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 […]
Clinical Trials, Research and Development
August 21, 2023
Via: Biopharm InternationalOn Aug. 21, 2023, Gilead Sciences announced that FDA has placed a partial clinical hold on the company initiating new patients into US studies for magrolimab, an investigational anti-CD47 immunotherapy, to treat acute myeloid leukemia (AML). FDA’s decision follows a […]
Clinical Trials, Research and Development
August 7, 2023
Via: Biopharma DiveAlthough diseases such as Ehlers-Danlos syndrome, Sanfilippo syndrome and Hemophilia are considered rare, their impact looms large. Rare diseases, defined as occurring in fewer than one in 2,000 individuals, affect more than 300 million people across the globe, and most […]
Cell and Gene Therapy, Industry
July 27, 2023
Via: Contract PharmaKincell Bio, a technology-forward CDMO focused on cell therapies, has launched having received $36 million in new funding led by Kineticos Ventures. Kincell is a spinout of Inceptor Bio’s CMC, manufacturing and quality organizations formed to accelerate innovator research and […]
Cell and Gene Therapy, Industry
July 24, 2023
Via: Biopharma DiveIn January 2022, the Milken Institute published a report, “Cell and Gene Therapies: Looking Ahead to 2022,”1 describing the growth of the CGT industry in 2021. In the U.S., 7 new therapies were approved for commercialization, a similar number were […]
Clinical Trials, Research and Development
July 17, 2023
Via: Biopharma DiveAn 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 […]
Clinical Trials, Research and Development
June 28, 2023
Via: Biopharma DiveThe 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 […]
Cell and Gene Therapy, Industry
June 27, 2023
Via: Biopharm InternationalFDA announced on June 22, 2023 the approval of Elevidys (delandistrogene moxeparvovec-rokl), the first gene therapy for the treatment of children ages four through five years that have Duchenne muscular dystrophy (DMD) and do not have a pre-existing medical reason […]
Clinical Trials, Research and Development
June 27, 2023
Via: Drugs.comAn 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, […]
Clinical Trials, Research and Development
June 12, 2023
Via: Biopharma DiveMany 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 […]
Clinical Trials, Research and Development
June 5, 2023
Via: Biopharma DiveBiogen 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 […]
Clinical Trials, Research and Development
May 19, 2023
Via: Biopharma DiveModerna 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
May 15, 2023
Via: PMLiVEPreliminary 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
May 4, 2023
Via: PMLiVEThis 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 2, 2023
Via: Biopharm InternationalFDA 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
May 1, 2023
Via: Contract PharmaFlatiron 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
April 20, 2023
Via: World Pharma NewsUC 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
April 17, 2023
Via: Biopharma DivePatient 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+. […]