Home » Posts tagged 'PROCESS' (Page 12)
Tag Archives: PROCESS
DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
.....FOR BLOG HOME CLICK HEREFlag and hits
ORGANIC SPECTROSCOPY
SUBSCRIBE
Subscribe in a reader
Enter your email address:
Delivered by FeedBurner
Subscribe to New Drug Approvals by Email
Dr. Reddy’s Announces the Launch of Decitabine for Injection
Decitabine
Hyderabad, India, July 12, 2013 — Dr. Reddy’s Laboratories announced today that it has launched Decitabine for Injection (50mg) a therapeutic equivalent generic version of Dacogen (Decitabine for Injection) in the US market on July 11, 2013, following the approval by the United States Food & Drug Administration (USFDA) of Dr. Reddy’s ANDA for Decitabine for Injection.
The Dacogen brand has U.S. sales of approximately $260 Million MAT for the most recent twelve months ending in July 2013 according to IMS Health*.
Dr. Reddy’s Decitabine for Injection 50 mg is available as a single dose vial.
About Dr. Reddy’s
Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars, differentiated formulations and NCEs. Therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management, anti-infective and pediatrics. Major markets include India, USA, Russia and CIS, Germany, UK, Venezuela, S. Africa, Romania, and New Zealand. For more information, log on to: http://www.drreddys.com.
Dacogen® is a registered trademark used by Eisai Inc. under license from Astex Pharmaceuticals, Inc
Decitabine (trade name Dacogen), or 5-aza-2′-deoxycytidine, is a drug for the treatment of myelodysplastic syndromes, a class of conditions where certain blood cells are dysfunctional, and for acute myeloid leukemia (AML).[1] Chemically, it is a cytidine analog.
Decitabine is a hypomethylating agent.[2][3] It hypomethylates DNA by inhibiting DNA methyltransferase.
It functions in a similar manner to azacitidine, although decitabine can only be incorporated into DNA strands while azacitidine can be incorporated into both DNA and RNA chains.
Clinical uses
Decitabine is indicated for the treatment of myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and Intermediate-1, Intermediate-2, and High-Risk International Prognostic Scoring System groups. In patients with renal insufficiency, Batty and colleagues reported the first case series on the feasibility of therapy with hypomethylating agents in patients with renal insufficiency.[4]
Chemical synthesis
Decitabine can be synthesized from a benzoyl-protected chlorosugar:[5] 
- “EC Approves Marketing Authorization Of DACOGEN For Acute Myeloid Leukemia”. 2012-09-28. Retrieved 28 September 2012.
- Kantarjian H, Issa JP, Rosenfeld CS, et al. (April 2006). “Decitabine improves patient outcomes in myelodysplastic syndromes: results of a phase III randomized study”. Cancer 106 (8): 1794–803. doi:10.1002/cncr.21792. PMID 16532500.
- Kantarjian HM, O’Brien S, Cortes J, et al. (August 2003). “Results of decitabine (5-aza-2’deoxycytidine) therapy in 130 patients with chronic myelogenous leukemia”. Cancer 98 (3): 522–8. doi:10.1002/cncr.11543. PMID 12879469.
- Ravandi, F.; Cortés, J. E.; O’Brien, S.; Pierce, S.; Garcia-Manero, G.; McCue, D.; Santos, F. P. S.; Jabbour, E. et al. (2010). “Feasibility of Therapy with Hypomethylating Agents in Patients with Renal Insufficiency”. Clinical Lymphoma, Myeloma & Leukemia 10 (3): 205–210. doi:10.3816/CLML.2010.n.032. PMID 20511166.
|displayauthors=suggested (help) edit - Piml, J.; Sorm, F. (1964). Coll. Czech. Chem. Commun. 29: 2576.
Improve Immunity Through Ayurveda
allow slideshare to load………..
Greek Herbs- Fennel (saunf)
………………………………………………
……………………………………………….
