RSS

Monthly Archives: July 2013

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…

View original post 320 more words

Advertisements
 
Leave a comment

Posted by on July 24, 2013 in Uncategorized

 

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

 

 

 

View original post

 
Leave a comment

Posted by on July 24, 2013 in Uncategorized

 

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…

View original post 46 more words

 
Leave a comment

Posted by on July 24, 2013 in Uncategorized

 

A Survey of Promising Late-Stage Diabetes Drugs

New Drug Approvals

 

THIS IS DEC2012 COMPILATION. READER MAY ENCOUNTER AN APPROVED OR DROPPED ENTRY

A variety of new drugs are in development for the treatment of type 1 or type 2 diabetes. In addition to new dipeptidyl peptidase-4 (DPP-IV) inhibitors, glucagon-like peptide (GLP) 1 analogs, basal insulin analogs, and new insulin formulations, there are also unique dual peroxisome proliferator-activated receptor (PPAR) α/γ agonist, G-protein-coupled receptor (GPR) 40 agonist, sodium dependent glucose transporter 2 (SGLT2) inhibitor, and several other unique agents now in development.

A list of 25 drug candidates has been compiled for which diabetes is at least one proposed or approved indication, and for which one indication has reached Phase III or Registration phases. Each entry includes the name of the drug candidate, the sponsor, and, where applicable, chemical structures, collaboration partners; method of action; indication (by market, where applicable); and phase of trial. Some products are still in clinical…

View original post 2,309 more words

 
Leave a comment

Posted by on July 24, 2013 in Uncategorized

 

Prevenar 13/ Prevnar 13 approval history in Europe and in the U.S

 
Leave a comment

Posted by on July 24, 2013 in Uncategorized

 

Predicting cancer targets modulated by Ayurvedic medicines

 
Leave a comment

Posted by on July 24, 2013 in Uncategorized

 

Six new drugs in clinical development stage: Dr Reddy’s

New Drug Approvals

Hyderabad: Country’s second largest drug maker Dr Reddy’s Laboratories has said it is working on six new drugs in different areas, including metabolic disorders and cardiovascular diseases, psoriasis and migraine.

According to a filing with US Securities Exchange Commission, the drug maker said as of March 31, 2013, DRL had 21 active products in the proprietary products pipeline, of which six are in clinical development stage.

including metabolic disorders and cardiovascular diseases, psoriasis and migraine.

read all at

http://www.deccanchronicle.com/130721/news-businesstech/article/six-new-drugs-clinical-development-stage-dr-reddys

View original post

 
Leave a comment

Posted by on July 24, 2013 in Uncategorized

 
 
DRUG REGULATORY AFFAIRS INTERNATIONAL

Drug Regulatory affairs by DR ANTHONY MELVIN CRASTO, Worlddrugtracker

Seven Spheres

Aqua Terra Ignis et Aer

Chemtips

Because Organic Chemistry is Hard Enough

Fathisaffar

A Blog by Mohamed Fathi SAFFAR Pharm.D;Docteur es-sciences Pharmaceutiques;GMP-Inspector; Director at NATIONAL LABORATORY FOR DRUG CONTROL

%d bloggers like this: