Scaling up to manufacture a massive volume of a COVID-19 vaccine, drug or innovative device that’s still in early stage development is easier said than done, especially in a global pandemic that has the supply chain stretched beyond capacity. Read More
LONDON – Human challenge specialist Open Orphan plc has raised £12 million (US$14.6 million) in a placing to accelerate development of COVID-19 challenge study models, to meet demand from vaccines and therapeutics developers worldwide. Read More
Navidea Biopharmaceuticals Inc. CEO Jed Latkin said positive findings from the second interim analysis of the phase IIb study called NAV3-31 “were certainly better than what we were looking for” and will “make our partnering discussions a lot more interesting.” Read More
Nearly four years after differences between U.S. and Russian clinical results derailed an NDA for its pregnancy prevention candidate, Phexxi, San Diego-based Evofem Biosciences Inc. has prevailed, winning FDA approval today for the vaginal pH regulator. Read More
Researchers at Duke University have identified a region in the central amygdala – more often thought of as a processing hub for emotions – that could suppress pain when activated. Read More
BEIJING – Androgen receptor (AR)-related disease specialist Kintor Pharmaceutical Ltd., of Suzhou, China, raised $240 million on the Hong Kong Stock Exchange (HKEX) on May 22 by issuing 92.3 million shares at HK$20.15 apiece. The IPO was oversubscribed by 551 times, showing the city’s biotech fever. Read More
Sunovion Pharmaceuticals Inc.’s apomorphine sublingual film (APL-130277), a dopamine agonist the company will market as Kynmobi, has won FDA approval for the acute intermittent treatment of motor fluctuations (off episodes) associated with Parkinson’s disease. Read More
Mammoth Biosciences Inc., of South San Francisco, and London-based Glaxosmithkline plc (GSK) have joined forces to develop a point-of-care test to detect active COVID-19 infections using Mammoth’s CRISPR-based DETECTR platform. The two companies hope to submit an application to the U.S. FDA for emergency use of the test before the end of the year. Read More
BioWorld looks at translational medicine, including: SIRPa blockade wakes up macrophages post-infection; Lasting immunity to SARS-CoV-2 looks possible; Atherosclerosis, AD meet at the myelin; T cell aging induces broad senescence; P53 loss leads to immune evasion; Early roots of ALS visible in teeth; SLAPping down MDR gram-negatives; ALK is candidate thinness gene; Can N-BPs become MVP again? Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Boehringer, Daiichi, Geron, Incuron, Incyte, Leo, Navidea, Nektar, Oncopeptides, Retinset, Roche, Samumed, Syndax, Xeris. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apellis, Astrazeneca, Beigene, Bluebird, BMS, Daiichi, Evofem, Geron, Intercept, Orphazyme, Sunovion. Read More
Of the 160 biopharma deals tracked by BioWorld during the month of April, 36% are for collaborations focusing on the development of therapeutics and vaccines for COVID-19. Read More