History of Fennel
Ancient Greeks and Indian cultures used fennel for cooking and as part of traditional herbal medicine. The Greeks and Indians traditionally combined fennel with other herbs to make home remedies for the relief of gastrointestinal problems such as acidity and indigestion.
Fennel Composition
The essential oil of fennel contains approximately 5 percent limonene, 50 to 80 percent anethole and 5 percent fenchone. Additionally, the oil contains trace amounts of a-pinene, estragole, b-pinene, safrole, b-myrcene, camphene and p-cymene. The seeds from the fennel plant also contain fiber and complex carbohydrates. Fennel contains nutrients including vitamin B-3, magnesium, molybdenum, copper, phosphorus, iron, calcium, manganese, vitamin C, folate and potassium.
Fennel Uses
As a health supplement, fennel can help to prevent gas, support digestion and function as an expectorant that can help to relieve minor respiratory problems such as mucus. Fennel also contains anti-inflammatory properties when used externally. The leaves from the fennel plant can facilitate the healing of wounds and burns. The root of the fennel plant is diuretic and can help treat urine infections. Fennel also contains a combination of phytonutrients including the flavonoids rutin, quercitin and kaempferol. Fennel also has antioxidant properties and as a dietary fiber, it can help lower your cholesterol levels.
Fennel Supplements
Health supplement manufacturers offer fennel supplements in powdered form. As a supplement, manufacturers recommend taking 1 to 4 g per day of the powdered fennel supplement. The Food and Drug Administration, however, has not established a recommended dose for fennel powder. There are no known side effects of consuming fennel powder supplements, although you should speak with your doctor prior to using fennel powder if you are attempting to treat a specific medical condition.
The bulb, foliage, and seeds of the fennel plant are widely used in many of the culinary traditions of the world. The small flowers of wild fennel (mistakenly known in America as fennel “pollen” ) are the most potent form of fennel, but also the most expensive.Dried fennel seed is an aromatic, anise-flavoured spice, brown or green in colour when fresh, slowly turning a dull grey as the seed ages. For cooking, green seeds are optimal. The leaves are delicately flavoured and similar in shape to those of dill. The bulb is a crisp vegetable that can be sautéed, stewed, braised, grilled, or eaten raw. They are used for garnishes and to add flavor to salads. They are also added to sauces and served with pudding. The leaves used in soups and fish sauce and sometimes eaten raw as salad.
Fennel seeds are sometimes confused with those of anise, which are similar in taste and appearance, though smaller. Fennel is also used as a flavouring in some natural toothpastes. The seeds are used in cookery and sweet desserts.
Many cultures in India, Pakistan, Afghanistan, Iran and the Middle East use fennel seed in their cookery. It is one of the most important spices in Kashmiri Pandit and Gujarati cooking. It is an essential ingredient of the Assamese/Bengali/Oriya spice mixture panch phoron and in Chinese five-spice powders. In many parts of India and Pakistan, roasted fennel seeds are consumed as mukhwas, an after-meal digestive and breath freshener. Fennel leaves are used as leafy green vegetables either by themselves or mixed with other vegetables, cooked to be served and consumed as part of a meal, in some parts of India. In Syria and Lebanon, it is used to make a special kind of egg omelette (along with onions, and flour) called ijjeh.
Many egg, fish, and other dishes employ fresh or dried fennel leaves. Florence fennel is a key ingredient in some Italian and German salads, often tossed with chicory and avocado, or it can be braised and served as a warm side dish. It may be blanched or marinated, or cooked in risotto.
In Spain the stems of the fennel plant are used in the preparation of pickled eggplants, “berenjenas de Almagro”.
Medicinal uses
Fennel (Foeniculum vulgare) essential oil in clear glass vial
Fennel contains anethole, which can explain some of its medical effects: It, or its polymers, act as phytoestrogens.
The essence of fennel can be used as a safe and effective herbal drug for primary dysmenorrhea, but could have lower potency than mefenamic acid at the current study level.
