
Nanoform and Herantis have signed a biologics proof of concept agreement for formulation proof of concept projects aimed at improving nasal drug delivery to the brain.
Nanoform and Herantis have signed a biologics proof of concept agreement for formulation proof of concept projects aimed at improving nasal drug delivery to the brain.
Rentschler Biopharma will establish its manufacturing capability for advanced therapy medicinal products at the CGT Catapult site in Stevenage, UK.
4D pharma has signed a clinical trial collaboration and supply agreement with Merck and Pfizer for Bavencio (avelumab).
Scientists and policy makers are looking more sharply at the lag in identifying and producing medicines to moderate early infections and to treat seriously ill patients.
The EC has granted Vico Therapeutics with orphan drug designation for its investigational antisense oligonucleotide therapy for the treatment of SCA.
Exscientia has formed a partnership with the ARUK-ODDI for the development of medicines targeting neuroinflammation to treat Alzheimer’s disease.
The new business services site will house the company’s North American human resource operations, along with certain finance and information technology teams.
The EUA is based on positive results from a Phase III trial that showed bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalizations and death by 70%.
Evonik has revealed plans for investment in the short-term expansion of its specialty lipids production, which are used with mRNA-based COVID-19 vaccines.
EMA has clarified its position on the European approval process of the Sputnik V vaccine.
The agency is developing guidance to help manufacturers make changes to existing COVID-19 vaccines to treat new variants in the coronavirus.
The companies will build capacity in Germany that will be ready in 2022 and are exploring options for increasing volume in 2021.
The selection of a new FDA commissioner has become a contentious issue in Washington, as the White House delays a decision and interest groups line up behind competing candidates.
The cell therapy will be manufactured for each individual patient at BMS’ immunotherapy manufacturing facility in Bothell, WA, and will be launched across a network of treatment centers.
Through the agreement, AbbVie will use Caribou’s next-generation Cas12a CRISPR hybrid RNA–DNA genome editing and cell therapy technologies to develop two new CAR-T cell therapies.
The company has divested its specialty ingredients business and operations to Bain Capital and Cinven, two private equity firms.
Through the agreement, Catalent will manufacture Trizell’s Phase I cell therapy for the treatment of micro- and macroangiopathies at its Belgium facility.
FDA considers regulatory flexibility to allow the agency and sponsors to adapt and pivot to changes in coronavirus.
The study found that more than 90% of packages and cases scanned at three companies met all of the labeling requirements, with three years remaining until the final DSCSA deadline in 2023.
FDA’s Vaccines and Related Biological Products Advisory Committee will meet on Feb. 26, 2021 to discuss the request for emergency use authorization for Janssen Biotech’s COVID-19 vaccine candidate.
The company recently installed a fully validated visual inspection system that uses artificial intelligence in an automated inspection machine.
The CGMP manufacturing agreement will expand production of lenzilumab, a candidate for COVID-19 therapy, to support a potential emergency use authorization filing.
PathoQuest will apply its experience in viral safety testing and quality control of biologics for mitigating the risk of adventitious agent contamination in biopharmaceutical manufacturing.
Catalent will offer materials from its gene therapy facilities in Maryland to support IND-enabling studies and a Phase I/II clinical trial of the product.
Through the acquisition, Jazz will gain access to GW’s novel cannabinoid platform, including Epidiolex, a plant-derived cannabinoid medicine for the treatment of high-growth childhood-onset epilepsy.
Scientists at the company learned that deagglomeration techniques lose efficacy through equipment wear over time and developed a tactic that makes up for the wear and prepares an ideal sample for each particle size test.
Both companies will provide resources and expertise to research, develop, and manufacture multiple mRNA vaccine candidates, including multi-valent and monovalent approaches.
The companies have entered into a research collaboration and license agreement for the potential treatment of rheumatoid arthritis via Imcyse’s RA program based on its Imotope technology.
As demand for COVID-19 vaccines increases, Big Pharma offers its manufacturing capacity and expertise.
Through the acquisition, Element will have access to Avomeen’s expertise in formulation chemistry, product manufacturing, extractables and leachables, and large molecule testing.