April 17, 2024
Via: 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
Via: 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 11, 2024
Via: 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 […]
April 9, 2024
Via: 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 […]
April 4, 2024
Via: 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 […]
April 1, 2024
Via: Biopharma DiveThe 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
Via: PharmaphorumVoydeya (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
Via: Drugs.comSome 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
Via: Biopharma DiveDrug 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
Via: PharmaphorumThe 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 25, 2024
Via: World Pharma NewsThe 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 22, 2024
Via: PharmaphorumThe 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 19, 2024
Via: Drugs.comThe 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
Via: PMLiVEThe 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 18, 2024
Via: PMLiVEThe 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 15, 2024
Via: Drugs.comMillions 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 13, 2024
Via: Biopharma DiveTwo 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 8, 2024
Via: Drugs.comInstead of approving the new Alzheimer’s drug donanemab this month, as was expected, the U.S. Food and Drug Administration will now require the experimental medication be scrutinized more closely by an expert panel, the drug’s maker said Friday. “The FDA […]
March 4, 2024
Via: Biopharma DiveFor the second time in less than a month, a federal court has rejected a pharmaceutical industry lawsuit challenging the drug pricing powers Medicare was granted by the Inflation Reduction Act. The U.S. District Court for the District of Delaware […]
FDA, Industry, Regulations, Vaccines
March 4, 2024
Via: Drugs.comAs new outbreaks of measles — a once nearly eliminated illness in the United States — continue to emerge, experts remind Americans that there’s an easy way to stop infection: Get vaccinated. “Measles spreads so easily that if one person […]
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