Home » Articles posted by DR ANTHONY MELVIN CRASTO Ph.D (Page 424)
Author Archives: DR ANTHONY MELVIN CRASTO Ph.D
DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
.....FOR BLOG HOME CLICK HEREFlag and hits
ORGANIC SPECTROSCOPY
SUBSCRIBE
Subscribe in a reader
Enter your email address:
Delivered by FeedBurner
Subscribe to New Drug Approvals by Email
Recent Comments
 | shivkr2 on SPSR Excellence Award 2025 – S… |
 | Bonkasaurus on Infigratinib phosphate |
 | PALOVAROTENE | ORGAN… on Palovarotene |
| Pfizer just purchase… on Temanogrel | |
| Pfizer To Cash In On… on Temanogrel |
Transverse myletis, one in a million ailment, will give self support to any one
Today when this blog has taken 10,000 views across 100 countries in 2 months, I take this opportunity to update any one needing information on transverse myletis, one in a million ailment, which I am going through myself , will give self support to any one approaching on mail, person or phone
IT CAN BE CONQUERED
amcrasto@gmail.com
call me in India, +91 9323115463
DETAILS
Paralysis head to toe, from DEC 2007 TILL TODAY MAR 2013. poor recovery, hands ok , head ok and miraculously all organs ok, diabetic and medical attention needed for that
on a wheel chair
bowel zero, all sensation zero below neck
plus points
motivation unmatched, sleep 5 hrs, office work 7 hrs, computer or ipad 6 hrs
special care
control blood thickness, avoid vein thrombosis, stretch limbs physically using help,try more exercises on bed, avoid fever, try antibiotics quickly in iv format, keep tight control on diabetes if any
divine
sixth sense extraordinary, knowledge grasp 1000 times more, motivation high to live and focussed on living only, no much desires except childrens happiness. television, news , sports are hobbies
Biogen’s Tecfidera MS Drug Wins EU Agency’s Backing
Tecfidera
Biogen Idec Inc. won European Union backing for Tecfidera, one of the first therapies for multiple sclerosis available in an easy-to-take pill that analysts say may generate $3.25 billion in annual sales.
Current MS drugs, including Biogen’s Avonex and Tysabri, are given by injection or intravenous infusion, and patient anticipation for Tecfidera may drive it to capture as much as 20 percent of the market within a year, according to Eric Schmidt of Cowen & Co. Sanofi (SAN)’s oral MS drug, Aubagio, was also recommended for marketing authorization today in Europe.
Biogen’s drug, formerly known as BG-12, will follow Novartis AG’s Gilenya to the market in the EU as an oral option for the treatment of MS. Because of its safety profile and efficacy, Weston, Massachusetts-based Biogen’s Tecfidera may generate $3.25 billion by 2017
Sanofi/Genzyme’s Lemtrada shows durable effect in MS trial
About Alemtuzumab/LEMTRADA™
Alemtuzumab is a monoclonal antibody that selectively targets CD52, a protein abundant on T and B cells. Treatment with alemtuzumab results in the depletion of circulating T and B cells thought to be responsible for the damaging inflammatory process in MS. Alemtuzumab has minimal impact on other immune cells. The acute anti-inflammatory effect of alemtuzumab is immediately followed by the onset of a distinctive pattern of T and B cell repopulation that continues over time, rebalancing the immune system in a way that potentially reduces MS disease activity.
mar22, 2013
There was good news for French drug giant Sanofi this week as data from an extension study backed the long-term efficacy of its multiple sclerosis drug Lemtrada.
Interim data from the first 12 months of the extension trial showed that relapse rates and sustained accumulation of disability were low among patients previously treated with Lemtrada (alemtuzumab) in either of the two-year Phase III CARE-MS I or CARE-MS II studies.
In both these Phase III trials, Lemtrada was was given as an IV administration on five consecutive days, and the second course was administered on three days 12 months later.
