BioSpace News Archive

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• 

  Christoph Schwaiger

  Christoph is a freelance journalist based in the Netherlands. He can be reached on LinkedIn.
• 

  Nick Paul Taylor

  Nick is a freelance writer who has been reporting on the global life sciences industry since 2008.
• 

  Editorial

  Eyes, Ears Get Their Due With Cell and Gene Therapy

  With promising early results, cell and gene therapies are making headway against both rare and common ocular and auditory diseases.

  September 3, 2024

   · 

  4 min read

   · 

  Heather McKenzie
• 

  COVID-19

  Novavax Catches Up to Competitors With FDA Approval for Updated COVID-19 Boosters

  Unlike Pfizer/BioNTech and Moderna, Novavax does not use mRNA technology for its COVID-19 vaccine, instead opting for a recombinant version of the virus’ spike protein to elicit protection.

  September 3, 2024

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Duchenne muscular dystrophy

  Dyne Touts ‘Unprecedented’ Dystrophin Expression in Phase I/II DMD Trial for Exon-Skipping Therapy

  The highly anticipated results come as the company makes significant changes to its C-suite. Despite the turnover, Dyne said it is looking toward expedited approval pathways for its DMD treatment.

  September 3, 2024

   · 

  3 min read

   · 

  Tristan Manalac
• 

  Clinical research

  Bayer’s Kidney Disease Drug Kerendia Reduces Cardiovascular Risk by 16%

  Bayer’s Kerendia, at the center of a $3 billion sales forecast, reduced the risk of cardiovascular death and heart failure in a Phase III trial.

  September 3, 2024

   · 

  2 min read

   · 

  Annalee Armstrong
• 

  Regulatory

  FDA Action Alert: Travere, Avadel and Roche

  The FDA has three regulatory milestones in the next two weeks, including a decision on a subcutaneous formulation of an effective multiple sclerosis therapy.

  September 3, 2024

   · 

  3 min read

   · 

  Tristan Manalac
• 

  Gene Therapy

  Beyond Rare Disease: Wet AMD Gene Therapy Could Reach Millions

  With gene therapies by REGENXBIO and AbbVie, Adverum and others in mid- or late-stage trials, this therapeutic class could soon be an option for this common cause of blindness in the elderly.

  September 3, 2024

   · 

  7 min read

   · 

  Kate Goodwin
• 

  Supply chain

  Novo’s Ozempic to Remain in Shortage Into Q4 as Supply Woes Continue

  Novo Nordisk’s continuing supply problems for semaglutide come as the pharma tries to expand the drug’s indication, opening it up to more patients—and potentially to heavier production pressures.

  September 3, 2024

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Multiple sclerosis

  Sanofi’s Tolebrutinib Misses Two of Three Late-Stage Multiple Sclerosis Readouts

  The BTK inhibitor showed promise in non-relapsing secondary progressive multiple sclerosis but not relapsing MS. The company said it plans to apply for approval for the former “as soon as possible.”

  September 3, 2024

   · 

  3 min read

   · 

  Tristan Manalac