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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.
Roche’s Perjeta Gets FDA Priority Review
The structure of HER2 and pertuzumab
Application follows proposed new FDA pathway designed to help bring promising medicines to people with earlier stages of breast cancer faster
Perjeta is one of the first medicines the FDA will evaluate as an option given before surgery (neoadjuvant treatment)
Perjeta, in combination with Herceptin and chemotherapy, was approved by the FDA in 2012 for HER2-positive metastatic breast cancer
Pertuzumab (also called 2C4, trade name Perjeta) is a monoclonal antibody. The first of its class in a line of agents called “HER dimerization inhibitors”. By binding to HER2, it inhibits the dimerization of HER2 with other HER receptors, which is hypothesized to result in slowed tumor growth. Pertuzumab received US FDA approval for the treatment of HER2-positive metastatic breast cancer on June 8, 2012. Pertuzumab was developed at Genentech and is now owned by Roche which acquired Genentech in 2009.
Early clinical trials of pertuzumab in prostate, breast, and ovarian cancers met with limited success.
The dosage of pertuzumab used in the pivotal phase III CLEOPATRA (Clinical Evaluation of Pertuzumab and Trastuzumab) trial was as follows: IV 840 mg loading dose followed by IV 420 mg every three weeks.
The pharmacokinetics of intravenous pertuzumab appear to be unaffected by age and no drug-drug interaction has been reported with docetaxel. The pharmacokinetics and pharmacodynamics of pertuzumab were summarized in a Feb 2012 review by Gillian Keating.
The combination of pertuzumab plus trastuzumab plus docetaxel, as compared with placebo plus trastuzumab plus docetaxel, when used as first-line treatment for HER2-positive metastatic breast cancer, significantly prolonged progression-free survival, with no increase in cardiac toxic effects in the randomized, double-blind, multinational, phase III CLEOPATRA trial.
Intravenous pertuzumab is currently being evaluated in patients with breast cancer in the following trials: MARIANNE (advanced breast cancer), NEOSPHERE (early breast cancer), TRYPHAENA (HER2-positive stage II/III breast cancer) and APHINITY (HER2-positive nonmetastatic breast cancer)
DR ANTHONY MELVIN CRASTO
ORGANIC SPECTROSCOPY
New Drug Approvals 