About two months ahead of the priority review action date, Novartis AG scored FDA clearance for Adakveo (crizanlizumab), previously known as SEG-101, to reduce the frequency of vaso-occlusive crises (VOCs), or pain crises, in adult and pediatric patients ages 16 and older with sickle cell disease (SCD).
South San Francisco-based Pliant Therapeutics Inc. CEO Bernard Coulie told BioWorld that Novartis AG was drawn to the $80 million deal in nonalcoholic steatohepatitis (NASH) because other firms working in the integrin space "are very much focused on early stages of the disease, with what we call a metabolic approach. We are addressing with our compound, which is a pure antifibrotic, the late stage of the disease, [categorized as] F3 and F4, where most of the liver is already gone. We think that the real market will be there, because that's where health care costs go up" and where patients facing an increased mortality rate "need proper treatment rather than changing their lifestyle" while using something milder.
Following FDA approval of Novartis AG's VEGF-A inhibitor, Beovu, in wet age-related macular degeneration earlier this month, speculation immediately started on how much market share that new therapeutic will capture at the expense of Regeneron Pharmaceutical Inc.'s Eylea.
DUBLIN – Novartis AG gained FDA approval for its VEGF-A inhibitor Beovu (brolucizumab) in wet age-related macular degeneration (AMD) a week ahead of its presumed PDUFA date. The Basel, Switzerland-based pharma used a priority review voucher to speed up the review process, which kicked off on April 15. The stage is now set for what could be an eye-catching – pun intended – contest between Beovu, a single-chain antibody fragment that binds all VEGF-A isoforms, and Eylea (aflibercept), the VEGF trap that has developed into a multibillion-dollar behemoth straddling several ophthalmic indications since its original approval for treating wet AMD in November 2011.
PERTH, Australia – Australia is at risk of falling behind the U.S. and Europe in preventing recurrence of melanoma, the Melanoma Institute Australia warns. It is urging the Australian government to undertake a timely review of immunotherapy treatments effective in preventing the spread of melanoma and to fast track listings on the government-subsidized Pharmaceutical Benefits Scheme (PBS).
The failure of Novartis AG's Entresto in a phase III clinical trial staggered the stock (NASDAQ:NVS) somewhat Monday, down just 1.14%, but the real trauma may well be the loss of roughly $2.5 billion in anticipated sales.
PARIS – Six months after opening its first Biome digital innovation lab in San Francisco, the Swiss pharmaceutical company Novartis AG announces the opening of its first European digital innovation lab, located at the head office of its subsidiary in Rueil-Malmaison, France. The French hub Biome Paris boasts 250 square meters of space, allowing French or foreign-based startups to innovate and respond to specific challenges arising in the pharmaceutical sector. "It is a platform interface between ourselves as drug specialists, startups and internet giants. Biome Paris will make our treatments available to patients more quickly," Frédéric Collet, Novartis country president, France, told BioWorld MedTech.