Intestinal tract
Fennel is widely employed as a carminative, both in humans and in veterinary medicine (e.g., dogs), to treat flatulence by encouraging the expulsion of intestinal gas. Anethole is responsible for the carminative action.
Mrs. Eencher Herbal states:
On account of its carminative properties, fennel is chiefly used medicinally with purgatives to allay their side effects, and for this purpose forms one of the ingredients of the well-known compound liquorice powder. Fennel water has properties similar to those of anise and dill water: mixed with sodium bicarbonate and syrup, these waters constitute the domestic ‘gripe water‘ used to correct the flatulence of infants. Volatile oil of fennel has these properties in concentration. Commercial preparations of fennel are widely available as alternative treatment for baby colic. Fennel tea, also employed as a carminative, is made by pouring boiling water on a teaspoonful of bruised fennel seeds.
Fennel can be made into a syrup to treat babies with colic (formerly thought to be due to digestive upset), but long-term ingestion of fennel preparations by babies is a known cause of thelarche.
Eyes
In the Indian subcontinent, fennel seeds are also eaten raw, sometimes with some sweetener, as they are said to improve eyesight. Ancient Romans regarded fennel as the herb of sight.Root extracts were often used in tonics to clear cloudy eyes. Extracts of fennel seed have been shown in animal studies to have a potential use in the treatment of glaucoma.
Blood and urine
Fennel may be an effective diuretic and a potential drug for treatment of hypertension.
Breastmilk
There are historical anecdotes that fennel is a galactagogue,improving the milk supply of a breastfeeding mother. This use, although not supported by direct evidence, is sometimes justified by the fact that fennel is a source of phytoestrogens, which promote growth of breast tissue. However, normal lactation does not involve growth of breast tissue. A single case report of fennel tea ingested by a breastfeeding mother resulted in neurotoxicity for the newborn child.
Other uses
Syrup prepared from fennel juice was formerly given for chronic coughs. It is one of the plants which is said to be disliked by fleas, and powdered fennel has the effect of driving away fleas from kennels and stables.
References
- “Herbs That Work: The Scientific Evidence of Their Healing Powers”; David Armstrong
- “The Encyclopedia of Herbs: A Comprehensive Reference to Herbs of Flavor and Fragrance”; Arthur O. Tucker and Thomas DeBaggio; 2009
- “Pocket Guide to Herbal Remedies”; Lane P. Johnson; 2002
- “Encyclopedia of Natural Medicine”; Michael Murray and Joseph Pizzorno; 1997
seeds
Study links vitamin D deficiency to accelerated bone aging
Robert Ritchie (left) and Hrishikesh Bale used a combination of FTIR spectroscopy and X-ray CT at the Advanced Light Source to find that vitamin D deficiency speeds the aging process of bone and reduces its quality. Photo by Roy Kaltschmidt
A team of scientists led by researchers at Lawrence Berkeley National Laboratory and the Univ. of California, Berkeley, have recently used a combination of Fourier transform infrared spectroscopy and X-ray computed tomography at the Advanced Light Source to find that vitamin D deficiency speeds the aging process of bone and reduces its quality.FULL STORY
Novartis teams with India’s Biological E for typhoid vaccine development
Novartis teams with India’s Biological E for typhoid vaccine…
| Novartis and Indian biopharma Biological E have entered into a development and licensing agreement to deliver accessible and affordable typhoid and paratyphoid A vaccines to the developing world. Yearly, over 21 million cases and 5 million cases of typhoid and paratyphoid A… read more › |
read all at
H7N9 vaccines in development–where are we?
Since early 2013, the newly emergent H7N9 avian influenza virus has been infecting humans in China, leading to the temporary closure of numerous poultry markets in a bid to control the outbreak. In recent weeks, the rate at which new cases are reported has been declining – but some experts are asking whether this is just the calm before the storm. The development of a vaccine against the virus is therefore still of great interest – but where are we with vaccine development?
