Pressure had been building for more than a year for something to be done about drug prices, and specifically inflated list prices to the patient at the pharmacy counter that do not reflect the substantial rebates manufacturers are providing. Where was all the money going? How could the list price and patient copays for drugs keep rising when the net prices — accounting for manufacturer rebates — stayed level?
March 30, 2019 — Brexit D-Day — isn’t as far in the distant future as some might hope. For U.S. pharma companies with headquarters or CROs in the U.K., much needs to be decided, planned, and executed before that time to ensure a smooth transition.
Recounting what an executive did while on sabbatical wouldn’t normally fit into our editorial model. That is, unless that executive is Richard Bagger, J.D., EVP of corporate affairs and market access for Celgene.
Casey Lynch has long had the gut feeling there was more to the cause of Alzheimer’s than beta amyloid and tau proteins. Turns out, she was right.
Camilla Harder Hartvig is SVP of Canada and EMEA for Alexion Pharmaceuticals. Previously she was president, Europe and emerging markets, at Glenmark Pharmaceuticals and also worked for companies such as Allergan, AstraZeneca, and Novartis in various managerial positions.
Three top biopharmaceutical executives share their ideas on what bio clusters biopharmaceutical executives should be paying attention to for 2018. In addition, insights are provided on other future potential bio hot spots.
Five top biopharmaceutical executives share their thoughts on Big Data, industry trends, personalized medicine, and more in preparing you for what to expect in 2018 – and beyond.
Five female biopharmaceutical industry CEOs share exclusive insights on what to expect for 2018 and beyond.
Daniel Skovronsky, M.D., Ph.D., former CEO of Avid Radiopharmaceuticals, sold his company to Eli Lilly and Company in 2010 for $300 million -- $850 million if you add in all the milestones achieved. This successful biopharmaceutical entrepreneur shares personal insights on the process of valuing his company prior to acquisition, his philosophy on optionality, and what if anything he’d do differently.
What do you do when the reality of a commercial launch is finally within reach? The fact is, there’s no one-size-fits-all approach.
Three non-oncology and three oncology examples since 2014 point to higher rates of successful me-too drugs versus a handful of drugs from 2005 to 2012.
Since 1983, pharmaceutical developers have been incentivized by the FDA via an Orphan Drug Designation (ODD) program to develop products to treat rare diseases and/or conditions. The program awards orphan status to drugs that show likelihood of benefitting an afflicted population that might not otherwise be the focus of targeted development efforts. To meet the FDA’s specific requirements, sponsors have found specificity matters. Though other steps in a drug’s life cycle require a wider scope, when it comes to defining the orphan population and making a case for the drug’s potential efficacy in that population, a razor-focused effort is key.
For clinical researchers, patient-centricity is not a buzzword. It reflects a commitment to patients. They should always be at the center of everything we do.
The 21st Century Cures Act encourages the use of Real-World Evidence (RWE). But what’s the best approach for this relatively new arena of Big Data and analytics?
Would a standardized approach to orphan drug development result in more and better therapies being made available to patients? We think so.
The revised version of the Agreement on Mutual Recognition (MRA), once fully implemented, will allow the FDA and the EU inspectorates to use inspection reports and other related information obtained during GMP inspections to help determine whether statutory and regulatory requirements of the respective authorities have been met.
The current situation in biopharma is exciting, with new technologies, biosimilars, cellular and gene therapies, and opportunities in emerging markets. And these innovative platforms are going to continue to need improved manufacturing technologies in the future.