→ Oph­thal­mol­o­gy-fo­cused Swiss drug de­vel­op­er Oculis has rolled out pos­i­tive da­ta from their Phase II study of OCS-01 — an eye drop for­mu­la­tion of dex­am­etha­sone for the treat­ment of di­a­bet­ic mac­u­lar ede­ma (DME). The study met its pre-de­fined ef­fi­ca­cy end­points and showed that OCS-01 eye drops were more ef­fec­tive than the ve­hi­cle in di­min­ish­ing cen­tral mac­u­lar thick­ness and im­prov­ing acu­ity in pa­tients with DME.

→ Af­ter re­ceiv­ing the green light from the FDA to mar­ket Exser­van, oral film ver­sion of a gener­ic ALS drug last No­vem­ber, Aque­s­tive Ther­a­peu­tics an­nounced that the FDA has ac­cept­ed the com­pa­ny’s NDA for Liber­vant (di­azepam) buc­cal film for the man­age­ment of seizure clus­ters. A PDU­FA date has been set for Sep­tem­ber 27, 2020.

David Mor­ris En­ter­prise

→ Res­pi­ra­to­ry dis­ease-fo­cused En­ter­prise Ther­a­peu­tics has tapped David Mor­ris as CMO. In his new role, Mor­ris will lead the clin­i­cal de­vel­op­ment for ETD002 and ETD001 — ther­a­pies aimed at treat­ing cys­tic fi­bro­sis pa­tients. Mor­ris joins the com­pa­ny from No­var­tis Ven­ture Fund, where he cur­rent­ly serves as a man­ag­ing di­rec­tor and will con­tin­ue as op­er­at­ing part­ner. Pri­or to that, Mor­ris worked with No­var­tis and Roche.

→ Af­ter win­ning a la­bel ex­ten­sion from the FDA for their block­buster Ozem­pic, No­vo Nordisk is drop­ping DKK 800 mil­lion in up­grad­ing and ex­pand­ing fa­cil­i­ties at the com­pa­ny’s pro­duc­tion site in Kalund­borg, Den­mark. The in­jec­tion of cash will boost its ca­pac­i­ty to pro­duce di­a­betes treat­ments — and the ex­pan­sion is ex­pect­ed to be com­plet­ed by 2022.

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.