AbbVie, a research and development based global biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc. , announced that the U.S. Food and Drug Administration (FDA) has granted priority review for elagolix, an investigational, orally administered gonadotropin-releasing hormone (GnRH) antagonist, being investigated for the management of endometriosis with associated pain.
AbbVie (ABBV), a global biopharmaceutical company, and Alector, a privately owned biotechnology company, announced a global strategic collaboration to develop and commercialize medicines to treat Alzheimer's disease and other neurodegenerative disorders.
"This collaboration is the first for Harpoon and highlights the high level of industry interest in best-in-class platform technologies. We are excited about partnering with AbbVie to help generate novel T-cell engagers for the treatment of cancer based on the combination of T-cell receptors with TriTACs," said Jerry McMahon, Ph.D., chief executive officer, Harpoon Therapeutics.
AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced that the Phase 3 MURANO study of VENCLEXTA/VENCLYXTO (Venetoclax) Tablets in combination with Rituxan® (rituximab) met its primary endpoint.
AbbVie’s upadacitinib has hit primary and secondary targets in the first late-stage trial of the drug involving patients with moderate-to-severe rheumatoid arthritis (RA).
On April 18, AbbVie announced positive results from SELECT-GCA. Based on the results of this Phase 3, multicenter, randomized, double-blind, placebo-controlled study, upadacitinib (RINVOQ®; 15 mg once daily) in combination with a 26-week hormone tapering regimen met the primary endpoint of sustained remissiona in adult patients with giant cell arteritis (GCA) from Week 12 to Week 52. In this study, 46% of patients treated with Rinvoq in combination with the 26-week hormone tapering regimen achieved sustained remission, compared to 29% of patients treated with placebo in combination with the 52-week hormone tapering regimen (p=0.0019). Dr. Kori Wallace, Vice President, Global Head of Clinical Development, Immunology at AbbVie, said, “Many patients with GCA continue to suffer from the potentially debilitating symptoms of the disease, and their treatment options are limited. These results demonstrate that there remains a significant medical need for this type of disease, and we are relentlessly committed to ...
The FDA clinical hold keeps Neumora Therapeutics from catching up to the field of biopharmaceutical companies pursuing the same target for schizophrenia. But Neumora remains on track with its lead program, a different drug in late-stage clinical testing for major depressive disorder. A Neumora Therapeutics drug candidate addressing a promising and competitive target for schizophrenia has been placed under an FDA clinical hold after new preclinical data emerged showing convulsions in rabbits that received the experimental treatment. The Neumora drug, NMRA-266, began Phase 1 testing last November. The clinical hold announced Monday pauses the study, which had dosed about 30 healthy participants so far. Watertown, Massachusetts-based Neumora said no convulsions have been observed in any of the study participants. The company added that it is working with the FDA to resolve the clinical hold and will provide an update on the program’s status when new information becomes available. “We are ...
EUR 20m to identify new targets and develop first in class drugs DISCO Pharmaceuticals – a company specialising in unlocking the surfaceome of cancer cells at scale – has raided EUR 20m to identify new targets and develop first in class drugs. The funding round was backed by a formidable investor syndicate, including Sofinnova Partners, Panakes Partners, M Ventures and AbbVie Ventures. The development of new treatment modalities in oncology is increasing, however, the lack of cell surface targets limits the application to some clinically effective targets. Also, the development of new biologics, such as bi-specific antibodies and antibody drug conjugates, is increasing and there are currently less than 30 molecular targets, which form the basis of all antibody-based therapies. Consequently, there is a significant need to identify novel cancer-selective targets and target pairs. DISCO’s surfaceome mapping platform transforms the current approach of target discovery for large molecule R&D. This ...
The US Department of Health and Human Services (HHS), as part of the Centers for Medicare and Medicaid Services (CMS), has announced that all ten pharmaceutical manufacturers taking part in the Medicare drug price negotiations have submitted counteroffers. The announcement comes after the HHS sent initial offers on 1 February in an ongoing effort to lower drug prices in the US as part of the Inflation Reduction Act (IRA) and negotiations will continue over the next several months. First selected last August, the ten medicines subject to the first round of Medicare pricing negotiations included therapies for diabetes, heart failure, immunological disorders and cancer, as well as anticoagulants. The medicines selected included Bristol Myers Squibb/Pfizer’s Eliquis (apixaban), Novartis’ Entresto (valsartan/sacubitril), AstraZeneca’s Farxiga (dapagliflozin), AbbVie/Johnson & Johnson’s Imbruvica (ibrutinib), Eli Lilly/Boehringer Ingelheim’s Jardiance (empagliflozin), and Johnson & Johnson’s Stelara (ustekinumab) and Xarelto (rivaroxaban). According to the HHS, collectively, the drugs were ...
Don Tracy, Associate Editor New label marks the first Bruton’s tyrosine kinase inhibitor to be approved with an oral suspension formulation. The FDA has approved an addendum to the Imbruvica (ibrutinib) label to include an oral suspension formulation across the drug’s indications. Johnson & Johnson (J&J), in partnership with Pharmacyclics LLC, an AbbVie Company, announced that the new formulation is approved to treat patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), and chronic graft versus host disease (cGVHD) following the failure of one or more lines of systemic therapy. This option is designed for patients who have difficulty swallowing pills, part of J&J’s ongoing efforts to provide multiple patient-friendly treatment options, the company stated in a press release.1 “As the most comprehensively studied therapy in its class, Imbruvica has helped change the standard of care for adults living with certain blood cancers and cGVHD. Nearly 300,000 ...
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