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

New Drug Approvals

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…

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FDA Approves New Drug to Treat Nephropathic Cystinosis

New Drug Approvals

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

 

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Alkermes unveils three new drug candidates

New Drug Approvals

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

 

 

 

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Natural Remedies for Ulcerative Colitis

New Drug Approvals

 

Written by Michael Sapko for drugs.com
.http://www.drugs.com/health/ulcerative-colitis/natural-remedy-1234/#1

There are a number of medical treatments available to manage ulcerative colitis. Modern therapy is targeted at preventing flares and inducing remission (at least temporarily). These medications, however, have serious side effects, especially when taken for long periods. Corticosteroids, for example, can cause a number of cosmetic, psychological, and hormonal problems. Many patients simply cannot tolerate these medications. Children have particular problems with standard medications. When compliance with prescribed medicines is poor, treatment failure is common.^1,2 Thus, many patients turn to natural remedies for their ulcerative colitis..http://www.drugs.com/health/ulcerative-colitis/natural-remedy-1234/#1

Some herbal or organic remedies may help promote gut health and prolong the time between remissions (flares).

• Dietary modification includes elimination of food allergens and optimizing living conditions. A relatively high proportion of Europeans (either primary or of European descent) have an allergy to gluten, a substance found…

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Astellas pharma announced today that the U.S. Food and Drug Administration (FDA) has approved Astagraf XL (tacrolimus extended-release capsules) for the prophylaxis of organ rejection in patients receiving a kidney transplant with mycophenolate mofetil (MMF) and corticosteroids, with or without basiliximab induction

New Drug Approvals

Tacrolimus

July 19, 2013 /PRNewswire/ — Astellas Pharma US, Inc. (“Astellas”), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved Astagraf XL (tacrolimus extended-release capsules) for the prophylaxis of organ rejection in patients receiving a kidney transplant with mycophenolate mofetil (MMF) and corticosteroids, with or without basiliximab induction. 

“Each transplant recipient is different and requires a personalized treatment approach. The approval of Astagraf XL marks an important milestone in post-transplant care as it provides physicians with a new treatment option for kidney t recipients,” said Sef Kurstjens, M.D., PhD., chief medical officer, Astellas Pharma, Inc. “Astellas is pleased to continue our more than 20-year commitment to the field of transplant immunology.”

http://www.drugs.com/newdrugs/astellas-announces-fda-approval-astagraf-xl-tacrolimus-extended-release-capsules-prophylaxis-organ-3855.html

Read more at http://www.drugs.com/newdrugs/astellas-announces-fda-approval-astagraf-xl-tacrolimus-extended-release-capsules-prophylaxis-organ-3855.html#43KX8fBakpHoz5Kh.99

 

Tacrolimus (also FK-506 or fujimycin, trade names Prograf, Advagraf, Protopic) is an immunosuppressivedrug that is mainly used…

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Benzoxaboroles: A New Potential Drug for African Sleeping Sickness

New Drug Approvals

Life cycle of the Trypanosoma brucei parasites, source: CDC

Human African trypanosomiasis, caused by the kinetoplastid parasite Trypanosoma brucei, affects thousands of people across sub-Saharan Africa, and is fatal if left untreated. Treatment options for this disease, particularly stage 2 disease, which occurs after parasites have infected brain tissue, are limited due to inadequate efficacy, toxicity, and the complexity of treatment regimens.

We have discovered and optimized a series of benzoxaborole- 6-carboxamides to provide trypanocidal compounds that are orally active in murine models of human African trypanosomiasis. A key feature of this series is the presence of a boron atom in the heterocyclic core structure, which is essential to the observed trypanocidal activity. We also report the in vivo pharmacokinetic properties of lead compounds from the series and selection of SCYX-7158 as a preclinical candidate.

Human African trypanosomiasis (HAT), more commonly known as African sleeping sickness, is caused…

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Generic Licensing News-SPIRAMYCIN Featured product

New Drug Approvals

SPIRAMYCIN

Spiramycin is a macrolide antibiotic. It is used to treat certain types of infections that are caused by bacteria. It is most commonly used to treat infections of the lung, skin, and mouth.

