Pharmaceutical Technology Editors

The guidance answers questions on changes made to the regulatory framework to address challenges during the COVID-19 pandemic.

The platform is part of IMA’s remote factory acceptance testing (FAT) initiative that involves providing customers with virtual solutions to meet their machine and packaging testing needs.

The company is advancing its lung-selective nebulized Janus kinase inhibitor into clinical development to determine its ability to prevent acute lung injury in patients with COVID-19.

The partners have formed a joint venture to produce muscle-derived mesenchymal stem cells as a source of exosomes and other cellular products to develop related therapies and advance clinical trials.

EMA's CHMP has recommended the use of remdesivir, an investigational antiviral medicine, in compassionate use programs across the European Union.

Horizon Discovery has announced that it has expanded its cell-based clustered regularly interspaced short palindromic repeats (CRISPR) screening services to include primary human B cells, which complements the T cell screening service.

Belgian biopharmaceutical company, UCB, has successfully completed its acquisition of Ra Pharmaceuticals, which is now a wholly-owned subsidiary of the company.

The drug discovery platform was developed to rapidly predict blocking of COVID-19 pneumocyte cellular entry.

The agency has been tasked with coordinating efforts to mitigate shortages of medicines within Europe during the COVID-19 pandemic.

The agency sent a warning letter to Genesis II Church for marketing fraudulent chlorine dioxide products the company claims treats and prevents COVID-19.

Second Genome will use its Microbiome Analytics Platform throughout the collaboration to identify novel biomarkers associated with clinical response to Gilead’s investigational medicines.

The partnership, led by Takeda and CSL Behring, will focus on developing a hyperimmune immunoglobulin against COVID-19.

The digital event, called Bio Digital 2020, will now take place from June 8–12, 2020.

The companies will collaborate on research and development solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19.

The company closed two new funds, ARCH Venture Fund X and ARCH Venture Fund X Overage, for a total of $1.46 billion combined.

The medical service volunteer programs will allow their employees who are licensed medical professionals to help fight against COVID-19 while maintaining their base pay.

The acquisition will include PBMI’s trademarks, conference, website, education, and membership assets.

Specialty pharmaceutical company, Diurnal, has announced that the marketing authorization application (MAA) for Chronocort has passed validation with the European Medicines Agency (EMA).

N4 Pharma will be undertaking a proof-of-concept research project using a COVID-19 DNA plasmid to demonstrate the ability of its delivery system, Nuvec, to collaborative partners developing DNA or RNA vaccines.

CPS will be integrated into CB, who will proceed as the operating company while CMIC group continues to expand its business in China.

The companies are entering into a partnership to develop fully human neutralizing antibodies targeting SARS-CoV-2 to prevent or treat COVID-19.

The event, which was originally scheduled for May 11–13, 2020 at the Gaylord Palms Resort and Convention Center in Kissimmee, FL, will be canceled due to concerns regarding the spread of COVID-19.

GE biopharma brands are now part of Cytiva, a Danaher Corporation Life Sciences company.

With new tests showing NDMA levels increase under normal storage conditions, FDA calls for removal of ranitidine products from the market.

Daiichi Sankyo has entered into a partnership with Ultragenyx Pharmaceutical for the use of Ultragenyx’s proprietary AAV-based gene-therapy manufacturing technology.

The patent includes the use of fibroblast cells and adjuvants such as peptides and hydroxychloroquine, which fuels the assembly of natural interferon to overpower the virus.

The new patented process results in uniform, scalable production and the ability to deliver cell cargo similar to natural exosomes/extracellular vesicles.

The company is currently seeking interest from companies who have the skill and means to rapidly advance BOLD-100 for the treatment of COVID-19.

The partnership will focus on the development of up to five novel protein replacement and mRNA therapies.

Pre-clinical immunization studies of iBio’s SARS-CoV-2 VLP candidates are being performed by Texas A&M.