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.
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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.
Adding vesicles to cell-free gene expression (CFE) systems increases yield
Enriching cell-free gene expression system extracts with membrane bound vesicles can significantly increase their ability to produce protein-based products, shows study.
Highlights of the EMA’s human medicine committee meeting, April 2021
The Committee for Medicinal Products for Human Use (CHMP) recommended eight drugs for approval and nine indication extensions.
Trends to watch out for in the pharmaceutical robot market
EPR’s Hannah Balfour summarises a market research report exploring trends in the pharmaceutical robot market between 2021 and 2028.
Further woes for Emergent’s Bayview vaccine production facility
An FDA inspection identified nine concerns including unsanitary conditions and ineffective practices for preventing cross-contamination at Emergent’s facility.
