Genentech and Pfizer urged the FDA in written comments to make its draft guidance on statistical analyses of analytical similarity data for biosimilars more specific and narrower in scope. Source:…
The FDA fleshed out its public numbers on ANDA approvals for the first month of GDUFA II, notably underscoring 26 first-cycle approvals, plus two tentative. Source: Drug Industry Daily
Many manufacturers are offering larger rebates on medicines, but in many cases patients do not share in the negotiated discounts, according to a new analysis from PhRMA. Source: Drug Industry…
Tudorza, also marketed as Eklira and Bretaris, is available in more than 50 countries. Source: BioSpace
Sanofi said the analysis showed more cases of severe disease could occur following vaccination in patients who had not been previously infected by the dengue virus. Source: BioSpace
Following FDA priority review, Repatha is the only PCSK9 inhibitor approved to reduce risk of heart attack, stroke and coronary revascularization. Source: BioSpace
A look at two life science companies that are expected to grow more than 67 percent over the next five years. Source: BioSpace
Today, Janssen Biotech announced it had exercised its option to enter into a collaboration deal with Idorsia to jointly develop and market aprocitentan and any derivative compounds. Source: BioSpace
The COO of Seattle Genetics, Eric Dobmeier, is leaving the company to helm Silverback Therapeutics. Source: BioSpace
Gilead will partner with three coordinating centers to lead the corporate giving program of the initiative. Source: BioSpace