Sandoz launches generic metronidazole in the US

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Roche’s Perjeta Gets FDA Priority Review

New Drug Approvals

The structure of HER2 and pertuzumab

FDA grants Roche’s Perjeta regimen Priority Review for use before surgery in HER2-positive early-stage breast cancer
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…

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Array Starts First Phase 3 Trial, Shifts to Late-Stage Development

New Drug Approvals

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

 

Array Starts First Phase 3 Trial, Shifts to Late-Stage Development
Xconomy
Array Biopharma said Tuesday it has received a $5 million milestone payment from Novartis for beginning Phase 3 testing of a drug it hopes can treat ovarian cancer. The milestone is just part of a larger transition for the Boulder, CO-based biopharmaceutical company.

read all at

http://www.xconomy.com/boulder-denver/2013/07/03/array-starts-first-phase-3-trial-shifts-to-late-stage-development/

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FDA publishes new GMP Guide for Cosmetic Products

DRUG REGULATORY AFFAIRS INTERNATIONAL

 

FDA publishes new GMP Guide for Cosmetic Products

On June 25, 2013 the US FDA published a new Good Manufacturing Practice Guide for Cosmetic Products. Please read more here.

http://www.gmp-compliance.org/ecanl_621_0_news_3776_n.html

On June 25, 2013 the US FDA published a new Good Manufacturing Practice Guide for Cosmetic Products. This new draft Guideline includes recommendations on documentation, recordkeeping, buildings and facilities, equipment, raw materials, production, internal audits, laboratory controls, handling of complaints and reports of adverse events as well as on conducting recalls.

The new guidance document revises the existing “Cosmetic Good Manufacturing (GMP) Guidelines/Inspection Checklist” by updating it to set forth current practice, and clarify certain topic areas based on recent experience. In addition the FDA intends to harmonize their own requirments with those published by the International Organization for Standardization (ISO) standard for cosmetic GMPs (ISO 22716:2007). However, FDA has only incorporated elements of ISO 22716, as appropriate, and consistent with…

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Biosimilar drugs step up complexity, by Phillip Broadwith

New Drug Approvals

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.

read all at

http://www.rsc.org/chemistryworld/2013/07/biosimilar-approval-steps-complexity

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FDA publishes new GMP Guide for Cosmetic Products

DRUG REGULATORY AFFAIRS INTERNATIONAL

 

FDA publishes new GMP Guide for Cosmetic Products

On June 25, 2013 the US FDA published a new Good Manufacturing Practice Guide for Cosmetic Products. Please read more here.

http://www.gmp-compliance.org/ecanl_621_0_news_3776_n.html

On June 25, 2013 the US FDA published a new Good Manufacturing Practice Guide for Cosmetic Products. This new draft Guideline includes recommendations on documentation, recordkeeping, buildings and facilities, equipment, raw materials, production, internal audits, laboratory controls, handling of complaints and reports of adverse events as well as on conducting recalls.

The new guidance document revises the existing “Cosmetic Good Manufacturing (GMP) Guidelines/Inspection Checklist” by updating it to set forth current practice, and clarify certain topic areas based on recent experience. In addition the FDA intends to harmonize their own requirments with those published by the International Organization for Standardization (ISO) standard for cosmetic GMPs (ISO 22716:2007). However, FDA has only incorporated elements of ISO 22716, as appropriate, and consistent with…

View original post 95 more words

Array Starts First Phase 3 Trial, Shifts to Late-Stage Development

New Drug Approvals

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

 

Array Starts First Phase 3 Trial, Shifts to Late-Stage Development
Xconomy
Array Biopharma said Tuesday it has received a $5 million milestone payment from Novartis for beginning Phase 3 testing of a drug it hopes can treat ovarian cancer. The milestone is just part of a larger transition for the Boulder, CO-based biopharmaceutical company.

read all at

http://www.xconomy.com/boulder-denver/2013/07/03/array-starts-first-phase-3-trial-shifts-to-late-stage-development/

View original post