A split decision from the U.S. Court of Appeals for the Federal Circuit could give Novartis AG’s blockbuster multiple sclerosis drug, Gilenya (fingolimod), a little more breathing room from unlicensed generics.
Novartis AG’s FDA go-ahead for Leqvio (inclisiran), the first and only small interfering RNA therapy to lower LDL-C, “should come as a relief, given fears that the pandemic could again limit FDA's ability to conduct manufacturing-site inspections,” Jefferies analyst Peter Welford said. PCSK9-targeting Leqvio’s Dec. 22 approval, which came slightly ahead of the Jan. 1, 2022, PDUFA date, landed after a complete response letter about a year ago, citing unresolved facility inspection-related conditions. The drug is dosed twice per year, unlike competitors in the space.
DUBLIN – Novartis AG is deepening its commitment to ocular gene therapy by picking up Gyroscope Therapeutics Ltd. for $800 million up front and up to $700 million more in potential milestone payments.
Novartis AG has forged even stronger links with Beigene Ltd., taking an option on the latter’s late-stage TIGIT inhibitor cancer immunotherapy ociperlimab in a deal worth up to $1 billion.
Novartis AG has forged even stronger links with Beigene Ltd., taking an option on the latter’s late-stage TIGIT inhibitor cancer immunotherapy ociperlimab in a deal worth up to $1 billion. Basel, Switzerland-based Novartis will pay the Beijing-based pharma $300 million up front in the option, collaboration and license agreement plus up to $700 million if it exercises its option before late 2023.
Novartis AG, keen to expand its central nervous system franchise as generics chase down crown jewel Gilenya (fingolimod), has secured rights from UCB SA to co-develop and commercialize two potential Parkinson's disease therapies for $150 million up front and milestone payments approaching $1.5 billion.
A more than 20-year uneasy biopharma romance between two Swiss giants will be ending as Novartis AG plans to sell its stake in Roche Holding AG back to Roche for about $20.7 billion. Roche described it as a “disentanglement of the two competitors” that will allow it to regain “full strategic flexibility.” Basel, Switzerland-based Novartis currently owns about one-third of Roche, whose shareholders get the final say-so when they vote yea or nay at the company’s Nov. 26 extraordinary general meeting. Novartis was very clear about how it views its stake in Roche, as the company said it “does not consider the financial investment in Roche as part of its core business and therefore not a strategic asset” and that it’s time to “monetize our investment.”
Biopharma scored a victory of sorts in the ongoing 340B war that’s pitting drug companies against the combined forces of hospital groups, contract pharmacies and the U.S. Department of Health and Human Services.
With the FDA approval of Scemblix (asciminib), a STAMP inhibitor for treating chronic myeloid leukemia (CML) in adults, Novartis AG has a companion to its longstanding therapy Gleevec (imatinib) as a treatment for the indication.
Novartis AG has had another setback in its attempt to get canakinumab to work in oncology, after the interleukin-1beta (IL-1β) inhibitor flunked a phase III trial in first-line advanced lung cancer.
