novel PPI Drug

Sihuan Pharma received CFDA permission to begin clinical trials of a Category 1.1 (a novel treatment never approved anywhere in the world) for ulcers. Sihuan describes Anaprazole Sodium as a latest-generation proton pump inhibitor. It is the fifth Category 1 drug that Sihuan has put into clinical trials. Sihuan is the largest maker of cardio-cerebral vascular drugs for the China market

HONG KONG, July 18, 2013  Sihuan Pharmaceutical Holdings Group Ltd.  (“Sihuan Pharmaceutical” or the “Company”), a leading pharmaceutical company with the largest cardio-cerebral vascular (“CCV”) drug franchise in China’s prescription market, today announced that Anaprazole Sodium, a Category 1.1 new drug received the Approval for Clinical Studies from the State Food and Drug Administration (“SFDA”) of the People’s Republic of China. Anaprazole Sodium is the fifth Category 1 innovative drug in respect of which the Company has received approval for Clinical Studies, applications for patents have been made in China, the United States, Japan and Europe.

Anaprazole Sodium is a new generation of proton pump inhibitors (“PPIs”) which treats ulcers quickly and efficiently by inhibiting gastric acid secretion and eradicating Helicobacter pylori. Preclinical studies have shown that the new drug covalently binds to proton pump, thus providing substantially stronger and longer inhibitory effects when compared to other PPI drugs, traditional H2-receptor antagonists and antacids currently available in the market. Therefore, it can effectively treat various gastric acid diseases