Spiramycin is sometimes used to treat gonorrhea for people who are allergic to penicillin. Spiramycin is also used as an alternative agent in the treatment of toxoplasmosis during pregnancy.

Click here to contact Pharma Dreams about this product.

READ Generic Licensing News-SPIRAMYCIN    Featured product at

http://newsletter.lead-doctors.com/ef1/preview_campaign.php?lf1=916521877f641012625317c9856823

more info from wiki

Spiramycin is a macrolide antibiotic. It is used to treat toxoplasmosisand various other infections of soft tissues. Although used in Europe, Canada and Mexico,^[1] spiramycin is still considered an experimental drug in the United States, but can sometimes be obtained by special permission from the FDA for toxoplasmosis in the first trimester of pregnancy.^[2]

Spiramycin has been used in Europe since the year 2000 under thetrade…

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Enbrel (etanercept), Biosimilar innovator drug companies scrambling to copy

New Drug Approvals

Enbrel (etanercept)

 

http://www.biosimilarnews.com/enbrel-patent-in-the-us

Biosimilars are protein products that are sufficiently similar to a biopharmaceutical already approved by a regulatory agency. Several biotechnology companies and generic drug manufacturers in Asia and Europe are developing biosimilars of tumor necrosis factor inhibitors and rituximab. A biosimilar etanercept is already being marketed in Colombia and China. In the US, several natural source products and recombinant proteins have been approved as generic drugs under Section 505(b)(2) of the Food, Drug, and Cosmetic Act. However, because the complexity of large biopharmaceuticals makes it difficult to demonstrate that a biosimilar is structurally identical to an already approved biopharmaceutical, this Act does not apply to biosimilars of large biopharmaceuticals. Section 7002 of the Patient Protection and Affordable Care Act of 2010, which is referred to as the Biologics Price Competition and Innovation Act of 2009, amends Section 351 of the Public Health Service Act to create an…

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Cabozantinib, Cometriq

New Drug Approvals

Cabozantinib (marketed under the tradename Cometriq, formerly known as XL184) is asmall molecule inhibitor of the tyrosine kinases c-Met and VEGFR2, and has been shown to reduce tumor growth, metastasis, and angiogenesis.

It was developed by Exelixis Inc.

Cabozantinib was granted orphan drug status by the U.S. Food and Drug Administration(FDA) in January 2011.

Cabozantinib was approved by the U.S. FDA in November 2012 for the treatment of medullary thyroid cancer.It is currently undergoing clinical trials for the treatment of prostate, ovarian, brain, melanoma, breast, non-small cell lung, pancreatic, hepatocellular and kidney cancers.

In October 2011, cabozantinib met its primary endpoint in a phase 3 clinical trial (EXAM) conducted by Exelixis investigating its effect on progression-free survival in medullary thyroid cancer.A new drug application was submitted in the first half of 2012, and on November 29, 2012 cabozantinib was granted marketing approval by…

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Actavis to Launch Generic Epilepsy/Bipolar Drug

New Drug Approvals

LAMOTRIGINE

 

PARSIPPANY, N.J., July 15, 2013 (AP) — Drugmaker Actavis Inc. said Monday it’s received U.S. approval to sell a generic version of Lamictal, a tablet for treating epilepsy and bipolar disorder.

Actavis, based in Parsippany, N.J., said the Food and Drug Administration has granted approval for it to sell lamotrigine tablets in doses of 25, 50, 100 and 200 milligrams.http://www.pharmalive.com/actavis-to-launch-generic-epilepsybipolar-drug

Lamotrigine, marketed in the US and most of Europe as Lamictal /ləˈmɪktəl/ byGlaxoSmithKline, is an anticonvulsant drug used in the treatment of epilepsy and bipolar disorder. It is also used off-label as an adjunct in treating depression. For epilepsy, it is used to treat focal seizures, primary and secondary tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome. Like many other anticonvulsant medications, Lamotrigine also seems to act as an effective 

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