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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Novartis vaccine Bexsero® approved in Australia to help protect against MenB disease, a deadly form of bacterial meningitis
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 risk of infection read all at……………
http://www.pharmalive.com/novartis-bexsero-okd-in-australia
Health Canada Approves ThromboGenics’ JETREA® for the Treatment of Symptomatic Vitreomacular Adhesion
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, for which it received FDA approval on 17 October 2012. It works by dissolving the proteins that link the vitreous to the macula, resulting in posterior detachment of the vitreous from the retina.[1]
References
1 Stalmans, P; Benz, MS; Gandorfer, A; Kampik, A; Girach, A; Pakola, S; Haller, JA; MIVI-TRUST Study, Group (2012 Aug 16). “Enzymatic vitreolysis with ocriplasmin for vitreomacular traction and macular holes.”. The New England journal of medicine 367 (7): 606–15. PMID 22894573.
Need For A Smarter Regulatory System To Ensure Access To Affordable Biologics: The Biosimilars
Propecia Could Save 70,000 Men From Prostate Cancer
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.
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 of the Cancer Therapy & Research Center at the University of Texas, said in a statement. “That’s more than 71,000 men. That’s more than 175 jumbo jets full of men who won’t get cancer, who won’t face treatments with side effects like sexual dysfunction.”
read all at
Finasteride (brand names Proscar and Propecia by Merck, among other generic names) is a synthetic drug for the treatment of benign prostatic hyperplasia (BPH) and male pattern baldness (MPB). It is a type II 5α-reductase inhibitor. 5α-reductase is an enzymethat converts testosterone to dihydrotestosterone (DHT).
Finasteride is synthesized fromprogesterone:
- Rasmusson GH, Reynolds GF, Steinberg NG, Walton E, Patel GF, Liang T, Cascieri MA, Cheung AH, Brooks JR, Berman C (November 1986). “Azasteroids: structure-activity relationships for inhibition of 5 alpha-reductase and of androgen receptor binding”. J. Med. Chem.29 (11): 2298–315. doi:10.1021/jm00161a028. PMID 3783591.
- ^ Bhattacharya A, Dimichele LM, Dolling U, Douglas AW, Grabowski EJJ (1988). “Silylation-mediated oxidation of 4-aza-3-ketosteroids with DDQ proceeds via DDQ-substrate adducts”. Journal of the American Chemical Society 110: 3318–9. doi:10.1021/ja00218a062.
Alnylam Hemophilia Drug Garners Orphan Drug Status
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
Personalized Tumor Vaccine Hits Phase 2
bevacizumab
str ref———-http://www.kidneycancerinstitute.com/Bevacizumab.html
Northwestern Medicine recently joined a landmark clinical trial to investigate if a vaccine made from a patient’s own brain tumor is effective in slowing tumor progression and extending survival. The randomized phase 2 trial will study how well giving the study vaccine with or without Avastin (bevacizumab) works in treating patients with recurrent glioblastoma multiforme (GBM).
Bevacizumab
(Avastin, Genentech Inc.- Year approved:2009)
Avastin (or bevacizumab to the scientific community) is a humanised monoclonal antibody that is directed against all biologically active forms of VEGF. Antibodies are molecules that are typically a normal part of the human immune system. An antibody is meant to bind to a very specific target which is then typically destroyed and removed by the body. Avastin is an antibody that binds VEGF and acts to block its action.
Bevacizumab was one of the first antiangiogenic agents to demonstrate activity against metastatic kidney cancer. Bevacizumab is administered intravenously every two weeks. On July 31, 2009, the FDA granted approval for the use of Avastin in combination with interferon-? for the treatment of patients with metastatic renal cell carcinoma. The approval was based on results published in the journal Lancet in 2007. In this double-blind phase III trial 649 patients with metastatic kidney cancer who had undergone nephrectomy, were randomized to either bevacizumab plus Interferon-? or placebo plus Interferon-? as a first-line treatment. Median progression-free survival of patients was significantly improved in those receiving the combination treatment including Bevacizumab and Interferon-? compared to the control group (10.2 vs 5.4 months). Response rates were also significantly improved in the Bevacizumab and Interferon-? groups (31% vs 13%). The most common severe (grade 3) toxicity was fatigue: 12% in the bevacizumab and IFN arm versus 8% in the control arm.
