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Tag: clinical trials


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 […]


Industry, Vaccines

WHO announces recommended 2023-24 flu vaccines for northern hemisphere

March 1, 2023

Via: PMLiVE

National vaccine regulatory agencies and pharmaceutical companies will now use this guidance to develop, produce and license influenza vaccines for the following season. WHO organises consultations with an advisory group of experts twice a year to analyse influenza virus surveillance […]


News

Talaris restructures, ending effort to develop a cell therapy for kidney transplants

February 16, 2023

Via: Biopharma Dive

Talaris Therapeutics plans to dial back its research plans and restructure, the latest setback for a biotechnology company that’s been reeling since the death of a patient in a clinical trial last year. In a Thursday statement, Talaris said it’s […]


Clinical Trials, Research and Development

Frequency to cut jobs after clinical trial setback

February 13, 2023

Via: Biopharma Dive

A spinout of the Massachusetts Institute of Technology, Frequency sought to develop treatments for hearing loss by regenerating lost hair cells in the inner ear, rather than turning to hearing aids or implants. Both its lead drug FX-322 and FX-345, […]


Clinical Trials, Research and Development

Clinical Trial Diversity Continues to Face Challenges

February 13, 2023

Via: Biopharm International

Policymakers and biopharma companies acknowledge the importance of assessing drugs and medical products on a wide range of ethnic and racial populations to fully understand medical effects on patients. This has bolstered support for studies to enroll patients in proportion […]


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 […]


News

Robust Development Fuels Drive to Finish Line

February 2, 2023

Via: Biopharm International

Regenerative medicines have the attention of investors, industry players, and regulatory authorities. Prompted by an influx of funding in the regenerative medicines sector, drug developers have jumped forward with clinical development of product candidates. Factors that remain critical to the […]


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 […]


Mergers and Acquisitions

Roche, Boehringer tap biosensor firms for patient studies

January 26, 2023

Via: Pharmaphorum

Roche’s alliance with France’s Sysnav Healthcare is in the area of movement disorders, and will build on the tech company’s wearable magneto-inertial sensor device for 3D movement tracking, which has already been accepted as a digital endpoint for use in […]