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Tag: clinical trials


Cell and Gene Therapy, Industry

FDA approves two cell-based gene therapies for sickle cell disease

December 11, 2023

Via: PMLiVE

Affecting approximately 100,000 people in the US, SCD is a life-long, genetic disease that causes red blood cells to take a distinct crescent shape, which can block blood vessels and affect the way oxygen is carried around the body. The […]


Cell and Gene Therapy, Industry

New data in C3G sets up filings for Novartis’ Fabhalta

December 11, 2023

Via: Pharmaphorum

The results from the phase 3 APPEAR-C3G study showed that Fabhalta (iptacopan) met its primary objective of an improvement of protein in the urine (proteinuria) compared to placebo at six months, setting up filings for regulatory approval. Last week, targeted […]


Industry, Pharma

ASH23: Pharma branding, Editas’ high bar and clinical trial diversity

December 11, 2023

Via: Biopharma Dive

At the American Society of Hematology’s annual meeting, pharmaceutical branding is inescapable. Johnson & Johnson’s and GSK’s new logos are splashed across the side of phone charging stations. Sanofi, among others, let attendees know via hand sanitizer stands that it […]


Cell and Gene Therapy, Industry

CRISPR eyes autoimmune disease in revamp of cell therapy plans

December 5, 2023

Via: Biopharma Dive

CRISPR Therapeutics achieved a major scientific milestone last month with the U.K. approval of Casgevy, the first in the world for a CRISPR medicine. Wall Street analysts are expecting a similar outcome with U.S. regulators. Yet the sales outlook for […]


Clinical Trials, Research and Development

Revolutionizing clinical trials: Unlocking peak efficiency with total laboratory automation in bioanalysis

December 4, 2023

Via: Biopharma Dive

With clinical trials becoming more complex, finding ways to streamline and automate laboratory processes is vital when analyzing bioanalytical samples. As the chief scientific officer of large-molecule bioanalysis, Dr. Tom Zhang leverages his expertise to promote ever-evolving automation technologies. He […]


Cell and Gene Therapy, Industry

AbbVie to expand solid tumour portfolio with $10bn ImmunoGen acquisition

December 1, 2023

Via: PMLiVE

The definitive agreement grants AbbVie access to ImmunoGen’s antibody-drug conjugate (ADC) Elahere (mirvetuximab soravtansine-gynx), which received accelerated approval from the US Food and Drug Administration last year to treat platinum-resistant ovarian cancer. ADCs are a new class of cancer therapies […]


Cell and Gene Therapy, Industry

FDA to investigate risk of T-cell malignancy from CAR-T cell immunotherapies

November 30, 2023

Via: PMLiVE

Following reports from clinical trials and post-marketing adverse event data sources, the wide probe is directed at patients who received treatment with all currently approved BCMA- or CD19-directed autologous CAR-T cell immunotherapies. CAR-T-cell therapy is a type of immunotherapy that […]


Cell and Gene Therapy, Industry

Stem cell therapy trial shows promising results for treating progressive MS

November 28, 2023

Via: PMLiVE

Results from the trial show potential for developing an advanced cell therapy treatment for the condition. Affecting around two million people globally, MS is a neurodegenerative condition that affects the brain and spinal cord. Around two-thirds of people with MS […]


Cell and Gene Therapy, Industry

FDA approves SpringWork’s Ogsiveo as first therapy for desmoid tumours

November 28, 2023

Via: PMLiVE

Ogsiveo has been specifically approved for use in adults with progressing desmoid tumours who require systemic treatment. Each year, an estimated 1,650 people in the US are diagnosed with desmoid tumours, which may invade surrounding structures and organs, resulting in […]


Clinical Trials, Research and Development

AstraZeneca announces launch of new healthtech business Evinova to optimise clinical trials

November 21, 2023

Via: PMLiVE

Evinova will aim to better meet the needs of healthcare professionals, regulators and patients. The new healthtech business aims to bring to market established and scaled digital technology solutions which are already used globally by AZ, to pharmaceutical, biotechnology and […]


Cell and Gene Therapy, Industry

AZ first to AKT finish line, but FDA clears narrow label

November 17, 2023

Via: Pharmaphorum

Capivasertib has been approved as Truqap for use in combination with AZ’s oestrogen receptor antagonist Faslodex (fulvestrant) for adults with hormone receptor (HR)-positive and HER2-negative locally advanced or metastatic breast cancer, but only if they also have PIK3CA, AKT1, or […]


Clinical Trials, Research and Development

Australian retail pharmacy enters clinical trials market

November 15, 2023

Via: Pharmaphorum

The two companies say their partnership could unlock access to millions of customers across a network of more than 550 Chemist Warehouse retail locations in Australia and other countries including New Zealand, Ireland and China, as well as its online […]


Clinical Trials, Research and Development

3 ways decentralized clinical trials could help advance research on rare diseases

November 13, 2023

Via: Biopharma Dive

Pandemic-era changes may have permanently altered the clinical trial landscape as decentralized clinical trials gain broader acceptance. During COVID-19, more than three-quarters (76%) of pharmaceutical companies, device manufacturers and contract research organizations conducted off-site clinical trials. These types of trials […]


Biotech, Industry

An Orbimed-backed biotech launches with $85M and plans for a new kind of DNA medicine

October 24, 2023

Via: Biopharma Dive

When developing new medicines, drugmakers typically try to make treatments that are more effective, durable or safer than what’s already available. If they’re lucky, they can hit on something that meets at least one of those goals. Rampart Bioscience, a […]


Clinical Trials, Research and Development

5 steps to help increase the odds of clinical trial success

October 16, 2023

Via: Biopharma Dive

Pharmaceutical companies can spend 10 to 15 years and more than $2.3 billion to bring new drugs to market. Despite these significant investments in drug development, 90% of clinical trials fail. For a greater chance of success, pharmaceutical companies must […]


FDA, Regulations

Research group says FDA found no misconduct in Pfizer Lyme vaccine trial it helped run

October 12, 2023

Via: Biopharma Dive

Care Access had disagreed with Pfizer and Valneva’s decision to remove more than 3,000 participants from the study over alleged violations of Good Clinical Practice, an international ethical and scientific standard clinical researchers must follow during trials. But the setback […]


Clinical Trials, Research and Development

MHRA pledges two-week review for low-risk clinical trials

October 12, 2023

Via: Pharmaphorum

The notification scheme stems from the agency’s overhaul of rules announced in March, with the aim of making it “faster and easier” to gain approval and to run clinical trials in the UK – and elevate the country’s position in […]


Biotech, Industry

Seagen partners with Nurix to create new kind of cancer drug

September 7, 2023

Via: Biopharma Dive

Seagen is the biotech sector’s leading developer of antibody-drug conjugates, which deliver cell-killing toxins to diseased cells by attaching them to an antibody that seeks out proteins on tumor cells. Its first, Adcetris, is on track to become a blockbuster […]


Clinical Trials, Industry, Pharma, Research and Development

Clinical Trials and their Impact on the Pharma Industry

September 1, 2023

Via: Biopharm International

Clinical trials are essential for establishing the efficacy of new drugs, observing patients’ reactions to treatments, and representing populations of people that may not always be discussed in everyday conversation. Although there are many diseases and disorders that are waiting […]


Cell and Gene Therapy, Industry

Bayer reports positive early data for Parkinson’s cell therapy

August 28, 2023

Via: Biopharma Dive

Estimates hold that around half a million people in the U.S. have Parkinson’s, though, due to underdiagnosis or misdiagnosis, some believe the true number is much higher. The disease causes nerve cells in the part of the brain that controls […]