In this week’s news, Biden’s proposed FDA Commissioner backed by Senate, industry seeks clarity on gene therapy regs and more.
US Senate gives Califf nod for second stint as FDA commisioner
The US Senate has voted to advance Robert Califf nomination as commissioner of the US Food and Drug Administration (FDA).
The hearing – available online here – saw Califf announce that his priority would be emergency preparedness and response to the COVID-19 pandemic. He also said he planned to enhance the agency’s ability to keep up with advances in science and technology.
Gene therapy firms seek clarity on FDA draft guidance
The industry has asked the FDA to clarify draft guidelines on the development of cell and gene therapies.
The request was made in response to the guidelines that were published in the US FDA in September. Many of the comments focused on agency proposals for “umbrella trials” in which multiple versions of a gene therapy could be examined in a single study.
Pharma and CDMOs need time to meet CARES Act reporting regs
Drug firms and CDMOs have asked for more time to set up the technologies needed to comply with manufacturing volume reporting rules in the Coronavirus Aid, Relief, and Economic Security Act, (CARES Act).
Industry groups sought the extension this week, calling for another extension to the implementation of reporting rules which are due to come into force next month.
Under the CARES Act, manufacturers of finished dosage forms, API suppliers, over-the-counter drug and animal drug suppliers are required to report the amount of each drug manufactured, prepared, propagated, compounded or processed for commercial distribution each year.
Also in the news
Fierce Pharma looked at FDA efforts to reduce its inspection backlog in 2022.
STAT spoke with the agency about efforts to bring cell and gene therapy reviews back up to speed after two years of disruption caused by the pandemic.
Arrowhead Pharmaceuticals has acquired land at the Verona Technology Park in Verona, WI, and plans to build a drug plant. The site will support development and commercialization of the firm’s range of RNAi-based drugs.
COVID-19 vaccine production is causing shortages of other medicines required by hospitals, according to a report by Inside Health Policy, which reports that manufacturers are prioritizing jabs to the detriment of other much needed drugs
Industry group EFPIA was unimpressed by EU efforts to prevent drug shortages according to a report by the Pink Sheet.
Some developments of note in the contracting sector:
Continuus Pharmaceuticals has hired Skanska to build a pharmaceutical manufacturing facility in Woburn, Massachusetts, USA.
Curia, previously AMRI, has launched a range of messenger RNA (mRNA) production and development services. The firm said the “extraordinary impact of mRNA on the COVID-19 pandemic” prompted the move. See press release.
Novo Holdings, which is owned by the Novo Nordisk Foundation, will buy sterile pharmaceutical manufacturer Ritedose. The deal will include the latter’s blow-fill-seal technology and range of generic drugs.
Novavax has expanded its deal with SK bioscience with respect to NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine. SK bioscience will reserve significant additional manufacturing capacity for the product through 2022.
Optimvia and Ginkgo Bioworks have teamed up to improve the manufacturing efficiency of biosynthetic heparin. The deal will focus on Ginkgo’s cell and enzyme engineering platform and process development services.
Rentschler Biopharma plans to hire additional manufacturing employees at three of its production sites.
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