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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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World Drug Tracker: Garlic an antifungal, garlic can also support your immune system, reduce cholesterol, and help control blood sugar levels.


World Drug Tracker: Garlic an antifungal, garlic can also support your immune system, reduce cholesterol, and help control blood sugar levels..

World Drug Tracker: Alexza Pharmaceuticals Announces European Launch of ADASUVE® (Staccato® Loxapine)


World Drug Tracker: Alexza Pharmaceuticals Announces European Launch of ADASUVE® (Staccato® Loxapine).

FDA Grants Priority Review To New Drug Application For MNK-795 Submitted By Depomed Licensee Mallinckrodt


FDA Grants Priority Review To New Drug Application For MNK-795 Submitted By Depomed Licensee Mallinckrodt

Controlled Substance Analgesic Combination Product Uses Depomed’s Proprietary Acuform® Technology

NEWARK, Calif., July 29, 2013 /PRNewswire/ — Depomed, Inc. (NASDAQ:DEPO) announced today that the U. S. Food and Drug Administration (FDA) has accepted for filing a New Drug Application (NDA) from Mallinckrodt (NYSE: MNK) for MNK-795.  MNK-795 is a controlled-release oral formulation of oxycodone and acetaminophen that has been studied for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.  MNK-795 is formulated with Depomed’s Acuform® drug delivery technology.

http://www.pharmalive.com/fda-grants-priority-review-to-new-drug-application-for-mnk-795

British drugmaker AstraZeneca and US biotechnology company FibroGen have formed a strategic partnership to develop and commercialize FG-4592 to treat anemia in patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD).


cas no 808118-40-3 FG 4592
FG-4592 oral presentation at ASN 2012

FG-4592 is an orally administered small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase activity.

As part of the agreement, the deal will focus on US, China and all major markets except the Commonwealth of Independent States, the Middle East, South Africa, Japan and Europe, while both companies can exercise the option to extend their collaboration to other anemia indications.

http://drugdiscovery.pharmaceutical-business-review.com/news/astrazeneca-and-fibrogen-partner-to-develop-anemia-drug-010813

AstraZeneca will pay FibroGen at least $350 million as part of a strategic collaboration to develop and commercialize FG-4592, a first-in-class oral compound in late stage development for the treatment of anaemia associated with chronic kidney disease (CKD) and end-stage renal disease (ESRD).

This broad collaboration focuses on the US, China and all major markets excluding Japan, Europe, the Commonwealth of Independent States, the Middle East and South Africa, which are covered by an existing agreement between FibroGen and Astellas Pharma. The AstraZeneca-FibroGen joint effort will be focused on the development of FG-4592 to treat anaemia in CKD and ESRD, and may be extended to other anaemia indications. The companies plan to undertake an extensive FG-4592 Phase III development program for the US, and to initiate Phase III trials in China, with anticipated regulatory filings in China in 2015 and in the US in 2017.

In addition to $350 million in up front and non-contingent payments, AstraZeneca could pay FibroGen potential future development related milestone payments of up to $465 million, and potential future sales related milestone payments in addition to tiered royalty payments on future sales on FG-4592 in the low 20% range. Additional development milestones will be payable for any subsequent indications which the companies choose to pursue. AstraZeneca will be responsible for the US commercialization of FG-4592, with FibroGen undertaking specified promotional activities in the ESRD segment in this market. The companies will also co-commercialize FG-4592 in China where FibroGen will be responsible for clinical trials, regulatory matters, manufacturing and medical affairs, and AstraZeneca will oversee promotional activities and commercial distribution.

FG-4592 is a small molecule inhibitor of hypoxia-inducible factor (HIF), a protein that responds to oxygen changes in the cellular environment and meets the body’s demands for oxygen by inducing erythropoiesis, the process by which red blood cells are produced. The firms claim FG-4592 has the potential to address the considerable unmet medical need for an effective treatment for anaemia that offers the convenience of oral administration and an improved safety profile when compard with current standards of care. At present, treatment options involve a combination of injectable erythropoiesis-stimulating agents (ESAs) and iron supplements.

“Our collaboration with FibroGen on FG-4592 is an important addition to AstraZeneca’s growing late-stage portfolio in cardiovascular and metabolic disease, one of our core therapy areas,” comments Pascal Soriot, AstraZeneca CEO. “We know from our research into complications of renal disease that anaemia continues to be a challenge for patients with chronic kidney disease, due in part to the inconvenience and complexity of existing injectable and intravenous therapies and the safety concerns associated with them. The science behind this compound is compelling. Through our collaboration with FibroGen we aim to offer a first-in-class, convenient treatment option for doctors and patients.”

