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Alnylam Hemophilia Drug Garners Orphan Drug Status

New Drug Approvals

CAMBRIDGE, Mass., Aug 14, 2013 (AP) — The Food and Drug Administration has granted an “orphan drug designation” to a potential hemophilia treatment from Alnylam Pharmaceuticals Inc.

Orphan drug status is awarded to drugs that could treat diseases that affect fewer than 200,000 people in the United States. It comes with some added marketing exclusivity.

The Cambridge, Mass., company said Wednesday that the agency gave the designation to a drug labeled ALN-AT3 for the treatment of hemophilia B. Alnylam has tested the drug in mice and plans to start studies involving humans early next year.

for the treatment of hemophilia B. Alnylam has tested the drug in mice and plans to start studies involving humans early next year.

http://www.pharmalive.com/alnylam-hemophilia-drug-garners-orphan-drug-status

 

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Posted by on August 17, 2013 in Uncategorized

 

Propecia Could Save 70,000 Men From Prostate Cancer

New Drug Approvals

File:Finasteride.svg

finasteride

The baldness drug propecia could help reduce the risk of prostate cancer with less side-effects than previously thought, according to a new study.

By Amir Khan, Everyday Health Staff Writer

Warding off prostate cancer may be as easy as growing your hair, according to new data published in the New England Journal of Medicine by researchers from the University of Texas Health Science Center at San Antonio. The researchers followed up on patients from one of their previous studies, and found that the baldness drug finasteride, also known as Propecia, reduced the risk of prostate cancer by more than a third, and resulted in less-severe side effects than previously thought.

“If you look at the number of prostate cancers that are diagnosed annually and multiply that by 30 percent, that’s the number of cancers we might be able to prevent each year,” Ian Thompson Jr., MD, study author and director…

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Posted by on August 17, 2013 in Uncategorized

 

Need For A Smarter Regulatory System To Ensure Access To Affordable Biologics: The Biosimilars

New Drug Approvals

Kiran Mazumdar Shaw
by
Kiran Mazumdar Shaw, MD, BIOCON
The global pharmaceutical industry is going through a paradigm change as biologics such as monoclonal antibodies and recombinant proteins find greater acceptance for treating a wide range of chronic diseases.
Today biologics make for up half of the top 10 best-selling drugs worldwide.

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Posted by on August 17, 2013 in Uncategorized

 

Health Canada Approves ThromboGenics’ JETREA® for the Treatment of Symptomatic Vitreomacular Adhesion

New Drug Approvals

LEUVEN, Belgium, August 16, 2013 /PRNewswire/ —

Canada is first market outside the US and Europe where JETREA® is approved

ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, today announces that Health Canada has approved JETREA® (ocriplasmin) for the treatment of symptomatic vitreomacular adhesion (VMA). The priority review of the New Drug Submission for JETREA in Canada was conducted within 180 calendar days. Canada is the first market where JETREA® is approved outside the US and Europe. ThromboGenics’ partner Alcon holds the commercialization rights to JETREA® outside the US and will be responsible for the launch of the drug in Canada.

read all at

http://www.pharmalive.com/health-canda-approves-jetrea-for-vma

Ocriplasmin (trade name Jetrea) is a recombinant protease with activity against fibronectin and laminin, components of the vitreoretinal interface. It is used for treatment of symptomatic vitreomacular adhesion

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Posted by on August 17, 2013 in Uncategorized

 

Novartis vaccine Bexsero® approved in Australia to help protect against MenB disease, a deadly form of bacterial meningitis

New Drug Approvals

Australia approval marks a key step in expanding access to the first and only broad coverage vaccine against MenB disease[1],[2];Bexsero was granted European licensure this past January[1]

•    MenB disease is a leading cause of meningitis and sepsis globally, and causes approximately 85 percent of all meningococcal disease cases in Australia[3],[4],[5]

•    Bexsero safety and efficacy have been shown through clinical trials involving more than 8,000 people including infants, children, adolescents and adults[6]

Basel, August 15, 2013 – Novartis announced today that the Australian Therapeutic Goods Administration (TGA) has added Bexsero®, a multi-component Meningococcal B (MenB) vaccine (recombinant, adsorbed) suspension for injection 0.5 ml pre-filled syringe, to the Australian Register of Therapeutic Goods (ARTG) for use in individuals from two months of age and older[6]. Bexsero is the first and only broad coverage vaccine to help protect all age groups against MenB disease, including infants who are at the greatest…

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Posted by on August 17, 2013 in Uncategorized

 

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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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

 

 

 

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Posted by on July 24, 2013 in Uncategorized

 
 
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