Industry News

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.

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

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

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.

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

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

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.

Successful negotiation of life-sciences collaboration agreements involves careful planning.

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 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.

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.

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.

Johnson & Johnson announces clinical trial plans for COVID-19 vaccine candidate, as well as plans to produce 1 billion vaccine doses.

The bill includes multiple less-noticed provisions to bolster healthcare programs and to advance the development of new treatments and preventives to combat the virus.

The joint public-private initiative will provide $4 million in funding to a Johns Hopkins-led research team exploring therapeutic uses of blood plasma from recovered COVID-19 patients.

Data and analytics company GlobalData announced that there is a strain on the global biopharma industry’s supply chain due to the ongoing outbreak of COVID-19.

Grifols has entered into a formal collaboration with US Federal public health agencies, including the Biomedical Advanced Research Development Authority (BARDA) and the Food and Drug Administration (FDA), to produce a treatment that specifically targets COVID-19.

Prior to the global market downturn, data from the United Kingdom BioIndustry Association (BIA) and Informa Pharma Intelligence have revealed that biotech companies in the UK had raised £309 million (US$379 million).

Noting traditional clinical trials for COVID-19 convalescent plasma will take time, FDA is allowing physicians to submit requests for single-patient emergency INDs.

In light of the current COVID-19 pandemic, the agencies co-chaired the first global regulators meeting to facilitate development of vaccines against SARS-CoV-2, which causes COVID-19.

FDA officials are rolling out guidance and support for researchers striving to assess potential treatments for COVID-19 while the agency tries to object to premature optimism and regain public credibility.

FDA is offering advice and added flexibility to help sponsors adjust ongoing and planned clinical research programs during the COVID-19 outbreak.

The facility, which handles discovery chemistry services, will accelerate its operations over the next few weeks while taking precautions to guarantee the health and safety of its employees across every site.

USP technical advisors will offer assistance to drug developers to ensure material quality and testing.

The partners have initiated an observational case-control study of siltuximab in patients with COVID-19 who have developed serious respiratory complications.