This week we highlight regulatory challenges for the United States and China; a softening of guidelines in the prescription of opioids; and record-breaking sales figures for Pfizer as it sees a more than 600% increase in vaccine revenue. Finally, we look at a new cartilage implant inspired by spiders and produced by proteins from moths.
Each week we highlight five things you need to know in the life sciences industry. Here’s the latest.
Should drugs tested in other countries with potentially less diverse populations receive approval in the U.S., even if effective? What impact would less expensive cancer therapies developed in international markets have on domestic drug prices? Can drug companies successfully collaborate internationally if tensions rise between foreign governments? These are just a few of the high-profile questions brought to the forefront as a result of the Food and Drug Administration’s decision to reject a lung cancer immunotherapy that was tested in China and licensed by Lilly for sale in the U.S. Safety and efficacy remain the primary focus of the FDA, but rising pressures on drug pricing and an increasingly globalized economy are likely to push regulators and drug companies to bring more affordable drugs to market faster and via non-traditional avenues.
Shares of the Chinese biotech giant, Wuxi Biologics, fell by approximately 30% on Feb. 8 and wiped out over $10 billion in market value after the company was added to the U.S. Department of Commerce’s unverified list. Inclusion on this list leads to stricter import controls for the company. Trading was halted following its plummeting share price. COVID-19 has made it more challenging for U.S. regulators to perform routine inspections contributing to Wuxi’s unverified status.
The Centers for Disease Control and Prevention has softened its opioid prescribing guidelines. The authors of the original guidelines indicated that they were not meant to be authoritative but rather suggested approaches to be applied at the doctors’ discretion. Regardless, the guidelines had been used by insurers to impose caps on treatment coverage. Additionally, critics said that the guidelines led to inappropriate tapering and lack of prescriptions for patients in need.
Pfizer’s bottom line has grown significantly during the COVID-19 pandemic. For the year ending Dec. 31, Pfizer reported $81 billion in total revenues, including $43 billion related to vaccine revenue which was up from $7 billion in the prior year. Approximately $37 billion of Pfizer’s vaccine revenue related to its COVID-19 vaccine labeled Comirnarty. Its oral COVID-19 treatment, Paxlovid, contributed less than $100 million to its total revenue.
The Oxford-based company Orthox is bringing its spider-inspired technology to clinical trials. Its FibroFix product uses fibroin protein extracted from silk produced by the domestic silk moth. The protein is then formed into implants using a process similar to spiders spinning their webs. The implants are intended to be a replacement for articular cartilage which covers the ends of the thigh and shin bones.