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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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FDA approves Orexo’s Zubsolv for people suffering from opioid dependence
U.S. Food and Drug Administration (FDA) has approved Zubsolv™ (buprenorphine/naloxone) sublingual tablet CIII. Zubsolv is indicated for use as maintenance treatment for people suffering from opioid dependence and should be used as part of a complete treatment plan to include counselling and psychosocial support. Zubsolv is a once-daily, sublingual tablet with an advanced formulation of buprenorphine and naloxone that fully dissolves within minutes. Compared with other buprenorphine/naloxone treatments, Zubsolv has higher bioavailability, faster dissolve time, and smaller tablet size with a new menthol taste. Zubsolv will be launched in September by our subsidiary in the United States, Orexo US, Inc and our partner Publicis Touchpoint Solutions…
FDA approves Orexo’s Zubsolv for people suffering from opioid dependence.
FDA clears Aurobindo’s Rizatriptan Benzoate orally disintegrating tablets
India-based Aurobindo Pharma has obtained final FDA approvals to manufacture and market Rizatriptan Benzoate orally disintegrating tablets (ODT) 5mg and 10mg (ANDA 203062)…
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Rizatriptan (trade name Maxalt) is a 5-HT1 agonist triptan drug developed by Merck & Co. for the treatment of migraine headaches. It is available in strengths of 5 and 10 mg as tablets and orally disintegrating tablets (Maxalt-MLT).
Maxalt obtained approval by the United States Food and Drug Administration (FDA) on June 29, 1998. It is a second-generation triptan.
Rizatriptan is available only by prescription in Australia, the United States, Canada andNew Zealand. Similarly, it is classed as a POM (Prescription Only Medicine) in the United Kingdom, Italy (as Rizaliv), Israel (as Rizalt), The Netherlands, Croatia and Spain (asMaxalt)
Anthrax Killer from the Sea
Anthrax Killer from the Sea
Unusual antibiotic from a marine actinomycete is effective against anthrax
http://www.chemistryviews.org/details/ezine/4972631/Anthrax_Killer_from_the_Sea.html
- Anthracimycin, a Potent Anthrax Antibiotic from a Marine-Derived Actinomycete,
Kyoung Hwa Jang, Sang-Jip Nam, Jeffrey B. Locke, Christopher A. Kauffman, Deanna S. Beatty, Lauren A. Paul, William Fenical,
Angew. Chem. Int. Ed. 2013.
DOI: 10.1002/anie.201302749
From Pharmacy to the Pub — A Bark Conquers the World: Part 3
The long road from the structure determination to the total synthesis of quinine is an exciting detective story
Sandoz launches generic metronidazole in the US
Sandoz has launched metronidazole 1% topical gel, the first generic version of METROGEL® 1%.
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Biosimilar drugs step up complexity, by Phillip Broadwith
The first ever generic monoclonal antibody therapies have been recommended for approval in Europe. The two biosimilar versions of infliximab (Johnson & Johnson’s Remicade) have passed assessment by the European Medicines Agency’s committee for medicinal products for human use, but will need to be fully approved by the European commission before they can be marketed.
Monoclonal antibodies are significantly larger and more complex than previously approved biosimilars, which include growth hormones and erythropoietin. Proving that they are functionally similar to the original drug is therefore complex. Both manufacturers, Celltrion and Hospira, had to complete human trials to prove that their generic infliximab products were as safe and effective as Remicade in treating autoimmune diseases.
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http://www.rsc.org/chemistryworld/2013/07/biosimilar-approval-steps-complexity
Array Starts First Phase 3 Trial, Shifts to Late-Stage Development
HY-15202
MEK162
(Synonyms ARRY-162; ARRY-438162; MEK 162; ARRY 162; ARRY 438162)
MEK162 M.Wt: 441.23
MEK162 Formula: C17H15BrF2N4O3
MEK162 Storage: at -20℃ 2 years
MEK162 CAS No.: 606143-89-9
http://clinicaltrials.gov/ct2/show/NCT00959127
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Array Starts First Phase 3 Trial, Shifts to Late-Stage Development read all at |
Cancer treatment using the nanofiber mesh with self-heating/anticancer drug release functions
A research team headed by Dr. Mitsuhiro Ebara, a MANA Scientist of the Biomaterials Unit of the International Center for Materials Nanoarchitectonics (WPI-MANA, NIMS) developed a new nanofiber mesh which is capable of simultaneously realizing thermotherapy (hyperthermia) and chemotherapy (treatment with anticancer drugs) of tumors.
Using this nanofiber mesh, the team succeeded in efficiently inducing natural death (apoptosis) of epithelial cancer cells.
FDA awards Activartis brain cancer drug Orphan Drug Designation
Austrian biotech company Activartis has received Orphan Drug Designation for its cancer immunotherapy AV0113 from the US Food and Drug Administration.
The experimental vaccine will be fast-tracked for evaluation after it was shown to improve survival rates in people with malignant glioma, an advanced form of brain cancer in a phase II clinical trial earlier this year.
DR ANTHONY MELVIN CRASTO
ORGANIC SPECTROSCOPY
New Drug Approvals 