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.

Wall Street pleased with Navidea’s second phase IIb interim analysis of imaging agent

Navidea Biopharmaceuticals Inc. shares (NYSE:NAVB) were trading at $2.46, up $1.19, or 93%, on upbeat news from the second interim analysis of its ongoing phase IIb study NAV3-31. Findings further back the company’s claim that imaging with Tc99m tilmanocept (Tc-Til) can provide robust, quantitative looks at healthy controls and in patients with active rheumatoid arthritis (RA). The checkup was designed to examine data from the third arm of the study in order to evaluate the magnitude of change of Tc-Til signal localized to RA-involved joints in patients before and after treatment with an anti-TNF alpha therapy, as well as to examine whether this change in localization, if any, can serve as an early, quantifiable predictor of treatment efficacy. Tc-Til combines a radioactive marker (technetium 99m) with a ligand (tilmanocept) for the CD206 receptor found on activated macrophages.

Kintor’s $240M IPO well received in Hong Kong; CEO says internal early stage R&D will be future focus

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. Kintor’s IPO is the fourth pre-revenue biotech IPO to be significantly oversubscribed since December, following Akeso Inc., Innocare Pharma Ltd. and Alphamab Oncology Co. Ltd., which saw oversubscription rates between 192.1 and 639.2 times. Kintor’s share price closed at HK$21.5 by the end of Friday, up 6.7% from its offer price.

Amygdala contains pain suppression circuit

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. The work, which was published in the May 18, 2020, online issue of Nature Neuroscience, gives new insights into the relationship between analgesia and anesthesia, and might help clarify the molecular underpinnings of the placebo effect.

Sunovion’s ‘off’ PD drug wins FDA approval

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.

Mammoth Biosciences, GSK team up on CRISPR-based COVID-19 test

Mammoth Biosciences Inc., of South San Francisco, and London-based Glaxosmithkline plc 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.

Holiday notice

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Amag, Amarin, Ampio, Astrazeneca, Bellerophon, Bristol Myers Squibb, Calcimedica, Contrafect, Correvio, Daiichi Sankyo, Dynavax, Geron, Glaxosmithkline, Hikma, Hoth, Incuron, Incyte, Innocan, Intercept, Jaguar Health, Leo, Molecular Templates, Navidea, Nektar, Ngio, Oncopeptides, Orphazyme, Psybio, Retinset, Roche, Samsung Biologics, Samumed, Seneca, Sinovac, Sunovion, Syndax, Tetraphase, Tiziana, Xeris