AGC Biologics looks set to start making Orchard Therapeutics’ Libmeldy after an EMA panel recommended the gene therapy be approved. The agency’s the Committee for Medicinal Products for Human Use (CHMP) recommended approval last week, explaining Libmeldy (cryopreserved autologous CD34+ cells encoding the arylsulfatase-A, or ARSA, gene) slows down progression of the lysosomal storage disease, metachromatic leukodystrophy (MLD). Orchard CEO Bobby Gaspar welcomed the recommendation. He said it “brings us closer to delivering a one-time, potentially transformative therapy for eligible…

Regeneron says rapid response technologies pioneered to combat Ebola are helping accelerate efforts to create COVID-19 countermeasures. Last week Regeneron won US FDA approval for Inmazeb (atoltivimab, maftivimab and odesivimab-), its treatment for Zaire Ebola. The product is made from three monoclonal antibodies that target the Ebola glycoprotein, preventing the virus binding and infecting cells. Regeneron created Inmazeb using the same rapid response manufacturing platform it is currently using for RGEN-COV2, its COVID-19 treatment candidate. Shawn Lawrence, senior director, cell…

Johnson & Johnson says the pausing of dosing in trials of its COVID-19 candidate is not unusual, but one analyst believes this could have significant negative impact for viral-vector based vaccines. Johnson & Johnson announced at the beginning of the week it has temporarily paused further dosing in all its COVID-19 vaccine candidate clinical trials due to an unexplained illness in a study participant. This included the Phase III ENSEMBLE trial of JNJ-78436735, also known as Ad26.COV2-S, recombinant, which is…

SQZ Biotechnologies says its technology can produce cell therapies in less than 24 hours compared to a month or more for current products and is looking to use IPO proceeds toward the completion of Phase I development of its lead therapeutic candidate. In paperwork filed with securities regulators late last week, SQZ set a preliminary $75 million goal for its IPO. The Watertown, MA-based biotech has applied for a listing on the New York Stock Exchange under the stock symbol “SQZ.” SQZ…

Coronavirus-related constraints mean the US FDA has not yet inspected manufacturing facilities in Washington and Texas, risking a delay in the approval of Bristol-Myers Squibb’s lymphoma CAR-T candidate liso-cel. Bristol-Myers Squibb added anti-CD19 targeting lymphoma candidate lisocabtagene maraleucel (liso-cel) to its pipeline through the $74 billion acquisition of Celgene. In May, the action date of the Biologics License Application (BLA) for the chimeric antigen receptor (CAR) T-cell therapy was extended by three months by the US Food and Drug Administration…