Executive Summary Tumor-agnostic treatments first came to market in 2017 with the revolutionary indication extension of KEYTRUDA® into microsatellite instability-high cancer Since then we have seen two more products launch: VITRAKVI® and ROZLYTREK®. While the products gained access in the USA market, the first tumor-agnostic product to be approved in Europe,…
Key takeaways: After focusing efforts on protein and more recently RNA targets, the bio-pharmaceutical industry is now getting ready to modify DNA, the final piece of the central dogma of molecular biology While genome editing technologies were being developed for many years, it is only now that we are…
As drug reimbursement continues to evolve with some areas converging. The global payer approach to decision making offers significant variation across geographies. Key takeaways Several factors contribute towards manufacturers seeking new ways to develop global drug pricing strategies Product launches vary based on geography; when comparing the USA to…
The American Society of Hematology’s (ASH) annual meeting is a well-established indicator of the innovations that are coming down the pipeline for hematologic diseases. As this year’s meeting approaches (Dec 7-10), CBPartners’ experts from our Cell and Gene Therapy Center of Excellence have selected 8 promising presentations on the future…
Executive Summary In 2011, The Cancer Drugs Fund (CDF) was launched to help patients in England access cancer drugs that had been rejected by the NHS As a result of financial struggles, the CDF faced a reform and partnered with NICE and pharmaceutical companies The partnership has led to earlier…
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…
The ever changing landscape of M&A Executive Summary 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 Historically, FTC involvement in health care M&A was concentrated in ‘non-innovative’…
Microbiome and fecal transplant therapeutics 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…
Key Takeaways 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…
The CAR T- cell therapy revolution In 2017, the first therapy designed to genetically modify patients’ own T-cells to attack cancer was FDA-approved. These are known as CAR T-cell therapies. The therapies are an exceptional scientific advancement that have captured global attention due to their innovative nature. They have been…