→ 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.

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

The first potential gene therapy for hemophilia B has gotten one step closer to reaching patients as the FDA has accepted CSL Behring’s BLA for its uniQure-partnered one-time treatment. The therapy, dubbed etranacogene dezaparvovec, was accepted under “accelerated assessment” by the European Medicines Agency in March.

A priority review will be conducted for the gene therapy intended for patients with the hereditary bleeding disorder, CSL said Tuesday morning. The Pennsylvania biotech did not indicate the regulator’s decision date, but a priority review generally means the treatment’s fate will be handed down within six months rather than 10.

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Two Big Pharma companies are going to the mat over genetically modified mice in a licensing dispute.

Bristol Myers Squibb is suing Novartis in New York over a dispute concerning an evaluation, research and commercialization agreement stretching back to the late ’90s initially inked between Novartis and BMS’ predecessor Medarex. The deal in question allowed Novartis to use Medarex’s patented transgenic mice to develop therapeutic drugs. Novartis agreed to pay Medarex – and subsequently BMS – a royalty on sales of drugs it developed using the mice.