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Top Stories Wednesday, July 6, 2016 Seres Therapeutics is putting the first synthetically created designer microbiome therapeutic into the clinic in order to reach larger markets. Thursday, July 7, 2016 BioMarin has long been rumored to be a takeout candidate. Roche, in particular, has before been highlighted as a potential suitor for it. Now, that rumor has popped up again--sending the biotech’s shares climbing fast with it. Thursday, July 7, 2016 Amicus Therapeutics, which has seen an FDA delay on one hand and a key European approval on the other over the past year, has gained access to a new, early-stage genetic disease program from its buyout of MiaMed. Thursday, July 7, 2016 Confidentially, EMA head Guido Rasi has said that a move from the U.K. to leave the EU was “a nightmare with immediate consequences,” although publicly the regulator has been keen to dampen concerns from behind a wall of silence. Thursday, July 7, 2016 Ablynx has posted Phase IIb data showing its anti-IL-6R antibody vobarilizumab can compete with Roche’s rheumatoid arthritis drug Actemra. But, with vobarilizumab failing to blow Actemra out of the water in terms of efficacy, doubts remain about whether AbbVie will take up its option on the drug. | | | KaloBios has signed a deal with former exec Martin Shkreli which allows the biotech the ability to repurchase his shares, as well as provisions that significantly restrict his actions as a shareholder. Statement Californian biotech Ionis Pharmaceuticals has posted positive clinical data for IONIS-TTR Rx at the XV International Symposium on Amyloidosis. Release Alexion has published new data at the ICNMD conference from its Phase III REGAIN study of its rare disease treatment eculizumab in patients with refractory generalized myasthenia gravis, showing the drug missed its primary endpoint. Statement ArmaGen and the Rett Syndrome Research Trust have signed a pact to develop a new treatment for Rett syndrome. Release Puma Biotechnology has released data from the I-SPY 2 Phase II study of its experimental breast cancer med neratinib in the NEJM. Statement | |
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Resources Sponsored by: SDC Interested in intended use validation of SaaS-based EDC systems? Prefer to discuss rescue study strategies and considerations? How about understanding statistical power for non-statisticians? Vote for your favorite webinar topic to be presented by SDC at DIA on June 28, 2016, 12pm EDT. Cast Your Vote Here to receive your exclusive event invitation and a recording of the webinar after the event. Sponsored by: Covance Al Blunt, MD, Executive Medical Director, Oncology at Covance discusses how the lessons learned from the past decade of developing targeted therapies are relevant to the future development of cancer immunotherapy. Download today! Sponsored by: Veeva Systems Gartner research on short- and long-term strategies for IDMP compliance. |
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