When the engine of innovation gets the green light of marketing authorisation, it is typically first in the USA, and sometimes for the EMA’s (European Medicines Agency) jurisdiction over much of Europe. Unfortunately, CHN (China) is too often one the last markets among the major and highest-tier of emerging markets…
Following years of hushed excitement and mounting anticipation in biotech circles, gene and cell therapies finally made the jump in 2017 from the safety of guarded clinical trial experimentation to broad availability to patients and their caregivers in the USA. The USA’s FDA (Food and Drug Administration) approvals of the…
2017 was a banner year for innovation as the healthcare world witnessed the first three cell and gene therapies launch in the USA, with the FDA’s approval of two CAR-Ts (KYMRIAH™ (tisagenlecleucel, $NVS) and YESCARTA™ (axicabtagene ciloleucel, $GILD)) as well as blindness gene therapy LUXTURNA™ (voretigene neparvovec, $ONCE). These three…
After years of anticipation, CAR-Ts (chimeric antigen receptor–T-cells) finally made the transition from being promising future therapies, to breakthrough marketed products in 2017. Novartis’s KYMRIAH™ got the FDA nod in late August for pediatric B-ALL (B-cell acute lymphoblastic leukemia), followed by Kite’s YESCARTA™ in October for NHL (Non-Hodgkin lymphoma) (Figure 1)….
Most companies prioritise launching innovative therapies in high-income countries due to their greater ability and willingness to pay. This greater funding opportunity allows for earlier adoption of innovative, high-value products, which help to fulfil commercial expectations and realise returns on their research and development investment. As a result, these high-income…
In an unprecedented move, GBR’s (United Kingdom) NICE (National Institute for Health and Care Excellence) recently recommended NHS (National Health Services) funding of $GSK’s gene therapy STRIMVELIS™ for an ultra-orphan immunodeficiency disorder ADA-SCID1 – also dubbed the “Bubble Baby Syndrome” – at EUR 594,000 (ex-VAT2 price, about USD 700,000). Importantly,…
CBPartners’ holistic international reference pricing (CHIRP) app is updated and available for download! CHIRP is a one-stop, on-the-go reference guide, as well as your source for the latest from CBPartners’ global thought leaders and Global Health Advisory Board – all in the palm of your hand! FEATURES: Updated reference pricing…
October is breast cancer awareness month, and in light of our recent PDx (PD1 / PD-L1) analysis, our team decided to take a closer look at the potential for these paradigm-shifting therapies to make a difference for patients diagnosed with breast cancer. While no PDx brand has yet achieved marketing authorisation…
As a class, manufacturers of PDxs (PD1s / PD-L1) are enjoying great success when it comes to marketing authorisation, with four of the five brands achieving multiple FDA and EMA approvals. These groundbreaking therapies display versatility across tumour types, which gives patients great hope (just ask former President Jimmy Carter)…
In 2015, Greek Prime Minister Alexis Tsipras was holding strong in his contempt for austerity and desire to flee the euro return to the drachma – going so far as to state that “the bailout choices and reforms imposed upon Greece (GRC) by its creditors have been akin to placing…