Category: Research and Development

Clinical Trials, Industry, Research and Development, Vaccines

Study demonstrates safety and efficacy of co-administering COVID-19 and flu vaccines

June 16, 2021

Via: Pharma Times

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 […]

Manufacturing, Research and Development

After COVID-19 spotlighted supply chain weaknesses, Biden unveils plan to resurrect U.S. drug manufacturing

June 8, 2021

Via: FiercePharma

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 […]

Clinical Trials, Manufacturing, Research and Development

Recro to Expand its Clinical Trial Services Offerings

June 3, 2021

Via: Biopharm International

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 […]

Manufacturing, News, Research and Development

Moderna ramps up EU COVID jab capacity via Lonza deal

June 2, 2021

Via: Pharmaphorum

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 […]

Clinical Trials, Research and Development

4 insights on decentralized trials for biotechs

June 1, 2021

Via: Biopharma Dive

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 […]

Manufacturing, Research and Development

Biogen’s $1B Swiss plant scores regulatory nod as drugmaker awaits pivotal FDA decision on aducanumab

May 25, 2021

Via: FiercePharma

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 […]

Clinical Trials, Research and Development

FDA Promotes Master Protocols to Modernize Clinical Trials

May 20, 2021

Via: Biopharm International

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 […]

Industry, Manufacturing, Research and Development, Vaccines

Oxford Biomedica to manufacture more doses of AstraZeneca’s Covid-19 vaccine

May 18, 2021

Via: EPM Magazine

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 […]

Clinical Trials, Research and Development

Exscientia starts trials of AI-designed Alzheimer’s drug

May 13, 2021

Via: Pharmaphorum

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 […]

Clinical Trials, Research and Development

How BYOD leads to patient-centric clinical trials

May 3, 2021

Via: Biopharma Dive

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 […]

Clinical Trials, News, Research and Development

AI Drug Developer Exscientia Closes $525M in Financing

April 28, 2021

Via: Genetic Engineering and Biotechnology News

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 […]

Manufacturing, Mergers and Acquisitions, News, Research and Development

Samsung and TG Therapeutics to Expand mAb Manufacturing Collaboration

April 27, 2021

Via: Biopharm International

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 […]