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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.
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Regulation & Legislation
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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.
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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.
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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.
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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.
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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.
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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.
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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…
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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.
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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.
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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…
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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.
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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.
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Science and risk-based specification setting for excipients
Reducing unnecessary regulatory burden relating to excipients is important for any pharmaceutical manufacturer. In this article, Sunil Kumar Nataraj, Bastiaan Dickhoff and Kalyan Janjanam discuss a rational basis for controlling and specifying conflicting excipient attributes to avoid potentially tedious and complex regulatory processes.
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Pharma urged to review anti-counterfeiting strategies ahead of no-deal Brexit
According to various associations, the UK could experience a high influx of counterfeit medicines if it leaves the EU without a deal.
