Clinical Trials - November 20, 2014
Drug-Development Costs Rising
The estimated average cost of developing an approved new drug has more than doubled to more than $2.5 billion from a 2003 estimate by Tufts University. But critics questioned the figure and noted the school’s strong financial ties to the pharmaceutical industry. The Tufts Center for the Study of Drug Development, located in Boston, in […]
Regulatory compliance - November 20, 2014
Novo Nordisk Pays Settlement
Novo Nordisk A/S has agreed to pay $19 million to settle a putative class action in Michigan federal court accusing it of attempting to monopolize the market for popular diabetes treatment Prandin by pursuing sham infringement litigation against generic-drug makers. In an unopposed motion Tuesday for an award of attorneys’ fees, reimbursement of expenses and […]
Drug Development Pharma - November 20, 2014
BerGenBio Drug Gets Orphan-Drug Status
BerGenBio AS, a Norwegian oncology biopharmaceutical company, announced Wednesday that the US Food and Drug Administration (FDA) granted orphan-drug designation for BGB324 for treatment of acute myeloid leukemia (AML). Earlier this month BerGenBio announced that the first patient was dosed in its multi-center Phase 1b trial of BGB324, a selective inhibitor of Axl, in patients […]
Collaboration - November 19, 2014
Call for More Cooperation
The Joint Committee of the Nordic Medical Research Councils (NOS-M) recently published a white paper “Nordic Potential in Medical Research – Cooperation for Success.” The committee released the white paper in connection with the NOS-M workshop held in Stockholm on Nov. 6. The new paper is a continuation of the previous Nordic white paper on […]
New Market - November 19, 2014
Recognition for Nordic Biomarker
Sweden’s Nordic Biomarker is having a week to remember. First it earned the spin-off company of the year award at Umeågalan, and then discovered it made Deloitte’s list of the fastest growing tech companies in Sweden. Nordic Biomarker manufactures reagents for diagnostic tests, which are used to rule out if a patient has had a […]
Drug Development Pharma - November 19, 2014
AstraZeneca Officials Optimistic
AstraZeneca officials are feeling positive about the future, with enough drugs in production to fuel double-digit submissions and approvals by 2017, reaffirming its promise to grow sales by 75 percent. The company has 14 Phase III drugs that will account for eight-to-ten approvals over the next two years. Leading the way is the company’s revitalized […]