A second multicenter phase III trial which was performed in 2008 and which was conducted in the United States and Canada, was nearly identical in design with the exception that it lacked a placebo element and did not require prior nephrectomy. In this second study, the average progression-free survival was 8.5 months in patients receiving The combination of Bevacizumab and Interferon-? compared to 5.2 months for patients receiving Interferon-? therapy alone. The overall response rate was in favour of the combination group (25.5% vs 13.1%). However, both studies failed to show any significant difference regarding overall survival between the combination of Bevacizumab and Interferon-? versus Interferon-? alone (18.3 vs 17.4 months).
Bevacizumab (trade name Avastin, Genentech/Roche) is an angiogenesis inhibitor, a drug that slows the growth of new blood vessels. It is licensed to treat various cancers, including colorectal, lung, breast (outside the USA), glioblastoma (USA only), kidney and ovarian.
Bevacizumab is a humanized monoclonal antibody that inhibits vascular endothelial growth factor A (VEGF-A). VEGF-A is a chemical signal that stimulates angiogenesis in a variety of diseases, especially in cancer. Bevacizumab was the first clinically availableangiogenesis inhibitor in the United States.
Bevacizumab was approved by the U.S. Food and Drug Administration (FDA) for certainmetastatic cancers. It received its first approval in 2004, for combination use with standardchemotherapy for metastatic colon cancer.It has since been approved for use in certain lung cancers, renal cancers, and glioblastoma multiforme of the brain.
At one point bevacizumab was approved for breast cancer by the FDA, but the approval was revoked on 18 November 2011. The approval for breast cancer was revoked because, although there was evidence that it slowed progression of metastatic breast cancer, there was no evidence that it extended life or improved quality of life, and it caused adverse effects including severe high blood pressure and hemorrhaging. In 2008, the FDA gave bevacizumab provisional approval for metastatic breast cancer, subject to further studies. The FDA’s advisory panel had recommended against approval. In July 2010, after new studies failed to show a significant benefit, the FDA’s advisory panel recommended against the indication for advanced breast cancer. Genentech requested a hearing, which was granted in June 2011. The FDA ruled to withdraw the breast cancer indication in November 2011. FDA approval is required for Genentech to market a drug for that indication. Doctors may sometimes prescribe it for that indication, although insurance companies are less likely to pay for it. The drug remains approved for breast cancer use in other countries including Australia.
Clinical trials are underway for many other indications including ovarian cancer, pediatric osteosarcoma, and certain non-malignant eye diseases. In the curative setting (adjuvant therapy), clinical studies are underway in breast cancer and lung cancer.
FDA Approves Investigational MS Trial
The stem cell research division of the Tisch MS Research Center of New York announced that the U.S. Food and Drug Administration (FDA) approved autologous, mesenchymal stem cell-derived neural progenitor cells (MSC-NPs) as an Investigational New Drug (IND) for an open label, phase 1 clinical trial in the treatment of multiple sclerosis.
FDA approves GlaxoSmithKline’s Tivicay, for the treatment of AIDS
August 14, 2013 | By Márcio Barra
GSK announced yesterday that the FDA has given green light for ViiV Healthcare’s Tivicay(dolutegravir) 50-mg tablets, an integrase inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 in adults and children aged 12 years and older weighing at least 40 kg (approx. 88 lbs). It can be used to treat infected adults who have been treated with other drugs or are new to treatment.
Integrase inhibitors are a new class of antiretroviral agents that block HIV replication in the body by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). In short, they stop the virus from entering cells.
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