→ Am­gen and part­ner UCB have man­aged to con­vince the EMA to fi­nal­ly ap­prove their bone-build­ing drug, Eveni­ty, to treat os­teo­poro­sis. The drug, which was orig­i­nal­ly slapped with a neg­a­tive rec­om­men­da­tion by the EU reg­u­la­tor, was test­ed in three late-stage stud­ies. Da­ta showed the drug was ef­fec­tive, but se­ri­ous CV ad­verse events were ob­served in one tri­al — trig­ger­ing reg­u­la­to­ry con­cern in the Unit­ed States and Eu­rope. The FDA grant­ed Eveni­ty ap­proval in April, but the man­u­fac­tur­ers view the EU as the least valu­able re­gion in terms of Eveni­ty, Cred­it Su­isse an­a­lysts wrote in a note in June, pre­dict­ing mod­est EU sales and es­ti­mat­ing the EU op­por­tu­ni­ty is worth $1-2 per share.

→ A lit­tle more than a year af­ter bag­ging a $75 mil­lion round de­signed to boost its lead drug, Bel­gian biotech iTeos has inked an agree­ment with Mer­ck to test the com­pound, EOS100850, in com­bi­na­tion with Keytru­da. The Phase I/II tri­al will fo­cus on pa­tients with sol­id tu­mors and en­roll­ment will be­gin in ear­ly 2020.

→ Emory Uni­ver­si­ty’s drug de­vel­op­ment arm has sealed a li­cens­ing deal with its part­ners at Neu­ro­Trau­ma Sci­ences, who are ex­er­cis­ing their op­tion af­ter con­duct­ing pre­clin­i­cal re­search on Emory’s neu­ro­pro­tec­tant com­pounds in the past year. The lead can­di­date is NTS-1104, but the deal al­so cov­ers re­lat­ed small mol­e­cules en­gi­neered to pen­e­trate the blood-brain bar­ri­er and po­ten­tial­ly treat ac­quired brain in­jury — a cat­e­go­ry that spans is­chemic stroke and trau­mat­ic brain in­jury, in­clud­ing con­cus­sion. Neu­ro­Trau­ma plans to pri­or­i­tize their work in stroke ini­tial­ly.

→ US-Chi­na bi­o­log­ics CD­MO JOINN Bio, a sub­sidiary of JOINN Lab­o­ra­to­ries, has hauled in $60 mil­lion in Se­ries A fi­nanc­ing led by HG Cap­i­tal, with par­tic­i­pa­tion from Nest­bio Cap­i­tal, Hong Kong LINK­AGE Hold­ings, Xi­ang­tang Cap­i­tal and oth­ers. Pro­ceeds from the fund­ing will be used to­ward the con­struc­tion of a 100,000-liter pro­duc­tion base in Bei­jing and ex­pan­sion of its bi­o­log­ics busi­ness in Chi­na and the US.

→ Mati­nas Bio­Phar­ma, which is get­ting some re­newed love from in­vestors af­ter Bak­er Bros took a stake in it, is boast­ing of a new agree­ment with Roche. The phar­ma gi­ant will eval­u­ate the fea­si­bil­i­ty of de­vel­op­ing oral for­mu­la­tions of its drugs us­ing Mati­nas’ lipid nano-crys­tal de­liv­ery tech.

Once a promising $725 million play in immunology, Gilead’s big bet on filgotinib effectively disintegrated in December when the drugmaker reworked its partnership with Galapagos. Now, Galapagos is sporting safety data that will come as a relief — but will it make a difference on filgotinib’s chances in the US?

In a study designed to compare filgotinib’s effect on sperm count with placebo, Galapagos’ JAK inhibitor saw fewer patients post a 50% or more reduction in sperm concentration after 13 weeks of treatment, according to data from the MANTA and MANTA-RAy studies unveiled Thursday.

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.