As­traZeneca has been grow­ing its pres­ence in Chi­na over the past sev­er­al years, and the phar­ma’s lat­est ven­ture in the coun­try will see it es­tab­lish a man­u­fac­tur­ing process for COPD treat­ments.

Ac­cord­ing to a press re­lease, trans­lat­ed from Chi­nese, As­traZeneca of­fi­cial­ly an­nounced it will ex­pand its in­vest­ment in Chi­na and plans to spend some cash to con­struct a pro­duc­tion and sup­ply base as well, as a re­gion­al head­quar­ters in the port city of Qing­dao, Shan­dong in east­ern Chi­na. Qing­dao will al­so be home to an in­no­va­tion cen­ter fo­cused on rare dis­eases, a life sci­ence in­no­va­tion park and an in­dus­tri­al fund.

The com­pa­ny ad­di­tion­al­ly said that the planned man­u­fac­tur­ing and sup­ply base in Qing­dao will pro­duce the in­gre­di­ents for Breztri, a ther­a­peu­tic that treats COPD. As­traZeneca de­clined to com­ment on the cost, size or time­lines on the man­u­fac­tur­ing space and in­no­va­tion cen­ter.

“As­traZeneca’s in­vest­ment in the Qing­dao pro­duc­tion and sup­ply base aims to bet­ter meet the huge de­mand of pa­tients for Breztri in­hala­tion aerosols. To fur­ther pro­mote the de­vel­op­ment of Qing­dao’s bio­phar­ma­ceu­ti­cal in­dus­try and con­tribute to the Na­tion­al Health Vi­sion 2030, As­traZeneca will con­tin­ue to strength­en its con­fi­dence in in­creas­ing in­vest­ment in Chi­na,” said Wang Lei, the Chi­na pres­i­dent of As­traZeneca, in a state­ment.

Breztri, which gained ap­proval in Chi­na in 2019, had a rocky jour­ney with US reg­u­la­tors. In 2019, the triple-drug com­bi­na­tion treat­ment was orig­i­nal­ly shot down with a CRL, but it fi­nal­ly re­ceived the green light in 2020.

And while As­traZeneca has a sol­id pres­ence in Chi­na with sup­ply bases in Wuxi and Taizhou, Jiang­su, Chi­na, some staffers re­cent­ly found them­selves in trou­ble.

In Jan­u­ary, mul­ti­ple sus­pects were ar­rest­ed in con­nec­tion with an al­leged med­ical in­sur­ance fraud scheme or­ga­nized by As­traZeneca Chi­na em­ploy­ees, the coun­try’s Na­tion­al Health­care Se­cu­ri­ty Ad­min­is­tra­tion (NHSA) said. The ar­rests oc­curred af­ter an in­ves­ti­ga­tion found ev­i­dence that staff mem­bers tam­pered with the ge­net­ic test­ing re­sults of tu­mor pa­tients to de­fraud med­ical in­sur­ance funds.

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

German pharma giant Bayer will be looking to make a significant investment into one of its US plants that produces over-the-counter drugs.

Bayer announced that it will spend $43.6 million to expand its facility in Myerstown, PA, a small town east of Harrisburg. Bayer plans to increase the site by 70,000 square feet and will have room for the installation of eight packaging lines and an area to install rooftop solar panels. The project is expected to be completed by 2025 and will add around 50 to 75 jobs.

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).