After the first year of the extension arm, more than 80% of patients did not need further treatment with the drug, and more than half remained relapse-free through the first year of the extension study, the drugmaker said.
Alemtuzumab (marketed as Campath, MabCampath or Campath-1H and currently under further development as Lemtrada) is a monoclonal antibody used in the treatment of chronic lymphocytic leukemia (CLL), cutaneous T-cell lymphoma (CTCL) and T-cell lymphoma. It is also used in some conditioning regimens for bone marrow transplantation, kidney transplantation and Islet cell transplantation.
Alemtuzumab binds to CD52, a protein present on the surface of mature lymphocytes, but not on the stem cells from which these lymphocytes are derived. After treatment with alemtuzumab, these CD52-bearing lymphocytes are targeted for destruction.
Alemtuzumab is used as second-line therapy for CLL. It was approved by the US Food and Drug Administration for CLL patients who have been treated with alkylating agents and who have failed fludarabine therapy. It has been approved by Health Canada for the same indication, and additionally for CLL patients who have not had any previous therapies.
It is also used under clinical trial protocols for treatment of some autoimmune diseases, such as multiple sclerosis, in which it shows promise.[1][2] Alemtuzumab was withdrawn from the markets in the US and Europe in 2012 to prepare for a higher-priced relaunch aimed at multiple sclerosis.[3]
A complication of therapy with alemtuzumab is that it significantly increases the risk for opportunistic infections, in particular, reactivation of cytomegalovirus.
- Drug may reverse MS brain damage”. 22 Oct 2008.
- “Sanofi and Genzyme Report New Positive Data from First Phase III Study with MS Drug”. 24 Oct 2011.
- “Sanofi withdraws Campath in US and EU”. Pharma Times Online. August 21, 2012.
NN1954, Long acting oral insulin may be a reality with NovoNordisk Using Merrion Pharmaceuticals GIPET Technology
20 MAR 2013
OI362GT (NN1954)
:Type 1 and 2 diabetes
:Phase 1
A long-acting oral basal insulin analogue intended as a tablet treatment.
Merrion Pharmaceuticals plc today announces that its partner, Novo Nordisk, successfully completed a single dose Phase I trial with a novel oral insulin (NN1954). Merrion Pharmaceuticals GIPET Technology was used in the formulation of NN1954.
The aim of this randomised, double-blind placebo and active controlled single ascending dose trial was to investigate the safety, tolerability, pharmacokinetics (exposure of drug) and pharmacodynamics (effect on blood glucose levels) of NN1954.
Under the terms of the license agreement entered into with Novo Nordisk in 2008 Merrion, receives payments on achievement of certain development, regulatory and sales milestones as well as royalties on sales.
Merrion’s Chairman, Michael Donnelly, said “This is another step towards improving the management options for diabetes. This type of ascending dose trial is a critical stage in the development of a new therapeutic. We continue to be encouraged with the commitment of Novo Nordisk to the incorporation of Merrion’s GIPET technology in the plan to bring an oral insulin tablet to the market.”
TLC388 (Lipotecan®) Taiwan Liposome Company Hepatic cancer drug candidate gets fast track approval status from SFDA
TLC388 (Lipotecan®) structure can be figured out from a link below of a poster
http://www.tlcbio.com/files/news/2011111701580783.pdf
IT IS A CAMPOTHECIN ANALOGUE
The str can be concluded from above picture from a poster by TLC BIO
TLC388 (Lipotecan) is a potent Topoisomerase-1 inhibitor and it can disrupt both Sonic Hedgehog and HIF1-α pathways to overcome cancer drug resistance and inhibit angiogenesis induced by tumor hypoxia. This phase I first-in-human study of Lipotecan examined the MTD, safety, anti-tumor activity and pharmacokinetic profiles of TLC388 in patients with advanced incurable solid tumors.
