FDA updates LDL-C lowering indication for Nexletol (bempedoic acid) tablet and Nexlizet (bempedoic acid and ezetimibe) tablet – Esperion

Esperion announced that the FDA has approved an updated LDL-cholesterol lowering indication for Nexletol and Nexlizet to include the treatment of primary hyperlipidemia as a qualifier for existing approved populations . Additionally, the maximally tolerated qualifier for statin use has been removed, and the prior limitation of use stating “the effect of Nexlizet or Nexletol on cardiovascular morbidity and mortality […]

FDA grants expanded approval to wilate as the first VWF concentrate for prophylaxis in all types of von Willebrand disease – Octapharma

Octapharma USA announced the expansion of the FDA approval for wilate, von Willebrand Factor/Coagulation Factor VIII Complex (Human) Lyophilized Powder for Solution for Intravenous Injection. The approved label now includes routine prophylaxis aimed at reducing the frequency of bleeding episodes in adults and children aged 6 and older with any type of von Willebrand disease (VWD), the most prevalent bleeding […]

Analyses of Yescarta CAR T-cell therapy support curative potential in patients with non-Hodgkin lymphomas – Kite/Gilead Sciences

Kite, a Gilead Company announced data from follow-up analyses of three studies of Yescarta (axicabtagene ciloleucel) that demonstrate the long-term survival potential for patients living with several sub-types of relapsed or refractory (R/R) non-Hodgkin lymphoma, which were presented at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition. This included ZUMA-1 (Abstract #4864) showing that patients with refractory […]

FDA approves Trogarzo 90-second intravenous (IV) push loading dose for the treatment of HIV infection – Theratechnologies Inc

Theratechnologies Inc. announced that the FDA has approved the company’s Labelling Prior Approval Supplement to include a 2000-mg intravenous (IV) push loading dose for Trogarzo (ibalizumab-uiyk). IV push is a method by which the undiluted medication is “pushed” by syringe for faster administration into the body’s circulation and is designed to make Trogarzo administration easier and more convenient for people […]

Complete Response Letter for gefapixant, an investigational, non-narcotic, oral selective P2X3 receptor antagonist, under development for the treatment of refractory chronic cough – Merck

Merck Inc., known as MSD outside of the United States and Canada, announced that the FDA has issued a Complete Response Letter (CRL) regarding Merck’s New Drug Application (NDA) for gefapixant, an investigational, non-narcotic, oral selective P2X3 receptor antagonist, under development for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults . In the CRL, […]

CHMP recommends Velsipity (etrasimod) for the treatment of ulcerative colitis – Pfizer

On 14 December 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Velsipity, intended for the treatment of ulcerative colitis. The applicant for this medicinal product is Pfizer Europe. Velsipity will be available as a 2 mg film-coated tablet. The active substance of Velsipity […]

Positive results from DREAMM-7 head-to-head phase III trial for Blenrep (belantamab mafodotin) in relapsed/refractory multiple myeloma – GSK

GSK plc announced positive headline results from a planned interim efficacy analysis of the DREAMM-7 head-to-head phase III trial evaluating belantamab mafodotin as a second-line treatment for relapsed or refractory multiple myeloma The trial met its primary endpoint of progression-free survival (PFS) and showed that belantamab mafodotin when combined with bortezomib plus dexamethasone (BorDex) significantly extended the time to disease […]

New clinical data on Rayaldee (ER calcifediol) presented at Kidney Week 2023 – OPKO Health Inc

OPKO Health, Inc. presented late-breaking clinical data on Rayaldee extended-release calcifediol (ERC) at the American Society of Nephrology (ASN) Kidney Week in Philadelphia. These data, presented in a poster titled “Control of Secondary Hyperparathyroidism with Extended-release Calcifediol is Associated with Slower CKD Progression” (#TH-PO1152), indicate that early, sustained and effective treatment of secondary hyperparathyroidism (SHPT) with Rayaldee is associated with […]

FDA approval for Zepbound (tirzepatide) injection, the first and only obesity treatment of its kind that activates both GIP and GLP-1 hormone receptors – Eli Lilly

The FDA approved Eli Lilly and Company’s Zepbound (tirzepatide) injection, the first and only obesity treatment of its kind that activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) hormone receptors. Zepbound is indicated for adults with obesity (with a BMI of 30 kg/m2 or greater), or those who are overweight (with a BMI of 27 kg/m2 or greater) […]

Galapagos concludes strategic evaluation and signs letter of intent to transfer Jyseleca business to Alfasigma

Galapagos NV and Alfasigma S.p.A. announced that they have signed a letter of intent contemplating a transfer of the Jyseleca business to Alfasigma, including the European and UK Marketing Authorizations, the commercial, medical and development activities for Jyseleca and approximately 400 positions in 14 European countries. In the contemplated transaction, Galapagos will receive a €50 million upfront, potential milestone payments […]