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...
New Zealand now has enough COVID-19 vaccines for everyone in the country, says the government, as it announces two new supply agreements with Novavax and AstraZeneca today.
Sterling Pharma Solutions, a global contract development and manufacturing organization (CDMO), has announced a new strategic partnership with ADC Biotechnology, a UK based company specializing in antibody-drug conjugates (ADCs).
The US Food and Drug Administration (FDA), in a review of Moderna’s COVID-19 vaccine candidate, found no safety concerns that would preclude the granting of emergency use authorization (EUA) for the vaccine in the US during the pandemic.
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.
Sanofi has made a new five-year, $25m partnership agreement with the World Health Organization (WHO) to fight Neglected Topical Diseases (NTD); and eliminate sleeping sickness by 2030.
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.
Sanofi and GSK announced a delay on Friday in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in the elderly, saying clinical trials showed an insufficient immune response in older people.
The FDA is set to make a decision on Emergency Use Authorization (EUA) in the coming days for the mRNA COVID-19 vaccine candidate, BNT162b2, from drug makers, Pfizer and BioNTech.
The UK’s MHRA says anyone with a history of anaphylaxis should not receive the Pfizer/BioNTech COVID-19 vaccine: following two reports of anaphylaxis and one report of a possible allergic reaction in the first immunizations carried out this week.
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....
The US Food and Drug Administration (FDA) said there are ‘no specific safety concerns that would preclude issuance of an EUA’ for the investigational COVID-19 vaccine (BNT162b2) from US pharma giant, Pfizer, and its German partner BioNTech.
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.
ERS Genomics, which was formed to provide broad access to the foundational CRISPR/Cas9 intellectual property co-owned by the one of the joint 2020 Nobel Prize winners for Chemistry, Dr Emmanuelle Charpentier, has granted a non-exclusive license agreement...
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,'...
The Medicines & Healthcare Products Regulatory Agency (MHRA) in the UK has granted a temporary authorization for emergency use for Pfizer and BioNTech's mRNA vaccine (BNT162b2), against COVID-19.
Pfizer/BioNTech and Moderna have each submitted formal applications for Conditional Marketing Authorization (CMA) to the European Medicines Agency (EMA) for their COVID-19 vaccines: completing the rolling review process.
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%.
Sanofi’s MenQuadfi becomes the first quadrivalent meningococcal conjugate vaccine available in Europe in a fully liquid presentation, avoiding the need for vaccine reconstitution.
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.
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....
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.
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.
Biotech funding kicked back into higher gear in October, pushing toward the summer monthly record highs with $10.5B raised, writes analyst firm, Jefferies
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...
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.
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....