Inovio Pharmaceuticals announced on July 8th that in a preclinical study of its influenza DNA vaccine, 100% of the vaccinated animals were protected against sickness and death when challenged with a lethal dose of A/Anhui/1/13 strain of H7N9 virus. On the same day, Novavax made an announcement that enrolment had begun for a Phase I clinical trial of its monovalent virus-like particle (VLP) vaccine candidate – again based on the A/Anhui/1/13 strain
read all at
J and J Submits Leukemia Drug, Ibrutinib for Approval
IBRUTINIB
1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)pyrazolo[3,4-d]pyrimidin-1-yl]piperidin-1-yl]prop-2-en-1-one
New Drug Application Submitted to U.S. FDA for Ibrutinib in the Treatment of Two B-Cell Malignancies
If approved, ibrutinib will address a high unmet need in relapsed/refractory chronic lymphocytic leukemia and relapsed/refractory mantle cell lymphoma
RARITAN, N.J., July 10, 2013
Janssen Research & Development, LLC announced the submission of a New Drug Application for ibrutinib to the U.S. Food and Drug Administration (FDA) for its use in the treatment of previously treated patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and for its use in the treatment of previously treated patients with mantle cell lymphoma (MCL). The regulatory submission for ibrutinib is supported by data from two pivotal Phase 2 studies, one in relapsed/refractory CLL/SLL (PCYC-1102) and one in relapsed/refractory MCL (PCYC-1104), both of which were published in The New England Journal of Medicine online on June 19, 2013. Ibrutinib is a novel Bruton’s tyrosine kinase (BTK) inhibitor being jointly developed by Janssen and Pharmacyclics, Inc. for the treatment of B-cell malignancies.
If approved, ibrutinib would be the first in a class of oral BTK inhibitors and is one of the first medicines to file for FDA approval via the new Breakthrough Therapy Designation pathway. Ibrutinib will be co-commercialized in the U.S. by Janssen Biotech, Inc. and Pharmacyclics.
“The FDA submission is another important milestone for ibrutinib since we formed our strategic partnership with Pharmacyclics just 18 months ago,” said Peter F. Lebowitz, M.D., Ph.D., Global Oncology Head, Janssen. “Both companies recognize that there is great unmet need among these patient populations, and together in close collaboration with the FDA, as part of its Breakthrough Therapy Designation pathway, we have been able to accelerate the ibrutinib development program for the benefit of patients.”
About Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia (CLL) is a slow-growing blood cancer that starts in the white blood cells (lymphocytes), most commonly from B-cells. CLL is the second most common adult leukemia. Approximately 16,000 patients in the US are diagnosed each year with CLL. The prevalence of CLL is approximately 113,000 in the US. The disease is a chronic disease of the elderly with an average survival of about 5 years. Patients commonly receive multiple lines of treatment over the course of their disease.
In CLL the genetic mutation 17p deletion occurs when the short arm of chromosome 17 is missing. Del 17p is associated with abnormalities of a key tumor suppressor gene, TP53, which results in poor response to chemoimmunotherapy and worse treatment outcomes. It occurs in about 7% of treatment naive CLL patients and is estimated to be approximately 20% to 40% of relapsed or refractory patients harboring the mutation.
About Ibrutinib
Ibrutinib , previously publicly known as PCI-32765, is an experimental drug candidate for the treatment of various types of cancer. It was first synthesized at Celera Genomics as a selective inhibitor of Bruton’s tyrosine kinase (Btk).It was later discovered to have anti-lymphoma properties in vivo by scientists at Pharmacyclics, Inc.Ibrutinib is currently under development by Pharmacyclics, Inc and Johnson & Johnson‘sJanssen Pharmaceutical division for chronic lymphocytic leukemia, mantle cell lymphoma,diffuse large B-cell lymphoma, and multiple myeloma. It also has potential effects against autoimmune arthritis.
