Here are the latest stories being discussed in biopharma today:
European regulator supports approval of Carvykti for multiple myeloma treatment
The Committee for Medicinal Products for Human Use (CHMP) at European Medicines Agency has recommended that the label for Legend Biotech and Johnson & Johnson’s CAR-T therapy, Carvykti, be expanded to treat multiple myeloma patients as a second-line option. This recommendation could significantly increase the eligible patient population for Carvykti if ratified by European regulators.
BioMarin’s Roctavian fails to meet sales forecasts
BioMarin’s gene therapy, Roctavian, fell significantly short of its sales forecast for 2023. Originally projected to reach between $50 million and $100 million, it managed only $3.5 million in sales, coming from just three patients. BioMarin’s CEO, Alexander Hardy, insisted this was part of the early stage process for a pioneering therapy and that they expected to see progress through 2024 and 2025.
FDA withdraws approval for Oncopetides’ cancer drug
The FDA has formally withdrawn approval for Pepaxto, a cancer drug from Swedish company Oncopetides. This follows a lengthy appeal process after the FDA recommended the withdrawal of the drug over a year ago. Pepaxto originally won accelerated approval as a fifth-line therapy for blood cancer multiple myeloma.
FDA will not fine for noncompliant trial reporting
The FDA has stated it will not impose fines or enforce greater action against clinical trial sponsors failing to properly report trial information. Instead, the FDA continues to encourage voluntary compliance. They admitted that resource allocation is currently insufficient to identify all applicable clinical trials.
Gilead settles over counterfeit HIV drugs
Gilead has reached a settlement with Maryland-based pharmaceutical distributor, Safe Chain Solutions, and its owners Patrick and Charles Boyd for allegedly trafficking counterfeit HIV medicine. The settlement sees Safe Chain barred from selling Gilead products, giving up $2.7 million in frozen assets, and facing severe penalties for any violation of the terms.
Bipartisan group opposes President Biden’s drug pricing proposal
President Biden’s proposal to use ‘march-in’ rights to lower drug prices has been opposed by a bipartisan group of 28 senators and Congress members. Biden’s plan would allow the government to consider the price of a drug when deciding to take over patents developed with federally-funded research.
Pharmaceutical CEO influencers
An analysis has found that the CEOs of Pfizer and Novartis lead the pack when it comes to social media influence in the pharmaceutical sector.
