Pfizer has upped its 2021 sales forecast for its mRNA COVID-19 vaccine to $26bn: as well as reporting strong Q1 results for the business overall this morning.
As COVID-19 response initiatives and vaccine rollouts begin to bring the pandemic under control, we consider what changes to clinical trials will be made permanent.
The European Commission has decided to bring legal proceedings against AstraZeneca, it confirmed today. But AstraZeneca says the litigation is without merit, adding it will ‘strongly defend itself’ in court.
The US Food and Drug Administration (FDA) has approved ADC Therapeutics’ ZYNLONTA as a third-line therapy for patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).
Roche witnessed a slight decrease in Q1 2021 pharmaceutical sales – a drop of 9% compared to the first three months of 2020 - as it faced continued biosimilars competition; the COVID-19 pandemic also played a role.
Bristol Myers Squibb (BMS) will build a new cell therapy manufacturing site in Leiden, the Netherlands: marking the company’s first cell therapy manufacturing facility in Europe and its fifth globally.
The European Medicines Agency’s safety committee (PRAC) says a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen: but says the benefit-risk analysis for the vaccine remains...
The European Union has exercised its option, under a previous agreement, to order 100 million additional doses of the Pfizer/BioNTech COVID-19 vaccine, Comirnaty.
Emergent BioSolutions, a contract development and manufacturing organization (CDMO), has agreed with the US FDA not to manufacture any new COVID-19 vaccine materials at its Bayview facility in Baltimore, Maryland, while the regulator investigates the...
Efficiency in the biopharmaceutical space has never been more top-of-mind. The COVID-19 pandemic brought an unprecedented urgency to R&D and the key players delivered: Several groups produced a vaccine in record time. To maintain and improve on this...
The UK’s Joint Committee on Vaccination and Immunisation (JCVI) says that pregnant women should be offered either the Pfizer/BioNTech or Moderna COVID-19 vaccines.
US pharma group, Lilly, has requested the US FDA revoke the Emergency Use Authorization (EUA) for bamlanivimab 700 mg alone due to the evolving variant landscape in the US.
Sterling Pharma Solutions, a global contract development and manufacturing organization (CDMO), has acquired ADC Biotechnology (ADC Bio), a UK based company specializing in antibody-drug conjugates (ADCs).
The EU has entered into negotiations with Pfizer/BioNTech for a third COVID-19 vaccine contract: which would see delivery of 1.8 billion doses of the vaccine between 2021-2023.
Driven by encouraging clinical trial data, and a growing demand for effective and personalized therapeutic modalities, the CGT services market is anticipated to witness significant development, growing at a CAGR of over 25% up to 2030, forecasts a new...
The European Medicines Agency (EMA) is evaluating a possible link between blood clots and Johnson & Johnson’s COVID-19 vaccine, while also reviewing reports of a bleeding condition in some individuals who received AstraZeneca’s COVID-19 shot.
Moderna today highlighted the publication of antibody persistence data out to six months following the second dose of its COVID-19 vaccine in The New England Journal of Medicine.
The European Medicines Agency’s safety committee, PRAC, has concluded there is a possible link between the use of AstraZeneca’s COVID-19 vaccine and rare side effects of unusual blood clots and low blood platelets in individuals who received the shot.
Emergent BioSolutions Inc yesterday reported that is on target in terms of all its commitments for COVID-19 vaccine production; it also reaffirmed its financial guidance, after a production issue at its Baltimore plant last week saw a massive batch of...
Media reports claim the UK regulator is set to ban the use of COVID-19 Vaccine AstraZeneca in individuals below the age of 30 over blood clot risk concerns.
Pfizer and BioNTech’s COVID-19 vaccine demonstrated 100% efficacy and robust antibody responses in adolescents aged 12-15 years old, according to results from a Phase 3 trial released this week. “We plan to submit these data to the FDA as a proposed amendment...
A couple of new developments to report in relation to Merck, known as MSD outside the US and Canada: the first being the rejection by the US FDA of the company’s application to use its anti-PD-1 therapy, Keytruda, in certain breast cancer patients.
The EU has approved new storage conditions for Pfizer/BioNTech’s vaccine: allowing the ultra-cold storage vaccine to now be kept at standard pharmaceutical freezer temperatures for a total of two weeks.
