Tag: featured

April 24, 2024

The 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 […]

April 23, 2024

The 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

Anktiva (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 […]

April 22, 2024

CAR-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. […]

April 18, 2024

A 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

Stelara 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

The 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 11, 2024

Drugmakers 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 […]

April 10, 2024

RSV 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

That 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 […]

April 8, 2024

Exclusion 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

The 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 […]

April 4, 2024

It’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 […]

April 3, 2024

On 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 […]

April 2, 2024

Ginkgo Bioworks is expanding its ability to help other companies make cell and gene therapies, this time by acquiring a startup with tools to improve cell-based treatments. Ginkgo on Tuesday announced it has bought Modulus Therapeutics, a Seattle-based biotechnology startup. […]

April 1, 2024

The Food and Drug Administration has approved a first-of-its-kind drug for people with the rare and serious blood disease paroxysmal nocturnal hemoglobinuria, or PNH. Called Voydeya and owned by AstraZeneca, the drug is cleared for use as an add-on therapy […]

April 1, 2024

Voydeya (danicopan) can now be used as add-on therapy to AZ’s complement C5 inhibitors Ultomiris (ravulizumab) or Soliris (eculizumab) to treat extravascular haemolysis (EVH) in adults with PNH who don’t get a satisfactory response from the C5 drugs on their […]

March 28, 2024

Drug developers have studied pills like Jesduvroq and Vafseo as alternatives to injectable biologic drugs like Amgen’s Epogen in the hopes they would be safer and more convenient. Rather than mimicking a natural blood-boosting protein called erythropoietin as the biologics […]

March 27, 2024

The first-in-class activin receptor type IIA-Fc (ActRIIA-Fc) fusion protein, given the trade name Winrevair, has been cleared to improve exercise capacity, improve lung function, and reduce the risk of worsening clinical events in adults with PAH after a priority review. […]

March 26, 2024

The Dallas, Texas-based biotech said it plans to submit a dossier to the FDA later this year after its MCO-010 (sonpiretigene isteparvovec) gene therapy achieved almost all its primary and secondary efficacy objectives in the phase 2b RESTORE trial. Approximately […]