By Barbara Obstoj-Cardwell
Among last week’s notable news, US biotech firm bluebird bio revealed a double whammy on Wednesday, when it announced a US Food and Drug Administration clinical hold on its gene therapy Skysona (eli-cel) as well as its decision to pull out of Europe because of difficulties in gaining reimbursement for its products. AstraZeneca and partner FibroGen suffered a setback with the FDA issuing a complete response letter (CRL) on their anemia of chronic kidney disease candidate roxadustat. On the deal-making front, US biotech Seagen last week announced a licensing agreement with China’s RemeGen to develop disitamab vedotin as a treatment for various cancers, worth up to $2.2 billion. mRNA specialist Moderna released new data showing its COVID-19 vaccine Spikevax generated neutralizing antibodies against variants.
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