Following the loss of the hypertension drug Diovan (valsartan) in September, Novartis AG has a little – but just a little – breathing room before its next big cliff: the loss of exclusivity for its leukemia drug Gleevec (imatinib), likely beginning in the U.S. in July 2015. The impending loss of the mega blockbuster that catapulted Novartis into a leading oncology player is putting pressure on the Swiss pharma to bring new cancer drugs to market to maintain growth within oncology, its largest franchise.
As Sun Sets On Gleevec, Novartis Looks To New Horizons In Oncology
The blockbuster leukemia drug will likely face generic competition in 2015, putting pressure on Novartis to bring new cancer drugs to market to make up for the lost sales. The company has several promising mid- to late-stage candidates in the pipeline, but developing another blockbuster the likes of Gleevec won’t be easy.
More from Clinical Trials
The chair of a European Medicines Agency working group on reducing animal testing said that companies can provide “thoughts and suggestions” in relation to a review of its scientific guidelines on regulatory testing requirements and new approach methodologies.
The EU Clinical Trials Information System has achieved primary registry designation in the International Clinical Trials Registry Platform in a move that is expected to reduce regulatory burden for companies and help them lower compliance costs by aligning with publication requirements in medical journals.
Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.
The new global GCP guideline, ICH E6(R3), enables researchers and clinical trial administrators to tailor their documentation processes, but also opens the door for more scrutiny during GCP inspections.
More from R&D
The EU Clinical Trials Information System has achieved primary registry designation in the International Clinical Trials Registry Platform in a move that is expected to reduce regulatory burden for companies and help them lower compliance costs by aligning with publication requirements in medical journals.
Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.
South Korea announces planned revisions to a government scheme to designate "innovative" biopharma companies amid allegations of "discrimination" against foreign firms.