Category: Research and Development

July 17, 2023

An experimental medicine benefited patients with a deadly heart condition in a closely watched Phase 3 trial, lifting the fortunes of its developer, BridgeBio Pharma, and clearing the way for the biotechnology company to seek U.S. approval. Trial results showed […]

July 14, 2023

Caribou Biosciences – a company focused on genome-editing – has announced follow-up data from the dose escalation element of its ongoing ANTLER phase 1 trial. This new data set includes all 16 patients treated in dose escalation with the CB-010 […]

July 11, 2023

FDA recently granted full, or traditional, approval to Eisai Pharmaceutical’s Alzheimer’s treatment Leqembi, converting an earlier conditional approval status with further data from a multi-regional study of nearly 1800 patients. Results indicated that the drug slows the rate of cognitive […]

June 30, 2023

Vertex Pharmaceuticals and Lonza are partnering in the production of a new facility. Both companies are working together to manufacture and support the production of Vertex’s experimental cell therapy VX-880 for Type 1 diabetes and a second candidate VX-264. The […]

June 28, 2023

The next six months will be full of dramatic moments for the biotechnology industry. The Food and Drug Administration will either be validated or undermined for its decision to grant an early approval to the first gene therapy for Duchenne […]

June 27, 2023

An experimental drug appears to outperform the trendy medications Wegovy and Ozempic for both weight loss and diabetes control, a pair of early clinical trials shows. Retatrutide helped people with obesity drop about one-quarter of their starting weight, on average, […]

June 22, 2023

On June 22, 2023, Andelyn Biosciences, a cell and gene therapy (CGT) contract development and manufacturing organization, announced the opening of its newly constructed manufacturing headquarters in Columbus, Ohio. According to a company press release, the 180,000-ft2 facility is intended […]

June 15, 2023

Mendus, a biopharmaceutical company focused on immunotherapies addressing tumor recurrence, and NorthX Biologics, a contract development and manufacturing organization that serves as the National Swedish Innovation Hub for the good manufacturing practice (GMP) manufacture of biologics used in vaccines, gene […]

June 12, 2023

Many professionals in the life sciences industry are excited about the benefits decentralized clinical trials (DCTs) bring to the clinical research process and specifically to patients. The use of wearables, electronic consent forms, digital outcomes assessments, and other DCT technologies […]

June 6, 2023

Today, the U.S. Food and Drug Administration is announcing the availability of a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials, making them more agile without compromising data […]

June 5, 2023

Biogen has disclosed plans to stop a late-stage clinical trial testing one of its drugs as a potential treatment for Parkinson’s disease. According to a Monday announcement, the decision is due to several factors, including the trial’s complexity and run […]

May 31, 2023

Nexcella, a subsidiary of US-based Immix Biopharma and a clinical-stage biopharmaceutical company, announced on May 26, 2023 that it has begun producing engineering batches of NXC-201, its lead candidate and a chimeric antigen receptor T cell (CAR-T) therapy, at its […]

May 30, 2023

Since biological drugs first became available, their demand has been increasing—with the biologic market being valued at approximately US$302.63 billion in 2020 and expecting to reach US$509.23 billion by 2026 at a compound annual growth rate of 9.06% (1). With […]

May 24, 2023

TriLink BioTechnologies announced the expansion of its messenger RNA (mRNA) manufacturing capabilities on May 24, 2023. The new construction of the current good manufacturing practice (CGMP)-grade facility will help the company with its mission to advance the field as more […]

May 22, 2023

Opening the digital front door to clinical trials means creating a great user experience for patients, clinicians and ultimately sites and sponsors. As anyone in healthcare knows all too well, it has historically been much easier said than done. However, […]

May 19, 2023

Moderna said Friday that one of its rare disease drug programs showed promise in its first clinical trials, according to an early look at the data. The drug is meant to treat propionic acidemia, an uncommon genetic disorder that causes […]

May 15, 2023

Preliminary results for the MenABCWY candidate were presented by the company at the European Society for Paediatric Infectious Diseases congress in Lisbon, Portugal. Invasive meningococcal disease (IMD) is an uncommon but serious illness that can cause life-threatening complications or even […]

May 4, 2023

This could include carrying out clinical tests at a local facility rather than a research medical centre, or conducting follow-up visits in the participants’ homes using telemedicine. The 16-page document provides recommendations for sponsors, investigators and other stakeholders on the […]

May 1, 2023

Flatiron Health is collaborating with Sanofi to redesign the clinical trial experience for sponsors, sites, and patients in the therapeutic area of oncology. The multi-study collaboration will focus on improving clinical trial data acquisition, delivery, and quality through site-facing technology […]

April 28, 2023

Yposkesi, SK pharmteco’s clinical and commercial viral vector manufacturing arm for cell and gene therapies, launched LentiSure, an optimized Lentiviral (LV) Vector manufacturing platform for increasing lentivirus production efficiency and robustness. Lentivirus or LV vectors are used to produce cell-based […]