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Category Archives: R&D
FDA: From Risk Aversion to Approval Activism
During the Rutgers Business School’s annual healthcare symposium, an FDA official encouraged industry to put its drugs on the reviewing table and be prepared for good news.
On a panel titled “Activist FDA: Transformation Agent,” Prevision Policy founder and former Pink Sheet editorial head Cole Werble relayed the tale of Acadia Pharmaceuticals, a San Diego-based [...]
Also posted in Agency Insight, Biotech, FDA, Legal, Market Access, Orphan Drugs, People, Regulatory, Strategy, leadership Tagged access, breakthrough therapies, CDER, Cole Werble, FDA, IMS, Rachel Sherman, Regulatory 2 Comments
Drug Pipelines in Canada: Is There a Buyer for Future Innovation?
Last week, Canada’s National Prescription Drug Utilization Information System (NPDUIS), a federal-provincial fact-finding panel that works closely with the Patented Medicines Prices Review Board (PMPRB), issued its fourth New Drug Pipeline Monitor (NDPM) looking at drugs currently under development that may have an impact on future drug expenditures. The report is another example of how [...]
Also posted in Global, IP, Market Access, Orphan Drugs, Regulatory, healthcare, pricing Tagged Bernard Lachapelle, Canada, Health Canada, NPDUIS, pipeline, PMPRB Leave a comment
For Becton Dickinson, Medication Errors are a Business Opportunity
Over the next few years, med tech company Becton Dickinson will launch up to 30 generic, pre-filled syringes in an attempt to lower medication errors and raise company revenues, according to BD Rx president Mark Sebree.
One man’s goof is another man’s growth, potentially.
Also posted in FDA, Manufacturing, Safety, Strategy, Technology, pricing Tagged Becton Dickinson and Company, Medical Devices, medical supplies, medication error, payers, pre-filled syringes Leave a comment
AstraZeneca's R&D Trimdown, Points to Shift in The Way Big Pharma Invents
AstraZeneca’s decision to cut 5,050 jobs by 2016 and cease R&D operations at its Alderley Park, UK facility has many wondering where CEO Pascal Soriot plans to take the company. The opening of a new $500 million facility in Cambridge is at once a consolation prize for the UK government’s efforts to placate a skittish [...]
Global Biosimilars Market to Reach $2.4 Billion in 2013