Production & Sales September 5, 2023 Novo Nordisk launches Wegovy for obese patients in UK By PBR Staff Writer The latest move is aimed at sharing the government’s objective to make obesity care accessible to patients with high unmet medical need. Through a controlled and limited launch,
Research & Development September 4, 2023 Innovac raises funding for lead programmes development By PBR Staff Writer The company will utilise proceeds from the round for further developing its technology platform to accelerate its lead programmes to clinical stage. The participants in the financing round
Approvals September 1, 2023 Mallinckrodt announces FDA approval for Lisdexamfetamine Dimesylate Capsules By PBR Staff Writer The approval was granted to the company’s Specialty Generics segment, operating as SpecGx. Mallinckrodt started selling the product after securing approval, which happened the day after the expiration
Approvals August 31, 2023 Kyowa Kirin gets approval in Japan for calcimimetics agent Orkedia Tablets 4mg By PBR Staff Writer A small molecular compound and a novel type of calcimimetics discovered by Mitsubishi Tanabe Pharma Corporation, Orkedia Tablets suppresses parathyroid hormone (PTH) secretion as it acts on the
Approvals August 30, 2023 FDA grants orphan drug designation to Faron’s bexmarilimab By PBR Staff Writer The designation will provide certain benefits to Faron including exemption of FDA application fees, tax credits for qualified trials, and on receiving regulatory approval, will get market exclusivity.
Research & Development August 29, 2023 Allucent to expedite Covid-19 booster vaccines development By PBR Staff Writer These candidates are being developed to offer better protection, extend the duration in preventing illness and transmission, as compared to the current vaccine technologies. As part of the
Approvals August 28, 2023 Akeso receives priority review of ivonescimab NDA in China By PBR Staff Writer Ivonescimab is a potential first-in-class investigational PD-1/VEGF bi-specific antibody. It is the company’s other new antibody with a priority review following the marketing approval of cadonilimab. After the
Oncology August 25, 2023 Alentis’ ALE.C04 receives fast track designation from FDA By PBR Staff Writer The first-in-class, investigational monoclonal antibody ALE.C04 has been developed for targeting exposed CLDN1 in specific on cancer cells. It is designed to treat cancer by remodelling of the
Prostate Cancer August 24, 2023 FDA grants priority review to Pfizer and Astellas’ sNDA for XTANDI By PBR Staff Writer The regulator has provided a prescription drug user fee act (PDUFA) date of fourth quarter this year for the review. The sNDA is being reviewed under two initiatives
Immunology August 23, 2023 EC grants CMA to Janssen’s Talvey for multiple myeloma By PBR Staff Writer These therapies include an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. Talvey recently received the US Food and Drug Administration’s approval for the same indication in