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 29, 2024

Some pain-relieving skin products contain potentially harmful doses of the numbing agent lidocaine and should be avoided, the U.S. Food and Drug Administration warns. These creams, gels, sprays and soaps are marketed for topical use to relieve the pain of […]

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 […]

March 25, 2024

Lonza announced on March 20, 2024 that is has signed an agreement to acquire from Roche its Vacaville, Calif., site, a large-scale biologics manufacturing site, for $1.2 billion. Beyond the acquisition, Lonza plans to invest approximately CHF 500 million (US$557 […]

March 25, 2024

The U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat is the first nonsteroidal drug approved to treat patients with all genetic […]

March 25, 2024

Additive manufacturing (AM) and 3D printing came into the tech scene as some of the most disruptive technologies, indicating that we are on the precipice of the fourth industrial revolution. These advancements have affected pharmaceutical market growth, which has expanded […]

March 22, 2024

The approval comes just a few months after Johnson & Johnson’s Janssen Biotech unit handed back rights to the drug in resistant hypertension, although the two companies are still partnered on a follow-up use in pulmonary hypertension. As part of […]

March 21, 2024

On March 19, 2024, Cytiva and White Raven, a Belgium-based contract development and manufacturing organization (CDMO), announced that White Raven has selected Cytiva’s SA25 Aseptic Filling Workcell for its fill/finish site. The installation of the workcell will complete White Raven’s […]

March 20, 2024

Gene therapy makers like Orchard are counting on insurers to recognize the value proposition of their products. Unlike traditional pharmaceuticals that might be taken regularly for the rest of a person’s life, gene therapies carry the promise of a long-lasting […]

March 19, 2024

The U.S. Food and Drug Administration has approved the first drug to treat yeast ear infections in dogs. DuOtic is also the first ear infection medication that does not contain an antibiotic, the FDA said in its approval announcement. The […]

March 18, 2024

The regulator’s decision specifically applies to adult patients with relapsed or refractory disease who have received at least two prior lines of therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitor. CLL is one of the […]

March 18, 2024

The authorisation specifically applies to adult patients with unresectable or metastatic ESCC after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. Oesophageal cancer is the sixth most common cause of cancer-related deaths globally and ESCC accounts for almost […]

March 15, 2024

Millions of Americans whose livers develop scar tissue due to a common disease now have the first approved drug, Rezdiffra, to treat the condition, the U.S. Food and Drug Administration announced Thursday. The condition is called non-cirrhotic non-alcoholic steatohepatitis (NASH). […]

March 14, 2024

AstraZeneca announced that it has entered into a definitive agreement to acquire Amolyt Pharma, a clinical-stage biotechnology company focused on developing novel treatments for rare endocrine diseases. The proposed acquisition will bolster the Alexion, AstraZeneca Rare Disease late-stage pipeline and […]

March 13, 2024

Two cellular medicines for multiple myeloma were associated with an increased risk of early death in clinical testing, raising questions about whether they should be earlier in a patient’s disease, Food and Drug Administration scientists wrote in a briefing document […]

March 12, 2024

For Rick Bedlack, director of the ALS clinic at Duke University, tough times come with the job. He and his team treat about 500 people with the rare, fatal disorder that rapidly erodes nerve cells. Friday, though, was particularly difficult. […]