Sanofi, Joslin Diabetes Center enter collaboration
PARIS — A drug maker and a teaching and research affiliate of Harvard Medical School announced a new collaboration to promote the development of new medicines for the treatment of diabetes and related disorders.
Sanofi and Joslin Diabetes Center said their collaboration will "focus on four key areas within diabetes and related metabolic disorders to identify potential new biologics or small drug candidates for the treatment of late complications of diabetes and new insulin analogs with more targeted efficacy, [while] research will address the challenges of insulin resistance and personalized medicine, with the overall aim of improving the lives of people living with diabetes."
Under the terms of the agreement, Sanofi has options to commercialize the results of the research, while both parties will have access to intellectual property for internal research use. Financial details of the collaboration were not disclosed.
Pfizer: Phase-3 study of Xalkori met primary endpoint
NEW YORK — Pfizer announced the results of its late-stage clinical trial of Xalkori (crizotinib).
The drug maker confirmed that its Profile 1007 study met its primary endpoint, demonstrating that the drug significantly improved progression-free survival in previously treated patients with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer, compared with those treated with pemetrexed or docetaxel. The study also marked the first randomized phase-3 study in ALK-positive advanced NSCLC patients, Pfizer said.
"These results are important because they demonstrate, for the first time, that Xalkori is superior to standard chemotherapy in prolonging survival without progression in patients with previously-treated ALK-positive advanced NSCLC," said Mace Rothenberg, SVP clinical development and medical affairs for Pfizer’s oncology business unit. "This study provides further support for the precision medicine approach to drug development being taken at Pfizer by demonstrating how knowledge about the underlying genetic abnormalities within a cancer can be used to improve the standard of care for that disease."
FDA declines to approve Pfizer’s tafamidis meglumine
NEW YORK — The Food and Drug Administration has declined to approve a drug designed to treat a rare, progressive and fatal neurodegenerative disease.
The FDA issued a complete response letter to Pfizer pertaining to the company’s new drug application for tafamidis meglumine, requesting the completion of a second efficacy study to establish substantial evidence of effectiveness prior to an approval. The agency also has asked for additional information on the data within the current tafamidis NDA.
Tafamidis meglumine is a novel, investigational medication designed to treat transthyretin familial amyloid polyneuropathy, or TTR-FAP, in adult patients with symptomatic polyneuropathy to delay neurologic impairment. Currently, there is no FDA-approved treatment for this disease.
Pfizer said it will work with the FDA to address the content of the CRL.