The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a text on analytical strategy options for the control of COVID-19 recombinant viral vectored vaccines.
A panel discussion at the Reuters Events' Cell & Gene Therapy Conference USA 2020 looked at the key challenges in the cell and gene therapy (CGT) space, namely affordability and access, and how to circumvent those.
A new multi-stakeholder group of experts has been set up to provide input and ideas in the context of the ongoing evaluation of the orphan medicinal products (OMP) regulation in Europe.
Thermo Fisher Scientific is seeing “very, very significant demand” for its cold storage range as the race to get COVID-19 vaccines to market enters its closing stages.
A new mathematical modeling study by Ashish Goyal and colleagues, informed by data collected from 25 patients hospitalized with COVID-19 in four different countries, offers some important new insights into the optimal timing of four different antiviral...
Moderna has flagged the diversity of the US-based Phase 3 trial of its COVID-19 vaccine candidate, mRNA-1273, for which enrollment, now at 30,000, has completed.
The use of CRISPR, the genetic scissors that allow scientists to edit the instruction manual of life, DNA, has drawn massive global attention over the last several years.
Current COVID-19 vaccine Phase 3 trials are not designed to show whether they will save lives or reduce transmission: with trials instead based on events with mild symptoms, according to a feature published in The BMJ.
Ori Biotech Ltd (Ori), a London and New Jersey based innovator in the cell and gene therapy (CGT) manufacturing sphere, last week announced the successful close of a US$30m Series A financing round, bringing the company’s total funding to date to US$41m.
UNICEF, the world’s largest single buyer of vaccines, is laying the groundwork for quick and efficient delivery of COVID-19 vaccines by purchasing and distributing more than half a billion single-dose syringes and other critical equipment in countries...
US company, Dyno Therapeutics, has inked a deal with Roche to develop next-generation AAV gene therapy vectors for central nervous system (CNS) diseases and liver-directed therapies.
Enrollment is temporarily on hold in the ACTIV-3 clinical trial, which is evaluating Lilly's investigational neutralizing antibody bamlanivimab (LY-CoV555) as a treatment for COVID-19 in hospitalized patients. The pause was recommended by the study's...
The US Department of Defense (DoD) and BARDA have expanded a partnership with AstraZeneca (AZ) to develop and manufacture its long-acting antibody (LAAB) combination, AZD7442, that may help treat or prevent infection with SARS-CoV-2.
Regeneron has submitted a request for Emergency Use Authorization (EUA) for its REGN-COV2 investigational antibody combination for COVID-19: which was given to US President Donald Trump last week.
A contract between the EU and Janssen Pharmaceutica NV will see Janssen supply 200 million doses of a COVID-19 vaccine, with the potential for an additional 200 million doses.
Locus Biosciences has signed a contract with BARDA to co-fund development of LBP-EC01, a CRISPR Cas3-enhanced bacteriophage (crPhage) that targets E. coli bacteria causing recurrent urinary tract infections (UTIs).
On Tuesday the FDA released its guidance on Emergency Use Authorization for COVID-19 vaccines: a move welcomed by the industry as a ‘tried and true tradition of releasing guidance in a public and transparent way’.
Emerging biotech, NanoSyrinx, has announced the closing of a pre-seed financing round to continue developing its ‘nanosyringes’, a selective non-viral peptide and protein delivery system.
German life science company Sartorius will merge Slovenian purification specialist BIA Separations with Sartorius Stedim Biotech, in a deal worth €360m ($423m).
The release of the FDA guidance on emergency use authorization (EUA) for vaccines to prevent the spread of COVID-19 would provide regulatory clarity to scientists and strengthen public confidence in any vaccine authorized by the US regulator, says the...
The pharma ingredients provider discusses new products, supply-chain obstacles, and what the future of the industry might hold, ahead of the online event.
The pandemic has required a rethink of how we do business: and CPhI Festival of Pharma is encouraging companies to prioritize sustainability efforts moving forward.
Fujifilm Irvine Scientific has become the exclusive, worldwide distributor of cellnest, a recombinant peptide attachment substrate that is said to provide optimal adhesion and proliferation of stem cells in chemically defined, animal component-free conditions.
Symbiosis Pharmaceutical Services reported a successful audit outcome by the UK government regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) for its Scottish production site.
Axon Neuroscience is launching the world's first crowdfunding exercise for the development of a COVID-19 vaccine, following what it says are strong pre-clinical results for its candidate.
Accord Healthcare has announced the launch of a Herceptin biosimilar in the UK. Zercepac is the first monoclonal antibody (mAb) and fourth biosimilar launched by the company in Europe.
AstraZeneca's phase 3 COVID-19 vaccine trial remains on hold in the US as the FDA probe into a patient illness in the UK trial that initiated the global pause continues, the US Department of Health and Human Services Secretary, Alex Azar, told US...
A project run by Gavi, the vaccine alliance, and the World Health Organization (WHO) to guarantee fair access to COVID-19 vaccines worldwide, has secured the backing of 64 higher income countries, with more set to sign up in the coming days.
AstraZeneca paused its COVID-19 vaccine trial earlier this month for a safety review – generating headlines across mainstream press worldwide. Such pauses are not uncommon in clinical trials – so what’s the best way to deal with them?
This month marks a major US milestone for biosimilar medicines as five years ago, September 2015, saw the first biosimilar made available to US patients – the Sandoz developed Zarxio (filgrastim-sndz).
Sanofi and GSK will provide the EU with up to 300 million doses of their COVID-19 vaccine candidate, with the agreement suppporting scale-up of manufacturing capabilities in several European countries.
To accelerate Covid-19 vaccine development, as well as upscale domestic manufacturing capabilities, the German government has announced a €750m (US$890m) fund to support the vaccine programs of three German developers, BioNTech, CureVac and IDT Biologika....
In a deal valued at US$21bn, Gilead Sciences is to acquire Immunomedics Inc, a New Jersey headquartered biotech that has been highly focused on breast cancer drug innovation.
