Merck has entered into non-exclusive voluntary licensing agreements with five Indian generic drug manufacturers for the development of molnupiravir, an investigational, oral antiviral agent for the treatment of non-hospitalized patients with confirmed COVID-19.
AkesoBio’s expanded manufacturing capacity, enabled by the addition of another Cytiva FlexFactory platform, will be used to meet current and future market needs in China as well as worldwide.
With a $5 million grant from DARPA, DNA Script and Moderna will develop a prototype for rapid mobile manufacturing of vaccines and therapeutics as part of the DARPA’s Nucleic Acids On-Demand World-Wide program.
Sanofi will perform the fill/finish of up to 200 million doses of Moderna’s COVID-19 vaccine at its Ridgefield, NJ, facility starting in September 2021.
Samsung and TG Therapeutics have expanded their 2018 contract manufacturing deal for the supply of TG’s ublituximab, an investigational anti-CD20 monoclonal antibody.
Lonza’s new complex will occupy 2000 m2 of the facility with six levels of manufacturing space and will provide room for future small-molecule technologies expansion.
Since launching the partnership, Evotec and Bristol Myers Squibb have established a pipeline of novel first-in-class targeted protein degradation projects, two of which have transitioned into lead optimization.
DCAT’s annual bio/pharmaceutical development and manufacturing business event, DCAT Week, will take place virtually from July 12–16, 2021, with the in-person even postponed to March 20–24, 2022 in New York City.
The decision comes from the US CDC Advisory Committee on Immunization Practices following the evaluation of data showing a rare adverse event involving blood clots in combination with low platelet counts within approximately one to two weeks following vaccination.
EMA's PRAC has concluded that there is a possible link to rare cases of blood clots with low blood platelets with Janssen’s COVID-19 vaccine.
Phico Therapeutics has been awarded up to $18.2 million in grant funding from the CARB-X partnership to advance its lead antibacterial therapy.
Adaptate Biotherapeutics has raised a further $18 million in equity investment during a Series A2 funding round.
Executives that participated in the CPhI post-pandemic survey are predicting a push for repatriation of manufacturing globally.
Lipid production at Evonik’s Hanau, Germany, site was set up in eight weeks and met high-quality requirements, accelerating delivery time, which was originally set for mid-2021.
DFE’s new line will offer market purity and low endotoxin excipients for use in formulation, while providing drug developers and manufacturers high-quality excipient technology and services.
Vertex and CRISPR have amended their collaboration agreement to include the development, manufacture, and commercialization of CTX001, an investigational CRISPR/Cas9-based gene editing therapy for sickle cell disease and transfusion-dependent beta-thalassemia.
Waters and Genovis will work to develop automated workflows for the fast and constant characterization of critical quality attributes of monoclonal antibodies and other protein-based drugs in bioprocess development, formulation, stability testing, and quality control.
Post-inspection report reveals nine sanitary and process problems at Bayview, Md., facility.
The new facility, which will be Evotec’s first in Europe, will aim to offer capacity, flexibility, and quality for biotherapeutic development and manufacturing while utilizing technology that employs small, automated, highly intensified, and continuous bioprocessing operations inside autonomous cleanrooms.
Pending a completed FDA inspection, Emergent BioSolutions halts manufacture of vaccine drug substance at Maryland facility.
The additional doses are a result of the European Commission’s expanded advance purchase agreement, which brings the total number of doses delivered to the EU to 600 million.
The agency revoked EUA status for the monoclonal antibody bamlanivimab to be administered alone to treat mild-to-moderate COVID-19.
CordenPharma’s expansion will include the addition of new production lines which will be merged into the lipid manufacturing process in April 2021.
Sartorius has expanded in the United Kingdom with the relocation to a new facility in Havant, Hampshire, for downstream processing equipment.
The agency will use technology for “voluntary remote interactive evaluations” for pre- and post-approval and other types of inspections.
BMS has announced that the EC has approved Opdivo in combination with Cabometyx for the first-line treatment of adults with advanced renal cell carcinoma.
EMA's Pharmacovigilance Risk Assessment Committee is reviewing very rare cases of unusual blood clots in the US, following administration of Janssen’s COVID-19 vaccine.
EMA is continuing to monitor the incidences of very rare blood clots with low blood platelets occurring after vaccination with the AstraZeneca COVID-19 vaccine (Vaxzevria).
EMA has started its review of monoclonal antibody VIR-7831 (also known as GSK4182136) as a treatment for patients with COVID-19.
HTL Biotechnology and Echelon Biosciences have formed a strategic partnership for the distribution of high-quality HA and GAG, and the co-development of novel GAG products.
