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Category: Research and Development


Clinical Trials, Mergers and Acquisitions, Research and Development

Cambridge Cognition and Aardex collaborate to boost decentralised clinical trials

February 3, 2023

Via: Pharma Times

Aardex Group – a company focused on remote research and healthcare adherence – and Cambridge Cognition have firmed a partnership up to provide monitoring during hybrid and decentralised clinical trials (DCTs). The link-up will involve the incorporation of Aardex’s MEMS […]


Clinical Trials, Industry, Research and Development, Vaccines

Transforming the way cancer vaccines are designed and made

February 3, 2023

Via: World Pharma News

A new way to significantly increase the potency of almost any vaccine has been developed by researchers from the International Institute for Nanotechnology (IIN) at Northwestern University. The scientists used chemistry and nanotechnology to change the structural location of adjuvants […]


Manufacturing, Research and Development

Current Trends in Host Cell Protein Detection for Biologics Manufacturing

February 1, 2023

Via: Biopharm International

Biologics, especially protein drugs, are often produced in cultured cells. Those cultured cells, called host cells, synthesize the target proteins along with the proteins coded by the cell genome for the cells’ own survival, function, and reproduction. Purifying the target […]


Cell and Gene Therapy, Clinical Trials, Industry, Research and Development

Be The Match BioTherapies Launches CRO Services for Cell and Gene Therapy

January 31, 2023

Via: Biopharm International

Be The Match BioTherapies, a provider of solutions for developing and commercializing cell and gene therapies, in conjunction with the Center for International Blood and Marrow Transplant Research (CIBMTR), is offering expanded clinical research organization (CRO) services. These services are […]


Clinical Trials, Research and Development

Merck’s Keytruda flunks another prostate cancer test

January 26, 2023

Via: Pharmaphorum

Merck has said it will abandon the KEYNOTE-991 study of PD-1 inhibitor Keytruda (pembrolizumab) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) after it showed no benefit on either overall survival (OS) or radiographic progression-free survival (rPFS) when the data […]


Manufacturing, Research and Development

Lilly to boost diabetes drug production with $450M factory investment

January 24, 2023

Via: Biopharma Dive

Eli Lilly will invest $450 million in a North Carolina manufacturing plant to meet growing demand for its diabetes drugs Mounjaro and Trulicity, the company said Tuesday. The investment in the Research Triangle Park plant will expand filling, device assembly […]


Manufacturing, Research and Development

Call to arms as UK falls back in medicines manufacturing

January 24, 2023

Via: Pharmaphorum

A just-published report from the Medicines Manufacturing Industry Partnership (MMIP) – set up by the UK government and biopharma industry in 2014 to drive growth in the category – says the sector has the potential to be a driver for […]


Clinical Trials, Research and Development

Why early participant engagement is now a top priority in genetic disease research

January 18, 2023

Via: Pharmaphorum

The DNA of these so-called ‘genetic superheroes’ may contain clues about how to treat severe disease. By studying their natural resilience and using it to design new therapies, it could help so many people. However, the Resilience Project’s scientists had […]


Clinical Trials, Research and Development

Driving clinical trial innovation forward with precision medicine

January 17, 2023

Via: Pharmaphorum

Unify, launched in December 2020, is AstraZeneca’s patient app and clinical trial support tool. Already, it is operating at scale across the company, used in more than 28 countries and available in 62 languages. Dissecting heterogeneity To begin discussions, pharmaphorum […]


Clinical Trials, Research and Development

Phase 3 trial dashes Oramed’s oral insulin hopes

January 12, 2023

Via: Pharmaphorum

The announcement marks the disappointing end of a marathon effort by Oramed to develop an oral insulin formulation for type 2 diabetes struggling to control blood sugar on standard therapies and as an alternative to injections. It exposes once again […]


Clinical Trials, Research and Development

Arrowhead reports positive data from liver drug, but company’s shares slide

January 9, 2023

Via: Biopharma Dive

Arrowhead’s drug, called fazirsiran, is designed to treat alpha-1 antitrypsin deficiency, a genetic condition in which a mutant form of the namesake protein accumulates in liver cells, causing fibrosis and cirrhosis. Alpha-1 antitrypsin, or AAT, deficiency has become a target […]


Manufacturing, Research and Development

Ginkgo Bioworks Expands R&D Facilities with Opening of Bioworks7

January 9, 2023

Via: Contract Pharma

Ginkgo Bioworks, which is building a platform for cell programming and biosecurity, has opened Bioworks7, the latest expansion of its biological engineering foundry. With this new space, Ginkgo increases its capacity and capabilities to serve its partners in the spaces […]


Clinical Trials, Research and Development

Study shows there is still a long way to go on trial diversity

January 5, 2023

Via: Pharmaphorum

Bioethics International has developed a benchmarking tool for “fair inclusion” in clinical trials, drawing on pivotal trials submitted to the FDA in support of 59 new cancer therapeutics – submitted by 25 sponsors – that were approved by the regulator […]


Clinical Trials, Research and Development

RQ Bio-discovered antibody enters clinic as part of AstraZeneca COVID-19 study

January 4, 2023

Via: PMLiVE

The start of the trial triggers a $5m milestone payment from AZ, which licensed AZD3152 from RQ Bio in May last year, and reinforces the financial position of the UK-based biotech to execute its four scientific programmes focused on viral […]


Clinical Trials, Research and Development

10 clinical trials to watch in the first half of 2023

January 3, 2023

Via: Biopharma Dive

The biotechnology industry begins 2023 at a crossroads. In many ways, the sector is coming off of one of its toughest years in recent memory. Initial public offerings ground to a halt. A widely followed biotech stock index plunged nearly […]


Clinical Trials, Research and Development

Pfizer’s haemophilia B gene therapy meets phase 3 primary endpoint

January 3, 2023

Via: Pharmaphorum

Haemophilia is a rare genetic bleeding disorder that causes the blood to take a long time to clot because of a deficiency in one or several blood clotting factors. It is almost exclusively found in males. According to the World […]


Clinical Trials, Research and Development

CStone gets a win for sugemalimab in oesophageal cancer

January 3, 2023

Via: Pharmaphorum

The Hong Kong-listed cancer biotech said this morning that anti-PD-L1 inhibitor sugemalimab given in combination with chemotherapy showed “statistically significant and clinically meaningful” improvements in both progression-free survival (PFS) and overall survival (OS) in previously-untreated patients with unresectable locally advanced, […]


Clinical Trials, Research and Development

Newron says pivotal treatment-resistant schizophrenia trial is a go

January 3, 2023

Via: Pharmaphorum

The Italian biopharma said it had decided to press ahead with the new study after assessing results from 100 patients with TRS in open-label studies who received the glutamate modulator drug as an add-on to their current therapy for more […]


Clinical Trials, Research and Development

Upholding regulatory compliance in decentralised trials

December 30, 2022

Via: Pharmaphorum

These are all critical consideration for sponsors, as failing to conduct trials in accordance with GCP and other applicable regulations can lead to regulatory authorities rejecting data that is generated to support new treatments and regulatory applications, as well as […]


Clinical Trials, Research and Development

Pfizer says hemophilia B gene therapy controlled bleeding in key study

December 29, 2022

Via: Biopharma Dive

Drugmakers have long studied hemophilia gene therapies, seeking to replace the infusions that people with the disease take for life to control their bleeding. In recent years, their research has delivered clinical successes in both the “A” and “B” forms […]