The lab is expected to open in April 2020 and will increase the company’s capacity for diagnostic testing of rare genetic diseases along with its COVID-19 capabilities.

The guidance document describes the agency’s temporary policy for the compounding of drugs during the COVID-19 pandemic.

The company is recalling three lots of Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) due to potential N-Nitrosodimethylamine (NDMA) contamination.

Experts to discuss strategies for ensuring supply of quality drug products during a pandemic in April 28 online event.

Late-stage pharmaceutical company based in San Diego, MEI Pharma, and Japanese drug discovery company, Kyowa Kirin, have entered into a global license, development, and commercialization agreement for ME-401.

AstraZeneca has announced it will be commencing a randomized, global clinical trial to assess the efficacy and safety of Calquence (acalabrutinib) in treating the exaggerated immune response of patients with COVID-19.

Sanofi and GlaxoSmithKline (GSK) have revealed that they are joining forces to develop an adjuvanted vaccine using their respective technologies that can be used to fight COVID-19.

ISPE’s Facility of the Year Awards for 2020 go to bio/pharma companies in eight award categories, including two winners in the new Social Impact category.

The agency sent warning letters to three more companies for selling unapproved products claiming to treat COVID-19.

Drug manufacturers, distributors, and dispensers oppose Buy American policies as likely to reduce reliable supplies and raise product costs.

Through the agreement, Arrakis will receive an upfront payment of $190 million in cash and will have the potential to receive preclinical, clinical, commercial, and sales milestone payments and royalties for any resulting products.

The companies announced they are entering into a strategic collaboration under which Blackstone will provide up to $2 billion to fund Alnylam’s RNAi drugs to treat a range of diseases.

The task force will assist in the developing, authorizing, and monitoring of treatments of COVID-19.

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.

Industry opportunities are increasing for biosimilars, but companies should pay close attention to delivery device design to facilitate success.

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.

Characterizing and controlling protein aggregation is vital to ensure safety and efficacy of a biopharmaceutical product. In this interview, important aspects of protein aggregation and the tools available to address this issue are discussed.

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.