Category: Research and Development

June 16, 2021

The study, co-authored by Seqirus, was conducted as part of a Phase III clinical trial of Novavax’s COVID-19 vaccine NVX-CoV2373 in the UK. The co-administration sub-study enrolled a total of 431 volunteers, all of whom had received a flu vaccine […]

June 8, 2021

After investigating America’s supply chains, including those for drugs and pharmaceutical ingredients, the Biden administration has revelations to share—and it’s proposing a sweeping strategy to boost domestic drug production. Under the plan, the White House is establishing a public-private partnership […]

June 3, 2021

Recro Pharma, a contract development and manufacturing organization (CDMO), announced on June 2, 2021 that it has expanded the clinical capabilities of its clinical trial services (CTS) offerings. The added capabilities include clinical-scale sachet and blister packaging for clinical trial […]

June 2, 2021

The increased capacity depends on Moderna getting approval for a half dose of an updated version of the mRNA-1273 vaccine – targeting new variants of SARS-CoV-2 – that could be used as a booster shot and for immunising children. The […]

June 1, 2021

The COVID-19 pandemic accelerated the adoption of decentralized clinical trials (DCTs) by biopharma companies. The clinician-patient relationship will always be key to clinical trials, but decentralized aspects such as direct-to-patient shipments and telehealth are here to stay. Here are four […]

May 25, 2021

Despite a flurry of uncertainty surrounding Biogen’s Alzheimer’s hopeful aducanumab, the company has forged ahead with its launch preparations ahead of a pending FDA decision. Now, its Swiss manufacturing facility is a step closer to eventually churning out doses—should the […]

May 20, 2021

One lesson of the COVID-19 pandemic is the importance of being able to assess potential new therapies and vaccines quickly and reliably and in ways that can adapt to changing scientific evidence and public health needs. FDA has responded to […]

May 18, 2021

Oxford Biomedica signed an 18-month supply agreement in September 2020 with AstraZeneca for the large-scale commercial manufacture of the adenovirus vector-based Covid-19 vaccine, AZD1222. AstraZeneca has now requested that Oxford Biomedica increase the number of batches it is manufacturing in […]

May 13, 2021

The new molecule – called DSP-0038 – is being developed by Japan’s Sumitomo Dainippon Pharma (DSP), which is now starting a phase 1 trial in the US as a treatment for psychosis associated with Alzheimer’s, and to see if it […]

May 3, 2021

Some of the most time- and cost-consuming components of clinical research center on gathering, analyzing, and reporting data. To improve efficiency, many clinical trial sponsors have shifted to electronic clinical outcome assessments (eCOA), including electronic patient-reported outcome (ePRO) tools. In […]

April 28, 2021

Artificial intelligence (AI)-based drug developer Exscientia has closed on $525 million in financing, with the proceeds intended for advancing its pipeline through clinical trials, as well as expanding its technology platform toward autonomous drug design. Based in Oxford, U.K., Exscientia […]

April 27, 2021

Samsung Biologics announced on April 26, 2021 that it has expanded its 2018 contract manufacturing deal with TG Therapeutics, a US based healthcare company, for the supply of TG’s ublituximab, an investigational anti-CD20 monoclonal antibody (mAb). Since the start of […]