Given all the public-private partnerships responding to the need for timely COVID-19 therapies, diagnostics and vaccines, the demands to forgo patents or exclusive licenses for coronavirus products and the clamor that industry shouldn’t “profit” from U.S. taxpayer-supported research are growing louder.
DUBLIN – Sanofi SA and Glaxosmithkline plc are lending their considerable weight to the urgent global effort to develop a vaccine for COVID-19 by teaming up to develop an adjuvanted recombinant subunit vaccine that will employ technologies from each company. Paris-based Sanofi is contributing its recombinant spike protein antigen and its baculovirus expression system, which is also the basis of its U.S.-licensed influenza vaccine Flublok. London-based GSK is contributing its pandemic adjuvant technology.
After plunging dramatically at the beginning of the month, biopharmaceutical equities appear to be recovering some of the valuation they originally lost when the financial markets cratered. As the curtain closed on a very turbulent month that most investors will want to forget, the BioWorld Biopharmaceutical index finished up 0.75%, but down about 2% for the year.
As if the FDA doesn’t have enough on its hands with COVID-19, Monday is deeming day. That’s the day nearly 100 drugs approved via new drug applications (NDAs) are to be deemed biologics, courtesy of the 2010 Biologic Price Competition and Innovation Act (BPCIA).
PERTH, Australia – Australian digital health company Resapp Health Ltd. was down nearly 52% following news that the U.S. FDA rejected its de novo request for its smartphone application for the diagnosis and management of respiratory disease. The agency rejected the application, citing the need for additional information to demonstrate that the “clinical benefits of the device outweigh the risks,” CEO Tony Keating told analysts during a March 12 conference call on the news.
“For those of us who believe in a free market, it is really important that the market works well,” FDA Commissioner Stephen Hahn said March 9 at a public workshop on ensuring a U.S. biologic marketplace that includes sustainable biosimilar and interchangeable competition.
Paris-based Sanofi SA won FDA clearance of the intravenously given CD38-directed cytolytic antibody Sarclisa (isatuximab-irfc) in combination with pomalidomide (Pomalyst, Celgene Corp.) and dexamethasone (dex) for adults with multiple myeloma (MM) who have received at least two prior therapies, including lenalidomide (Revlimid, Celgene Corp.) and a proteasome inhibitor.
SAN DIEGO – At Biocom's 10th Annual Global Life Sciences Partnering Conference, a panel of players intimately familiar with last year's approval of myelofibrosis treatment Inrebic (fedratinib) explained the backstory of how they got the JAK2 kinase inhibitor off an FDA clinical hold, wrangled the rights to the drug back from the big pharma owner that had acquired the drug from Targegen Inc. and eventually helped the drug gain FDA approval after selling the rights to another large company.
Paris-based Sanofi SA, responding to increasing medicine shortages and drugmakers' heavy reliance on active pharmaceutical ingredients (APIs) sourced from Asia, said it plans to create a major new API manufacturer headquartered in France.
Paris-based Sanofi SA, responding to increasing medicine shortages and drugmakers' heavy reliance on active pharmaceutical ingredients (APIs) sourced from Asia, said it plans to create a major new API manufacturer headquartered in France.
