→ 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.”

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Eli Lilly’s $1.04 billion takeover of Prevail Therapeutics is officially complete, the company announced Friday.

The sides had entered into the buyout agreement last month with Lilly focusing on Prevail’s pipeline of gene therapies, highlighting two AAV9 programs in Parkinson’s disease and frontotemporal dementia as potential winners. Lilly paid $22.50 per share, which amounted to an 82% premium over the previous day’s closing price and a 117% premium over Prevail’s 60-day average.

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.