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Tag: clinical trials


Clinical Trials, Research and Development

Moderna reports ‘encouraging’ early data for one of its rare disease medicines

May 19, 2023

Via: Biopharma Dive

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 […]


Clinical Trials, Research and Development

GSK’s five-in-one meningococcal vaccine candidate shows promise in phase 3 trial

May 15, 2023

Via: PMLiVE

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 […]


Clinical Trials, Research and Development

FDA issues new draft guidance on decentralised clinical trials

May 4, 2023

Via: PMLiVE

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 […]


FDA, Regulations

FDA Gives Guidance for Decentralized Clinical Trials for Drugs, Devices

May 2, 2023

Via: Biopharm International

FDA released a new draft guidance that provides recommendations aimed at sponsors, investigators, and other stakeholders regarding the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and devices. This specific guidance refers to a DCT as a clinical […]


Clinical Trials, Research and Development

Flatiron, Sanofi Partner on Efficiency in Clinical Trials

May 1, 2023

Via: Contract Pharma

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 […]


Clinical Trials, Research and Development

Clinical trial begins using CAR T cells to potentially cure HIV

April 20, 2023

Via: World Pharma News

UC Davis Health researchers have dosed the second participant in their clinical trial looking to identify a potential cure for HIV utilizing CAR T-cell therapy. The novel study uses immunotherapy. It involves taking a patient’s own white blood cells, called […]


Clinical Trials, Research and Development

Patient-centered clinical trials improve recruitment and retention

April 17, 2023

Via: Biopharma Dive

Patient enrollment in clinical trials is time-intensive and costly. In 2015-2016, the average cost to recruit one patient1 to a clinical study was $6,500+ and the average cost to recruit a new patient to replace a lost one was $19,000+. […]


Cell and Gene Therapy, Industry

Novo’s latest deal targets cell therapy for diabetes, obesity

April 12, 2023

Via: Biopharma Dive

Novo, while historically not big on buyouts, has turned to acquisitions over the past couple years to expand its slate of technologies and research programs. In late 2021, it agreed to spend north of $3 billion on Dicerna Pharmaceuticals, a […]


News

Curevo Vaccine Names Guy De La Rosa Chief Medical Officer

April 11, 2023

Via: Contract Pharma

Curevo Vaccine, a privately held clinical-stage biotechnology company dedicated to reducing the burden of infectious disease by developing safe and highly effective vaccines, announced Guy De La Rosa has joined the company as its new chief medical officer. “The Curevo […]


Cell and Gene Therapy, Industry

New therapy harnesses patients’ blood cells to fight tumors

April 10, 2023

Via: World Pharma News

Adoptive cell therapy (ACT) has become a promising immunotherapy tool to help treat advanced melanoma. The therapy, which harnesses immune cells collected from the patient’s own tumors, could provide a new treatment option to cancer patients, potentially bypassing radiation therapies […]


FDA, Regulations

FDA Backs Randomized Trials for Accelerated Drug Approval

April 7, 2023

Via: Biopharm International

In an important update to its policies for conducting clinical trials to support accelerated approval of important oncology and other lifesaving therapies, FDA is articulating a preference for randomized controlled trials (RCTs), as opposed to single-arm studies, to support fast […]


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

Changing cell & gene therapy landscape and implications on clinical trials

April 3, 2023

Via: Biopharma Dive

Cell and gene therapy clinical research is a field that holds promise for the treatment of many diseases. These therapies involve using living cells or genes to treat or prevent diseases and have the potential to revolutionize how we approach […]


Clinical Trials, Research and Development

Monthly Injections Might Lower Bleeding in People With Hemophilia

March 31, 2023

Via: Drugs.com

An experimental injectable drug appears effective in reducing bleeds in patients with hemophilia A and B, according to a pair of new clinical trials. Two-thirds of people with treatment-resistant hemophilia who were treated with the drug fitusiran had no bleeds […]


Clinical Trials, Research and Development

Viking joins obesity drug development race with early study data

March 28, 2023

Via: Biopharma Dive

Novo Nordisk pioneered the use of insulin-stimulating diabetes drugs as weight loss treatments when it launched a high-dose version of its daily shot Victoza as Saxenda in 2014. It followed on that success years later with a weekly shot, marketed […]


Clinical Trials, Industry, Research and Development, Vaccines

BioNTech Revenues Slide with Waning Demand for COVID-19 Vaccines

March 27, 2023

Via: Contract Pharma

4Q Revenues: €4.3 billion (-23%) 4Q Earnings: €2.3 billion (-28%) YTD Revenues: €17.3 billion (-9%) YTD Earnings: €9.3 billion (-8%) Comments: Results in the quarter and FY reflect lower demand for COVID-19 vaccines. Approximately 2 billion doses of COMIRNATY invoiced […]


Clinical Trials, Research and Development

Syneos Health Partners with Microsoft to Optimize Clinical Trials

March 21, 2023

Via: Contract Pharma

Syneos Health has entered a multi-year strategic agreement with Microsoft. Using Microsoft Azure services, Syneos Health has developed an advanced analytics platform designed to enable agile deployment of machine learning (ML) supporting the analysis, design and execution of clinical trials […]


News

PBD Biotech reveals vital update to TB test

March 15, 2023

Via: Pharma Times

Lyophilized PCR reaction bead reduces the cost of transport and extends shelf life for the test PBD Biotech has developed a lyophilized PCR reaction bead for its Actiphage blood test which identifies active tuberculosis (TB). The new function enables transportation […]


Clinical Trials, Mergers and Acquisitions, Research and Development

LEO Pharma, ICON Partner to Advance Clinical Trials in Dermatology

March 10, 2023

Via: Contract Pharma

LEO Pharma, a global leader in medical dermatology, and ICON plc, entered into a strategic partnership that will enable LEO Pharma to scale clinical trial execution that is patient-centric and cost effective, to support the company’s clinical portfolio. The partnership […]


Clinical Trials, Research and Development

BridgeBio shares jump on dwarfism drug data

March 6, 2023

Via: Biopharma Dive

Based on the latest data, BridgeBio has started enrolling children in a Phase 3 trial of infigratinib in achondroplasia and also plans to develop the medicine for patients with a closely related skeletal abnormality known as hypochondroplasia. The company has […]


Industry, Vaccines

Is an Allergy to a COVID Vaccine Always Real? Placebo Trial Casts Doubt

March 2, 2023

Via: Drugs.com

Allergic reactions to the Pfizer or Moderna COVID vaccines are very rare, and a new study questions whether many of those that do occur are even real. In a small new study of 16 people who said they’d experienced an […]