European Commission Approves Gilead’s VitektaTM, an Integrase Inhibitor for the Treatment of HIV-1 Infection

New Drug Approvals

Elvitegravir

697761-98-1 CAS

FOSTER CITY, Calif.–(BUSINESS WIRE)–Nov. 18, 2013– Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for VitektaTM (elvitegravir 85 mg and 150 mg) tablets, an integrase inhibitor for the treatment of HIV-1 infection in adults without known mutations associated with resistance to elvitegravir. Vitekta is indicated for use as part of HIV treatment regimens that include a ritonavir-boosted protease inhibitor.http://www.pharmalive.com/eu-oks-gileads-vitekta Vitekta interferes with HIV replication by blocking the virus from integrating into the genetic material of human cells. In clinical trials, Vitekta was effective in suppressing HIV among patients with drug-resistant strains of HIV.http://www.pharmalive.com/eu-oks-gileads-vitekta

Elvitegravir (EVG, formerly GS-9137) is a drug used for the treatment of HIV infection. It acts as an integrase inhibitor. It was developed[1] by the pharmaceutical company Gilead Sciences, which licensed EVG from Japan Tobacco in March 2008.[2][3]

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Late-stage success for Sanofi/Regeneron RA drug sarilumab

New Drug Approvals

SARILUMAB

PRONUNCIATION sar il’ ue mab

THERAPEUTIC CLAIM Treatment of rheumatoid arthritis and
ankylosing spondylitis

CHEMICAL NAMES

1. Immunoglobulin G1, anti-(human interleukin 6 receptor α) (human REGN88 heavy
chain), disulfide with human REGN88 light chain, dimer

2. Immunoglobulin G1, anti-(human interleukin-6 receptor subunit alpha (IL-6RA,
membrane glycoprotein 80, CD126)); human monoclonal RGN88 γ1 heavy chain (219-
214′)-disulfide with human monoclonal RGN88 κ light chain dimer (225-225”:228-
228”)-bisdisulfide

MOLECULAR FORMULA C6388H9918N1718O1998S44

MOLECULAR WEIGHT 144.13 kDa

SPONSOR Regeneron Pharmaceuticals, Inc.

CODE DESIGNATION REGN88, SAR153191

CAS REGISTRY NUMBER 1189541-98-7

sarilumab

Sarilumab (REGN88/SAR153191) is a fully-human monoclonal antibody directed against the IL-6 receptor (IL-6R).  Sarilumab is a subcutaneously delivered inhibitor of IL-6 signaling, which binds with high affinity to the IL-6 receptor.  It blocks the binding of IL-6 to its receptor and interrupts the resultant cytokine-mediated inflammatory signaling.

Sanofi and Regeneron’s investigational rheumatoid arthritis drug sarilumab has succeeded in a late-stage trial.

The year-long…

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SCRIP Awards 2013 -Best Company in an Emerging Market – Dr Reddy’s Laboratories – India, Novartis’s Bexsero, Best New Drug

New Drug Approvals

champagne

The SCRIP Awards 2013 celebrated achievements in the global biopharma industry last night at the Lancaster, London.

Hosted by Justin Webb, the evening was a fantastic mix of dining, entertainment and awards.

Among the winners were:

  • Novartis’s Bexsero, Best New Drug
  • Genmab, Biotech Company of the Year
  • Regeneron Pharmaceuticals and Sanofi’s Phase IIa study dupilumab in asthma, Clinical Advance of the Year

You can view the full roll of honour by clicking on the button below.

It was a great night and we would like to thank all those who entered and attended this year’s awards.

Finally congratulations to our winners and a huge thanks to our sponsors for helping us make it such a fantastic success.

Don’t forget to check our website in the next couple of days for all the pictures from the night.

2013 Winners

Best Company in an Emerging Market – Sponsored by Clinigen Group

  • Dr…

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Bayer, Onyx win early FDA OK for Nexavar (sorafenib) in thyroid cancer

New Drug Approvals

The U.S. Food and Drug Administration said on Friday it has expanded the approved use of the cancer drug Nexavar to include late-stage differentiated thyroid cancer.

Differentiated thyroid cancer is the most common type of thyroid cancer, the FDA said. The National Cancer Institute estimates that 60,220 people in the United States will be diagnosed with it and 1,850 will die from the disease in 2013.

The drug, made by Germany’s Bayer AG and Onyx Pharmaceuticals, is already approved to treat advanced kidney cancer and liver cancer that cannot be surgically removed. Onyx was acquired by Amgen Inc earlier this year.

