→ In 2017, the FDA green­light­ed Flex­ion Ther­a­peu­tics‘ in­tra-ar­tic­u­lar ther­a­py, Zil­ret­ta, de­signed as a treat­ment for os­teoarthri­tis-re­lat­ed knee pain. Now, two years lat­er, the com­pa­ny has an­nounced that the FDA needs ad­di­tion­al time to com­plete the re­view of its sup­ple­men­tal NDA for Zil­ret­ta. The an­tic­i­pat­ed PDU­FA date was set for to­day. Al­though the FDA has not pro­vid­ed a new ac­tion date, Flex­ion says they were in­formed that the re­view should be com­plet­ed in the com­ing weeks. No ad­di­tion­al clin­i­cal da­ta has been re­quest­ed by the FDA.

→ Genen­tech has re­leased da­ta from its Phase III PEM­PHIX study eval­u­at­ing the ef­fi­ca­cy and safe­ty of Rit­ux­an (rit­ux­imab) com­pared to my­cophe­no­late mofetil (MMF), in adults with mod­er­ate to se­vere pem­phi­gus vul­garis (PV). The da­ta showed su­pe­ri­or re­sults in pa­tients giv­en Rit­ux­an, with 40.3% of pa­tients treat­ed with Rit­ux­an achiev­ing sus­tained com­plete re­mis­sion with­out the use of steroids for 16 con­sec­u­tive weeks or more, com­pared to 9.5% in the MMF arm (p<0.0001). The stud­ies pri­ma­ry end­point was reached at week 52.

→ John­son & John­son‘s drug Xarel­to (ri­varox­a­ban) has been ap­proved by the FDA for the pre­ven­tion of ve­nous throm­boem­bolism (VTE), or blood clots, in hos­pi­tal­ized, acute­ly ill med­ical pa­tients at risk for throm­boem­bol­ic com­pli­ca­tions who are not at high risk of bleed­ing. The ap­proval comes a few months af­ter J&J and Bay­er paid out $775 mil­lion to thou­sands of Xarel­to pa­tients af­ter a 5-year long le­gal war — the com­pa­nies were ac­cused of fail­ing to warn pa­tients prop­er­ly of the bleed­ing risk as­so­ci­at­ed with the blood thin­ner.

→ Ul­tragenyx Phar­ma­ceu­ti­cal has an­nounced that the FDA has ac­cept­ed their NDA for UX007 (tri­hep­tanoin) for the treat­ment of long-chain fat­ty acid ox­i­da­tion dis­or­ders. The PDU­FA is set for Ju­ly 31, 2020.

→ As­traZeneca, Pfiz­er and Take­da have come to­geth­er for a col­lab­o­ra­tion deal with Imag­inAb, agree­ing to guide a clin­i­cal tri­al for the imag­ing play­er in ex­change for ear­ly ac­cess to the da­ta. The study is aimed at as­sess­ing the util­i­ty and val­ue of Imag­inAb’s Im­munoPET tech­nol­o­gy, which us­es mi­ni an­ti­bod­ies and tags CD8+ T cells with ra­dioiso­topes to ren­der im­mune ac­tiv­i­ty vis­i­ble in a PET scan.

“One of our key ob­jec­tives is to stream­line the clin­i­cal de­vel­op­ment of next-gen­er­a­tion can­cer im­munother­a­pies so that ul­ti­mate­ly can­cer pa­tients have ac­cess to the best pos­si­ble treat­ments,” CEO Ian Wil­son said in a state­ment. “We be­lieve that work­ing with glob­al lead­ers in im­muno-on­col­o­gy will help us fur­ther de­vel­op CD8 Im­munoPET as a phar­ma­co­dy­nam­ic mark­er for use in drug de­vel­op­ment and, in the fu­ture, as a di­ag­nos­tic and pre­dic­tive test for use in hos­pi­tals.”

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

For nearly a decade now, the low-profile Cambridge biotech Kymab has been battling in US, UK, Japanese and Australian courts with the biotech behemoth Regeneron.

Regeneron has turned itself into a $70 billion company off of a platform of transgenically humanized mice they can use to make antibodies for anything from Ebola to colorectal cancer. The technology took decades and billions to build, 20 years from the company’s founding to the first approved drug. And the company guards and touts it zealously, breaking their production process down into various branded components — Velocimmune, Velocigene, Velocimouse and four other Velocis — and sometimes suing would-be copycats. In 2014, most notably, they sued two Pfizer-backed entities for patent infringement.

After pharma partner Novartis boosted its IPO with a $10 million private placement, Pliant Therapeutics has wrapped its journey to the Nasdaq on a high note.

Pliant had penciled in a $86 million raise back in May. But as has become the norm in recent months, that initial number has turned out to be a mere placeholder, making way for the final haul of $144 million.

The South San Francisco biotech did so by pricing at $16, the high end of the range, while bringing the number of shares offered up to 9 million.