Novartis set to begin late-stage testing of blood thinner

Portola Pharmaceuticals' partner Novartis will begin final-stage testing of the blood thinner elinogrel after researchers found the drug provides more rapid and greater antiplatelet activity than Plavix. The late-stage tests are slated to begin during the first quarter of 2011, Portola says. In a randomized, double-blind, multi-center Phase II trial, researchers compared IV and oral elinogrel against clopidogrel in addition to standard of care in approximately 650...

FDA approves Novartis’ combo pill Teklamo

The FDA has approved Teklamo, a high blood pressure medication that combines Tekturna with the calcium channel blocker amlodipine. Tekamlo is approved as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals, and as replacement therapy for patients whose blood pressure is not adequately controlled with either aliskiren or amlodipine alone. Tekturna is part of a new class of medicines known as direct renin inhibitors, which target an...

Novartis options Quark program in $680M pact

Underscoring the rich potential of new siRNA therapeutics, Novartis has agreed to pay Quark Pharmaceuticals up to $680 million to nail the licensing rights to a new therapy for kidney-related diseases. Quark will get $10 million upfront for an option on QPI-1002, which is currently in Phase II for kidney-related conditions. If Novartis decides to pull the trigger on the option, it will pay out up to $670 million more in fees and milestones. The drug is being developed for acute kidney disease...

GenVec, Novartis ink clinical trials supply deal

GenVec could receive approximately $13 million over four years after inking an agreement with Novartis through which it will manufacture clinical trial material for up to two lead candidates. The two companies are partnered on clinical programs for hearing loss and balance disorders. GenVec...

DMC: Novartis’ drug safe but not effective in mid-study analysis

An independent data monitoring committee (DMC) has weighed in on Novartis and Nordic Biosciences' Phase III study of oral calcitonin for the treatment of osteoarthritis of the knee. After analyzing a year's worth of data from the two-year study, the DMC concluded that the drug is safe. But the DMC also said there is no reason to continue the study for efficacy. The group recommended continuation of a similar study in 2009. Novartis and Nordic say they plan...

With Novartis deal, Adimab expects profitability this year

Lebanon, NH-based Adimab has inked a research collaboration with Novartis, marking its fifth deal with a major pharma company in just over a year. The developer will use its discovery platform to identify fully human antibodies against two targets selected by Novartis. Novartis has rights to commercialize the identified antibodies, while Adimab gets an undisclosed upfront payment, preclinical milestones and licensing fees. Adimab could also receive clinical development milestones...

Novartis study tries to temper regulatory onslaught in Europe

As European countries line up with ever-stricter rules designed to reduce the price they pay for pharmaceuticals, Novartis has commissioned a new report from a group of tech experts that draws a straight line between the strictness of the new regs and a reduction in R&D innovation. In clear and measured language, the European School of Management and Technology Competition Analysis note that a strict regulatory environment inevitably shifts the attention of drug developers to new therapies...

FDA panel hands Novartis lopsided endorsement of oral MS therapy

An FDA advisory panel has handed Novartis a big win, voting overwhelmingly to endorse the efficacy and safety of its new oral MS drug Gilenia (fingolimod). The only serious hitch today came on the safety side, with the experts backing a proposal to have Novartis study an even lower-dose version of the drug than had been under the microscope in late-stage studies. But the advisers agreed that the new study could commence after Novartis began marketing the therapy. The vote in its favor leaves...

Novartis drug shows early promise fragile X syndrome

Novartis this week announced results from a small clinical trial of a new drug which could help improve behaviors resulting from fragile X syndrome, an inherited genetic condition that can cause retardation and autism and affects one in 5,000 children. The study involved just a few dozen subjects, and only some of those responded to the therapy, but researchers are excited about any results for a condition that has been impossible to treat. "Just three years ago, I would have said that...

Novartis CEO plans to keep China R&D ops in-house

While Charles River's $1.6 billion deal to buy WuXi PharmaTech may have put the spotlight on China's growing role on the global contract research stage, Novartis' new CEO insists the pharma giant plans to handle most of its own R&D work in China in-house. "It should be a strategy owned by Novartis and directed by Novartis," says Joe Jimenez, who is pushing ahead with plans to invest a billion dollars in a Shanghai R&D complex that will employ around 500 scientists--all on the company's...