2021 could set a record in new product approvals in regenerative medicines and advanced therapies; alongside unprecedented levels of financing. And it’s a trend that looks to continue given the volume of trials ongoing worldwide, according to the Alliance...
The first COVID-19 vaccine drone delivery program in the US was launched last week by North Carolina-based health system, Atrium Health Wake Forest Baptist.
Catalent sees COVID-19 vaccines being an 'enduring and sustainable' revenue stream for the company, particularly with the advent of boosters, and the fact that developing countries, to date, have very low vaccination rates.
Seattle-based Umoja Biopharma, a company looking to reprogram immune cells in-vivo to create next-generation immunotherapies for the treatment of solid tumors and hematologic malignancies, has started work on its new development and manufacturing facility...
Boston-based company, Vertex, has signed a deal to use Arbor Biotechnologies’ CRISPR gene-editing technology to develop novel cell therapies for the treatment of serious diseases.
The European Medicines Agency’s human medicines committee (EMA CHMP) has this week approved additional manufacturing capacity for Pfizer/BioNTech and Moderna COVID-19 vaccines.
Pfizer will acquire Trillium Therapeutics Inc.; strengthening its work in oncology with the addition of next-generation, investigational immuno-therapeutics for hematological malignancies.
The World Health Organization’s Solidarity PLUS trial will kick off in 52 countries, trialing three drugs to treat patients hospitalized with COVID-19.
The pharma firm is working with five US colleges and universities onto create programming designed to boost recruitment of Black talent in the industry
Pfizer and BioNTech are lining up orders of their COVID-19 vaccine for next year and beyond, predicting total capacity in 2022 to rise to 4 billion doses.
PhRMA has called for the US FDA to ensure its capacity planning adjustment (CPA) methodology addresses the “unique needs” of the biosimilar review program.
The World Trade Organization (WTO) Secretariat has published a list of critical inputs for COVID-19 vaccines as part of an effort to address gaps in global production and distribution of the products.
Producers of CPhI North America 2021 offer a glimpse at programming, including sessions on COVID-19 challenges, supply chain issues, and more key topics.
An industry study from the producer of CPhI North America shows the pandemic and other factors are contributing to a very dynamic pharmaceutical market.
The success of mRNA vaccine technology could be one of the new opportunities for US pharmaceutical manufacturing looking forward, with pandemic investments helping turbocharge the sector.
There is “some way to go” before UnitedHealth Group has the clarity to make a coverage decision on Biogen’s Alzheimer’s disease drug Aduhelm, according to the CEO of the healthcare company.
The drug, intended for adult patients with moderate-to-severe systemic lupus erythematosus, is the only new therapy approved for SLE in more than a decade.
Pfizer and BioNTech’s deal with the US Government to supply an additional 200 million doses of its COVID-19 vaccine is the latest in the series of new orders.
An expert speaking during the industry event offers insight and perspective on the flurry of CDMO deal-making in recent months, and what might lie ahead.
A new UK eLearning program is targeted at healthcare and academic professionals to support their learning on advanced therapy medicinal products (ATMPs).
The EU Commission has extended vaccination with Moderna’s COVID-19 vaccine to adolescents, following on from the EMA's recommendation in relation to the use of the shot in children aged between 12 and 17.
Bluebird’s Lenti-D, or elivaldogene autotemcel, has won approval from the European Commission to treat children with a rare neurodegenerative disease called early cerebral adrenoleukodystrophy (CALD).
Celltrion Group has reported that data from an in vivo efficacy study shows that its monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59), has a strong neutralizing effect against the rapidly spreading Delta variant.
The US Food and Drug Administration (FDA) has granted priority review designation for Pfizer and BioNTech’s COVID-19 vaccine Biologics License Application (BLA).
A holistic approach to decentralized clinical trials that combines intentional design, stakeholder collaborations, and user-friendly technology is what’s needed to execute global clinical trials more efficiently, argues an expert.
The UK Competition and Markets Authority (CMA) has cleared AstraZeneca’s proposed acquisition of Alexion Pharmaceuticals, Inc.: with the acquisition now expected to close on July 21, 2021.
The World Health Organization yesterday warned there is not yet enough evidence to support the strategy of mixing and matching different COVID-19 vaccine types.
Curia, a contract research development and manufacturing organization, will acquire Californian formulation and fill-finish organization Integrity Bio.
Scotland will soon have access to the Novartis drug, Kesimpta, (ofatumumab), the first self-administered, targeted B-cell therapy for patients with relapsing remitting multiple sclerosis (RRMS).
Gavi, which manages COVAX, the global COVID-19 vaccine sharing scheme, says it has secured much-needed vaccines from Chinese producers, Sinovac and Sinopharm.
The safety committee of the European Medicines Agency (EMA) has concluded that myocarditis and pericarditis can occur in very rare cases following vaccination with the COVID-19 vaccines from Pfizer and Moderna.
Acting US FDA commissioner, Janet Woodcock, has called for an independent federal review of interactions between officials at her agency and representatives of Biogen, prior to the recent approval of the pharma company’s treatment for Alzheimer’s disease....
