From operational uncertainty and outdated manual processes to new cell lines and a potential shift towards allogeneic cell therapy, CRB’s new report - Horizons: Cell and Gene Therapy - finds the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...
Moderna has announced it will submit an Emergency Use Authorization request to the US FDA today for its COVID-19 vaccine candidate. It has also released the Phase 3 primary efficacy analysis, showing 94.1% efficacy.
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....
BioInvent, a Swedish biotech focused on the discovery and development of immuno-regulatory antibodies for oncology, reports that it has been contracted as manufacturer of Cantargia’s antibody CAN10.
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%.
GlaxoSmithKline has started dosing patients in a Phase 3 clinical program investigating the safety and efficacy of its Respiratory Syncytial Virus (RSV) candidate vaccine for maternal immunisation.
Biopharma company, CureVac, and Wacker Chemie have signed a contract for the manufacturing of CureVac’s mRNA-based COVID-19 vaccine candidate - CVnCoV.
Merck will acquire Oncolmmune for an upfront payment of $425m: pledging to accelerate the development of CD24Fc, a candidate for the treatment of patients with severe and critical COVID-19.
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.
Sanofi’s MenQuadfi becomes the first quadrivalent meningococcal conjugate vaccine available in Europe in a fully liquid presentation, avoiding the need for vaccine reconstitution.
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...
Pfizer and BioNTech announced on Friday [20 November] they are submiting a request for Emergency Use Authorization for their COVID-19 vaccine to the US FDA: saying the vaccine could be in use by mid-December.
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.
The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the Lucira COVID-19 All-In-One Test Kit: the first COVID-19 diagnostic test for self-testing at home.
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 future of treatment for many of the most challenging diseases in the world is said to reside in personalized cell and gene therapy (CGT). These expensive and complex therapies have proven highly effective in multiple cases, but a challenge remains...
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.
Watson-Marlow Limited Ireland has announced plans for a new state-of-the-art cleanroom facility in Cork to support Ireland’s biopharmaceutical manufacturing industry.
Biotech funding kicked back into higher gear in October, pushing toward the summer monthly record highs with $10.5B raised, writes analyst firm, Jefferies
Moderna’s mRNA COVID-19 vaccine candidate has reported vaccine efficacy of 94.5% in the first Phase 3 interim analysis, released this morning. "This is a pivotal moment," says Moderna's CEO.
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.
As vaccine development for COVID-19 continues to be successful in terms of clinical data, the next step in getting the vaccines to people is storage and distribution.
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.
COVID-19 is like a big oak tree casting shade on all other biopharma industry developments. Vaccine-related articles dominate the most popular story rankings. With Pfizer and BioNTech now out in front in the coronavirus vaccine race, we track the related...
Sinovac’s Phase 3 COVID-19 vaccine trial has been put on hold in Brazil after a serious adverse event. But in a statement this morning, the company says the event is not related to the vaccine.
The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for Novavax’s COVID-19 vaccine. Novavax plans to start Phase 3 trials for the candidate in the US and Mexico by the end of the month.
Lilly's monoclonal antibody therapy, bamlanivimab (LY-CoV555), has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for the treatment of adults and children with recently diagnosed, mild to moderate COVID-19.
Biogen Inc’s shares tumbled around 30% yesterday with the company hitting a roadblock late last week as it chases regulatory approval for its investigational Alzheimer's treatment.
Pfizer says its COVID-19 vaccine candidate is more than 90% effective in preventing COVID-19, releasing interim analysis from its Phase 3 study this morning. “Today is a great day for science and humanity,” says the company’s CEO.
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,...
Thermo Fisher Scientific Inc has inked a joint venture deal with Innoforce, a Chinese bioinnovation-enabling company, to establish a new pharma services facility in Hangzhou, China, for integrated biologics and steriles drug development and manufacturing....
