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Takeda agrees on $2bn deal with Code Bio to expand its gene therapy programmes

The pharma company will gain opt-in rights for four rare diseases candidates

- PMLiVE

FDA rejects Takeda’s Eohilia after delays

After more than a year on ‘priority review’, the FDA has said it cannot approve Takeda’s budesonide oral suspension without a further clinical study

Roche Basel Switzerland

FDA approval for Roche diagnostic solid tumour test

Test will identify which patients could benefit from GSK immunotherapy.

Roche Basel Switzerland

FDA approval for Roche diagnostic solid tumour test

Test will identify which patients could benefit from GSK immunotherapy.

Improving Health Through Integrated & Personalized Patient Care

Hicham Naim, Global Head, Integrated & Personalized Patient Care Program, Digital Advisory Board at Takeda & Founder of Curated Health, explores digital medicine & biomarkers, outcomes-based business models, Software as...

Impetus Digital

- PMLiVE

FDA leaders offer perspective on accelerated approval of Biogen’s Aduhelm

Leaders maintain that Aduhelm fits into the regulatory paradigm of the FDA’s accelerated approval pathway

- PMLiVE

FDA questions safety profile of AZ, FibroGen’s anaemia drug roxadustat

AZ and FibroGen are aiming for approval of roxadustat in anaemia caused by chronic kidney disease

- PMLiVE

FDA acting commissioner Janet Woodcock requests independent review of Aduhelm approval

Approval of Biogen's Alzheimer's disease treatment has raised concerns over FDA staff interactions with the company

- PMLiVE

Pfizer, BioNTech eye US approval for COVID-19 booster dose

Companies plan to request an emergency use authorisation from the FDA for the booster dose in August

- PMLiVE

FDA advisory committee to review oncology accelerated approvals

Review comes after voluntary indication withdrawals for a number of cancer therapies

- PMLiVE

Takeda and KSQ Therapeutics to develop immune-based cancer treatments

Collaboration will utilise KSQ’s CRISPR-screening technology

Effects of the Pandemic on Evidence Generation & Scientific Exchange

Farah Husein, Director, Evidence Generation, Canadian Centre of Excellence, at Takeda, discusses all things evidence generation, including the impact of the COVID-19 pandemic on HEOR, RWE, epidemiology, and PRO studies and...

Impetus Digital

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