Cell and Gene Therapy, Industry
December 11, 2023
Via: PMLiVEAffecting 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
December 11, 2023
Via: PharmaphorumThe 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 […]
December 11, 2023
Via: Biopharma DiveAt 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
December 5, 2023
Via: Biopharma DiveCRISPR 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
December 4, 2023
Via: Biopharma DiveWith 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
December 1, 2023
Via: PMLiVEThe 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
November 30, 2023
Via: PMLiVEFollowing 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
November 28, 2023
Via: PMLiVEResults 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
November 28, 2023
Via: PMLiVEOgsiveo 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
November 21, 2023
Via: PMLiVEEvinova 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
November 17, 2023
Via: PharmaphorumCapivasertib 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
November 15, 2023
Via: PharmaphorumThe 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
November 13, 2023
Via: Biopharma DivePandemic-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 […]
October 24, 2023
Via: Biopharma DiveWhen 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
October 16, 2023
Via: Biopharma DivePharmaceutical 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 […]
October 12, 2023
Via: Biopharma DiveCare 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
October 12, 2023
Via: PharmaphorumThe 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 […]
September 7, 2023
Via: Biopharma DiveSeagen 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
September 1, 2023
Via: Biopharm InternationalClinical 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
August 28, 2023
Via: Biopharma DiveEstimates 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 […]