Fol­low­ing up on our suc­cess­ful paid-sub­scrip­tion prod­uct roll­out last month, we’re ex­pand­ing the ed­i­to­r­i­al team so we can serve you bet­ter, bring­ing even more dai­ly news cov­er­age to the world­wide bio­phar­ma in­dus­try. Please wel­come Brit­tany Meil­ing, who joins End­points News af­ter three years cov­er­ing biotech and star­tups at the San Diego Busi­ness Jour­nal.

Brit­tany Meil­ing

She will be a Se­nior Writer on the team and her beat is now ex­pand­ing to cov­er bio­phar­ma around the globe, on top of the im­por­tant San Diego biotech cov­er­age she’s al­ready known for. Read­ers from South­ern Cal­i­for­nia make up the 5th largest bloc in the End­points News au­di­ence, af­ter NY/NJ, Boston, San Fran­cis­co, and Lon­don.

Watch for Brit­tany’s by­lines start­ing next week. You can con­tact her at brit­tany@end­pointsnews.com.

Am­ber Tong

In ad­di­tion, we’ve al­so hired Am­ber Tong as our newest Ed­i­to­r­i­al As­sis­tant. She’s a re­cent grad­u­ate of Rice Uni­ver­si­ty and a Hong Kong na­tive, and her role in­cludes copy edit­ing and re­search, as well as fol­low­ing the CRO, CMO, pre­clin­i­cal, and Chi­na beats. You can al­ready see her work in sev­er­al news re­ports and you can ex­pect much more in the fu­ture. Her email is am­ber@end­pointsnews.com.

Both of these hires come on the heels of some key busi­ness mile­stones we hit in Sep­tem­ber. We asked com­pa­nies and in­di­vid­u­als to join our paid sub­scrip­tion plans, which pro­vides ex­tra ben­e­fits such as a full li­cense to our news con­tent, ac­cess to John Car­roll’s In­sid­er columns, and spe­cial ver­sions of the email newslet­ters for all cor­po­rate sub­scribers.

Most of all, it al­lows our read­ers to di­rect­ly fund our fu­ture growth and sup­port in­de­pen­dent biotech jour­nal­ism, with­out hav­ing to close off our news con­tent un­der a pay­wall. We be­lieve strong­ly in a free and eas­i­ly ac­ces­si­ble news me­dia. Our mod­el pro­vides ex­clu­sive ben­e­fits for the peo­ple and or­ga­ni­za­tions who’ve elect­ed for a paid sub­scrip­tion, while di­ver­si­fy­ing our rev­enue sources in a way that our sur­vival and in­de­pen­dence can be as­sured re­gard­less of any ups and downs in­her­ent to ad­ver­tis­ing-based news busi­ness­es.

The mis­sion here at End­points is to pro­duce the best com­pre­hen­sive dai­ly bio­phar­ma news feed in the world. With your con­tin­ued sup­port, we’ll keep in­vest­ing in qual­i­ty ed­i­to­r­i­al.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.

A handful of CDMOs have made changes at the top over the past few weeks, including Genezen and Curia.

That also includes Australian CDMO BioCina, which announced last week that Mark Womack would be taking the helm. Womack previously served as chief business officer at AGC Biologics, CEO of Indian manufacturer Stelis Biopharma and most recently, CEO at CDMO KBI Biopharma and Selexis SA.

BioCina completed the takeover of a Pfizer manufacturing facility in Adelaide in 2021 and is now prepping for wider growth. Endpoints News sat down with Womack to discuss his new role, plans for the future, and how to compete in the wider CDMO market. This interview has been edited for brevity and clarity.