Friday Five – The pharma week in review (16 April 2021)

We break down five of the week's most important news stories.

For more analysis of recent biopharma news, listen to the latest episode of The FirstTake Podcast here.

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Vaccine watch

  • US health agencies recommended pausing use of Johnson & Johnson's COVID-19 vaccine Ad26.COV.2 after six cases of cerebral venous sinus thrombosis (CVST) were identified in 6.8 million recipients
  • Read our five key takeaways here
  • Moderna said it has seen no similar side effects with its mRNA vaccine, adding that follow-up data shows sustained protection against COVID-19 at six months
  • Moderna also outlined plans for future vaccine development, both in relation to COVID-19 and other viruses
  • Reports suggested that as of next year the EU will move exclusively to procuring mRNA COVID-19 vaccines

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Mixed data for Sage, Biogen's tremor drug

  • Sage Therapeutics and Biogen reported that SAGE-324 was associated with a significant reduction in tremor score compared to placebo in patients with essential tremor, meeting the primary endpoint of the Phase II KINETIC study
  • However, roughly two-thirds of patients given the experimental oral drug, a next-generation positive allosteric modulator of GABAA receptors, had to titrate to a lower dose due to adverse events (AEs)
  • Sage and Biogen were notably upbeat about the results, while investors were decidedly less so, as the companies' shares finished the day down 5% and 2%, respectively.
  • Honing in on the most important takeaway message lies at the heart of this difference of opinion – more analysis here

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Safety fears could weigh on JAK use in atopic dermatitis

  • We surveyed 54 US dermatologists about potential future use of JAK inhibitors (currently under regulatory review) to treat atopic dermatitis
  • Around half of all dermatologists expect adoption of JAK inhibitors at moderate levels and a fifth of respondents at high/very high levels
  • Approval with labelling that references class-wide safety concerns associated with post-marketing study data for Pfizer's Xeljanz will have a material impact on adoption, with a majority of dermatologists suggesting the effect will be moderate-to-significant in severity

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AACR in focus

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Pressure grows on GSK

  • GlaxoSmithKline announced on Wednesday it is ending two Phase II studies evaluating the ICOS receptor agonist feladilimab as first-line therapy for metastatic head and neck cancer
  • The drug had been pushed into the trials on the strength of a promising, but small Phase I dataset – more here
  • Setback follows confirmation earlier this year that GlaxoSmithKline's Merck KGaA-partnered asset bintrafusp alfa failed in Phase III studies for NSCLC and biliary tract cancer
  • Together, these setbacks will significantly slow momentum for the company's aspirations to revive its oncology pipeline
  • The feladilimab setback coincides with a report in the Financial Times that activist hedge fund Elliot Management has built a multibillion-pound stage in GlaxoSmithKline amid suggestions that shareholders have become increasingly disillusioned with CEO Emma Walmsley

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