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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 GLENMARK LIFE SCIENCES LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 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, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, 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 30 PLUS year tenure till date June 2021, 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 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 90 Lakh plus views on dozen plus blogs, 233 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 33 lakh plus views on New Drug Approvals Blog in 233 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

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FDA approves first drug Actemra (tocilizumab) to specifically treat giant cell arteritis


Image result for actemra logo
05/22/2017
The U.S. Food and Drug Administration today expanded the approved use of subcutaneous Actemra (tocilizumab) to treat adults with giant cell arteritis. This new indication provides the first FDA-approved therapy, specific to this type of vasculitis.

May 22, 2017

Release

The U.S. Food and Drug Administration today expanded the approved use of subcutaneous Actemra (tocilizumab) to treat adults with giant cell arteritis. This new indication provides the first FDA-approved therapy, specific to this type of vasculitis.

“We expedited the development and review of this application because this drug fulfills a critical need for patients with this serious disease who had limited treatment options,” said Badrul Chowdhury, M.D., Ph.D., director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.

Giant cell arteritis is a form of vasculitis, a group of disorders that results in inflammation of blood vessels. This inflammation causes the arteries to narrow or become irregular, impeding adequate blood flow. In giant cell arteritis, the vessels most involved are those of the head, especially the temporal arteries (located on each side of the head). For this reason, the disorder is sometimes called temporal arteritis. However, other blood vessels, including large ones like the aorta, can become inflamed in giant cell arteritis. Standard treatment involves high doses of corticosteroids that are tapered over time.

The efficacy and safety of subcutaneous (injected under the skin) Actemra for giant cell arteritis were established in a double-blind, placebo-controlled study with 251 patients with giant cell arteritis. The primary efficacy endpoint was the proportion of patients achieving sustained remission from Week 12 through Week 52. Sustained remission was defined as the absence of symptoms of giant cell arteritis, normalization of inflammatory laboratory tests, and tapering the use of prednisone (a steroid drug). A greater proportion of patients receiving subcutaneous Actemra with standardized prednisone regimens achieved sustained remission from Week 12 through Week 52 as compared to patients receiving placebo with standardized prednisone regimens. The cumulative prednisone dose was lower in treated patients with Actemra relative to placebo.

The overall safety profile observed in the Actemra treatment groups was generally consistent with the known safety profile of Actemra. Actemra carries a Boxed Warning for serious infections. Patients treated with Actemra who develop a serious infection should stop that treatment until the infection is controlled. Live vaccines should be avoided during treatment with Actemra. Actemra should be used with caution in patients at increased risk of gastrointestinal perforation. Hypersensitivity reactions, including anaphylaxis and death, have occurred. Laboratory monitoring is recommended due to potential consequences of treatment-related changes in neutrophils (type of white blood cell), platelets, lipids and liver function tests.

Subcutaneous Actemra was previously approved for the treatment of moderate to severely active rheumatoid arthritis. Intravenous Actemra was also previously approved for the treatment of moderate to severely active rheumatoid arthritis, systemic juvenile idiopathic arthritis and polyarticular juvenile idiopathic arthritis. Intravenous administration is not approved for giant cell arteritis.

The FDA granted this application a Breakthrough Therapy designation and a Priority Review.

The FDA granted the supplemental approval of Actemra to Hoffman La Roche, Inc.

//////////Actemra, tocilizumab, fda 2017, Breakthrough Therapy designation, Priority Review,  supplemental approval, Hoffman La Roche, Inc.

Tocilizumab Impresses in Polyarticular Juvenile Arthritis


tocilizumab

Tocilizumab Impresses in Polyarticular Juvenile Arthritis
Medscape

MADRID, Spain — Children with polyarticular juvenile idiopathic arthritis treated with tocilizumab (Actemra, Genentech) achieved high response rates with sustained improvement in the phase 3 CHERISH trial.

The results prompted the US Food and Drug Administration toapprove tocilizumab for this indication. The drug is already approved for systemic juvenile idiopathic arthritis and for adults with moderate to severe rheumatoid arthritis.

read all at

http://www.medscape.com/viewarticle/806572

Tocilizumab (INN, or atlizumab, developed by Hoffmann–La Roche and Chugai and sold under the trade names Actemra and RoActemra) is an immunosuppressive drug, mainly for the treatment of rheumatoid arthritis (RA) and systemic juvenile idiopathic arthritis, a severe form of RA in children. It is a humanized monoclonal antibody against the interleukin-6 receptor (IL-6R). Interleukin 6 (IL-6) is a cytokine that plays an important role in immune response and is implicated in the pathogenesis of many diseases, such asautoimmune diseasesmultiple myeloma and prostate cancer.

FDA Approves Actemra for Children with Polyarticular Juvenile Idiopathic Arthritis


tocilizumab

April 30, 2013

Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Actemra (tocilizumab) for the treatment of polyarticular juvenile idiopathic arthritis (PJIA). The medicine can be used in children two years of age and older with active disease. Actemra can be given alone or in combination with methotrexate (MTX) in people with PJIA.

