→ 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.

Pfizer and Merck KGaA have detailed the Phase III data that inspired FDA regulators to designate Bavencio a “breakthrough” for first-line advanced bladder cancer and offered an early glance at how the PD-L1 can help patients with a rare gynecological cancer — carving out niches in the checkpoint space for itself after being shut out of numerous others.

In JAVELIN Bladder 100, Bavencio led to a 31% reduction in risk of death compared to standard care alone. It also extended median survival by more than seven months — a historic feat in this setting, according to investigators at Queen Mary University of London.

Ipsen has turned to another Paris-based biopharma company for its next CEO.

Sanofi Pasteur chief David Loew — who’s been leading one of the most advanced efforts to develop vaccines for Covid-19 — is making the journey to Ipsen, 5 months after David Meek jumped ship to run a startup in late-stage development.

Loew arrives as Ipsen works to get back on track with their rare bone disease drug palovarotene, picked up in the $1.3 billion Clementia buyout, which was slammed with a partial hold after researchers observed cases of “early growth plate closure” in patients under the age of 14. But they are pushing ahead with the over-14 crowd after writing down slightly more than half of its initial development.

The delayed-release formulation of Ironwood and Allergan’s bowel drug Linzess will not see the light of day.

The experimental drug, MD-7246, failed to help patients with abdominal pain associated with irritable bowel syndrome with diarrhea (IBS-D) in a mid-stage study, prompting the partners to abandon the therapy.

First approved in 2012, Linzess (known chemically as linaclotide) enhances the activity of the intestinal enzyme guanylate cyclase-C to increase the secretion of intestinal fluid and then transit through the intestinal tract, as well as reduce visceral pain, to relieve pain and constipation associated with IBS.