“FG-4592 has the potential to offer anaemia patients an oral therapy that provides coordinated erythropoiesis, that increases natural erythropoietin within the normal physiological range, and that is effective without intravenous iron supplementation and without an increased risk for hypertension,” adds Thomas B. Neff, FibroGen CEO. “We are especially pleased that AstraZeneca will share our commitment to making China the first-to-launch country for FG-4592 and join our effort to bring important innovation in anaemia therapy to CKD and ESRD patients in the US and other countries. This agreement secures proper development and commercialization resources for FG-4592, and ensures US clinical trial efforts are fully funded.”

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Novavax announces positive preclinical data for vaccine against influenza


 
Influenza

Novavax announces positive preclinical data for vaccine against influenza

Novavax has announced positive preclinical results for its virus-like particle (VLP) vaccine candidate against A (H7N9) influenza.

The study examined the immunogenicity, the ability to provoke an immune response, and efficacy of two doses of its A(H7N9) VLP vaccine candidate against a lethal wild-type challenge mouse model.

There were three control groups, including Novavax’ non-homologous A(H7N3) VLP vaccine candidate, its A(H5N1) VLP vaccine candidate, and a placebo. All vaccine candidates were administered with or without Iscomatrix, a saponin-based adjuvant.

read all at

http://www.pharmaceutical-technology.com/news/newsnovavax-announces-positive-preclinical-data-for-vaccine-against-influenza?WT.mc_id=DN_News

 

 

 

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Animal testing failures put drug trial volunteers in danger


animal_testing

© Shutterstock

Poor pre-clinical data and an absence of negative results are pushing candidate molecules into the clinic too soon

The reporting of animal studies is biased, inflating the efficacy of drug candidates and pushing them into the clinic before they are ready. This is the verdict of new research, which finds that more treatments go from pre-clinical to human trials than ought to, wasting valuable resources and potentially putting trial participants in danger.1 It adds to a growing body of evidence pointing to problems in the way animal testing is reported and managed.

READ AT

http://www.rsc.org/chemistryworld/2013/07/failures-animal-testing-put-drug-trial-volunteers-danger

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Gene Therapy for Melanoma: Progress and Perspectives


media/image1.jpeg

FIGURE 1.

http://www.intechopen.com/books/recent-advances-in-the-biology-therapy-and-management-of-melanoma/gene-therapy-for-melanoma-progress-and-perspectives

Schematic representation of the wild type counterpart of the typically used recombinant viral vectors. (A) Gammaretroviruses and (B) lentiviruses share similar structures, but differ greatly in their genomes and their impact on cellular function. Gag, pro, pol and env genes encode structural proteins of the capsid, protease, reverse transcriptase and envelope proteins, respectively. The additional lentiviral genes perform regulatory functions as well as alter cellular function. (C) The serotype 5 adenovirus has a protein capsid (non-enveloped) and a large, complex genome that encodes critical genes for viral replication (E1a, E1b) as well as structural and functional genes that regulate both viral and cellular activities.

 Introduction

Gene therapy, the therapeutic transfer of genetic information to a target cell, continues to be a promising alternative in the fight against cancer. In the case of melanoma, the use of an experimental treatment is justified since this disease is incurable in its advanced stages. Is gene therapy a viable option for the treatment of melanoma patients? In this chapter, we will attempt to answer this question by exploring the intersection between the technology of gene therapy and the biology of melanoma, a point at which opportunities for intervention are revealed.

Gene Therapy for Melanoma: Progress and Perspectives

Bryan E. Strauss1 and Eugenia Costanzi-Strauss2

[1] Cancer Institute of Sao Paulo, University of Sao Paulo School of Medicine, Brazil

[2] University of Sao Paulo, Biomedical Sciences Institute, Brazil

http://www.intechopen.com/books/recent-advances-in-the-biology-therapy-and-management-of-melanoma/gene-therapy-for-melanoma-progress-and-perspectives

 

 

 

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Analysis Of Vical’s Allovectin-7: Best Results Ever In A Melanoma Phase 3 Trial


check this video

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immunotherapy - cancer

Vical’s (VICL) Allovectin-7 is a pure immune therapy.(1) Which means it does not directly kill cancer cells, but activates the immune system to do so. Vical will soon announce A-7 phase 3 results in Melanoma, but the mechanism of action is not specific to Melanoma, and can be used in any solid tumor cancer.(2) For this reason, I expect that Allovectin-7 will become one of the best selling cancer drugs of all time.

