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- PMLiVE

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EC approves Otsuka and Astex’s Inaqovi for acute myeloid leukaemia

Inaqovi is the first oral hypomethylating agent approved for this patient population

Biomarin

BioMarin announces first patient dosed with haemophilia A gene therapy in Europe

The therapy was granted conditional marketing authorisation by the EC in August 2022

- PMLiVE

Merck receives EC approval for Keytruda combination in gastric cancer

Over one million new cases of gastric cancer were diagnosed globally in 2020

- PMLiVE

Roche’s spinal muscular atrophy therapy Evrysdi approved by EC for newborns

The neuromuscular disease affects approximately one in every 10,000 babies

- PMLiVE

Pfizer’s RSV vaccine granted EC approval to protect infants and older adults

The decision allows Abrysvo to be given to those who are 24 to 36 weeks into their pregnancy

- PMLiVE

Bristol Myers Squibb’s Opdivo approved by EC for expanded melanoma use

The global incidence of skin cancer has been rising steadily over the past few decades

- PMLiVE

Janssen’s Tecvayli approved by EC for reduced dosing frequency in multiple myeloma

Tecvayli was the first BCMA-targeting bispecific antibody to be approved in Europe

- PMLiVE

Janssen’s Talvey granted FDA accelerated approval for difficult-to-treat blood cancer

The therapy showed an overall response rate of more than 70% in a broad range of patients

- PMLiVE

Johnson & Johnson’s attempt to resolve talcum powder lawsuits fails a second time

The company’s subsidiary LTL Management is set to appeal the court’s decision

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EMA reports actions to improve EU clinical trials conducted during health emergencies

All proposed actions will be acknowledged by the European Commission, EMA and member states

- PMLiVE

Janssen receives positive CHMP opinion for Talvey in multiple myeloma

More than 50,900 people in Europe were diagnosed with multiple myeloma in 2020

- PMLiVE

Johnson & Johnson sues US government over Medicare drug price negotiation programme

The IRA allows Medicare to negotiate lower prices for a selected group of medicines

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