Pharmafile Logo

LAMA

Eli Lilly HQ

Baricitinib delay casts a pall over Lilly’s results update

FDA requests further data that could keep the drug off the market for a couple of years

Bristol Myers Squibb logo

BMS wins first US immuno-oncology paediatric licence

FDA gives the green light to expanded use of its melanoma treatment Yervoy

- PMLiVE

Gilead gets OK for three-in-one hep C therapy in US

FDA clears the new product for the most common HCV genotypes

- PMLiVE

Spark closes on first US gene therapy approval

FDA starts review of Luxturna for patients with inherited retinal disease

- PMLiVE

FDA rejects Amgen’s osteoporosis hope romosozumab

Its partner UCB plans to submit the medicine for European approval later this year

- PMLiVE

Amgen aspires to new Kyprolis label in the US and Europe

Appeals to regulators to add survival data to multiple myeloma drug's labelling

- PMLiVE

FDA panel backs Avastin and Herceptin biosimilars

A decision from the US regulator is expected in September

- 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

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links