Methods: Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle. Patients underwent safety assessments regularly and tumor assessments every other cycle. Pharmacokinetic samples were drawn on days 1, 8 and 15 of cycles 1 and 2 for all treated patients.
http://mct.aacrjournals.org/cgi/content/meeting_abstract/10/11_MeetingAbstracts/A89
http://clinicaltrials.gov/show/NCT00747474
MAR19 2013
China SFDA has granted fast track approval status to Taiwan Liposome company hepatic cancer drug Lipotecan, shortening the review period. The drug will enter Phase 2 clinical trials in China in the second half of this year. Lipotecan has been granted orphan drug status by US FDA and EU EMEA for the treatment of hepatocellular carcinoma (HCC)
Nexavar is the standard of care in first line advanced liver cancer patients. Lipotecan as a second-line treatment allows patients who have failed prior treatment with Nexavar to maintain a six month course of the disease without progressing
ELQ-300, Promising new antimalarial to enter clinical testing phase
ELQ-300
6-chloro-7-methoxy-2-methyl-3-{4-[4-(trifluoromethoxy)phenoxy]phenyl}quinolin-4(1H)-one
21 MAR 2013
A promising new antimalarial drug with the potential to cure and block transmission of the mosquito-borne disease has been discovered by researchers.
The drug, known as ELQ-300, has demonstrated preventative transmission-blocking and a low likelihood of developing rapid resistance to major strains of malaria parasites.
Researchers say it is also likely that the drug could be produced more cheaply than existing antimalarials.
ELQ-300 is now moving into clinical testing.
This new treatment was developed by the Medicines for Malaria Venture (MMV) drug discovery initiative, which is made up of researchers from Oregon Health & Science University in Portland, Drexel University in Philadelphia, University of South Florida and Monash University in Australia.
The full details of their research was published yesterday in the Science Translational Medicine journal.
During the process of creating the drug, researchers discovered and developed a series of potent compounds to combat malaria quinolones.
From this series, they narrowed down the most effective drug candidates to one lead drug, ELQ-300.
“This is one of the first drugs ever to kill the malaria parasite in all three stages of its life cycle,” said Dr Kyle, a member of the Global Infectious Diseases Research team at the USF College of Public Health.
“So, it may become part of a new-generation therapy that not only treats sick people and prevents them from getting ill, but also blocks the transmission of malaria from mosquitoes to humans … If the drug can break the parasite life cycle, we may ultimately eradicate the disease.”
Malaria is a tropical disease that kills nearly one million people a year, mostly in developing countries.
ELQ-300 was derived from the first antimalarial quinolone, endochin, discovered more than 60 years ago but never pursued as a treatment because it appeared not to work in humans.
Researchers used new technology to develop this latest class of drug.
“This was a very challenging project requiring years of hard work, collaboration across disciplines, and a good portion of luck,” said Dr. Manetsch, from the University of South Florida.
ELQ-300 is an experimental antimalarial medication. It is an endochin-like quinolone and the first in a new class of antimalarials known as quinolone-3-diarylethers.[1]
ELQ-300 acts as an inhibitor of the mitochondrial cytochrome bc1 complex (complex III in the electron transport chain).[1] In preclinical studies with mice, it was found to be highly active against Plasmodium falciparum and Plasmodium vivax at all life cycle stages that play a role in the transmission of malaria, and to have good oral bioavailability.[1]
- Nilsen A et al (2013). “Quinolone-3-diarylethers: a new class of antimalarial drug”.Science Translational Medicine 5 (177): 177ra37. doi:10.1126/scitranslmed.3005029.ISSN 1946-6234.
- “NIH-Supported Researchers Identify New Class of Malaria Compounds” (Press release). U.S. National Institutes of Health. March 20, 2013.
- A Nilsen et al, Sci. Transl. Med., 2013, DOI:10.1126/scitranslmed.3005029
- ‘ELQ-300 targets the parasite mitochondrion,’ Riscoe says. In most organisms, the primary function of the mitochondria is to produce energy by making adenosine triphosphate (ATP). ‘But in the parasite, the primary function is to produce the pyrimidine building blocks for DNA [thymine and cytosine].’ The molecule prevents the synthesis of those bases, which prevents the parasite from reproducing, so it dies.
