MHRA authorises Vumerity for multiple sclerosis patients

The MHRA has granted marketing authorisation for diroximel fumarate as oral treatment for relapsing-remitting multiple sclerosis.

Amgen, Biohaven, Lilly and Teva plowed plenty into marketing migraine meds. Is it working?

Pharma companies vying for a piece of the lucrative migraine market have gone all-in on marketing. They've turned to Olympic athletes and Hollywood st…

FDA, aiming to curb another COVID-19 surge, clears Pfizer, Moderna boosters for all adults

The Food and Drug Administration on Friday authorized COVID-19 booster shots for all vaccinated Americans over 18, a move that's meant to stem a rise …

2021's Fiercest Women in Life Sciences

“It took a village to make me.” These words spoken by WeiQing Zhou, who is the cofounder of two biotechs, could apply to almost any of the women on th…

J&J, world's largest drugmaker, plans to split in two

Johnson & Johnson, the world's largest drugmaker and one of its oldest, is splitting in two in a major corporate shake-up that's meant to boost th…

NICE ‘no’ for BioMarin’s Vimizin

The National Institute for Health and Care Excellence (NICE) has published draft guidance in which it has decided not to recommend BioMarin’s rare dis…

Ethics & GCP Forum 14th December OPEN FOR BOOKINGS!

We are excited to announce that our Ethics & GCP Forum will take place online via Zoom on Tuesday 14^th December 2021. 

See here for the draft agen…

NICE issues draft recommendation for new kidney disease treatment

NICE has issued a draft recommendation for Forxiga (dapagliflozin) for the treatment of adults with chronic kidney disease. This preliminary recommend…

GlaxoSmithKline's novel anemia drug succeeds where AstraZeneca-FibroGen, Akebia failed

After the FDA’s resounding rejection for AstraZeneca and FibroGen’s roxadustat, attention on novel oral anemia therapies has shifted to later players.…

Pfizer’s COVID-19 pill cuts hospitalisation/death risk by 89%

Pfizer has announced that its investigational COVID-19 antiviral medicine cut the risk of hospitalisation or death by 89% in an interim analysis of th…

AbbVie's Vraylar turns in mixed results in depression, but pharma decides to file for approval anyway

Vraylar, used as an adjunctive treatment to existing antidepressants, significantly outdid placebo in a phase 3 trial, AbbVie unveiled Friday. But add…

Gilead and MSD collab on Trodelvy/Keytruda breast cancer trial

Gilead Sciences and MSD – known as Merck in the US and Canada – have announced a clinical trial collaboration to test a combination of Gilead’s Trodel…

Merck sees up to $7B in coming sales of coronavirus pill

• Merck & Co. executives forecast between $5 billion and $7 billion in sales of the company's COVID-19 pill through the end of 2022, assuming an ex…

Psychoactive compound to advance research in treatment of depressive disorders

FSD Pharma has signed an agreement with Covar Pharmaceuticals to support the development of Lucid-PSYCH, a psychoactive compound potentially viable fo…

Pfizer, in a first, shows booster shot strengthens COVID-19 protection in large study

• A third dose of Pfizer and BioNTech's coronavirus vaccine restored the shot's strong protection against COVID-19 in a large randomized trial, the com…

UK doctors: Renewed COVID response is urgent

Health Secretary Sajid Javid’s statement that 179 COVID deaths a day are “mercifully low” has sparked criticism from COVID-19 experts. Government stat…

Johnson & Johnson wins FDA panel backing for a second dose of its COVID shot but don’t call it a ‘booster’

Over the last year, the Johnson & Johnson COVID-19 vaccine has been commonly referred to as a single-shot alternative to the two-dose regimens of …

FDA clears Keytruda for first-line cervical cancer

MSD’s PD-1 inhibitor Keytruda (pembrolizumab) has received approval from the US Food and Drug Administration (FDA) for the first-line treatment of cer…