Daily Newsletter

01 September 2023

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Daily Newsletter

01 September 2023

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Spotlight

FDA issues guidance on using real-world data for drug development

The FDA has released final draft recommendations for using real-world data and evidence in drug development.

Latest news

Otsuka Pharmaceutical agrees to buy Mindset Pharma

The acquisition has received approvals from the boards of directors of both companies.

01 September 2023

Zerva acquires Acer Therapeutics to bolster rare disease portfolio

The $15m acquisition would give Zerva rights to Acer’s FDA-approved rare drug Olpruva.

01 September 2023

Signal: Novo Nordisk market cap higher than Danish GDP due to obesity drugs

Novo Nordisk's obesity drugs are driving Danish growth as well as record profits as the company becomes second-most valuable in Europe.

01 September 2023

Enhertu wins two FDA breakthrough therapy designations

Daiichi Sankyo and AstraZeneca’s blockbuster anti-cancer drug could become a pan-tumour drug, with projected sales of $9.9bn by 2029.

01 September 2023

Twist and Ono partner to develop antibodies for autoimmune diseases

Twist will obtain research fees at clinical and regulatory milestones based on success, and product sales royalties.

01 September 2023

Reset Pharma partners with Filament to license psilocybin drug

PEX010 is being assessed in several Phase I and II human clinical trials approved by the FDA and Health Canada.

01 September 2023

Huadong enters licence deal for MC2 Therapeutics’ Wynzora cream

Huadong will make upfront and regulatory milestone payments totalling $16m to MC2.

01 September 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.