FDA Approves Dotarem, a New Magnetic Resonance Imaging Agent
| Cas No. | 98059-18-8 |
| Name | 2-[4,7-bis(carboxylatomethyl)-10-(carboxymethyl)-1,4,7, 10-tetrazacyclododec-1-yl]acetate; gadolinium(3+); (2R,3R,4R,5S)-6-(methylamino)hexane-1,2,3,4,5-pentol |
March 20, 2013 — The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
Dotarem is a gadolinium-based contrast agent (GBCA) that helps radiologists see abnormalities on images of the central nervous system (CNS), the part of the body that contains the brain and spine, and surrounding tissues.
“Dotarem was shown to be a safe and effective magnetic resonance imaging agent in patients ages 2 years and older,” said Dwaine Rieves, M.D., director of the Division of Medical Imaging Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval provides doctors with another option to help evaluate anatomic abnormalities within the central nervous system.”
Dotarem (gadoterate meglumine)
Company: Guerbet
Treatment for: Diagnostic
Dotarem (gadoterate meglumine) is a gadolinium-based contrast agent under review for use in magnetic resonance imaging (MRI).
Dotarem is the only macrocyclic and ionic gadolinium-based contrast agent (GBCA) for the intravenous use with magnetic resonance imaging (MRI) in the brain (intracranial), spine and associated tissues in adults and pediatric patients to detect and visualize areas with disruption of the blood-brain barrier (BBB) and/or abnormal vascularity. The Guerbet NDA recommended dose is 0.1 mmol Gd/kg.
Gadoteric acid
Gadoteric acid (trade names Artirem, Dotarem) is a macrocycle-structured gadolinium-based MRI contrast agent. It consists of the organic acid DOTA as a chelating agent, and gadolinium (Gd3+), and is used in form of the meglumine salt.[1] The drug is approved and used in a number of countries worldwide.[2]
- Herborn, C. U.; Honold, E.; Wolf, M.; Kemper, J.; Kinner, S.; Adam, G.; Barkhausen, J. (2007). “Clinical Safety and Diagnostic Value of the Gadolinium Chelate Gadoterate Meglumine (Gd-DOTA)”. Investigative Radiology 42 (1): 58–62. doi:10.1097/01.rli.0000248893.01067.e5. PMID 17213750. edit
- Drugs.com: Gadoteric Acid
A gadolinium chelate paramagnetic contrast agent. When placed in a magnetic field, gadoterate meglumine produces a large magnetic moment and so a large local magnetic field, which can enhance the relaxation rate of nearby protons; as a result, the signal intensity of tissue images observed with magnetic resonance imaging (MRI) may be enhanced. Because this agent is preferentially taken up by normal functioning hepatocytes, normal hepatic tissue is enhanced with MRI while tumor tissue is unenhanced. In addition, because gadobenate dimeglumine is excreted in the bile, it may be used to visualize the biliary system using MRI.
TheraVida Presents Positive Phase 2 Data for Tolenix (THVD-201) in Patients with Overactive Bladder
mar18, 2013
TheraVida, Inc., a clinical-stage biopharmaceutical company developing novel combination drug products, presented positive results from a Phase 2 clinical trial of its lead product candidate, Tolenix ™ (THVD-201), for the treatment of overactive bladder (OAB) and urge urinary incontinence (UUI) at the 28 th Annual Congress of the European Urological Association (EAU) in Milan, Italy.
