Pharmafile Logo
T40 2022 Cover
Diversity, Equity and Inclusion
Communiqué 53 Cover Image
- PMLiVE

Trelegy

EU flag

EMA endorses digital measure as primary endpoint in Duchenne muscular dystrophy trials

The decision qualifies SV95C as an alternative to the widely used six-minute walking test

EU flag

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

Roche’s spinal muscular atrophy therapy recommended by CHMP for newborns

Evrysdi is already approved in the EU to treat SMA patients aged two months or older

- PMLiVE

Bristol Myers Squibb’s Opdivo recommended by CHMP for expanded melanoma use

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

- PMLiVE

Merck granted positive CHMP opinion for Keytruda combination in gastric cancer

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

- 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

Sandoz granted positive CHMP opinion for multiple sclerosis biosimilar

The neurological disease affects approximately 2.8 million people worldwide

EU flag

EMA recommends revoking marketing authorisation for Novartis’ sickle cell disease drug

The EU regulator concluded that the benefits of Adakveo did not outweigh its risks

EU flag

EMA addresses considerations for single-arm trials as pivotal evidence in regulatory filings

The reflection paper offers suggestions on trial design and strategies for minimising bias

- PMLiVE

AstraZeneca’s mild combination asthma reliever approved in UK

Over two and a half million adults with mild cases of asthma could be eligible for the treatment

- PMLiVE

EU outlines measures to mitigate antibiotic shortage across Europe

An unseasonably early upsurge in respiratory infections has led to the increase in demand

- PMLiVE

EU to revise pharmaceuticals law amid antibiotic shortages

The early upsurge in respiratory infections has led to a sudden increase in demand for antibiotics

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links