After a flurry of activity in December, when the FDA approved seven new molecular entities (NMEs), the total of novel drugs that were given the green light this year reached 48, a number that ranks third behind the record 59 new medicines the agency approved last year and 53 in 1996.
Digital therapeutics have made great strides in recent years, with Pear Therapeutics Inc. playing a key role. Now, the company has reported the dosing of the first patient in part two of a study assessing Pear-006 to address depressive symptoms in multiple sclerosis (MS).
Digital therapeutics have made great strides in recent years, with Pear Therapeutics Inc. playing a key role. Now, the company has reported the dosing of the first patient in part two of a study assessing Pear-006 – which Pear Therapeutics is developing in collaboration with Basel, Switzerland-based Novartis AG – to address depressive symptoms in multiple sclerosis (MS).
DUBLIN – Novartis AG is making a $9.7 billion bet that the economics of an siRNA-based drug can better those of monoclonal antibodies and thus provide it with a dominant position in a major but still emerging cardiovascular drug market. The Basel, Switzerland-based pharma made an $85 per share offer for The Medicines Co., which has taken inclisiran, an siRNA-based inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9) to the brink of an approval in reducing the risk of a cardiovascular event – heart attack or stroke – in high-risk patients with cardiovascular disease or high levels of low-density lipoprotein cholesterol (LDL-C) who are inadequately controlled on current therapies.
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.
