news
NICE recommends new chemo-free chronic lymphocytic leukaemia treatment
More than 1,000 people each year could benefit from treatment with a combination of venetoclax and obinutuzumab, according to NICE.
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Regulation & Legislation
whitepaper
Whitepaper: BPOG extractables data in single-use systems adoption
An overview on the role of BPOG extractables data in the effective adoption of single-use systems in biomanufacturing
news
Pfizer and BioNTech to supply the EU with 200 million doses of BNT162b2 vaccine
Subject to regulatory approval, EU member states will be supplied with the potentially highly effective BNT162b2 COVID-19 vaccine candidate.
news
FDA grants Fast Track Designation to Novavax COVID-19 vaccine candidate
The FDA has given Fast Track Designation to NVX-CoV2373, Novavax’s COVID-19 vaccine candidate, created using recombinant nanoparticle technology.
news
FDA grants emergency use authorisation to COVID-19 antibody bamlanivimab
The neutralising antibody therapy bamlanivimab (LY-CoV555) is authorised for emergency use in recently diagnosed patients who are at risk of developing severe COVID-19.
news
US pharma industry responds to American election result
PhRMA has released a statement following the announcement that Joe Biden will be the next President of the US.
news
NICE rules nivolumab is not cost effective for use on NHS
The regulatory body said that due to uncertainties surrounding the long-term effectiveness of nivolumab (Opdivo), its cost-effectiveness estimates are too high.
news
NICE recommends Liraglutide for treatment of obesity and non-diabetic hyperglycaemia
Liraglutide (Saxenda) will be offered to adults with non-diabetic hyperglycaemia and a high risk of cardiovascular disease.
news
EC approves Zejula (niraparib) as a monotherapy for advanced ovarian cancer
The European Commission (EC) has approved Zejula, the first PARP-inhibitor monotherapy approved in the EU for patients with advanced ovarian cancer, regardless of their biomarker status.
article
How will Trump’s ‘Buy American’ executive order impact pharmaceutical supply chains?
On 6 August 2020, US President Donald Trump signed an executive order, dubbed ‘Buy American’, with the aim of increasing the production of essential medicines in the US for domestic use. Here, Victoria Rees discusses the order and what it means for drug manufacturers in the US and rest of…
news
Novel non-opioid postsurgical pain implant launched
Innocoll Holdings Limited has announced the commercial launch of the XARACOLL® (bupivacaine HCI) implant, a non-opioid treatment for acute post-surgical pain for up to 24 hours in adults following open inguinal hernia repair.
news
FDA approves first-in-human trial of COVID-19 vaccine candidate
The safety and immunogenicity of CORVax12, a novel DNA-encodable COVID-19 vaccine, will be evaluated in 36 healthy volunteers.
article
Should life sciences businesses require employees to use the NHS COVID-19 App when at work?
The NHS COVID-19 App was introduced in the UK on 24 September. Many welcome its arrival as another step to contain the spread of COVID-19, while others are concerned about using the app for data and privacy reasons. In this article Helen Farr, a partner at Taylor Wessing, explores the…
article
Primary validation of the growth direct bioburden system and media
This article presents statistics required to validate rapid microbial methods (RMMs) according to the requirements in the most recent version of European Pharmacopoeia (EP) 5.1.6. The validation methods for bioburden test application performed are also described.
news
News: Microbial solutions product portfolio updates
Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts.
