BioCentury | Nov 23, 2020
Deals

Cytokinetics evaluating path forward for heart disease treatment after Amgen ends partnership

Cytokinetics is assessing whether to commercialize omecamtiv mecarbil on its own or to seek a new partner after Amgen returned the heart failure treatment’s rights, ending a 2006 deal. President and CEO Robert Blum told a...
BioCentury | Nov 20, 2020
Regulation

WHO counters FDA as it recommends against Veklury for COVID-19

The WHO’s new guidance counters FDA’s October approval of Gilead’s Veklury for hospitalized patients, adding to the debate around the drug’s use and variable performance in randomized, controlled trials. In The BMJ on Thursday, the WHO issued a...
BioCentury | Nov 20, 2020
Deals

Mesoblast rebounds from FDA setback by landing Novartis as partner to develop mesenchymal stromal cells

Eight weeks after a complete response letter for remestemcel-L sent its share price tumbling, Mesoblast has unveiled a partnership with Novartis to develop the mesenchymal stromal cell product, starting with  acute respiratory distress syndrome, including ARDS associated with...
BioCentury | Nov 17, 2020
Regulation

Another U-turn for COVID-19 testing regulation as HHS requires FDA to re-prioritize LDT review

The latest switchback in the U.S.’s regulation of COVID-19 tests sees HHS requiring FDA to review tests it previously said the agency lacked authority over, highlighting the challenge of pursuing a deregulatory agenda in the midst...
BioCentury | Nov 14, 2020
Deals

Innovation in a hurry: China biotechs see a fast track to global stage – survey

The Chinese biopharma landscape in five years will see a majority of the money magnet companies commanding innovation, with first-in-class targets filling their pipelines and innovative biologics outpacing...
BioCentury | Nov 13, 2020
Product Development

Cytokinetics sees path to market for omecamtiv mecarbil in more severe heart failure patients

Updated data from the Phase III GALACTIC-HF study of omecamtiv mecarbil show it may be particularly useful in a more severe subgroup of heart failure patients. The latest readout from Cytokinetics...
BioCentury | Nov 11, 2020
Product Development

Nov. 10 Quick Takes: Tezepelumab meets in asthma Phase III; plus a call for speedy trial results, updates on COVID vaccines from Sinovac, CureVac and more

AZ, Amgen rise on asthma dataTezepelumab from AstraZeneca plc (LSE:AZN; NYSE:AZN) and Amgen Inc. (NASDAQ:AMGN) met the primary endpoint of a statistically significant reduction in annualized asthma exacerbation...
BioCentury | Nov 10, 2020
Politics, Policy & Law

Bingham’s tenure with U.K. COVID vaccine task force drawing to a close

Kate Bingham will step down, as planned, as chair of the U.K. Vaccine Taskforce in the coming weeks. Bingham joined the COVID-focused task force in May shortly after its launch with a commitment to...
BioCentury | Nov 10, 2020
Regulation

EUA for Lilly, AbCellera COVID mAb despite Phase II miss for authorized dose

FDA’s first emergency use authorization for a SARS-CoV-2-targeting mAb covers the lowest dose of Lilly and AbCellera’s candidate to treat COVID-19 outpatients, a dose that was not effective in the Phase...
BioCentury | Nov 10, 2020
Product Development

New bar set by BioNTech, Pfizer COVID-19 vaccine could see swift influx of challengers

With interim COVID-19 vaccine efficacy data from BioNTech and Pfizer outstripping the field’s expectations, the results have set a high bar for what could be a rapid wave of readouts accelerated by surges...
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