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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Oncopeptides Testing Melflufen in Europe
Oncopeptides AB, a company working to enhance oncology therapies, announced that the first patient has been dosed as part of a phase 2 study in multiple myeloma patients with its drug candidate melflufen (previously called J1). The trial is an open-label phase 2 study, designed to determine the level of efficacy of melflufen in combination with dexamethasone, for late stage, relapsing or relapsing/refractory patients
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Diabetes Drug Trial Moves to Israel
Oramed Pharmaceuticals Inc., a developer of oral drug delivery systems, announced that it has initiated patient recruitment for a new clinical trial of its orally ingestible insulin capsule, ORMD-0801 for patients with type 1 diabetes mellitus (T1DM) in Israel.
Ajay Piramal’s 20-20 game planThree years after selling its generics business to Abbott, the group is ready with a new strategy on becoming a $20-billion company by 2020
Twenty is an important number for Ajay Piramal, founder of thePiramal Group. Whether it is the target of 20 per cent annual growth or the goal of taking market capitalisation to $20 billion by 2020, the number is key in his scheme of things.
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Biotech portfolio update – 2012 summary and 2013 outlook
read all here
http://www.orf-blog.com/biotech-portfolio-update-%E2%80%93-2012-summary-and-2013-outlook/
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Novartis Muscle Drug Bimagrumab Gets Breakthrough Status
immunoglobulin G1-lambda2, anti-[Homo sapiens ACVR2B (activin
A receptor type IIB, ActR-IIB)], Homo sapiens monoclonal antibody;
gamma1 heavy chain (1-445) [Homo sapiens VH (IGHV1-2*02
(91.80%) -(IGHD)-IGHJ5*01 [8.8.8] (1-115) -IGHG1*03 (CH1 (116-
213), hinge (214-228), CH2 L1.3>A (232), L1.2>A (233) (229-338),
CH3 (339-443), CHS (444-445)) (116-445)], (218-216′)-disulfide with
lambda light chain (1′-217′) [Homo sapiens V-LAMBDA (IGLV2-
23*02 (90.90%) -IGLJ2*01) [9.3.11] (1′-111′) -IGLC2*01 (112′-217′)];
dimer (224-224”:227-227”)-bisdisulfide
myostatin inhibitor
bimagrumab immunoglobuline G1-lambda2, anti-[Homo sapiens ACVR2B
(récepteur type IIB de l’activine A, ActR-IIB)], Homo sapiens
anticorps monoclonal;
chaîne lourde gamma1 (1-445) [Homo sapiens VH (IGHV1-2*02
(91.80%) -(IGHD)-IGHJ5*01 [8.8.8] (1-115) -IGHG1*03 (CH1 (116-
213), charnière (214-228), CH2 L1.3>A (232), L1.2>A (233) (229-
338), CH3 (339-443), CHS (444-445)) (116-445)], (218-216′)-
disulfure avec la chaîne légère lambda (1′-217′) [Homo sapiens
V-LAMBDA (IGLV2-23*02 (90.90%) -IGLJ2*01) [9.3.11] (1′-111′) –
IGLC2*01 (112′-217′)]; dimère (224-224”:227-227”)-bisdisulfure
inhibiteur de la myostatine
inmunoglobulina G1-lambda2, anti-[Homo sapiens ACVR2B
(receptor tipo IIB de la activina A, ActR-IIB)], anticuerpo monoclonal
de Homo sapiens;
cadena pesada gamma1 (1-445) [Homo sapiens VH (IGHV1-2*02
(91.80%) -(IGHD)-IGHJ5*01 [8.8.8] (1-115) -IGHG1*03 (CH1 (116-
213), bisagra (214-228), CH2 L1.3>A (232), L1.2>A (233) (229-338),
CH3 (339-443), CHS (444-445)) (116-445)], (218-216′)-disulfuro con
la cadena ligera lambda (1′-217′) [Homo sapiens V-LAMBDA
(IGLV2-23*02 (90.90%) -IGLJ2*01) [9.3.11] (1′-111′) -IGLC2*01
(112′-217′)]; dímero (224-224”:227-227”)-bisdisulfuro
inhibidor de la miostatina
1356922-05-8
Heavy chain / Chaîne lourde / Cadena pesada
QVQLVQSGAE VKKPGASVKV SCKASGYTFT SSYINWVRQA PGQGLEWMGT 50
INPVSGSTSY AQKFQGRVTM TRDTSISTAY MELSRLRSDD TAVYYCARGG 100
WFDYWGQGTL VTVSSASTKG PSVFPLAPSS KSTSGGTAAL GCLVKDYFPE 150
PVTVSWNSGA LTSGVHTFPA VLQSSGLYSL SSVVTVPSSS LGTQTYICNV 200
NHKPSNTKVD KRVEPKSCDK THTCPPCPAP EAAGGPSVFL FPPKPKDTLM 250
ISRTPEVTCV VVDVSHEDPE VKFNWYVDGV EVHNAKTKPR EEQYNSTYRV 300
VSVLTVLHQD WLNGKEYKCK VSNKALPAPI EKTISKAKGQ PREPQVYTLP 350
PSREEMTKNQ VSLTCLVKGF YPSDIAVEWE SNGQPENNYK TTPPVLDSDG 400
SFFLYSKLTV DKSRWQQGNV FSCSVMHEAL HNHYTQKSLS LSPGK 445
Light chain / Chaîne légère / Cadena ligera
QSALTQPASV SGSPGQSITI SCTGTSSDVG SYNYVNWYQQ HPGKAPKLMI 50
YGVSKRPSGV SNRFSGSKSG NTASLTISGL QAEDEADYYC GTFAGGSYYG 100
VFGGGTKLTV LGQPKAAPSV TLFPPSSEEL QANKATLVCL ISDFYPGAVT 150
VAWKADSSPV KAGVETTTPS KQSNNKYAAS SYLSLTPEQW KSHRSYSCQV 200
THEGSTVEKT VAPTECS 217
Disulfide bridges location / Position des ponts disulfure / Posiciones de los puentes disulfuro
Intra-H 22-96 142-198 259-319 365-423
22”-96” 142”-198” 259”-319” 365”-423”
Intra-L 22′-90′ 139′-198′
22”’-90”’ 139”’-198”’
Inter-H-L 218-216′ 218”-216”’
Inter-H-H 224-224” 227-227”
N-glycosylation sites / Sites de N-glycosylation / Posiciones de N-glicosilación
H CH2 N84.4
Bimagrumab
http://www.who.int/medicines/publications/druginformation/innlists/PL108_Final.pdf
Novartis announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to BYM338 for sporadic inclusion body myositis (sIBM). This designation is based on the results of a phase 2 proof-of-concept study that showed BYM338 substantially benefited patients with sIBM compared to placebo.
