It is known and expected that viruses constantly change through mutation leading to the emergence of new variants, but preliminary analysis in the UK suggests the new SARS-CoV-2 variant is significantly more transmissible than previous ones.
The US Food and Drug Administration (FDA) has authorized emergency use of Moderna’s vaccine against COVID-19, mRNA-1273, in individuals who are 18 years of age or older.
The first patient has been enrolled in the randomized Phase 3 SILVAR study to evaluate the efficacy and safety of siltuximab in patients with COVID-19 previously treated with corticosteroids, or another respiratory virus infection associated with serious...
The European Medicines Agency has brought forward a key meeting to assess the Pfizer/BioNTech COVID-19 vaccine: with its committee now convening a week earlier than scheduled.
Following the announcement yesterday by the UK’s Health Secretary Matt Hancock that a new strain of SARS-COV-2 could be responsible for faster spread of the virus in the South East of England, Shore Capital analysts give their perspective on what is known...
CureVac has announced today the enrollment of the first participant in the pivotal Phase 2b/3 study of its messenger ribonucleic acid (mRNA) vaccine candidate, CVnCoV, against COVID-19.
As the US FDA advisory committee meets to discuss the merits and risks of Pfizer/BioNTech’s application for emergency use of their COVID-19 vaccine candidate, we talk to two US legal experts to get their perspective on vaccine distribution stateside....
UnitedHealth Group is partnering with Eli Lilly and Co to test the efficacy of the Indianapolis-based pharma giant’s COVID-19 monoclonal antibody treatment, bamlanivimab, with patients at the highest risk of adverse outcomes.
New data shows a move towards commercialization and a 48% increase in GMP cell and gene therapy (CGT) manufacturing space in the UK this year despite the COVID-19 pandemic.
With the Pfizer/BioNTech COVID-19 vaccine authorized in the UK yesterday, the roll out of the first 800,000 doses will begin next week. 'We have spent months preparing for this day, so that as soon as we got the green light we would be ready to go,'...
From operational uncertainty and outdated manual processes to new cell lines and a potential shift towards allogeneic cell therapy, CRB’s new report - Horizons: Cell and Gene Therapy - finds the biopharma industry at the critical intersection of obstacle...
BioNTech and InstaDeep are creating a joint AI innovation lab in Europe to develop novel immunotherapies. “We see a significant opportunity at the intersection of AI and immunology by computational design of new precision immunotherapies,” says BioNTech....
The European Federation of Pharmaceutical Industries and Associations (EFPIA) gave a cautious welcome to the EU action plan on intellectual property (IP), published yesterday, expressing alarm, though, over proposals within it on compulsory licensing.
The new EU Pharmaceutical Strategy, adopted today by the European Commission, is designed to improve and accelerate patients’ access to safe and affordable medicines and address unmet medical needs in the areas of antimicrobial resistance, cancer, and...
Up to 10% of vaccines can be reportedly lost in transit due to breakage or fluctuations in sub-zero temperatures required for preservation, but a manufacturer of data-driven temperature-controlled smart containers says it can cut that rate to just 0.1%.
Biopharma company, CureVac, and Wacker Chemie have signed a contract for the manufacturing of CureVac’s mRNA-based COVID-19 vaccine candidate - CVnCoV.
Regeneron’s casirivimab and imdevimab antibody cocktail (formerly known as REGN-COV2 or REGEN-COV2), has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).
Eli Lilly and Company's neutralizing antibody bamlanivimab (LY-CoV555) has received interim authorization from Health Canada as a treatment for COVID-19.
AstraZeneca says interim analysis of clinical trials in the UK and Brazil of its candidate COVID-19 vaccine being developed in partnership with the University of Oxford - AZD1222 - showed the vaccine was highly effective in preventing COVID-19, the primary...
The European Commission has granted a marketing authorization for Sanofi’s Supemtek, a quadrivalent (four-strain) recombinant influenza vaccine: representing the first and only recombinant influenza vaccine approved in the European Union.
It’s been a big week for mRNA-based COVID-19 vaccines: with both Pfizer/BioNTech and Moderna reporting impressive efficacy for their COVID-19 vaccine candidates. Here's five key takeaways from this week's developments.
How prepared is the existing global cold chain, and especially refrigerated transport, to cope with the full temperature ranges required for the multiple COVID-19 vaccine candidates? A cold chain expert responds.
The COVID-19 pandemic is expected to continue to impose enormous burdens on societies and economies globally. While governments are now getting ready to ensure large-scale distribution of a vaccine, concern about vaccine hesitancy is growing worldwide....
Pfizer has revised the efficacy figures for its COVID-19 vaccine candidate – now stating the vaccine is 95% effective – with its Phase 3 study meeting all primary efficacy endpoints.
Vibalogics has announced it is expanding its global footprint with a late phase clinical and commercial manufacturing facility near Boston, Massachusetts, a major milestone as it looks to advance its services to drug developers across the globe.
The European Commission has reached an agreement with CureVac for up to 405 million doses of its mRNA-based COVID-19 vaccine candidate: representing the biggest COVID-19 vaccine deal the Commission has inked so far.
Johnson & Johnson has launched a second global Phase 3 trial for its Janssen COVID-19 vaccine candidate: this time exploring a 2-dose regimen (its existing Phase 3 trial is for a 1-dose regimen).
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published three new Official Control Authority Batch Release (OCABR) guidelines in preparation for the first three vaccines likely to be launched in Europe.
The clear evidence of increased risk of COVID-19 infection amongst ethnic minority groups, people from Black and Asian backgrounds, is of urgent public health importance, according to the authors of a paper published today by The Lancet.
Agenus Inc, an immuno-oncology company with a pipeline of agents designed to activate immune response to cancers and infectious diseases, has reported the dosing of the first COVID-19 patient with agenT-797, an allogeneic cell therapy, through its subsidiary,...
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.
Sanofi is eying up the European biopharmaceutical company’s proprietary next generation natural killer (K-NK) cell platform and pipeline of cell-based cancer immune-therapeutics and infectious disease therapies.
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.
Novavax’s Phase 3 COVID-19 vaccine trial in the UK has been expanded to 15,000 participants; while a 30,000 strong Phase 3 clinical trial is due to start in the US and Mexico next month.
Johnson & Johnson says it is preparing to resume recruitment in its Phase 3 Janssen COVID-19 vaccine trial in the US: after the trial was paused because of an unexplained illness earlier this month.
