Latest From Brenda Sandburg
Pilot program aims to examine applications for COVID-19 products subject to approval by FDA within 6 to 12 months; the prioritized examination is available solely for small entities and would save them $2,000.
FDA experts say there is deep bench in CDER and CBER to tackle review questions while directors Janet Woodcock and Peter Marks help lead Operation Warp Speed; regulatory community is 'reassured' they will oversee advancement of COVID-19 therapeutics and vaccines.
As World Health Assembly prepares resolution for voluntary pooling and licensing, Novartis global head of IP Corey Salsberg discusses how intellectual property is advancing development of therapeutics and vaccines and the benefits of voluntary rather than compulsory licensing;
FDA’s Peter Marks and Janet Woodcock will be on the bridge for Operation Warp Speed; Moncef Slaoui says early clinical data on one vaccine candidate makes him confident that a few hundred million doses of a vaccine can be available by the end of the year.
President Trump's Operation Warp Speed initiative aims to have a COVID-19 vaccine available by the end of the year; Slaoui, who helped get the first cervical cancer vaccine to market and win European approval of the first malaria vaccine while at GlaxoSmithKline, is tasked with coordinating the government's contributions to coronavirus vaccine effort and achieving what would be twin scientific and manufacturing miracles.
While former Sandoz and Heritage execs were charged in the government's generic price-fixing probe, Apotex and its employees will apparently escape such fate if they abide by the terms of DOJ agreement; company admits to fixing price of pravastatin and agrees to pay $24.1m criminal penalty.