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Novartis receives FDA breakthrough therapy designation for BYM338 (bimagrumab) for sporadic inclusion body myositis (sIBM)
• Designation highlights potential of BYM338 to address an unmet medical need in a serious disease
• If approved, BYM338 has the potential to be the first treatment for sIBM patients
• BYM338 is the third Novartis investigational treatment this year to receive a breakthrough therapy designation by the FDA, highlighting Novartis’ leadership in the industry in breakthrough therapy designations
Bimagrumab (BYM338) is a human monoclonal antibody developed by Novartis to treat pathological muscle loss and weakness. On August 20, 2013 it was announced that bimagrumab was granted breakthrough therapy designation for sporadic inclusion body myositis(sIBM) by US Food and Drug Administration.[1]
- “Novartis receives FDA breakthrough therapy designation for BYM338 (bimagrumab) for sporadic inclusion body myositis (sIBM)”. Retrieved 20 August 2013.
World Health Organization (2012). “International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 108” (PDF). WHO Drug Information 26(4)
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ANTHELMINTIC ACTIVITY OF THE LEAVES OF MORUS ALBA LINN
桑 Morus alba Linn.
Abstract
Present study was carried out to scientifically evaluate the anthelmintic potential of the methanolic extract of leaves of the plant morus alba(L) as it is used by the tribal community of different states and this is also highlighted in traditional uses of the plant.
Activity was performed using adult earthworms and albendazole was used as a standard. Various doses (2.5, 5, 10 mg/ml) of methanolic extracts of leaves were used for the study.
From results of the study it is clear that potency of the extracts is inversely proportional to the time taken for paralysis and death of worms.
All the tested doses showed significant activity (P<0.01) compared to the standard and activity also confirms dose dependant nature of the extracts.
read all at
http://www.pharmatutor.org/articles/anthelmintic-activity-leaves-of-morus-alba-linn
桑 Morus alba Linn.
A BRIEF REVIEW ON TREATMENT & PREVENTION OF CANCER
ABSTRACT
The rate of cancer rise is dramatic, doubling in the last 30 years. Furthermore, of the estimated 560,000 cancer victims who would die in 1997, most of them could have prevented their illness had they paid attention to some simple lifestyle factors.
Although the number of cancer deaths continues to rise each year in the U.S., the per capita cancer mortality rate has just recently started to decline. This celebrated small decline was first announced by the National Cancer Institute in late 1996, but a careful retrospective review of the data indicated that the per capita cancer death rate peaked in 1991 and has ever so slowly declined thereafter.
What was the reason for this decline? Not improved cancer treatments, but cancer prevention itself emerges as the cause for this good news. A national commitment to the prevention of cancer, largely replacing reliance on hopes for universal cures.
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http://www.pharmatutor.org/articles/brief-review-on-treatment-prevention-of-cancer
The US Food and Drug Administration (FDA) has approved the GlaxoSmithKline vaccine Flulaval Quadrivalent, used to treat seasonal influenza.
FDA backs second GSK flu vaccine
The US Food and Drug Administration (FDA) has approved the GlaxoSmithKline vaccine Flulaval Quadrivalent, used to treat seasonal influenza.
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http://www.pharmaceutical-technology.com/news/newsfda-backs-second-gsk-flu-vaccine?WT.mc_id=DN_News
to-BBB Receives IND Approval for Novel Brain Cancer Drug, 2B3-101 Company Proceeds Into Phase IIa Clinical Trials With Inclusion of US Medical Centers
LEIDEN, the Netherlands–(BUSINESS WIRE)–to-BBB, the brain drug delivery company, is pleased to announce the successful completion of its 2B3-101 Phase I clinical trial in brain cancer patients, safely reaching clinically effective dosages. to-BBB is now ready to proceed to the Phase IIa part of this trial, treating patients with brain metastases from breast cancer, small cell lung cancer and melanomas, as well as patients with primary, malignant brain cancers (recurrent gliomas). With no commercially available treatments for brain metastases of solid tumors and no effective treatment alternatives in recurrent gliomas, 2B3-101 is targeting a high unmet medical need. READ ALL AT
http://www.pharmalive.com/to-bbb-receives-ind-approval-for-brain-cancer-drug
New Drug Approvals 