 BioPharma Dealmakers
Science, strategy & innovation
Recent content exclusively made freely available to you
from Nature Biotechnology, Nature Reviews Drug Discovery and
Nature Medicine  Produced with support from TVG
| |
| Accelerated approval dust begins to settle
November, 2011
Nature Reviews Drug Discovery
In February this year the US Food and Drug Administration (FDA) and its Oncologic Drugs Advisory Committee (ODAC) met to discuss long-standing questions about the accelerated approval of anticancer drugs, such as the use of single-arm studies. For some, the meeting — as well as the agency's refusal to file Roche/Genentech's trastuzumab-DM1 and an ODAC vote to revoke accelerated approval for Roche/Genentech's bevacizumab for metastatic breast cancer — raised uncertainties about higher hurdles for the shorter approval route. But the recent accelerated approvals for Seattle Genetics' brentuximab vedotin and Pfizer's crizotinib have now restored confidence that the pathway remains open, say those watching from the sidelines.
Read the full story here
| |
| Bayer and Onyx settle over regorafenib
November, 2011
Nature Reviews Drug Discovery
Bayer and Onyx have settled their disagreement over ownership of regorafenib, a multi-receptor tyrosine kinase inhibitor that is in Phase III clinical trials for cancer.
The two companies began a partnership in 1994, which led to the discovery of sorafenib (Nexavar), also a multi-receptor tyrosine kinase inhibitor, which is marketed for the treatment of liver and kidney cancer. But in 2009 Onyx sued Bayer, alleging that Bayer tried to bypass the collaboration — and hence was trying to avoid sharing potential future profits — when developing regorafenib by surreptitiously filing patent applications and initiating clinical trials.
Read the full story here
| |
| Larger companies dominate cancer companion diagnostic approvals
November, 2011
Nature Biotechnology
Two novel cancer drugs and their companion diagnostics to predict treatment response were given a go-ahead to market in quick succession. On August 17, the US Food and Drug Administration (FDA) approved Roche/Genentech's Zelboraf (vemurafenib) and multiplex PCR-based diagnostic for the BRAF V600E gene for individuals with advanced melanoma harboring the mutation. Approval of Pfizer's drug Xalkori (crizotinib) for non-small cell lung cancer (NSCLC) patients with tumors containing anaplastic lymphoma kinase (ALK) gene structural variants, together with a fluorescent in situ hybridization (FISH) test for detecting rearrangements of the ALK gene, followed nine days later. Both Basel-based Roche and New York–based Pfizer claim the companion diagnostics used to screen tissue samples for the drugs' target mutations—by narrowing patient populations to likely responders—sped clinical trials and accelerated FDA approval. But other companies considering the approach remain uncertain about the economic feasibility of co-developing medicines with companion diagnostics.
Read the full story here
| |
SciBX: Science-Business eXchange
Recommend SciBX to your library today
SciBx is a weekly publication that identifies and analyzes the most important translational research articles from over 40 journals. Find out which papers have real scientific and commercial potential, and why. Subscribe to SciBX and you won't miss the next big thing.
For more information visit: www.nature.com/scibx | |
| You have been sent this Table of Contents Alert because you have opted in to receive it. You can change or discontinue your e-mail alerts at any time, by modifying your preferences on your nature.com account at: www.nature.com/nams/svc/myaccount
(You will need to log in to be recognised as a nature.com registrant).
For further technical assistance, please contact our registration department
For print subscription enquiries, please contact our subscription department
For other enquiries, please contact our feedback department
Nature Publishing Group | 75 Varick Street, 9th Floor | New York | NY 10013-1917 | USA Nature Publishing Group's worldwide offices: .London - Paris - Munich - New Delhi - Tokyo - Melbourne - .San Diego - San Francisco - Washington - New York - Boston
| | | |
No comments:
Post a Comment