At the end of March, JAMA Ophthalmology’s publication of first results from the NIH-sponsored, 328-patient trial with Regeneron Pharmaceuticals Inc.’s VEGF inhibitor, Eylea (aflibercept), in non-proliferative diabetic retinopathy bolstered investor hopes for wider use. But competitors loom for the compound, first approved in November 2011 for wet age-related macular degeneration.
HONG KONG – Chugai Pharmaceutical Co. Ltd. has obtained Ministry of Health, Labor and Welfare (MHLW) approval for a combination regimen containing antimicrotubule binding anti-CD79b monoclonal antibody Polivy (polatuzumab vedotin), bendamustine and Mabthera (rituximab) to treat relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).
Shares of Ionis Pharmaceuticals Inc. (NASDAQ:IONS) fell 21.7% to $43.59 on March 23 after its longtime partner, Roche Holding AG, decided to stop dosing the antisense oligonucleotide tominersen in a global phase III manifest Huntington's disease (HD) study. Roche subsidiary Genentech Inc. said the move was based on an independent data monitoring committee's preplanned assessment of the drug's risk-benefit profile.
Roche Holding AG will acquire Genmark Diagnostics Inc. for $24.05 per share in cash for a total of $1.8 billion on a fully diluted basis. The transaction will give Basel, Switzerland-based Roche access to Genmark’s molecular diagnostics portfolio. The deal is expected to close in the second quarter of 2021. The price represents a 43% premium on the Carlsbad, Calif.-headquartered diagnostics company’s share price as of Feb. 10, prior to media speculation about a potential acquisition.
Positive COVID-19 efficacy numbers from Vir Biotechnology Inc. and Glaxosmithkline plc (GSK) has prompted them to immediately seek an emergency use authorization (EUA) with the FDA and similar authorizations in other countries for their monoclonal antibody, VIR-7831. Meanwhile, the phase III Remdacta study of Actemra/RoActemra (tocilizumab) plus Veklury (remdesivir) vs. placebo plus Veklury, from Roche Holding AG and Gilead Sciences Inc., missed its primary endpoint in treating hospitalized patients with severe COVID-19 pneumonia receiving standard of care.
More than a decade after first approving Actemra (tocilizumab) for the treatment of rheumatoid arthritis, the FDA has added a sixth use to its label: slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease.
PERTH, Australia – Sydney-based Kazia Therapeutics Ltd. has out-licensed its ovarian cancer drug, Cantrixil (TRX-E-002-1), to Sweden’s Oasmia Pharmaceutical AB in a deal worth up to $46 million.
Oasmia will pay $4 million up front, and development milestones worth up to $42 million and double-digit sales royalties.
LONDON – After a number of equivocal small studies, the U.K. Recovery trial has applied its heft to turn in statistically significant evidence that the rheumatoid arthritis treatment Roactemra (tocilizumab) reduces mortality in hospitalized COVID-19 patients.
LONDON – The U.K. is to make treatment with interleukin-6 (IL-6) inhibitors standard of care for critically ill COVID-19 patients after a randomized trial found the arthritis drugs significantly improve survival.
Pointing to his company’s work on “the next frontier in small molecules,” Ribometrix Inc. CEO Mike Solomon said the potential $1 billion-plus deal with Roche Holding AG offers evidence of big pharma’s mounting interest. Expertise in RNA folds helped Ribometrix nail down an agreement with Basel, Switzerland-based Roche’s Genentech arm that brings $25 million up front and potential milestone payments beyond $1 billion, as the pair discovers and develops RNA-targeted small-molecule therapeutics. Genentech gains exclusive rights to several predefined targets, including an exclusive global license for the development and commercialization of molecules.
