Please login to the form below

I have forgotten my password

Novo Nordisk gets another OK for oral GLP-1 drug Rybelsus

Novo Nordisk headquarters

Drug is first and so far only oral alternative to injectable GLP-1 agonists

New Japanese approvals include first OK for GSK’s anaemia drug Duvroq

And Novartis gets green light for non-small cell lung cancer drug Tabrecta

Novartis pulls EU filing for $3.4bn eye therapy Xiidra

Company says EMA’s concerns “could not be addressed within the available timeframe”

BMS scores EU okay for first-in-class anaemia drug Reblozyl

Drug is one of five of Celgene’s late-stage pipeline drugs with blockbuster potential

Novartis agrees $347m settlement for bribery allegations

Settlements involve bribery schemes in Greece and Vietnam

Early knockback for AbbVie as FDA rejects Allergan eye drug

Drug as effective as rival Novartis’ drug but has more side effects

CSL licenses uniQure haemophila B gene therapy in $2bn-plus deal

Could free patients from the need for regulator injections with clotting factor drugs

FDA approval for Merck’s Keytruda threatens Libtayo in skin cancer

Another registration trial of Libtayo is due to report in 2021

EMA starts review of Bavencio in first-line bladder cancer

Results from phase 3 study may lead to possible approval next year

‘Post-Brexit landscape for EU-wide IP Rights: The Story So Far’

Brexit means pharma must review its intellectual property rights across Europe

Moving times

Continuity and stability are vital when it comes to the EMA's relocation when it leaves London
SMC gives green light for Amgen’s Kyprolis

The committee also gives verdict on three other products

More regulatory features

Epidarex closes £102m biotech fund for UK life sciences

Around half of that investment comes from the UK government’s British Business Bank
Ipsen scores FDA fast-track for Onivyde in first-line pancreatic cancer

Treatment could meet unmet need in rare cancer type
Roche preps filings for Tecentriq in early TNBC after trial win

First and only PD-1/PD-L1 inhibitor approved for triple-negative breast cancer
Novartis nabs new FDA approvals for Ilaris and Cosentyx

Drug gets first-ever green light in rare disorder Still’s disease
GSK strikes $170m-plus ‘synthetic lethality’ cancer deal with Ideaya

Deal allows GSK to bulk up its in-house work on synthetic lethality
FDA pulls emergency OK for hydroxychloroquine in COVID-19

Data shows drug may reduce effectiveness of remdesivir
bluebird set for 2021 filing for sickle cell gene therapy LentiGlobin

Gene therapy was approved last year as Zynteglo for beta thalassaemia

More regulatory news

Latest regulatory appointments

ABPI appoints industry veteran Richard Torbett as new chief executive

Torbett initially joined the pharma association in March 2016
Professor Carole Longson moves from NICE to the ABPI

She joins the UK pharma body as its chief scientific officer
MedTech Europe appoints new board of directors

Chair of the board Michelle Brennan is among those newly elected
Greg Perry joins IFPMA as assistant director general

Will move to the global industry body from the Medicines Patent Pool
AVEO appoints Nikhil Mehta as its senior VP, regulatory and quality assurance

He joins the biopharma from Tang Capital Management

More appointments

Communiqué Awards 2020

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company

Virgo Health

Virgo Health is an award-winning global healthcare communications and medical education agency. We dispense pioneering and creative campaigns, driven by...

Latest intelligence

The search for treatments for Parkinson’s disease: The research requires resilience but pharma is urged to ‘keep innovating, keep trying’...
Margot Hannah, OPEN Health - A personal perspective of LGBT+ and diversity.: Ditch the Label – it’s just me....
The impact of COVID-19 on clinical trials: As all industry sectors work to assess both the impact and the optimal path forward, the effects are expected to be diverse and long-lasting...

Quick links

Infographics

Multimedia

<>