Inflarx GmbH, of Jena, Germany, said the first patient was dosed preventively in the phase II trial of IFX-1, a monoclonal anti-complement C5a antibody, in patients undergoing complex cardiac surgery. Read More
Remedy Pharmaceuticals Inc., of New York, said the FDA granted fast track designation to Cirara for the treatment of large hemispheric infarctions. Read More
Briefing documents the FDA released ahead of Thursday's Antimicrobial Drugs Advisory Committee meeting on Merck & Co. Inc.'s bezlotoxumab hint at the challenges in developing new antimicrobials. Medarex, now part of Bristol-Myers Squibb Co., developed the fully human monoclonal IgG1/kappa antibody and filed the first investigational new drug application for the biologic in 2005. Read More
HONG KONG – Catching up with international markets, China is unbinding its drug manufacturing licensing regime from the marketing authorization in a move aimed at revolutionizing the country's drug development space. Read More
After wrestling once again with what passes muster as abuse deterrence, two FDA advisory committees voted 9-6 Wednesday to recommend approval of Pfizer Inc.'s Troxyca ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment when alternative options are inadequate. Read More
SAN FRANCISCO – If there were any doubts that the drug pricing debate – exacerbated by recent political volleys – was a hot topic coming into this year BIO International Convention, they were surely dashed Tuesday afternoon during an increasingly animated fireside chat between recently named Celgene Corp. CEO Mark Alles and Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood. Read More
SAN FRANCISCO – Antimicrobial resistance, an agenda item gaining urgency and attention on the world stage, also gathered further attention at the BIO International Convention on Wednesday, where policy thinkers joined industry representatives in praising the recent publication of the U.K.-driven final Review on Antimicrobial Resistance (AMR). Read More
SAN FRANCISCO – Calling "unconscionable" the way some Alzheimer's disease (AD) trials have gone about enrollment and pointing to the misguided approach as a reason many experiments failed, University of Oxford neuroscience professor Simon Lovestone told a packed room at the BIO International Convention that studies have tested patients when "it's already too late." Read More
LONDON – Under pressure from the European Commission, industry and patients' groups, the EMA has solicited and published proposals for improving the way it regulates cell, gene and tissue therapies, with the aim of speeding approvals and expanding patient access. Read More