 

READ ABOUT SORAFENIB IN MY EARLIER BLOGPOST

http://newdrugapprovals.wordpress.com/2013/07/16/nexavar-sorafenib/

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Otsuka and Lundbeck’s Once-Monthly Abilify Maintena(R) (Aripiprazole) Now Approved in Europe

New Drug Approvals

Otsuka and Lundbeck’s Once-Monthly Abilify Maintena(R) (Aripiprazole) Now Approved in Europe for Maintenance Treatment of Schizophrenia in Adult Patients Stabilized with Oral Aripiprazole

do not forget to see my old blog post, contains synthesis

http://newdrugapprovals.wordpress.com/2013/02/07/the-european-medicines-agency-ema-approves-otsukas-aripiprazole-abilify-for-the-treatment-of-moderate-to-severe-manic-episodes-in-bipolar-i-disorder-in-adolescents/

Preventing relapse is critical in the treatment of schizophrenia. Pivotal studies, that supported the EU submission, demonstrate that Abilify Maintena can reduce the risk of relapse relative to placebo and is non-inferior to oral aripiprazole in patients with schizophrenia1,2 -- The approval of Abilify Maintena now provides patients with schizophrenia access to a once-monthly formulation with established efficacy together with a tolerability profile that is comparable to that of oral ABILIFY(R) (aripiprazole)2 -- At the end of the randomized, double-blind treatment phase in one of the pivotal trials, 93 percent of patients reported being extremely, very or somewhat satisfied with Abilify Maintena treatment3 -- Abilify Maintena is the only dopamine D2 partial agonist in a once-monthly…

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EPROSARTAN MESYLATE

New Drug Approvals

TEVETEN® (eprosartan mesylate) is a non-biphenyl non-tetrazole angiotensin II receptor (AT1) antagonist. A selective non-peptide molecule, TEVETEN® is chemically described as the monomethanesulfonate of (E)-2-butyl-1 -(p-carboxybenzyl)-α-2-thienylmethylimid-azole-5 -acrylic acid.

Its empirical formula is C23H24N2O4S•CH4O3S and molecular weight is 520.625. Its structural formula is:

Teveten (Eprosartan Mesylate) Structural Formula Illustration

EPROSARTAN MESYLATE

tevetenEprosartan mesilate, SK&F-108566-J(?, SK&F-108566, Teveten SB, Navixen, Regulaten, Tevetenz, Teveten

US 5656650 exp Aug 12, 2014

CAS EPROSARTAN

144143-96-4 

133040-01-4 

Chemical Name: Eprosartan mesylate
Synonyms: EPROSARTAN MESYLATE;Eprosartan Methanesulfonate;4-[[2-butyl-5-(2-carboxy-3-thiophen-2-yl-prop-1-enyl)-imidazol-1-yl]methyl]benzoic acid mesylate;4-({2-butyl-5-[(1E)-2-carboxy-2-(thiophen-2-ylMethyl)eth-1-en-1-yl]-1H-iMidazol-1-yl}Methyl)benzoic acid;(E)-α-[[2-Butyl-1-[(4-carboxyphenyl)Methyl]-1H-iMidazol-5-yl]Methylene]-2-thiophenepropanoic Acid Methanesulfonate;(αE)-α-[[2-Butyl-1-[(4-carboxyphenyl)Methyl]-1H-iMidazol-5-yl]Methylene]-2-thiophenepropanoic Acid MonoMethanesulfonate
CBNumber: CB4842192
Molecular Formula: C24H28N2O7S2
Formula Weight: 520.61832

Eprosartan is an angiotensin II receptor antagonist used for the treatment of high blood pressure. It is marketed as Teveten byAbbott Laboratories in the United States.It is marketed as Eprozar by INTAS Pharmaceuticals in India and by Abbott Laboratorieselsewhere. It is sometimes paired with hydrochlorothiazide, marketed in the US as Teveten HCT and…

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Pramlintide

New Drug Approvals

Pramlintide (Symlin), a synthetic version of amylin, is a 37-amino acid peptide that is co-secreted with insulin by pancreatic β-cells. It was developed and approved in 2005 by the FDA for use in US patients with type I and II diabetes in conjunction with the administration of prandial insulin to improve postprandial glycemic control

 

Pramlintide

 

Pramlintide (Symlin) is a relatively new adjunct for diabetes (both type 1 and 2), developed by Amylin Pharmaceuticals (now a wholly owned subsidiary of Bristol Myers-Squibb). Pramlintide is delivered as an acetate salt.

 

Pramlintide is an analogue of amylin, a small peptide hormone that is released into the bloodstream by the β-cells of the pancreas along with insulin, after a meal.[1] Like insulin, amylin is completely absent in individuals with Type I diabetes.[2]

Reduction in glycated hemoglobin and weight loss have been shown in insulin-treated patients with…

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