PJIA is a form of juvenile idiopathic arthritis (JIA), also known as juvenile rheumatoid arthritis, a chronic disease of childhood.1 JIA affects approximately 100 in every 100,000 children2 of which PJIA accounts for around 30 percent.3 PJIA is characterised by inflammation in five or more joints within the first six months of the disease and most commonly affects the small joints in the body such as the hands and feet.3

 

“Polyarticular juvenile idiopathic arthritis is a rare debilitating condition in children that worsens over time,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “We are pleased to offer Actemra to doctors and parents of children aged two or older to help improve the signs and symptoms of this often painful disease.”

 

This FDA approval marks the second Actemra indication in children and is the first FDA approval for the treatment of PJIA in approximately five years. The EU Committee for Medicinal Products for Human Use (CHMP) also announced a positive opinion for this indication on Friday, April 26. The final approval from the European Medicines Agency (EMA) is expected this summer.

 

 

The expanded indication for Actemra was based on positive data from the Phase III CHERISH study in children with PJIA, which had an open label phase, followed by a randomised double-blind placebo-controlled withdrawal phase. The study demonstrated that patients treated with Actemra experienced clinically meaningful improvement in signs and symptoms of PJIA. A total of 91 percent of patients taking Actemra plus MTX and 83 percent of patients taking Actemra alone achieved an ACR 30 response at week 16 compared to baseline. In the randomised double-blind placebo-controlled withdrawal phase of the trial, Actemra-treated patients experienced significantly fewer disease flares compared to placebo-treated patients [26 percent (21/82) vs. 48 percent (39/81)].

 

The safety data collected to date for Actemra in PJIA patients is consistent with that observed in previous studies in Actemra-treated patients.4 In the CHERISH study, infections were the most common adverse events (AEs) and serious adverse events (SAEs) over 40-weeks. Laboratory abnormalities known to occur with Actemra were also observed in this study, including decreases in white blood cell counts and platelet counts, and elevation in ALT and AST liver enzyme levels.

 

About Actemra (tocilizumab)

 

Actemra is the first humanised interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). The extensive Actemra clinical development programme included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries, including the United States. In addition, Actemra is also approved for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients two years of age and older and polyarticular juvenile idiopathic arthritis (PJIA) in patients two years of age and older who have responded inadequately to previous therapy with MTX.

 

Actemra is part of a co-development agreement with Chugai Pharmaceutical Co. and has been approved in Japan since June 2005. Actemra is approved in the European Union, where it is known as RoActemra, and several other countries, including China, India, Brazil, Switzerland and Australia.

 

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, infectious diseases, inflammation, metabolism and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2012 Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

Tocilizumab (INN, or atlizumab, developed by Hoffmann–La Roche and Chugai and sold under the trade names Actemra and RoActemra) is an immunosuppressive drug, mainly for the treatment of rheumatoid arthritis (RA) and systemic juvenile idiopathic arthritis, a severe form of RA in children. It is a humanized monoclonal antibody against the interleukin-6 receptor (IL-6R). Interleukin 6 (IL-6) is a cytokine that plays an important role in immune response and is implicated in the pathogenesis of many diseases, such as autoimmune diseases, multiple myeloma and prostate cancer.

 

Newzealand’s PHARMAC is seeking feedback on a proposal to list pegfilgrastim (Neulastim) and tocilizumab (Actemra) , from 1 July 2013, with Roche Products (NZ) Limited.


https://i0.wp.com/www.voxy.co.nz/files/imagecache/news_item_image/files/pharmac_22.jpg

NEWZEALAND

Tocilizumab and pegfilgrastim

12 April 2013

PHARMAC is seeking feedback on a proposal to list pegfilgrastim (Neulastim) for prevention of neutropenia in patients undergoing cancer chemotherapy, and tocilizumab (Actemra) for systemic juvenile idiopathic arthritis, from 1 July 2013, through a provisional agreement with Roche Products (NZ) Limited.

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 5:00 pm on Monday 29 April 2013 to:

Geraldine MacGibbon
Senior Therapeutic Group Manager

Email: geraldine.macgibbon@pharmac.govt.nz

Fax: 04 460 4995

Post: PO Box 10 254, Wellington 6143.

All feedback received before the closing date will be considered by PHARMAC’s Board (or Chief Executive acting under delegated authority) prior to making a decision on this proposal.

http://www.pharmac.health.nz/news/item/tocilizumab-and-pegfilgrastim

 

Tocilizumab (INN, or atlizumab, developed by Hoffmann–La Roche and Chugai and sold under the trade names Actemra and RoActemra) is an immunosuppressive drug, mainly for the treatment of rheumatoid arthritis (RA) and systemic juvenile idiopathic arthritis, a severe form of RA in children. It is a humanized monoclonal antibody against the interleukin-6 receptor (IL-6R). Interleukin 6 (IL-6) is a cytokine that plays an important role in immune response and is implicated in the pathogenesis of many diseases, such as autoimmune diseases, multiple myeloma and prostate cancer.

 

Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (GCSF) analog filgrastim. It serves to stimulate the level of white blood cells (neutrophils).

Amgen manufactures pegfilgrastim under the brand name Neulasta Which was mainly worked on by Martine Allard, and Roche under the name Neulastim. In India it is also marketed by Abbott Healthcare under the brand name Imupeg. The drug is prepared by coupling a 20 kDa polyethylene glycol (PEG) molecule to the N-terminus of the filgrastim protein. Pegfilgrastim has a human half-life of 15 to 80 hours, much longer than the parent filgrastim (3–4 hours).

Pegfilgrastim treatment can be used to stimulate the bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy.

 

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