http://seekingalpha.com/article/1584402-analysis-of-vicals-allovectin-7-best-results-ever-in-a-melanoma-phase-3-trial?source=google_news

Allovectin-7 is a substance that is being studied as a gene therapy agent in the treatment of cancer, such as malignant melanoma. It is a plasmid/lipid complex containing the DNA sequences encoding HLA-B7 and ß2 microglobulin – two components of major histocompatibility complex (MHC, class I). It increases the ability of the immune system to recognize cancer cells and kill them.

In 1999, FDA granted Allovectin-7 orphan drug designation for the treatment of invasive and metastatic melanoma.

  • Allovectin-7 entry in the public domain NCI Dictionary of Cancer Terms

 This article incorporates public domain material from the U.S. National Cancer Institute document “Dictionary of Cancer Terms”.

Vical’s Allovectin-7

Allovectin is a first-class DNA-based immunotherapeutic designed to stimulate both innate and adaptive immune responses in local tumors and distal metastases. The goal is to become a first-line treatment for Stage III and IV melanoma, where it is intended to provide improved efficacy, a better safety profile, and simple outpatient administration.

As last reported, the company is approaching completion of a Phase III registration trial versus chemotherapy in patients with metastatic melanoma. The reporting of end results has had numerous delays, but the results are now expected by Q3.

Outside of Allovectin, Vical has ten clinical trials ongoing, three of those independent and the rest in collaboration. Clearly, Vical is not totally dependent on this immunotherapy though it is the most advanced independent program in the company’s pipeline.

Vical has a market cap of $257M, so clearly a homerun therapy could send the stock soaring.

Pfizer second quarter earnings beat estimates


marciocbarra's avatar

July 30 2013 | By Márcio Barra

Pfizer reported today their second-quarter profits, beating analysts’ estimates as it prepares to rearrange its business operations. Earnings excluding one-time items were 56 cents a share, compared with the 55 cents average estimated by Bloomberg and Thomson Reuters I/B/E/S. Net income rose more than fourfold to $14.1 billion, or $1.98 a share, from $3.25 billion, or 43 cents last year. Revenue however, fell 7% to $12.97 billion, compared with the $13.03 billion analysts estimated.

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Kiran Mazumdar-Shaw, chairman and managing director of Indian biopharma giant Biocon propels company to clock revenue worth $121 mn


Kiran Mazumdar-Shaw, chairman and managing director, Biocon.

Kiran Mazumdar Shaw: She has the odd passion—artwork, horses—but it’s Biocon that really gives her joy

What do our other billionairesses like to splurge on? Kiran’s abiding passion, apart from her work, are horses and paintings—she particularly enjoys collecting the works of Yusuf Arakkal and S.G. Vasudev. Sailoja confesses she loves Louis Vuitton purses and diamond and gold jewellery. “But I haven’t bought any great jewellery for two years now,” she says. Shobhana admits to a weakness for designer watches and bags, as well as light, trendy and stylish fashion jewellery which is not necessarily very expensive. Ekta loves dressing up—but of course her biggest pleasure comes from watching her audience ratings soar.

For most, making billions is not what drives them. Sulajja, who recently sold a 15 per cent stake in her company to Anil Ambani’s Reliance Capital, could be speaking for all of them when she sums up: “Neither me nor my family has been about money. That’s not how we relate to people either. I appreciate that I have certain comforts and don’t have to struggle as much as some for basics, but beyond that we’re just simple hard-working people.”


By Paromita Shastri with Charubala Annuncio, Archana Rai and Madhavi Tata

FROM

Kiran Mazumdar-Shaw thinks her training in brewing helped her found biotech company Biocon.

Kiran Mazumdar-Shaw is one of the richest women in India. She is the founder of Biocon, a biotech company and Asia’s largest insulin maker.

But the chairman and managing director attributes her success to her go-getting nature rather than entrepreneurial spirit.

Ms Mazumdar-Shaw originally trained to become a brewer in Australia, before returning to India to follow in her father’s footsteps as a brew-master.

But she struggled to find a job on her return and recalls the industry wasn’t ready for a strong female presence. “The brewing industry is a very, very male dominated industry” she says. “It’s a male bastion.”