Janssen Biotech, Inc. and Pharmacyclics entered a collaboration and license agreement in December 2011 to co-develop and co-commercialize ibrutinib. Ibrutinib was designed to specifically target and selectively inhibit an enzyme called Bruton’s tyrosine kinase (BTK). BTK is a key mediator of at least three critical B-cell pro-survival mechanisms occurring in parallel – regulation of apoptosis, adhesion, and cell migration and homing. Through these multiple signals, BTK regulation helps to direct malignant B-cells to lymphoid tissues, thus allowing access to a micro environment necessary for survival.
The effectiveness of ibrutinib alone or in combination with other treatments is being studied in several B-cell malignancies, including chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, Waldenstrom’s macroglobulinemia and multiple myeloma. To date five Phase III trials have been initiated with ibrutinib and a total of 26 trials are currently registered on www.clinicaltrials.gov.
About Pharmacyclics
Pharmacyclics® is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative small-molecule drugs for the treatment of cancer and immune mediated diseases. Our mission and goal is to build a viable biopharmaceutical company that designs, develops and commercializes novel therapies intended to improve quality of life, increase duration of life and resolve serious unmet medical healthcare needs; and to identify promising product candidates based on scientific development and administrational expertise, develop our products in a rapid, cost-efficient manner and pursue commercialization and/or development partners when and where appropriate.
Presently, Pharmacyclics has three product candidates in clinical development and several preclinical molecules in lead optimization. The Company is committed to high standards of ethics, scientific rigor, and operational efficiency as it moves each of these programs to viable commercialization.
The Company is headquartered in Sunnyvale, California and is listed on NASDAQ under the symbol PCYC. To learn more about how Pharmacyclics advances science to improve human healthcare visit at http://www.pharmacyclics.com.
Omthera files heart drug anti-triglyceride, Epanova with FDA
july, 10, 2013
Omthera Pharmaceuticals, which is in the process of being acquired by AstraZeneca, has filed its anti-triglyceride drug Epanova with regulators in the USA.The Princeton, New Jersey-based company is seeking approval from the US Food and Drug Administration to sell Epanova, a coated soft gelatin capsule containing a mixture of polyunsaturated free fatty acids derived from fish oils, for the treatment of patients with severe hypertriglyceridemia. The submission is based on two Phase III trials (EVOLVE and ESPRIT) examining the effectiveness of Epanova in lowering very high triglycerides, and in reducing non-HDL cholesterol in combination with a statin. Both trials were conducted under a special protocol assessment with the FDA.
The filing will please AstraZeneca which announced at the end of May that it will buy Omthera for $12.70 per share, or around $323 million. In addition to the cash payment, each Omthera shareholder will receive contingent value rights of up to $4.70 per share – or around $120 million in total – if specified milestones related to Epanova are achieved.
When the deal was announced, Omthera chief executive Gerald Wisler said he expects AstraZeneca to “maximise the value of Epanova not only as a monotherapy treatment for dyslipidemia but also as a treatment for cardiovascular disease in combination with Crestor (atorvastatin)”, the firm’s cholesterol blockbuster.
Chelsea Therapeutics Resubmits New Drug Application for NORTHERA(TM) (droxidopa) for the Treatment of Symptomatic NOH
Droxidopa
Submission Includes Successful 300 mg Bioequivalence Study
* Six Month Review Decision Expected Under PDUFA
July 9, 2013
— Chelsea Therapeutics International, Ltd. today announced that it resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market NORTHERA(TM) (droxidopa), an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure (Parkinson’s disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.
http://www.pharmalive.com/chelsea-resubmits-northera-nda
L-DOPS (L-threo-dihydroxyphenylserine; Droxidopa; SM-5688) is a psychoactive drugand synthetic amino acid precursor which acts as a prodrug to the neurotransmittersnorepinephrine (noradrenaline) and epinephrine (adrenaline).[1] Unlike norepinephrine and epinephrine themselves, L-DOPS is capable of crossing the protective blood–brain barrier(BBB)