J&J will supply the African Vaccine Acquisition Trust (AVAT) with up to 220 million doses of its single-shot vaccine, with the potential to increase the order to a total of 400 million.
The European Medicines Agency (EMA) has approved BioNTech’s Marburg site for COVID-19 vaccine production; which will become one of the largest mRNA vaccine manufacturing sites in Europe and the world. Elsewhere, additional sites are also set to produce...
The European Medicines Agency (EMA) concludes that Celltrion’s monoclonal antibody, regdanvimab, can be used in COVID-19 patients not requiring oxygen and at high risk of progressing to severe disease.
A US court’s recent decision to find in favor of Sanofi and invalidate Amgen's broad antibody patent claims has biotech manufacturers concerned about how to preserve their IP.
As tensions over COVID-19 vaccine supplies in Europe continue, AstraZeneca clarifies that a set of doses at its Anagni plant in Italy are destined for the EU and COVAX.
AstraZeneca has released the primary analysis from its COVID-19 vaccine US Phase 3 trial, showing 76% efficacy for the vaccine against symptomatic COVID-19. The company highlights that this backs efficacy data from Monday's interim analysis, responding...
The EU Commission has adapted its export authorization mechanism for COVID-19 vaccines, shoring up its ability to prevent shipments going to countries with advanced immunization rates and good access to vaccines.
The pharma company and the CDC are recommending that adults continue routine vaccination during the COVID-19 pandemic to reduce future vaccine-preventable disease (VPD) outbreaks and overall strain on the healthcare system.
The US National Institute of Allergy and Infectious Diseases (NIAID) says it is concerned that AstraZeneca 'may have included outdated information’ when releasing initial data from its COVID-19 vaccine clinical trial.
Australia’s Therapeutic Goods Administration (TGA) has approved manufacture of the AstraZeneca COVID-19 vaccine by CSL – Seqirus: reducing the country's dependence on limited supply from abroad and allowing a wider vaccination campaign to begin....
CureVac is expanding its late-stage clinical trials for its COVID-19 vaccine candidate; while confirming it is on schedule to apply for formal market authorization in the EU in Q2 2021.
The RDIF, Russia’s sovereign wealth fund, and India based, Virchow Biotech Private Limited, have today announced a partnership to produce and supply a minimum of 200 million doses of the Russia developed Sputnik V vaccine against COVID-19.
The Oxford-AstraZeneca vaccine was 79% effective in preventing symptomatic COVID-19, according to the findings of the Phase 3 study in the US, Chile and Peru, says AstraZeneca.
The European Medicine Agency (EMA) says its safety committee has ruled that COVID-19 Vaccine AstraZeneca is safe and effective, and the benefits of its use outweigh any possible risks.
Pfizer is selling a biologics manufacturing unit in the eastern city of Hangzhou to WuXi Biologics, despite the US pharma giant having ploughed US$350m into the site in 2016 to develop biosimilars.
Biogen has estimated 10 million patients in the US are suitable for treatment with its Alzheimer’s disease candidate aducanumab, setting it up to generate blockbuster sales if it wins approval.
Governments want to 'build up a vaccine and biologics infrastructure locally' to insulate themselves from the sorts of supply disruptions seen in the COVID-19 pandemic, according to Merck KGaA CEO Stefan Oschmann.
US biotech, Moderna, reports today that the first participants have been dosed in its Phase 2/3 clinical trial investigating the efficacy of its COVID-19 vaccine in children ages 6 months to less than 12 years.
As more countries temporarily pause the use of the COVID-19 Vaccine AstraZeneca in their vaccination programs, the company stressed the safety of the jab, based on scientific evidence.
The Coalition for Epidemic Preparedness Innovations (CEPI) has set out a $3.5bn plan to ‘dramatically reduce or even eliminate the future risk of pandemics’. Its ambitions are for an ‘all-in-one’ vaccine against SARS, MERS-CoV and SARS-CoV-2 coronaviruses;...
Denmark has halted its vaccination campaign with COVID-19 Vaccine AstraZeneca, as a precautionary measure while a full probe is ongoing into reports of blood clots in people who received the vaccine, including one case in that country, where a person...