Opportunity

She refused to be thwarted. “I really wanted to do something with my life,” she remembers. It was this rebellious streak that inspired her to start her own company, although she admits the opportunity was more by chance.

“This is why I call myself an accidental entrepreneur – because it was an accidental encounter with another entrepreneur… who wanted to set up shop in India and… asked me whether I would be able to partner this venture,” she says.

The chance meeting persuaded Ms Mazumdar-Shaw to launch into the business of developing and making enzymes.

She says she wasn’t daunted by the transition from brewery to biotech. “If you think about brewing, it is biotechnology. And I would say that I was a technologist at heart. So whether I… fermented beer or whether I fermented enzymes, the base technology was the same.”

Female entrepreneurs

Gradually she moved the business into manufacturing medicines. The original development and sale of enzymes gave her the cash flow to fund the research and production of pharmaceutical drugs.

She feels this was a canny business move.

“There was no venture funding in India, so it forced me to create a business model that was based on revenues and profits.”

She adds: “That got us into a very different kind of format… to the typical biotech format, which depends largely on VC [venture capitalist] funding.”

But she admits that even as a female entrepreneur she still had to contend with the old issue of gender prejudice.

“Banks were very fearful of lending to a woman because I was considered high risk.”

Her age and the relatively new area of biotechnology didn’t help matters: “I was young, I was twenty-five years old… banks were very nervous about lending to young entrepreneurs because they felt we didn’t have the business experience… and then I had… this strange business called biotechnology which no one understood.”

Kiran Mazumdar-Shaw says her previous experience of failure gave her the resilience to persevere.

Biocon, BangaloreBangalore has developed from a quiet city into South India’s technology hub

“I was determined to make a success of this business because I had failed to be a brew master,” she admits.

“I just kept knocking at people’s doors and I said ‘look you’ve got to… help me’. I did manage to persuade a few people to stand by me and fund me and that’s how I got the business started.”

Bangalore

Ms Mazumdar-Shaw started Biocon in 1978 when Bangalore had yet to become the hub of technology of South India.

She remembers it as a “sleepy old retired city” but says it was an exciting place to start experimenting.

“We were first generation entrepreneurs trying to start high technology businesses… whether it was IT and services, or whether it was my biotech business… that was a time where there was tremendous energy, you know, being unleashed.”

Now she says the transformation of Bangalore into a “vibrant high growth centre” reflects the paradox of India. She believes the contrast between high wealth and extreme poverty – often within a few kilometres of each other – is the result of a failure to follow an inclusive economic agenda.

Social Entrepreneurship

Aside from running Biocon, Kiran Mazumdar-Shaw has also undertaken some social entrepreneurship projects.

One area she’s become involved with is public health. “I am very concerned about the fact that India as a country does not have a national health system, and I am determined to try and influence the government to really build a national health system for the country,” she says.

In the meantime, she has created a network of small clinics to provide some basic health care in rural areas.

BIOCON

  • Turnover (2010): Rs 2400 Cr, approx 535 million US dollars
  • Number of employees: 5000
  • HQ Location: Bangalore
  • Year founded: 1978
  • Ownership: Listed on BSE & NSE (India)

It’s a part of a “micro health insurance programme” funded largely by her, with small donations from those using it.

Pick yourself up

Kiran Mazumdar-Shaw says self-confidence is an important factor in entrepreneurship.

“A can-do attitude” is essential because obstacles and difficulties are inevitable. “I’ve had many failures in terms of technological… business… and even research failures,” she explains.

“I really believe that entrepreneurship is about being able to face failure, manage failure and succeed after failing.”

The key is to be able to tell the difference between total failure and setbacks which can be overcome.

“I think in my particular case, I’ve seen that failures are not absolute. That you can build and modify those failures to succeed.”

 

Kiran Mazumdar-Shaw, chairman and managing director, Biocon.
Indian biopharma giant Biocon reported healthy growth of 22 percent for Q1 FY14 riding on the back of an increased geographical footprint in the emerging markets

Bangalore: Indian biopharma giant Biocon reported healthy growth of 22 percent for Q1 FY14. The firm clocked revenues worth $121 million (Rs723 crore), EBITDA of $29.50 million (Rs175 crore); and profit after tax (PAT) of $15.80 million (Rs94 crore).

Read more at: http://www.biospectrumasia.com/biospectrum/news/192549/how-biocon-clock-revenue-worth-usd121-mn#.UfdqX6I3CSo

Biocon’s India-focused branded formulations vertical as well as research services continue to grow at a steady pace

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check this video

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