Editors' (re)View: mifepristone ruling, 3D organ tissue, malaria vax, Imbruvica rollback

April 14, 2023
Notable happenings from the week of April 10
Editor’s note: Welcome to Editors' (re)View, our editors’ takes on things going on in the pharma world that deserve some extra consideration.

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
About the Author

Karen P. Langhauser | Chief Content Director, Pharma Manufacturing

Karen currently serves as Pharma Manufacturing's chief content director.

Now having dedicated her entire career to b2b journalism, Karen got her start writing for Food Manufacturing magazine. She made the decision to trade food for drugs in 2013, when she joined Putman Media as the digital content manager for Pharma Manufacturing, later taking the helm on the brand in 2016.

As an award-winning journalist with 20+ years experience writing in the manufacturing space, Karen passionately believes that b2b content does not have to suck. As the content director, her ongoing mission has been to keep Pharma Manufacturing's editorial look, tone and content fresh and accessible.

Karen graduated with honors from Bucknell University, where she majored in English and played Division 1 softball for the Bison. Happily living in NJ's famed Asbury Park, Karen is a retired Garden State Rollergirl, known to the roller derby community as the 'Predator-in-Chief.' 

About the Author

Andrea Corona | Senior Editor

Andrea Corona serves as the Senior Editor of Pharma Manufacturing — a leading source of news and insights for pharma professionals — and is responsible for creation of editorial content, moderating webinars, and co-hosting the "Off script" podcast. Her editorial journey started as an as associate editor at Biocompare, an online platform providing product information, industry news, articles, and other resources to support scientists in their work. Before Biocompare, she was a digital producer at Science Friday, focusing on adapting radio segments for the web and social media management. Andrea earned her bachelor's degree in journalism and biology from the State University of New York, at Purchase College.