In the wake of a radical court ruling on mifepristone, the pharma industry rallies in defense of the FDA
Last week’s ruling by U.S. District judge in Texas that suspended the FDA's approval for a medical abortion drug felt like a massive Dobbs v. Jackson aftershock rippling through the country.
Pharma companies recognized the huge implications of what they called "judicial activism” and jumped to the defense of the FDA, noting in a signed letter that “If courts can overturn drug approvals without regard for science or evidence... any medicine is at risk for the same outcome as mifepristone."
The Texas injunction (which has since been overruled in part by a 5th Circuit Court) is radical for many reasons, chief among them that a court has never before overridden the FDA approval of a drug. Keep in mind that mifepristone was approved in 2000 and thus has almost 23 years of on-market safety and efficacy data.
Back in 2014, the governor of Massachusetts tried to overrule FDA's approval of an opioid called Zohydro in response to his state’s severe opioid epidemic. The drugmaker, Zogenix, sued Massachusetts and shortly after, a federal judge ruled that the ban was unconstitutional, saying the state did not have the power to overturn a decision by the FDA.
In addition to being extremely detrimental to women's health, the judicial actions are causing serious headaches for drugmakers in the reproductive space (shameless cover story plug) and the FDA (the agency that SHOULD be focusing on approving safe and effective drugs not litigation) — and have set the stage for protracted legal battles that could have far-reaching implications. (Sidenote: If you need me, I'll be busy pursuing the law degree I now need to cover pharma news)-Karen Langhauser
Cool tech of the week: This company is 3D printing organ tissue
We ran a news story this week about Novo Nordisk’s potential $2.7 billion collaboration with Vancouver-based Aspect Biosystems.
Aspect, which spun off from a University of British Columbia research lab in 2017, has developed a 3D bioprinter that makes ‘tissues’ that can be implanted into the body to replace or repair functions of damaged organs.
Check out the video here
The company, currently focused on type 1 diabetes and liver disease, is now testing treatments in animal models. It's the diabetes (and potential obesity) side of the business that got Novo to open its wallet.-Karen Langhauser
Ghana grants landmark approval to Oxford malaria vax
Just yesterday, Ghana became the first country in the world to greenlight an Oxford University-developed vaccine against malaria.
The country’s Food and Drugs Authority has authorized the use of the vaccine for children between the ages of five months and three years as a part of a larger effort to combat child mortality caused by the disease — about 20,000 children die from malaria in Ghana each year, and 25% of these fatalities occur among children under the age of five.
The jab, called R21/Matrix-M, has demonstrated 77% effectiveness in preventing disease, surpassing the WHO's 75% efficacy threshold, and administering a fourth booster dose 12 months after the primary 3-dose series provided additional benefits.
The vaccine uses the Matrix-M adjuvant developed by Novavax and will be manufactured by The Serum Institute of India, with a projected annual production capacity of more than 200 million doses.-Andrea Corona
AbbVie, J&J take some steps back with blockbuster drug
On Monday, we reported AbbVie’s plan to voluntarily withdraw two blood cancer indications for its oral Bruton's tyrosine kinase (BTK) inhibitor, Imbruvica.
Prior to the recent announcement, Imbruvica had obtained 12 approvals across 7 indications, two of which were accelerated approvals for mantle cell lymphoma (MCL) and refractory marginal zone lymphoma (MZL), which meant continued approval was dependent on the demonstration of clinical benefits.
Now, the FDA says that the primary outcomes of phase 3 confirmatory trials for the indications were inadequate to justify a conversion to full approval.
But despite failing to impress for other cancer indications, Imbruvica, which is jointly marketed by J&J, continues to generate significant revenue, with AbbVie disclosing global net revenues totaling $4.568 billion in 2022.-Andrea Corona