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

CSL

EU flag

EMA announces launch of two advice pilots to improve clinical trials in Europe

The pilots are part of the Accelerating Clinical Trials in the EU initiative to foster high-quality clinical research

- PMLiVE

Roche’s ALK inhibitor Alecensa granted EC approval to treat early-stage lung cancer

Non-small cell lung cancer represents up to 85% of all lung cancer diagnoses

- PMLiVE

Pfizer’s one-time haemophilia B therapy Durveqtix receives CHMP recommendation

More than 38,000 people worldwide are currently affected by the inherited bleeding disorder

Biogen Idec building

Biogen’s Qalsody granted EC approval to treat rare form of ALS in adults

Mutations in the SOD1 gene are responsible for an estimated 2% of all ALS cases

- PMLiVE

Bristol Myers Squibb’s Opdivo approved by EC for adults with urothelial carcinoma

UC accounts for approximately 90% of all bladder cancers, the ninth most common cancer globally

EU flag

European Commission finalises joint clinical assessment rules for faster access to medicines

Established under the regulation on Health Technology Assessment, the new rules are set to commence in January 2025

EU flag

EC approves Celltrion’s omalizumab biosimilar Omlyclo for immunological conditions

The drug can be used to treat patients with conditions including chronic spontaneous urticaria

- PMLiVE

Sobi’s Aspaveli receives expanded EC approval for rare blood disorder PNH

The C3 therapy can now be used as a first-line treatment for paroxysmal nocturnal haemoglobinuria

- PMLiVE

BeiGene’s Tizveni receives EC approval to treat non-small cell lung cancer

Under the brand name Tevimbra, the company will combine the NSCLC indications with the second-line ESCC indication in late 2024

- PMLiVE

J&J and Legend’s Carvykti receives EC approval to treat relapsed and refractory multiple myeloma

The BCMA-targeted therapy is the first to receive approval in Europe for RRMM patients as early as first relapse

- PMLiVE

Astellas announces EC approval of Xtandi for expanded prostate cancer use

Up to 40% of patients who have undergone definitive prostate cancer treatment will experience biochemical recurrence within ten years

- PMLiVE

AstraZeneca’s Voydeya granted EC approval to treat rare blood disease PNH

The factor D inhibitor has been authorised for use alongside the company’s complement C5 inhibitors

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links