The Dan­ish phar­ma gi­ant No­vo Nordisk is mak­ing a ma­jor ex­pan­sion close to home.

The com­pa­ny an­nounced on Tues­day that it plans to in­vest 5.4 bil­lion Dan­ish kro­ner ($747.2 mil­lion) in­to ex­pand­ing its ex­ist­ing fa­cil­i­ties in its home­town of Bagsværd, Den­mark, a sub­urb of Copen­hagen. Those plans al­so in­clude the con­struc­tion of a new plant.

A No­vo Nordisk spokesper­son did not con­firm the size of the new plant to End­points News by press time. How­ev­er, they did tell End­points that de­spite the ex­pan­sion of ex­ist­ing fa­cil­i­ties, the man­u­fac­tur­ing of ac­tive phar­ma­ceu­ti­cal in­gre­di­ents (API) is cur­rent­ly on­go­ing to sup­port clin­i­cal tri­als. The ex­pan­sions are ex­pect­ed to be fi­nal­ized and ful­ly op­er­a­tional in Au­gust of next year for pu­rifi­ca­tion. The new fa­cil­i­ty, which is cen­tered around fer­men­ta­tion and re­cov­ery, is ex­pect­ed to be fi­nal­ized in Au­gust 2024.

No­vo Nordisk al­so plans to cre­ate more ca­pac­i­ty for R&D ac­tiv­i­ties and the pro­duc­tion of APIs, main­ly to sup­ply its clin­i­cal tri­als as well as pro­vide room for fu­ture de­vel­op­ment for its in­jecta­bles and oral med­i­cines, in­clud­ing in the di­a­betes and obe­si­ty treat­ment space, ac­cord­ing to the spokesper­son.

“This in­vest­ment in ex­pand­ing our clin­i­cal API ca­pac­i­ty in Bagsværd is an im­por­tant step to en­sure the con­tin­u­ous progress of our de­vel­op­ment pipeline. In­creas­ing our API ca­pac­i­ty in R&D will be a key en­abler in bring­ing new in­no­va­tions to the mar­ket, and meet the fu­ture de­mand of our pa­tients,” said Jes­per Bøv­ing, se­nior vice pres­i­dent of CMC de­vel­op­ment at No­vo Nordisk, in a state­ment.

This is not the first time the com­pa­ny has dropped a mas­sive amount for API man­u­fac­tur­ing. Ac­cord­ing to the North Car­oli­na Biotech­nol­o­gy Cen­ter, the com­pa­ny in 2019 spent $1.8 bil­lion on a fac­to­ry meant for No­vo Nordisk’s di­a­betes med­i­cines at its site in Clay­ton, NC. The project mea­sured 833,000 square feet and was re­port­ed at the time to be the largest man­u­fac­tur­ing in­vest­ment in the state’s his­to­ry.

The in­vest­ment in Den­mark al­so comes as the com­pa­ny put two pro­grams in obe­si­ty and car­dio­vas­cu­lar dis­ease on the chop­ping block in its re­cent Q3 re­port. The com­pa­ny’s hop­ing for a Q4 re­bound for We­govy, its weight loss drug that ran in­to “un­prece­dent­ed de­mand” on top of man­u­fac­tur­ing is­sues last year.

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”

A small, Santa Ana-based biotech created in 2017 is looking to enter a SPAC deal as it lays out plans to begin trials in its lead cell therapy candidates and bring on new executives.

Graf Acquisition Corp. IV and NKGen Biotech announced Thursday, with few other details, that the two companies signed a non-binding letter of intent to “pursue a business combination.” Graf Acquisition II and III withdrew their IPOs last year.

Cyclerion Therapeutics may have the design of a Phase IIb study ready to go, but it’s scrambling for a way to fund it.

The company said in a press release that it’s “actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat,” its lead candidate for a rare, genetic mitochondrial disease known as MELAS.

In a separate SEC filing, Cyclerion once again flagged “substantial doubt about (its) ability to continue as a going concern.” As of the end of 2022, it had cash and cash equivalents of only $13.4 million.

The European Commission has once again delayed the release of its proposal for an overhaul of the continent’s pharmaceutical legislation.

The release, previously anticipated on March 29, will occur “slightly later” than expected due to the “very busy College agendas of the last few weeks,” a Commission spokesperson told Endpoints News via email.

While the agency hasn’t provided an updated timeline, the spokesperson said the agenda is “always indicative and adoption dates of Commission proposals may change any time, especially when these proposals concern reforms of complex legislations of major importance.”