→ Kala Phar­ma­ceu­ti­cals, one of the pletho­ra of biotechs that trace their roots to the pro­lif­ic lab at MIT led by Bob Langer, on Thurs­day dis­closed that its ex­per­i­men­tal drug for short-term dry eye re­lief did not pass muster with the FDA. Last year, the com­pa­ny post­ed mixed da­ta from two stud­ies — STRIDE 1 and STRIDE 2. Kala $KALA is now bank­ing on the on­go­ing STRIDE 3 study to re­verse its for­tunes. It ex­pects STRIDE 3 to read out by the end of the year, and to re­sub­mit its mar­ket­ing ap­pli­ca­tion the first half of 2020.

While dis­ap­point­ing, the CRL is not com­plete­ly un­ex­pect­ed, COO Todd Baze­more said. The com­pa­ny had ini­ti­at­ed STRIDE 3 last year at the ad­vice of the FDA, and is con­fi­dent that they have now got­ten the in­clu­sion/ex­clu­sion cri­te­ria right by screen­ing out pa­tients with un­sta­ble symp­toms. Once they have the da­ta, he added, they can re­file an NDA un­der a type 2 sub­mis­sion, which en­tails a 6-month in­stead of 12-month re­view.

Point­ing to No­var­tis‘ re­cent $5.3 bil­lion pur­chase of Shire’s Xi­idra — whose ap­proval process in­spired Kala to take its chances the first time — Baze­more em­pha­sized the po­ten­tial of KPI-121: “There’s so few prod­ucts in this cat­e­go­ry, it’s a huge un­tapped cat­e­go­ry in which on­ly about a mil­lion and a half of the 30 mil­lion pa­tients are cur­rent­ly be­ing treat­ed with a pre­scrip­tion prod­uct.”

→ Em­bat­tled In­sys, en­gulfed in lit­i­ga­tion and fi­nan­cial­ly starved, has found a buy­er for its unit-dose nasal and sub­lin­gual spray man­u­fac­tur­ing equip­ment, as well as two pipeline prod­ucts — nalox­one nasal spray and ep­i­neph­rine nasal spray — in UK-based Hik­ma. “Hik­ma is the largest sup­pli­er of gener­ic nasal sprays in the US and we have been look­ing for ways to build up­on our strong man­u­fac­tur­ing plat­form and ex­pand our prod­uct port­fo­lio,” said Hik­ma’s pres­i­dent of gener­ics Bri­an Hoff­mann in a state­ment.

→ Los An­ge­les biotech BioVie, which in April post­ed pos­i­tive da­ta from a small study test­ing its in­fu­sion ther­a­py for se­ri­ous com­pli­ca­tion of ad­vanced liv­er cir­rho­sis, on Thurs­day amend­ed the terms of its im­pend­ing IPO. The com­pa­ny now plans to raise $15 mil­lion by of­fer­ing 1.3 mil­lion shares for $11.44/share, the as-con­vert­ed last close of its shares on the over-the-counter mar­ket. The com­pa­ny, which plans to list un­der the sym­bol BIVI, had pre­vi­ous­ly filed to of­fer 1.3 mil­lion priced at $11.88/share.

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.

→ BeiGene $BGNE is getting a boost in its drive to field a rival to Imbruvica. The FDA has offered an accelerated review to zanubrutinib, a BTK inhibitor that has posted positive results for mantle cell lymphoma. The PDUFA date lands on February 27, 2020. The drug scored breakthrough status at the beginning of the year.

→ BeiGene isn’t the only biopharma company to gain special regulatory status today. Mustang Bio $MBIO and St. Jude Children’s Research Hospital announced that MB-107, a lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency, also known as bubble boy disease, has been granted Regenerative Medicine Advanced Therapy status.

The Trump administration is not giving up just yet. On Wednesday, the HHS filed an appeal against a judge’s decision in July to overturn a ruling obligating drug manufacturers to disclose the list price of their therapies in television adverts — hours before it was stipulated to go into effect.

In May, the HHS published a final ruling requiring drugmakers to divulge the wholesale acquisition cost— of a 30-day supply of the drug — in tv ads in a bid to enhance price transparency in the United States. The pharmaceutical industry has vehemently opposed the rule, asserting that list prices are not what a typical patient in the United States pays for treatment — that number is typically determined by the type of (or lack thereof) insurance coverage, deductibles and out-of-pocket costs. Although there is truth to that claim, the move was considered symbolic in the Trump administration’s healthcare agenda to hold drugmakers accountable in a climate where skyrocketing drug prices have incensed Americans on both sides of the aisle.

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll