Despite what University of Pennsylvania (Penn) immunotherapy pioneer Carl June referred to as a “cold slap last November” – a launched investigation by the U.S. FDA into a possible link between CAR T-cell immunotherapies and secondary cancers – new unpublished studies by Penn and Stanford University highlight the rarity of such cases.
A week after Bristol Myers Squibb Co. disclosed a significant restructuring plan to focus on long-term growth drivers, the big pharma partnered with Repertoire Immune Medicines Inc. in an early stage, multiyear collaboration to develop T-cell targeted medicines for up to three autoimmune diseases, paying $65 million up front, with a potential $1.8 billion in development, regulatory and commercial milestones, along with tiered royalties.
Boston-based South Korean biotech Genosco Inc. said on April 25 that it passed a technology review required for the special listing track on the tech-heavy Kosdaq market, as it readies an IPO on the Korea Exchange.
X4 Pharmaceuticals Inc. is raring to go with marketing after the firm scored U.S. FDA approval of Xolremdi (mavorixafor) capsules for patients 12 years and older with warts, hypogammaglobulinemia, infections and myelokathexis, or WHIM syndrome, to increase the number of circulating mature neutrophils and lymphocytes.
Females have a much greater risk of developing an autoimmune disease than males do. Eighty percent of autoimmune disease patients are female, and specific disorders can have an even more lopsided ratio – 90% of systemic lupus erythematosus (lupus) and almost 95% of Sjögren’s disease patients are female.
Gilead Sciences Inc. is aiming to capitalize on the early August 2022 buyout of privately held U.K. biotech Mirobio Ltd. with the advancement of PD-1 agonist GS-0151 into phase Ib trials for rheumatoid arthritis, a decision that Leerink analyst David Risinger hailed as positive for others at work with the intriguing mechanism. Paying $405 million for Oxford-based Mirobio, Gilead took ownership of the firm’s checkpoint agonists to treat autoimmune diseases.
The government of Colombia, after signaling its intent to do so at the end of 2023, issued a compulsory license on April 24 for access to generic versions of HIV drug dolutegravir, without the permission of patent owner Viiv Healthcare Ltd.
There was a time not that long ago when Merck & Co. Inc.’s Keytruda (pembrolizumab), with its multiple cancer indications, was seen as the heir apparent to Humira’s title of the biggest blockbuster drug. Not anymore. That title now belongs to Novo Nordisk A/S’ semaglutide, approved as Ozempic in 2017 to treat diabetes and as Wegovy in 2021 to help with weight loss.
Samsung Bioepis Co. Ltd. and Celltrion Inc. are making headway in Europe and U.S. with respective follow-on biologic products, with Samsung Bioepis the latest to gain EMA approval for Pyzchiva, a Stelara (ustekinumab, Janssen Pharmaceuticals Inc.) biosimilar, on April 23.
An oral Bruton’s tyrosine kinase (BTK) inhibitor that Sanofi SA acquired in 2020 through its $3.68 billion buyout of Principia Biopharma Inc. is headed toward regulatory filings in the U.S and EU by the end of the year, following phase III data in immune thrombocytopenia.
RSS
