The global safety organization of Novartis is in the process of conducting a comprehensive review of a limited number of cases where patients treated with Beovu (brolucizumab) have experienced severe vision loss, inflammation, and potential retinal vasculitis.
The new center expands the company’s R&D capabilities and will help it advance its portfolio of rare disease gene therapy programs.
The acquisition will expand Nexelis’ immunology testing expertise.
The conference, which was originally scheduled for March 31–April 3, 2020 at the Messe München in Germany, will be rescheduled for Oct. 19–22, 2020 at the same location.
The action involves allowing specific National Institute for Occupational Safety and Health-approved respirators not regulated by FDA to be used in healthcare settings to increase the number of respirators available in the United States.
The organization is postponing its annual meeting to July 2020 because of the developing COVID-19 outbreak.
Research from data and analytics company GlobalData shows that CAR-T cell therapy innovations across APAC will make the global market for these therapies more competitive.
FDA issued a notice to drug compounders regarding the transition of licensure of biologics to the Public Health Service Act.
A guidance document answers questions regarding the transition of biologics applications from under the FD&C Act to the PHS Act.
The technology enables the rapid production of large numbers of recombinant antibodies at 80-mL scale.
The deal is expected to close during the first half of 2021.
The therapy works by transferring pathogen-specific antibodies from plasma gathered from recovered individuals into an infected patient, which may help the patient’s immune system respond and increase recovery.
Thermo Fisher Scientific has announced that its acquisition proposal for Qiagen has been unanimously approved by the company’s managing board and board of directors.
CN Bio Innovations has raised $9 million (£6.9 million) in investment funding that will be used to support commercial development and strengthen market position in the United States
GW Pharmaceuticals and Bayer have revealed that GW will regain the exclusive commercialization rights for Sativex (delta-9-tetrahydrocannabinol [THC] and cannabidiol [CBD]) in the UK.
Full-service contract research organization, Pivotal, has announced its acquisition of Akcelis, a Belgian company that specializes in patient engagement, recruitment, and retention.
The acquisition will give Gilead access to Forty Seven’s investigational lead product candidate, magrolimab, a monoclonal antibody in clinical development for the treatment of numerous cancers.
Under the agreement, Takeda will divest the rights, title, and interest to 18 over-the-counter and prescription products sold in Brazil, Mexico, Argentina, Colombia, Ecuador, Panama, and Peru.
A study finds a potential risk of persistent visual side-effects in male patients taking the highest recommended dose of sildenafil.
Generic pharmaceutical company, Hikma Pharmaceuticals, and the Swiss subsidiary of Glenmark Pharmaceuticals, Glenmark Specialty, have signed an exclusive license agreement for the commercialization of Ryaltris in the United States.
German-based company, Insilico Biotechnology, has announced that it has opened its first subsidiary in the United States, specifically in Boston, MA, which is a biopharmaceutical hub in the country.
The partners will use ProBioGen’s DirectedLuck transposase technology to support development and large-scale manufacturing of ImmunOs’ biologics.
With the first announced drug shortage tied to the coronavirus outbreak, FDA emphasizes urgency for monitoring drug supply chain.
Eurofins DiscoverX partners with VelaLabs to enable VelaLabs to perform highly reproducible potency lot release assays under GLP/GMP conditions.
Under the agreement, ERS Genomics will license its gene-editing technology to Aelian Biotechnoloy to support its commercial functional genomic screening platform.
The companies are entering into a development and manufacturing collaboration for the advancement and production of human monoclonal antibodies for the potential treatment of novel coronavirus.
Perrigo will be producing a limited amount of the generic inhaler medication but will accelerate production to meet future demands in collaboration with Catalent.
Takeda announced the acquisition after the conclusion of a Phase 1 study of the investigational medicine TAK-062 (Kuma062) for the treatment of uncontrolled celiac disease.
If approved, the therapy may become the first-choice treatment for relapsing multiple sclerosis patients and will be the first B-cell therapy that can be self-administered using an autoinjector pen.
The expansion gives the company diversified capacity running cell production lines featuring Sartorius-brand 2000-L disposable bioreactors and now GE-brand 2000-L single-use bioreactors.
