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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 acquisition will expand Nexelis’ immunology testing expertise.

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.

The deal is expected to close during the first half of 2021.

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.

Emergency action to protect patients and the drug supply may have long-term implications.

No matter why change may be needed, it is important to comply with all the relevant regulatory requirements, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.

A study finds a potential risk of persistent visual side-effects in male patients taking the highest recommended dose of sildenafil.

Despite increasing R&D budgets by bio/pharma companies, returns on this investment are reducing and the cost of bringing an asset to market is increasing.

Outsourcing stability testing to full-service providers can offer comprehensive benefits to bio/pharma companies.

The huge potential of biopharma is presenting an important epoch for outsourcing partners that can support the development and manufacture of biologics in an efficient way.

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.

The partners will explore Dyadic’s C1 gene expression platform in conjunction with IIBR’s express gene sequences and targets to develop a potential vaccine candidate and monoclonal antibodies.

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.