EMA to assess if Olumiant should be authorised for hospitalised COVID-19 patients
The EMA will conduct an accelerated assessment and issue its decision on whether Olumiant (baricitinib) can be used in hospitalised COVID-19 patients by July.
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COVID-19 manufacturing requirements are lucrative for CMOs, says GlobalData
A new report shows half the drugs and all the vaccines approved for emergency use in 2020 had an associated contract manufacturing agreement.
Highest British business award goes to cannabis drug developer, GW Pharmaceuticals
The Queen’s Award for Enterprise in Innovation was awarded to GW for leadership in cannabinoid science and development of prescription cannabis-based medicines.
100 percent recovery rate for COVID-19 patients treated with Zofin™
The first ten patients in a Phase I trial of Zofin™ have recovered and been discharged, the trial will now expand with an additional 65 participants.
Acceleron receives FDA Notice of Noncompliance
The Notice of Noncompliance gives Acceleron 30 days to submit the required clinical trial results information to ClinicalTrials.Gov or face financial penalties.
Ampion™ reduces COVID-19 respiratory distress mortality
The final results from the Phase I trial show treatment with Ampion™ reduced all-cause mortality by almost 80 percent in COVID-19 patients with respiratory distress.
ISPE announces its manufacturing Facility of the Year Awards winners
The awardees, including Takeda, Janssen and Gilead, are recognised for their state-of-the-art facility design, construction and operation projects.
First patient dosed with dalbavancin in S. aureus bacteremia trial
The trial will assess the efficacy of a two week regimen of the FDA-approved antibiotic dalbavancin in treating 100 patients with Staphylococcus aureus bacteremia.
Global pharmacovigilance market to value almost $15bn by 2028
Research suggests outsourcing and the increasing incidence of adverse drug reactions (ADR) will be primary drivers of growth in the global pharmacovigilance market.
Novel vaccine 77 percent effective in preventing malaria, finds study
The R21 vaccine candidate, when administered with 50mg of adjuvant, was found to be 77 percent effective in preventing malaria in children over 12 months.
Gilead to support Indian COVID-19 crisis with donation of remdesivir
The company will donate 450,000 vials of remdesivir and support its licencing partners in expanding and accelerating the production of the drug.
EMA and ECDC to collaborate on post-marketing monitoring of COVID-19 vaccines
Under a new initiative, the EMA will monitor on the safety of marketed COVID-19 vaccines while the ECDC monitors their effectiveness in Europe.
Recombinant bacterial endotoxin testing techniques shown to be inferior
An evaluation comparing Limulus amebocyte lysate to recombinant alternative assays has found that the recombinant reagents had markedly low recovery of endotoxin activity.
New research could allow bioproduction of toxic compounds
A paper shows implementing riboregulated switchable feedback promoters enables cells to produce the precursors for potentially toxic chemotherapeutic and anti-malarial drugs.
![Two vials labelled 'Janssen COVID-19 Vaccine' [Credit: oasisamuel/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Janssen-COVID-19-Vaccine-300x278.jpg)
![Two vials labelled 'Janssen COVID-19 Vaccine' [Credit: oasisamuel/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Janssen-COVID-19-Vaccine-e1619436264802.jpg)
Janssen COVID-19 Vaccine approved for continued use in US
The US FDA and CDC have confirmed that the single-shot COVID-19 vaccine’s benefits continue to outweigh the risks of clotting and have given approval for its use to resume.
