Chris­t­ian Hogg Chi-Med

→ One of Chi-Med’s late-stage fa­vorites is grad­u­at­ing ear­ly from its Phase III study, hav­ing met its pri­ma­ry end­points at in­ter­im analy­sis. The Hong Kong-head­quar­tered biotech left out the num­bers in its brief state­ment, which not­ed that su­r­u­fa­tinib hit a PFS goal among pa­tients with ex­tra-pan­cre­at­ic neu­roen­docrine tu­mors. CEO Chris­t­ian Hogg has tapped the drug, along­side savoli­tinib, for ap­provals over the next two years to fol­low up on the land­mark OK for fruquin­tinib in Chi­na.

→ Am­gen $AMGN and Al­ler­gan $AGN have nabbed an OK to mar­ket their Her­ceptin copy­cat — chris­tened Kan­jin­ti — in the US for all ap­proved in­di­ca­tions of the Roche block­busters in­clud­ing HER2-over­ex­press­ing breast can­cer and gas­tric or gas­troe­sophageal junc­tion ade­no­car­ci­no­ma. “Kan­jin­ti is the sec­ond of four biosim­i­lars from Am­gen and Al­ler­gan’s col­lab­o­ra­tion to be ap­proved by the FDA,” David Nichol­son, Al­ler­gan’s chief re­search and de­vel­op­ment of­fi­cer, not­ed.

David Nichol­son Al­ler­gan

→ Last year, Sun Phar­ma­ceu­ti­cals en­tered the crowd­ed mar­ket for plaque pso­ri­a­sis with its IL-23 in­hibitor Ilumya. On Fri­day, the In­di­an drug­mak­er said the mon­o­clon­al an­ti­body — in-li­censed from Mer­ck $MRK back in 2014 for $80 mil­lion — cleared a mid-stage study in pa­tients with pso­ri­at­ic arthri­tis. The in­ter­im analy­sis re­vealed that over 71% of pa­tients treat­ed with the drug ex­pe­ri­enced a 20% im­prove­ment in joint and skin symp­toms, meet­ing the pri­ma­ry end­point of the study.

Vertex has clinched a priority review for the all-important cystic fibrosis triple that will blaze the trail for treating a large group of patients unhelped by its current drugs.

FDA regulators have set a PDUFA date of March 19, 2020, just a year after the Boston biotech posted positive Phase III results showing that people with two F508del mutations experienced statistically significant improvements in lung function after a 4-week regimen of VX-445, tezacaftor and ivacaftor. After reviewing 24-week data among patients with one F508del mutation and one minimal function mutation — and thoroughly comparing the VX-445 triple with another combo featuring VX-659 on scores like safety, drug-drug interactions, and photosensitivity — Vertex ultimately went with VX-445.

Just a few weeks after bagging $80 million in a deal to collaborate with Gingko Bioworks on its special blend of engineered bacteria used for “living therapeutics,” little Synlogic in Boston $SYBX is tossing one of its two clinical programs after watching an early-stage study go down in defeat.

Their Phase Ib/IIa study for SYNB1020 to counter the accumulation of ammonia in the body, a condition called hyperammonemia or urea cycle disorder, floundered at the interim readout, forcing the biotech to kill it and reserve its cash for pipeline therapies with greater potential.

Last week, Elanco explicitly dodged answering questions about its rumored interest in Bayer’s animal health business in its post-earnings call. On Tuesday, the Eli Lilly spinoff disclosed it was purchasing the German drug maker’s veterinary unit in a cash-and-stock deal worth $7.6 billion. 

Elanco $ELAN has been busy on the deal-making front. In April, it laid out plans to swallow its partner, Kansas-based pet therapeutics company Aratana $PETX. A July report by Reuters suggested a potential Bayer deal was being explored, and Bloomberg last week said the deal was imminent, citing sources. 

Months ago, data on J&J’s $JNJ Invokana indicated the diabetes drug conferred cardiovascular (CV) benefit in patients who do and do not have preexisting CV disease. On Tuesday, AstraZeneca’s $AZN rival treatment, Farxiga, was shown to cut the risk of CV death or the worsening of heart failure in patients with heart disease, in a landmark trial.

The treatments, in addition to Jardiance from Eli Lilly $LLY, belong to a class of diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which work by curbing the absorption of glucose via the kidneys so that surplus glucose is excreted through urination.