news
Big Pharma deal-making primed for acceleration
Subin Baral, Global Deals Leader, Life Sciences, Ernst & Young LLP, offers his predictions for M&A activity within industry as we head into the later stages of 2022.
List view / Grid view
Therapeutics
news
UK recall of Clinigen’s Mexiletine hydrochloride hard capsules
A Class 1 Medicines Recall Notification has been issued for three batches of Mexiletine hydrochloride hard capsules due to potential for under- or overdosing.
news
Global alliance to end childhood AIDS
New global alliance launched by UNAIDS, UNICEF and WHO aims to overcome “outrageous” disparities in the AIDS response and ultimately end AIDS in children by 2030.
news
Litifilimab reduces skin disease activity in CLE trial
Phase II results suggest litifilimab safely and effectively reduces skin disease activity in cutaneous lupus erythematosus (CLE) patients.
news
ViiV agrees to expand access to long-acting HIV PrEP
Under a new agreement, licenced manufacturers will be able to supply generic versions of ViiV’s long-acting cabotegravir HIV pre-exposure prophylaxis (PrEP) medication to developing nations.
news
Microparticles could form self-boosting vaccines
New research suggests microparticles able to release their payloads at different times could form the basis of self-boosting vaccine courses that would require just a single injection.
news
CHMP meeting highlights – July 2022
At its July meeting, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended 11 medicines for approval and extended the indication of six more, including Imvanex for the prevention of monkeypox.
news
EU proposes new blood, tissues and cells Regulation
The draft Regulation aims to enhance the protection of donors and recipients of substances of human origin (SoHO) therapies, while facilitating supply and innovation.
article
How can evidence-based medicine (EBM) methodology support drug withdrawals?
In this article, Samantha Lane of the UK’s Drug Safety Research Unit discusses the development of an evidence-based medicine (EBM) methodology to assess the positive impact of withdrawing or revoking licences for medicines on public health. The approach leverages electronic health records to model the estimated number of adverse reactions…
news
NA to NAM ratio as a biomarker for cell therapy sterility
Study shows nicotinic acid (NA) to nicotinamide (NAM) ratio enables detection of early-stage microbial contaminations in cell therapy products.
news
Transpire Bio signs with Recipharm for inhaled medicine development
Under the agreement, Recipharm will help advance two inhaled medicines intended for asthma and chronic obstructive pulmonary disease (COPD).
news
Grünenthal to buy NebidoTM testosterone treatment from Bayer for €500m
Privately-owned Grünenthal estimates the Nebido brand will add about €100 million to its EBITDA in 2023.
article
Summer 2022 haemophilia trial update
Results from several haemophilia trials have been presented at the International Society on Thrombosis and Haemostasis (ISTH) Annual Congress 2022, here EPR summarises some of the key developments.
news
Dupixent® delivers histological remission for paediatric EoE patients
Phase III trial data shows Dupixent® (dupilumab) has the potential to improve signs of eosinophilic oesophagitis (EoE) and support healthy weight gain in children with the condition.
news
Research calls for regulators to accelerate the approval of antibiotics
Report by One Health Trust says acknowledging antimicrobial resistance in regulatory frameworks for accelerated drug approval could improve access to new antibiotics.
