Following a public backlash to Monday’s news that the FDA had granted Gilead Sciences Inc. an orphan drug designation for remdesivir, an antiviral in development to treat COVID-19, the Foster City, Calif., company is taking the unprecedented step of rescinding its request for the designation.
At the beginning of this week, the digitally-delivered Bio-Europe Spring 2020 conference launched with 6,000 partnering meetings, 45 company presentations, more than 50 virtual exhibits and 12 panel discussions scheduled.
HONG KONG – Singapore-based Proteona Pte. Ltd. has formed a couple of significant partnerships recently, including a Germany-Singapore partnership to develop a drug screening and discovery platform using single cell multi-omics analysis for patient-derived micro-tumors, and an international alliance to develop antibodies against coronaviruses.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Daiichi, EMD, Exelixis, Gilead, Infinity, Intrabio, Sumitomo, Takeda, Valneva.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allakos, Avadel, Cassava, Diffusion, Eloxx, Immutep, Lundbeck, Mind Medicine, Onconova, Opko.
BEIJING – Shanghai Junshi Biosciences Ltd. is developing neutralizing antibodies as a potential treatment for COVID-19, and the program will move on to clinical trials soon. Meanwhile, the biotech is set to launch a pre-revenue IPO on Shanghai’s STAR market.
The pressure is rising on the Trump administration to activate the Defense Production Act (DPA) for the COVID-19 outbreak as the Senate yet again reconsiders an economic stimulus package. Sens. Brian Schatz (D-Hawaii) and Chris Murphy (D-Conn.) unveiled the Medical Supply Chain Emergency Act in an effort to force the White House to mandate the production of needed supplies, a bill that is likely to languish until Congress can move on economic relief legislation.
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