Chris­t­ian Hogg Chi-Med

→ One of Chi-Med’s late-stage fa­vorites is grad­u­at­ing ear­ly from its Phase III study, hav­ing met its pri­ma­ry end­points at in­ter­im analy­sis. The Hong Kong-head­quar­tered biotech left out the num­bers in its brief state­ment, which not­ed that su­r­u­fa­tinib hit a PFS goal among pa­tients with ex­tra-pan­cre­at­ic neu­roen­docrine tu­mors. CEO Chris­t­ian Hogg has tapped the drug, along­side savoli­tinib, for ap­provals over the next two years to fol­low up on the land­mark OK for fruquin­tinib in Chi­na.

→ Am­gen $AMGN and Al­ler­gan $AGN have nabbed an OK to mar­ket their Her­ceptin copy­cat — chris­tened Kan­jin­ti — in the US for all ap­proved in­di­ca­tions of the Roche block­busters in­clud­ing HER2-over­ex­press­ing breast can­cer and gas­tric or gas­troe­sophageal junc­tion ade­no­car­ci­no­ma. “Kan­jin­ti is the sec­ond of four biosim­i­lars from Am­gen and Al­ler­gan’s col­lab­o­ra­tion to be ap­proved by the FDA,” David Nichol­son, Al­ler­gan’s chief re­search and de­vel­op­ment of­fi­cer, not­ed.

David Nichol­son Al­ler­gan

→ Last year, Sun Phar­ma­ceu­ti­cals en­tered the crowd­ed mar­ket for plaque pso­ri­a­sis with its IL-23 in­hibitor Ilumya. On Fri­day, the In­di­an drug­mak­er said the mon­o­clon­al an­ti­body — in-li­censed from Mer­ck $MRK back in 2014 for $80 mil­lion — cleared a mid-stage study in pa­tients with pso­ri­at­ic arthri­tis. The in­ter­im analy­sis re­vealed that over 71% of pa­tients treat­ed with the drug ex­pe­ri­enced a 20% im­prove­ment in joint and skin symp­toms, meet­ing the pri­ma­ry end­point of the study.

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.