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Showing 5 of 57 posts
October 29, 2019 | Blogs
When biopharmaceutical products launch in the European Union, even experienced manufacturers can struggle to overcome the demanding standards of European payers. The complex market authorisation requirements and subsequent access decisions across 28 countries can lead to challenging timelines and confusing rollouts. Unfortunately for manufacturers, the future of European commercial planning is likely to become more challenging, as nations look to raise evidence standards and increase the scrutiny of pricing. Looking ahead over the next ten years, CBPartners is tracking many policy and payer trends which will affect the playing field for future launches. Examining these key trends in detail can provide further understanding of how manufacturers can create an “Early Asset Success Plan” for new products.
October 9, 2019 | Blogs
Deal With It: FTC Regulation of Innovative Biopharmaceuticals Escalates During Record-Breaking M&A Streak
Amid a streak of health care merger and acquisition (M&A) activity in 2018 and 2019, the Federal Trade Commission (FTC) is taking an aggressive stance in its review of biopharmaceutical deals. CBPartners analyses what this means for pharmaceutical M&A.
September 26, 2019 | Blogs
Life sciences research continues to expand into new domains in the pursuit of innovative therapies. Along with this expansion comes a need for new regulations to ensure efficient and safe use of novel products. In the case of microbiome and fecal transplant therapeutics, the regulatory landscape is still uncertain, creating divergent outlooks for both patients and manufacturers alike. CBPartners has explored the pros and cons of different regulatory approaches, in order to better understand the balance of factors that will determine the future for this exciting area of research.
September 11, 2019 | Blogs
Since its founding in 2006, ICER has become an influential organization in the drug pricing and US healthcare landscape. ICER reports have been increasingly leveraged by payer organizations in coverage decisions; further, pharma has increasingly engaged with ICER when launching a product or announcing a new drug price. CBPartners US Center of Excellence explores whether ICER and pharmaceutical manufacturers are allies or adversaries.
August 22, 2019 | Blogs
In 2017, the first therapy designed to genetically modify patients’ own T-cells to attack cancer was FDA-approved, but are CAR T-cell therapies close to meeting the remaining needs of patients? CBPartners' Cell and Gene Therapy Center of Excellence investigates the current challenges and limitations of this therapy.