A report by the Institute of Clinical and Economic Review (ICER) has determined...
- ICER finds lack of evidence to support blockbuster drug price hikes
- Prescription dread: measuring psychiatric drugs against the alternatives
- Real world data: how can it improve clinical trial outcomes?
- US opioid crisis: charting Insys’ fall from grace
- Amgen and Novartis discontinue Alzheimer’s drug development programme
Kite Pharma’s Biopharmaceutical Manufacturing Facility
Kite Pharma, a subsidiary of Gilead Sciences, announced about the construction of its new biopharmaceutical manufacturing facility in Hoofddorp, the Netherlands.
ICER finds lack of evidence to support blockbuster drug price hikes
A report by the Institute of Clinical and Economic Review (ICER) has determined that seven of the nine top-selling drugs in the US had limited new clinical evidence of greater patient benefit to justify the significant price hikes these therapies underwent in 2017 and 2018.
J&J’s Janssen to pay $8bn in Risperdal anti-psychotic drug lawsuit
A jury at Philadelphia Court of Common Pleas has ordered Johnson & Johnson (J&J) subsidiary Janssen Pharmaceuticals to pay $8bn in punitive damages over its marketing of Risperdal, an anti-psychotic drug.
UK’s CMA accuses Aspen of price hike for Addison’s disease drug
The UK’s Competition and Markets Authority (CMA) has alleged that South Africa-based pharmaceutical company Aspen has entered an illegal agreement with Amilco and Tiofarma for marketing Addison’s disease drug, fludrocortisone acetate.
QuVa Pharma’s Pharmaceutical Manufacturing Facility Expansion, New Jersey
QuVa Pharma is expanding its biotech pharmaceutical manufacturing facility in Bloomsbury, New Jersey, US as part of its multi-year growth spree to extend its pharmaceutical facilities beyond Texas.
UK’s NAO warns of uncertain medicines supply in no-deal Brexit
A report by the National Audit Office (NAO), UK has warned that a no-deal Brexit still poses a threat to the supply of medicines, indicating the need for more measures to ensure adequate supply.
NICE rejects Novartis’ migraine drug Aimovig over data concerns
The UK’s National Institute for Health and Care Excellence (NICE) has published the final draft guidance for Novartis’ Aimovig (erenumab), rejecting the migraine drug for National Health Service (NHS) funding.
Pharmaceutical Regulatory Processes in Switzerland
This white paper highlights what it takes to bring a drug to the Swiss market, including the marketing authorisation application MAA), preapproval and launch preparation milestones and covering topics such as regulatory affairs, market access, quality management and pharmacovigilance.
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