Daily Newsletter

31 August 2023

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Daily Newsletter

31 August 2023

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Spotlight

FDA shuns Outlook Therapeutics with wet AMD drug BLA rejection

Shares in the company dropped by 80% following the FDA issued a CRL for its bevacizumab formulation.

Latest news

Roche wins first approval for subcutaneous Tecentriq

The subcutaneous formulation of Tecentriq has been approved in the UK for all indications that its intravenous counterpart has received approval.

31 August 2023

Pfizer and BioNTech’s Covid-19 vaccine gains CHMP recommendation

The recommendation is based on the safety data from studies of the companies’ previous Covid-19 vaccines.

31 August 2023

FibroGen’s pamrevlumab disappointing results marks second failure in a row

The Phase III trial for FibroGen’s antibody candidate failed to meet its primary endpoint in children with Duchenne muscular dystrophy.

31 August 2023

Signal: Apellis sheds staff weight plus R&D in a bid to restructure company

Apellis aims to attain long-term success and focus on star candidate Syfovre by trimming staff and cutting costs.

31 August 2023

Codagenix pursues RSV vaccine development amid unexpected challenges

Codagenix faces a late 2024 data readout following enrollment challenges in its paediatric RSV vaccine Phase I study.

31 August 2023

Novo Nordisk acquires Embark and lead asset metabolic programme

Novo Nordisk has an option to acquire selected assets of Embark’s discoveries in obesity and type 2 diabetes.

31 August 2023

Serina Therapeutics to merge with subsidiary of AgeX

The combined company will advance Serina’s lipid nanoparticles and antibody drug conjugates by collaborating with other partners.

31 August 2023

mRNA vaccines represent >40% of the authorized/approved COVID-19 vaccines and boosters in the 7 major pharmaceutical markets

There are currently 13 authorized/approved COVID-19 vaccines in the 7 major pharma markets. Currently, vaccine developers plan to launch updated boosters prior to the upcoming 2023 fall season to target the latest dominant strain, Omicron XBB.1.5. Per GlobalData analysis, mRNA vaccines will likely continue to dominate the market, though as the pandemic winds down, the global COVID-19 vaccines market is expected to decline.