BioCentury | Oct 30, 2020
Distillery Therapeutics

KSP as a neuroblastoma target

...kinesin KSP could treat neuroblastoma, a pediatric sympathetic nervous system malignancy. In neuroblastoma patients, high KSP...
...in tumors was associated with high-risk neuroblastoma, advanced tumor stage and poor overall survival. Two KSP...
...an oral inhibitor of KSP, in Phase I testing for solid tumors.TARGET/MARKER/PATHWAY: Kinesin spindle protein (KSP; Eg5; KIF11)EXPERIMENTAL...
BioCentury | Oct 27, 2020
Product Development

Oct. 26 Quick Takes: COVID trips up Spectrum’s Rolontis at FDA; plus Jazz-SpringWorks, Novartis’ iptacopan, Kantaro, Eternygen

Delay for Spectrum due to COVID-19 travel restrictionsSpectrum Pharmaceuticals Inc. (NASDAQ:SPPI) said FDA is deferring action on the company’s BLA for its Rolontis eflapegrastim because the agency was unable to inspect Hanmi Bioplant, the drug substance...
BioCentury | Oct 24, 2020
Regulation

Advice now, consent later, on COVID-19 vaccines

FDA’s Oct. 22 vaccines advisory committee meeting was principally intended to reassure the public that career staff will make decisions about COVID-19 vaccines and will not be influenced by political preferences or timetables. A second...
BioCentury | Oct 21, 2020
Regulation

Ethics arising from EUAs could disrupt COVID-19 vaccine trials

FDA and its vaccines advisory committee are facing ethical and practical conundrums that, unless they are resolved quickly, threaten to undermine the development of COVID-19 vaccines. The most pressing challenge centers on whether it is...
BioCentury | Oct 17, 2020
Politics, Policy & Law

Getting FDA back on track

Regardless of the outcome of the elections, FDA is likely to have a new commissioner next year, one who will step into a leadership vacuum that is exhausting the agency’s supply of credibility and...
BioCentury | Oct 8, 2020
Product Development

Next up for Cytokinetics: readout in CV setting that sparked BMS’s $13B MyoKardia takeout

Pivotal heart failure data 14 years in the making tripped up Cytokinetics and Amgen Thursday, leaving the former company looking ahead to 1H21 to complete enrollment for another Phase III study of omecamtiv mecarbil. Its next hope is the...
BioCentury | Oct 3, 2020
Product Development

How virtual drug launches could change the biopharma industry

The move to digital launch models that emerged during the pandemic is likely to permanently change the way biopharma companies approach new drug sales, with knock-on effects for partnering trends and pipeline...
BioCentury | Aug 15, 2020
Regulation

Cell therapy’s outlook brightens as Mesoblast clears ODAC hurdle

Mesoblast is looking ahead to Ryoncil’s Sept. 30 PDUFA date after ODAC panelists shrugged off FDA reviewers’ concerns over assays and backed approval of the stem cell therapy. Mesoblast Ltd. ( ASX:MSB;...
BioCentury | Aug 14, 2020
Product Development

Data Bytes: breaking down authorized COVID-19 tests

In the space of six months, at least 369 tests for COVID-19 received CE Mark or Emergency Use Authorization around the world. About a third of the tests (31%) provide information about past exposure by...
BioCentury | Aug 13, 2020
Emerging Company Profile

RA-incubated Aerovate to deploy $72.6M series A for inhaled imatinib for PAH

Aerovate emerged from RA Capital’s incubator last week with a $72.6 million series A round to support clinical testing of an inhaled dry powder formulation of imatinib for PAH that’s designed to avoid the systemic...
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