Clinical Trials, FDA, Regulations, Research and Development
April 25, 2024
PMLiVEPatients eligible for the therapy will be aged 12 years and older and have somatostatin receptor (SSTR)-positive gastroenteropancreatic NETs, including foregut, midgut and hindgut NETs. The FDA’s decision was supported by positive results from the NETTER-P trial, which evaluated Lutathera […]
April 24, 2024
PMLiVEThe deal gives Incyte access to an oral Mas-related G protein-coupled receptor X2 (MRGPRX2) antagonist which, according to the companies, “has the potential to treat multiple mast cell-mediated diseases”, including atopic dermatitis, chronic inducible urticaria and chronic spontaneous urticaria. Preclinical […]
Cell and Gene Therapy, FDA, Industry, Regulations
April 23, 2024
Biopharma DiveThe Food and Drug Administration has rejected an experimental cell therapy for a rare skin condition, asking its developer, Abeona Therapeutics, to provide more information about how the treatment is made. Abeona on Monday said the FDA issued a so-called […]
April 23, 2024
PharmaphorumAnktiva (nogapendekin alfa inbakicep, or N-803) can be used in combination with the BCG vaccine in non-muscle invasive bladder cancer (NMIBC) patients who had not responded to the BCG shot on its own, according to the FDA, which blocked the […]
Cell and Gene Therapy, Industry
April 22, 2024
Biopharma DiveCAR-T therapies are personalized treatments made from patients’ own immune cells. Their production is precisely choreographed, as frozen cells are brought to manufacturing hubs where they are engineered and expanded into a cancer-seeking drug product. It’s laborious, time-consuming and costly. […]
Industry, Mergers and Acquisitions, Vaccines
April 19, 2024
Pharma TimesCureVac and the University of Texas’s MD Anderson Cancer Center have announced a co-development and licensing agreement to develop novel messenger ribonucleic acid (mRNA)-based cancer vaccines. The strategic collaboration will focus on the development of differentiated cancer vaccine candidates in […]
April 18, 2024
Kaiser Health NewsA team of Montana researchers is playing a key role in the development of a more effective vaccine against tuberculosis, an infectious disease that has killed more people than any other. The BCG (Bacille Calmette-Guérin) vaccine, created in 1921, remains […]
April 17, 2024
Biopharma DiveStelara is one of many top-selling medicines that will face competition from copycat versions this decade, including a large number of biologic drugs. AbbVie’s anti-inflammatory medicine Humira — sales of which topped $21 billion in 2022 — has been a […]
April 15, 2024
PMLiVEThe approval was based on evidence from the open-label phase 3 TATE trial in addition to well-controlled trials in adult and adolescent populations. Asthma is one of the most common chronic childhood diseases and causes coughing, wheezing and difficulty breathing. […]
April 12, 2024
Biopharma DiveInitial public offerings by biotechnology companies reached pre-pandemic levels during the first quarter, with nine drugmakers collectively raising more than $1.3 billion, according to BioPharma Dive data. The sum is more than three times the $375 million in total proceeds […]
April 11, 2024
PharmaphorumThe pTau217 plasma biomarker test, which runs on Roche’s widely-used Elecsys analysers, is intended to look for the presence or absence of amyloid pathology in individuals with suspected Alzheimer’s. pTau217 is a phosphorylated fragment of the protein tau that in […]
Biotech, Cell and Gene Therapy, Industry
April 11, 2024
Biopharma DiveDrugmakers are moving quickly to study whether cell therapy, already a proven treatment for certain blood cancers, can tamp down autoimmune conditions, too. Lupus, a chronic disease that can cause inflammation and pain across the body, is one of the […]
Manufacturing, Research and Development
April 10, 2024
Biopharma DiveThe enrollment pause could affect at least one ongoing Phase 3 study of Novartis’ pill, which is approved for use in advanced and metastatic disease. That clearance is limited to people whose tumor can be treated with hormone drugs but […]
Clinical Trials, Industry, Research and Development, Vaccines
April 10, 2024
PMLiVERSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people recover within a week or two, the virus can cause severe illness in certain groups, including older adults, infants and those with certain underlying chronic […]
April 9, 2024
PharmaphorumThat is the conclusion of a study presented at the American Association of Cancer Research (AACR) in San Diego and simultaneously published in the Journal of the American Medical Association (JAMA), looking at 46 cancer drugs given accelerated approvals over […]
Clinical Trials, Research and Development
April 8, 2024
Biopharma DiveExclusion of women from clinical trials is rooted in historical tragedy. In the 1950s, nearly 20,000 Americans took part in clinical trials for the drug thalidomide, including 600 pregnant women hoping to ease morning sickness. But the drug caused serious […]
April 8, 2024
PharmaphorumThe decision came right after the US regulator also cleared Bristol-Myers Squibb and 2seventy bio’s rival CAR-T Abecma as a third-line therapy for relapsed or refractory multiple myeloma, moving the cell therapies much earlier in the treatment pathway from their […]
Clinical Trials, Research and Development
April 5, 2024
PMLiVEThe studies will be funded by the Blood Biomarker Challenge, a multi-million-pound award given by Alzheimer’s Research UK, Alzheimer’s Society, the National Institute for Health and Care Research and Gates Ventures. Affecting more than 944,000 people in the UK, dementia […]
April 4, 2024
Biopharma DiveIt’s been a long road for Basilea to reach the world’s biggest pharmaceutical market with Zevtera. The company first tried to win approval for Zevtera more than 15 years ago with its former partner, Johnson & Johnson. Setbacks in both […]
Industry, Mergers and Acquisitions, Vaccines
April 3, 2024
Biopharm InternationalOn Mar. 25, 2024 Univercells announced a collaboration with Altamira Therapeutics, a producer of nanoparticle-based technology, under which Univercells will use Altamira’s SemaPhore nanoparticle platform to deliver messenger RNA (mRNA) vaccines. Also on Mar. 25, Andelyn Biosciences, a contract development […]