The Indian government has issued a notification of the restriction on the export of 26 APIs and formulations, including paracetamol, progesterone, and vitamin B12, as a result of the outbreak of COVID-19.

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 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.

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.

The growing interest in developing cell and gene therapies has prompted industry investment to grow manufacturing capacity.

The last year has seen intense investment activity into raising cell and gene therapy manufacturing capacity.