Friday Five – The pharma week in review (23 April 2021)

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

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

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Europe gives the go-ahead for J&J's COVID-19 vaccine

  • The overall benefits of Johnson & Johnson's COVID-19 vaccine outweigh any risks associated with 'very rare' side effects, the EMA concluded this week. 
  • With a decision expected shortly, will the FDA follow suit? – 77% of infectious disease experts we surveyed said the agency was right to pause use of the vaccine in the US.
  • But 70% concede that confidence in Johnson & Johnson's vaccine will have been eroded as a result.

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Bluebird bio's wings clipped in Europe

  • The company said it will withdraw its transfusion-dependent β-thalassaemia (TDT) gene therapy Zynteglo from the German market following failed reimbursement talks.
  • As a result, bluebird has been forced into a restructuring with an undisclosed number of European job cuts pending (though to be around 30% of regional staff).
  • The setback will sharpen focus on potential commercialisation challenges of gene therapies outside of the US and bluebird’s proposed decision to split into two companies.

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Vertex takes lead in gene editing collaboration with CRISPR

  • Against this backdrop, Vertex Pharmaceuticals will pay CRISPR Therapeutics $900 million to amend an existing partnership giving it majority control over development and marketing of the experimental CRISPR/Cas9-based gene-editing therapy CTX001.
  • CTX001 is being developed as a curative therapy for sickle-cell disease (SCD) and transfusion-dependent beta-thalassaemia (TDT).
  • Vertex is under pressure to diversify its R&D pipeline, which is heavily focused on cystic fibrosis. Doubling down on CTX001 may suggest another pipeline asset being developed for the rare condition of alpha-1 antitrypsin deficiency (AATD) is stuck in a holding pattern.

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Pandemic and biosimilars drive contraction in Roche's Q1 revenues

  • Roche saw its pharma sales decline 14% year-on-year to $11.5 billion in Q1 with the COVID-19 pandemic and biosimilar erosion to legacy cancer franchises notable headwinds.
  • The company said the underlying performance of new growth driver brands such as Ocrevus, Hemlibra and Tecentriq was strong and the impact of biosimilar competition and COVID-19 would recede over the course of 2021.
  • As a result, Roche maintained its full-year guidance of percentage revenue growth in in the low- to mid-single digit range.

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Opdivo in driver's seat in early-stage lung cancer, says expert

  • A leading key opinion leader told FirstWord this week that he expects Bristol Myers Squibb's Opdivo to show a survival advantage as neoadjuvant therapy for non-small-cell lung cancer (NSCLC) when more data from CheckMate-816 are revealed.
  • The company recently unveiled promising data showing that 24% of patients treated with Opdivo and chemotherapy achieved pathological complete response (pCR) versus 2.2% of those treated with chemotherapy alone.
  • Expert says recent rejection of Merck & Co.'s Keytruda in early-stage triple-negative breast cancer by the FDA provides important context, but immunotherapy known to work better in lung cancer.

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