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Janssen gets speedy review for Hep C drug
simeprevir
US regulators have agreed to conduct an accelerated review of Janssen Research & Development’s investigational hepatitis C drug simeprevir.
The product, which is under review as a combination treatment for genotype 1 hepatitis C in adult patients with compensated liver disease, is an investigational NS3/4A protease inhibitor administered as a 150mg capsule once daily alongside pegylated interferon and ribavirin.
The US Food and Drug Administration grants Priority Review to medicines that potentially offer major advances where no adequate therapies exists, and aims to complete its assessment within six months. As such, Janssen said it expects a decision by November this year.
Simeprevir is also currently being assessed by regulators in Europe and Japan.
Simeprevir (formerly TMC435) is an experimental drug candidate for the treatment of hepatitis C. It is being developed by Medivir and Johnson & Johnson’s pharmaceutical division Janssen Pharmaceutica and is currently in Phase III clinical trials.
Simeprevir is a hepatitis C virus protease inhibitor.
Simeprevir is being tested in combination regimens with pegylated interferon alfa-2a and ribavirin, and in interferon-free regimens with other direct-acting antiviral agents including daclatasvir and sofosbuvir
India shows U.S. path to patent standards, By Swaminathan S. Anklesaria Aiyar MAY 6, 2013
WHO approves synthetic source of artemisinin
by
Ligand Partner Rib-X Initiates Phase 3 Trial of Captisol-enabled™ Delafloxacin IV
delafloxacin
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced today that its partner Rib-X Pharmaceuticals, Inc. has initiated a Phase 3 clinical trial of a Captisol-enabled™ intravenous (IV) formulation of delafloxacin for the first-line treatment of acute bacterial skin and skin structure infections (ABSSSI), including infections caused by MRSA. Under the terms of a license and supply agreement, Ligand has earned a $500,000 milestone payment.
read all at
http://www.fortmilltimes.com/2013/05/14/2688606/ligand-partner-rib-x-initiates.html
Delafloxacin (originally RX-3341) is a fluoroquinolone antibiotic being developed by Rib-X Pharmaceuticals, Inc.
It is more active (lower MIC90) than other quinolones against Gram-positive bacteria such as MRSA. In contrast to most approved fluoroquinolones, which are zwitterionic, delafloxacin has an anionic character, which results in a 10-fold increase in delafloxacin accumulation in both bacteria and cells at acidic pH. This property is believed to confer to delafloxacin an advantage for the eradication of Staphylococcus aureus in acidic environments, including intracellular infections.[1]
Phase II clinical trials have been completed,[2][3][4] including a trial with tigecycline as a comparator[5] The company states Delafloxacin met its primary and secondary efficacy endpoints based on the draft guidance from the FDA. A Phase III trial for acute bacterial skin and skin structure infections (ABSSSI) is due to begin in the 2nd half of 2012.[6]
- Lemaire, S. et al. Contrasting Effects of Acidic pH on the Extracellular and Intracellular Activities of the Anti-Gram-Positive Fluoroquinolones Moxifloxacin and Delafloxacin against Staphylococcus aureus Antimicrob. Agents Chemother. February 2011; 55:649-658 doi:10.1128/AAC.01201-10
- http://www.bio-medicine.org/biology-technology-1/Rib-X-Pharmaceuticals-Announces-Positive-Phase-2-Study-Results-for-Delafloxacin-and-a–2425-Million-Financing-10093-1/
- http://clinicaltrials.gov/ct2/show/NCT00719810
- http://www.medicalnewstoday.com/articles/132200.php “Rib-X Pharmaceuticals Reports Positive Top-Line Results From Phase 2 Study Of Delafloxacin” 9 Dec 2008
- http://www.citybizlist.com/lstg/lstgDetail.aspx?id=45749 “ABS Ventures Joins $25M Series D Rib-X Pharmaceuticals Inc.” 5 Feb 2009
- Delafloxacin – Pipeline – Rib-X Pharmaceuticals. Accessed: 6/27/2012
company-Turkey Abdi Ibrahim Ilac San.Tic. A.S
Abdi Ibrahim Ilac San.Tic. A.S
Abdi İbrahim started out as a pharmacy in the neighbourhood of Küçükmustafapaşa about 100 years ago. Since 2003, however, it has been the leading company in the Turkish pharmaceuticals markets, operating out of its factory, which was opened in 1919 in Mahmutpaşa with the name Abdi İbrahim Müstahzarat-ı İspençiyariye.
Abdi İbrahim is the first Turkish company to make the list of the top 100 pharmaceutical companies in the world.
READ AT
http://genericlicensing.com/abdi_ibrahim_4/company.html?lf1=848454812f907212625317c7279334
Celgene: Apremilast For Psoriatic Arthritis successfully reduced psoriatic arthritis symptoms by at least 20% versus placebo.
Celgene data from its ongoing Phase III trial of apremilast this month showing the drug successfully reduced psoriatic arthritis symptoms by at least 20% versus placebo.
The data is good news for the 1 million diagnosed patients in the U.S. and Europe and for shareholders eager to see apremilast win market share in the multibillion dollar immunology market.
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Scientists reveal drinking champagne could improve memory
(Medical Xpress)—New research shows that drinking one to three glasses of champagne a week may counteract the memory loss associated with ageing, and could help delay the onset of degenerative brain disorders, such as dementia.
Read more at:
http://medicalxpress.com/news/2013-05-scientists-reveal-champagne-memory.html
Glenmark Generics receives final ANDA approvals for Zolmitriptan Tablets, 2.5 and 5mg and Zolmitriptan Orally Disintegrating Tablets, 2.5 and 5mg
May 15, 2013: Glenmark Generics Inc., USA a subsidiary of Glenmark Generics Limited has been granted final abbreviated new drug approvals (ANDA’s) from the United States Food and Drug
Administration (US FDA) for Zolmitriptan Tablets, 2.5 and 5mg and Zolmitriptan Orally Disintegrating Tablets, 2.5 and 5mg. Glenmark will commence distribution of the product immediately.
Zolmitriptan Tablets and Zolmitriptan ODT are Glenmark’s generic versions of Zomig® and Zomig ZMT® by AstraZeneca, indicated for the acute treatment of migraine headaches in adults.
According to IMS Health for the 12 month period ending December 2012, the products garnered annual sales of USD 176 million.
UK researchers have developed an injectable microgel that can completely restore the mechanical function of damaged spinal discs – at least in an animal model.
Back problems could be tackled with an injectable microgel
read all at
http://www.rsc.org/chemistryworld/2012/08/new-gel-repairs-damaged-discs
DR ANTHONY MELVIN CRASTO
ORGANIC SPECTROSCOPY
New Drug Approvals 