Can “Novel-Novel” Drug Development Work? Deals Of The Week Considers Merck’s New Play
Partnering its PD-1-specific antibody candidate with three other companies, Merck indicates a new era may have arrived for testing novel agents in combination. Also, NIH partners with 10 biopharmas to transform the discovery model and Myriad moves to buy Crescendo.
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AMAG adds to its commercial and technological capabilities with a buyout of Cord Blood Registry. Meanwhile, ramifications of the GSK/Novartis asset swap from March continue, with GSK divesting a pair of vaccines to Pfizer, while Novartis acquires Australian biotech Spinifex.
The big pharma will establish a new oncology unit focused on bringing its anti-PD-1 immunotherapy MK-3475 to market as part of a massive R&D overhaul aimed at lowering costs while driving innovation. Merck isn’t one of the industry’s leading oncology players and may not have as much R&D expertise in the area as rivals, but it might not ultimately matter – as long as MK-3475 gets to market.
In a final guidance on co-development of two or more investigational new drugs for use in combination, FDA lays out general principles for IND and marketing application submissions, a topic on which the agency essentially punted in a December 2010 draft document.