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

etelcalcetide

- PMLiVE

Novartis’ CAR-T clears FDA panel with relative ease

Puts tisagenlecleucel-T on course to be first approved personalised CAR-T therapy

- PMLiVE

FDA halts third Merck myeloma trial after patient deaths

More patients died on Keytruda combination than those on other treatments

Taking a hybrid qualitative-quantitative approach to research

Directors Phil Rosenberg and Chris Gaj discuss ways to achieve qualitative insights with quantitative precision and the benefits of a hybrid approach.Watch the video: https://www.researchpartnership.com/news/2017/06/video-taking-a-hybrid-qualitative-quantitative-appr...

Research Partnership

- PMLiVE

Europe vs the US: New drug product approvals

As US approvals rates in the US drop,  the EU is not currently showing a similar trend

- PMLiVE

EMA and FDA calls for innovative approaches for Gaucher disease medicines

The regulatory agencies also urge a similar method for all paediatric diseases

- PMLiVE

FDA moves to tackle orphan designation backlog

Some 200 requests are awaiting review by the US regulator

- PMLiVE

FDA panel backs CV claims for Novo Nordisk’s Victoza

LEADER trial shows the diabetes treatment reduces risk of cardiovascular death by 13%

Bayer symbol

Bayer wins FDA approval for MS electronic autoinjector and app

US regulator gives green light to Betaconnect and myBETA app

Eli Lilly HQ

FDA fast-tracks Pfizer and Lilly’s tanezumab

The novel pain drug treats osteoarthritis and chronic low back pain

- PMLiVE

Novo Nordisk’s long-acting haemophilia B drug cleared by FDA

US approval sets up marketing battle with Bioverativ and CSL Behring

Novartis building

Novartis’ Zykadia claims US approval for first-line lung cancer

The Swiss pharma giant’s drug also receives CHMP positive opinion

- PMLiVE

FDA panel backs Puma’s breast cancer drug, with reservations

Side effects concerns could see medicines limited

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links