GlaxoSmithKline Submits New Melanoma Therapies

GlaxoSmithKline has submitted a Marketing Authorisation Application to the European Medicines Agency for trametininb as a monotherapy,and in combination with dabrafenib,for adult metastatic melanoma with a BRAF V600 mutation.The EMA granted GSK's request for accelerated assessment of the application.
The application contains data from two clinical trials of the therapies.
GSK initiated a randomised study early in the development programme to ascertain whether the combination therapy could circumvent resistance to single agent anti-BRAF melanoma therapy and were encouraged by trial results,said Dr.Rafa el Amado,Head of Oncology R and D.We are planning further submissions based on these data in the US and other countries in the coming months.
GSK had submitted applications for dabrafenib monotherapy to the EMA,and for trametinib monotherapy  to the US FDA,for BRAF V600 metastatic melanoma in August 2012.
Melanoma is the deadliest form of skin cancer and even kills numerous young people annually.
GlaxoSmithKline is one of the world's leading pharmaceutical and healthcare companies.London-based,it employs over 97,000 in more than 100 countries.
GlaxoSmithKline(GSK)

Pfizer Cancer Therapies Move Forward in Europe

The European Medicines Agency has accepted Pfizer's regulatory submissions for review of two investigational compounds.One of them,crizotinib,targets a form of advanced non-small cell lung cancer(NSCLC);the other,bosutinib,is aimed at newly diagnosed chronic myeloid leukemia.Both compounds are believed to inhibit signaling in cancer cells that allows them to grow,survive and reproduce.
Pfizer Oncology says its pipeline is focused on identifying and translating the best scientific breakthroughs into clinical applications across a wide range of cancers.It has biologics and small molecules in clinical development and more than 100 clinical trials underway.
With its wide array of research partners,ranging from individual researchers to academic institutions,Pfizer Oncology strives to deliver the right drug for each patient at the right time to cure or control cancer.
Pfizer is listed on the London and New York stock exchanges under the ticker symbols PFZ and PFE,respectively.CEO Ian Read heads the New York-based company.

Pfizer Acquires Biotech Firm

Pfizer,a world-leading drug producer and marketer,is to acquire FoldRx,a privately held company that specializes in innovative oral medicines to treat diseases caused by protein misfolding.Protein misfolding is increasingly considered an underlying cause of many chronic degenerative conditions.FoldRx's main candidate,tafamidis,is registered as an oral therapy for TTR amyloid polyneuropathy,or ATTR-PN,a progressively fatal genetic neurological disorder.The biotech firm has filed a marketing application for tafamidis with the European Medicines Agency,and the drug has been fast-tracked by the FDA.
To this point,only liver transplants have been available to treat ATTR-PN.Liver transplants are not uniformly effective and are often fatal in their own right.At least 8,000 patients worldwide have ATTR-PN,most of them in the European Union.
TTR is a liver protein that,when defective,gets lodged in peripheral nerve tissue,causing neurological disorders such as ATTR-PN.
FoldRx's small molecule therapeutics,based on proprietary expertise,are also being applied to a discovery program in cystic fibrosis,Parkinson's and Huntington's diseases.Pfizer sees the acquisition of FoldRx as a way to bolster its rare disease portfolio and assist the patients with its medical,administrative,manufacturing and marketing proficiencies.
Pfizer(PFE)