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.
Generate Life Sciences is establishing a GMP facility in La Jolla, California that it says will enable end-to-end manufacturing of newborn stem cell biologics, bolstering supply and safeguarding clinical research.
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).
South African biopharmaceutical company The Biovac Institute will manufacture and distribute Pfizer and BioNTech’s COVID-19 vaccine in Africa, with the three companies signing a letter of intent this week.
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.
Boston headquartered biotherapeutics company, GentiBio, Inc, and CGT focused CDMO, Forge Biologics, have set up a development and manufacturing partnership.
The US Food and Drug Administration (FDA) has granted priority review designation for Pfizer and BioNTech’s COVID-19 vaccine Biologics License Application (BLA).
Eli Lilly and Company and Banner Alzheimer’s Institute have announced a strategic research collaboration as part of the planned Phase 3 study for donanemab in participants at risk from cognitive and functional decline related to Alzheimer’s disease.
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.
Antibody responses against the SARS-CoV-2 spike protein were found in 99% of volunteers after the second dose of ReiThera’s COVID-19 vaccine candidate, according to Phase 2 preliminary data.
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....
Vaccine company Valneva has been awarded Breakthrough Therapy Designation for its single-shot chikungunya vaccine candidate, VLA1553, by the US Food and Drug Administration (FDA).
WHO is recommending the use of interleukin-6 (IL)-6 receptor blockers in patients with severe and critical COVID-19, adding them to its list of treatments for the virus.
Novasep has signed a manufacturing services agreement with Exelixis, an oncology-focused US biotechnology company, for the cGMP clinical production of XB002, a next-generation tissue factor-targeting antibody-drug conjugate (ADC).
Cell therapy player, Bone Therapeutics, has secured up to €16m (US$18.9m) in a financing loan from the European Investment Bank (EIB) to accelerate ongoing clinical and commercial development of innovative orthopedic treatments.
Eli Lilly and Company will make an equity investment of around $15m in MiNA Therapeutics: a company with a proprietary small activating RNA (saRNA) technology platform.
Sartorius is strengthening its product portfolio for cell and gene therapies with the acquisition of a majority stake in German reagent manufacturer CellGenix.
Bayer owned CDMO, Viralgen, has expanded its AAV vector manufacturing capabilities in San Sebastian, in the Basque region of Spain, with the opening last week of a new site.
The committee for human medicines (CHMP) of the European Medicines Agency (EMA) has approved a scale-up of the active substance manufacturing process at a Janssen Biologics BV site in the Netherlands.
Biotech, Mogrify, recently closed a Series A financing of US$17m, bringing the total raised to US$33m in the round, with the investment set to support the advancement of the company’s immuno-oncology and ophthalmology programs.
German company, CureVac, says it is in ongoing dialogue with the European Medicines Agency (EMA) and is continuing regulatory submissions on its first-generation mRNA COVID-19 vaccine candidate, CVnCoV.
Cobra Biologics, the gene therapy division of the Charles River owned Cognate BioServices, and Sweden's CombiGene recently announced the successful production and quality assurance of the plasmids to be used in the GMP production of the gene therapy,...
Moderna says new data indicates its COVID-19 vaccine offers protection against emerging variants, including the seemingly fast spreading Delta variant, first identified in India.
Simcere has announced a partnership with Vivoryon whereby it will leverage the potential of innovative N3pE amyloid-targeting agents to treat Alzheimer’s disease (AD) in Greater China.
The University of Oxford in partnership with AstraZeneca began vaccinations yesterday for a new phase in human trials to test a COVID-19 vaccine ‘AZD2816’ in volunteers against the Beta [South African] variant.
