Despite assembling the largest body of data the FDA said it may ever see for a drug intended to treat anemia due to chronic kidney disease, Fibrogen Inc. will have to get even more trial data to push roxadustat over the finish line in the U.S. – if the FDA follows the advice of its Cardiovascular and Renal Drugs Advisory Committee. Read More
Members of the California Technology Assessment Forum (CTAF), an independent appraisal committee of the Institute for Clinical and Economic Review (ICER), discussed – and voted on – the safety vs. efficacy and other aspects of Biogen Inc.’s embattled Aduhelm (aducanumab), the amyloid beta-targeting therapy recently approved for Alzheimer’s disease. It didn’t go well for Biogen. Read More
Private biopharma investment in 2021 continues to outpace that of the past two years as two gene therapy companies, Shape Therapeutics Inc. and Kriya Therapeutics Inc., posted series B financings this week totaling more than $200 million. Read More
Innovent Biologics Inc. and Ascentage Pharma Group Corp. Ltd. inked a three-component collaboration that comes with joint commercialization of an NDA-stage Bcr-Abl inhibitor and co-development of combination therapies, as well as Innovent taking a stake in Ascentage. The collaboration involves a deal worth up to $145 million and a $50 million investment. Read More
Cancer Research UK took a significant hit when its U.K.-wide charity shop chain had to close last year because of the pandemic. But, according to latest figures, its commercial arm could help it to bounce back after seeing its income more than double in the recent biotech boom. The organization reported record levels of investment in its spinout companies, which more than doubled in 2020-2021 compared with the previous year, jumping from £400 million (US$555 million) to £822 million (US$1.14 billion) Read More
Paq Therapeutics Inc. closed a $30 million series A round to take forward a novel approach to the targeted degradation and removal of a wide range of molecular substrates and defective organelles by developing drug molecules that can tap into autophagy, the cell’s general waste disposal and recycling system. Read More
LONDON – The message that COVID-19 is a disease of the elderly needs to change, according to U.K. researchers who have analyzed complications suffered by 73,197 patients admitted to 302 hospitals in the first wave of the pandemic last year. Read More
South Korea plans to create a bio data dam, a step toward generating the necessary industrial ecosystem in the country’s bid to become one of the top seven players in the global medical device market by 2025. Read More
The China NMPA’s Center for Drug Evaluation accepted Lepu Biopharma Co. Ltd.’s new drug application (NDA) for anti-PD-1 antibody candidate HX-008 (pucotenlimab). That comes after the company filed for an IPO in Hong Kong. Read More
The FDA took Amgen Inc. to task for promotions claiming Neulasta (pegfilgrastim) Onpro on-body injector is more effective than pegfilgrastim delivered via a prefilled syringe. Read More
10x Genomics Inc. launched its latest platform for single-cell analysis, the Chromium X Series, to cost-effectively "enable massively large-scale experiments," according to the company. Read More
New hires and promotions in the biopharma industry, including: Adicet, Aerie, Antag, Autolus, Celsion, Curative Biotechnology, Nervgen, Neximmune, Oligomerix, Oxford Biomedica, T-cypher. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Briacell, Cohbar, Cyxone, Escient, Kineta, Madrigal, Sirnaomics. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alkeus, Antengene, Immunitybio, Kintor, Qualigen, Ryvu, Sesen. Read More
