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Endotoxin testing milestone reached with European Pharmacopoeia’s animal shift
The quality control (QC) standards publication sets animal-free bacterial endotoxins testing (BET) as the new norm in Europe.
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SGS joins Oxford University consortium led by the Jenner Institute to develop COVID-19 vaccine
In a consortium led by the Jenner Institute, Oxford University, SGS has joined forces with specialists in infectious diseases, research and innovation, and pharmaceuticals to rapidly develop, scale-up and produce a potential vaccine called ChAdOx1 nCov-19.
FDA approves IMBRUVICA® (ibrutinib) for treatment of chronic lymphocytic leukaemia and small lymphocytic lymphoma
IMBRUVICA (ibrutinib), in combination with rituximab, has been given approval in the US for the treatment of chronic lymphocytic leukaemia and small lymphocytic lymphoma.
4D pharma to initiate Phase II study of MRx-4DP0004 to treat COVID-19
The UK MHRA granted expedited acceptance for the Phase II trial of MRx-4DP0004, a live biotherapy product and targeted immunomodulatory therapy.
Avet recalls tetracycline HCl capsules to consumer level
The company announced the voluntary recall is due to low, out of specification dissolution test results in specific batches of its tetracycline products.
CDMO recognised in six outsourcing award categories
A Contract Development and Manufacturing Organisation (CDMO) has been recognised in six different categories at the 2020 CMO Leadership Awards.
UK to begin clinical trials for COVID-19 vaccine this week
The UK government has announced that funding will be given to clinical trials to test a COVID-19 vaccine, with one study beginning tomorrow.
BARDA to give Moderna up to $483 million for COVID-19 vaccine development
The US Biomedical Advanced Research and Development Authority (BARDA) will fund Moderna’s COVID-19 vaccine candidate mRNA-1273 through Phase II and III clinical trials to FDA licensure.
Trial finds lopinavir/ritonavir and Arbidol ineffective for mild-to-moderate COVID-19
A Phase IV trial in 86 patients with mild-to-moderate COVID-19 has indicated that lopinavir/ritonavir (LPV/r) and Arbidol do not improve clinical outcomes.
‘Cocktail’ of pharmaceuticals identified in Bangladeshi waters
A study of both city and rural water sources identified antimicrobials at every site and suggests the contamination could be causing the emergence of treatment-resistant microbes.
COVID-19 pandemic spurs cyber-attacks on healthcare sector, says report
According to new research, as the healthcare and pharma sector relies on IT throughout the COVID-19 pandemic, cyber-attacks will be inevitable.
NICE recommends Vitrakvi (larotrectinib) for use on Cancer Drugs Fund
Larotrectinib has been given a positive opinion by NICE, following the submission of a revised price after it was previously rejected.
SGS digicomply launches COVID-19 INTEL
An ai platform for teams on the pandemic research frontline.
Nitrosamine detection: Meet EMA and FDA regulations
In 2018, the presence of the nitrosamine N-nitrosodimethylamine (NDMA), a potential carcinogen, in certain sartan active pharmaceutical ingredients (APIs) resulted in several regulatory warnings and recalls of contaminated products.
SGS biosafety laboratory offers gmp compliant vaccine testing solution for coronavirus
SGS's Center of Excellence for biosafety can help contribute to the fight against coronavirus.
UK national priority COVID-19 trial now recruiting patients
The PRINCIPLE trial aims to evaluate therapeutics that could slow the progression of COVID-19 symptoms in patients most at risk of complications.