Tolenix ™ is a twice-daily (BID) proprietary combination of tolterodine, to treat OAB and UUI, and pilocarpine, to reduce the significant dry mouth (xerostomia) caused by muscarinic antagonist medications such as tolterodine.
tolterodine
pilocarpine
The objectives of the randomized, double-blinded, multiple-crossover Phase 2 trial were to assess the safety and efficacy of Tolenix ™ in reducing the frequency of micturition (urination) and incontinence episodes per day, as compared to both placebo control and active control Detrol ® (tolterodine). In addition, common side effects of muscarinic antagonist therapies, such as dry mouth, were carefully assessed in the 138 patients enrolled in the trial. This international Phase 2 clinical trial was conducted in South Korea, Australia, and New Zealand.
Patients receiving Tolenix ™ (2mg tolterodine plus 9mg pilocarpine, administered BID) experienced statistically significant improvements in their OAB and UUI symptoms over placebo, with a reduction in daily micturitions of 0.88 (p<0.0001) and a reduction in daily incontinence episodes of 0.47 (p<0.0001). This efficacy was similar in magnitude to the maximum dose of active control Detrol ® (2mg tolterodine, administered BID).
Phase 1-Merck Serono, a division of Merck in Darmstadt, Germany, today announced aPhase 1- Merck Serono’s investigational drug sprifermin (recombinant human FGF-18) in osteoarthritis (OA) of the knee
recombinant human FGF-18
Darmstadt, Germany, March 18, 2013 –
Merck Serono, a division of Merck in Darmstadt, Germany, today announced a strategic alliance with Nordic Bioscience Clinical Development A/S on Merck Serono’s investigational drug sprifermin (recombinant human FGF-18) in osteoarthritis (OA) of the knee. This agreement underscores Merck Serono’s commitment to osteoarthritis research and development.
Under the terms of the agreement, Nordic Bioscience will provide clinical development services to Merck Serono on a shared-risk basis in exchange for a payment structure that includes service fees and potential milestone and royalty payments on the program. Merck Serono retains full responsibility for the development and commercialization of the investigational drug. Financial terms of the collaboration were not disclosed. The alliance will draw on the joint expertise and resources of Merck Serono and Nordic Bioscience to conduct a multi-national Phase IIb trial (the FORWARD study) to further evaluate sprifermin for inhibition of the progression of structural damage, reduction of pain and improvement of physical function in patients with OA of the knee. The FORWARD study is expected to begin enrollment in the second half of 2013.
The FDA has opened the inside track to Novartis’ experimental lung cancer drug, LDK378, which gained “Breakthrough Therapy” designation
The FDA has opened the inside track to Novartis’ experimental lung cancer drug, which gained “Breakthrough Therapy” designation that speeds the development and review schedules for new treatments. The Swiss drug giant plans to file for approval the drug, now in mid-stage clinical trials, in early 2014. Since clinical development began in 2011, the program has advanced with lightning speed compared with those that take 10 years or so to trial before submitted for approval.
While there are no guarantees of an FDA approval for Novartis’ compound, code-named LDK378, the “breakthrough” tag provides an early nod to the potential of the candidate to improve treatment for patients with metastatic non-small cell lung cancer with anaplastic lymphoma kinase (ALK) mutations.
The “breakthrough” designation is also important because Novartis’ compound and others with the coveted status have a shot to be approved by the FDA without completing all three phases of clinical trials typically required before an approval decision.
Novartis’ LDK378 joined the “breakthrough” club after showing an 80% response rate in patients studied in Phase I trial of 88 subjects with advanced cases of ALK-positive NSCLC. The company has already begun a pair of Phase II studies of the compound for patients with the same kind of ALK-positive cancers, which account for about 3% to 8% of cases of NSCLC. And plans call for kicking off Phase III development of the new drug later this year.
“LDK378 is a strong example of our research approach, which focuses on identifying the underlying cause of disease pathways,” said Alessandro Riva, Novartis’ global head of oncology development, in a statement. “This Breakthrough Therapy designation will allow us to collaborate more closely with the FDA and potentially to expedite the availability of an important new treatment option for patients with ALK+ NSCLC.”
New Drug Approvals 