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.

The deal al­so in­clud­ed a $4 con­tin­gent-val­ue right (CVR) based on one of the AAV9 gene ther­a­pies re­ceiv­ing ap­proval in one of the US, UK, Japan, France, Ger­many, Italy or Spain by the end of 2024. If that dead­line isn’t met, the val­ue of the CVR would drop by 8.3 cents each month be­fore even­tu­al­ly ex­pir­ing by the end of 2028.

It was Lil­ly’s sec­ond big M&A move in the last three months of 2020 af­ter the phar­ma picked up Dis­arm Ther­a­peu­tics and its SARM1 in­hibitors in Oc­to­ber for $135 mil­lion in cash, plus up to $1.225 bil­lion in mile­stones.

El­zon­ris tacks on ap­proval in Eu­rope for adult pa­tients

A lit­tle over two years af­ter re­ceiv­ing FDA ap­proval, El­zon­ris is now ap­proved to use in Eu­rope.

The Eu­ro­pean Com­mis­sion for­mal­ly OK’ed the drug late Thurs­day night, mak­ing it the first CD-123 ther­a­py ap­proved on the con­ti­nent. In Eu­rope, El­zon­ris is in­di­cat­ed as a monother­a­py for the first-line treat­ment of adults with blas­tic plas­ma­cy­toid den­drit­ic cell neo­plasm.

US reg­u­la­tors green­lit the drug back in Oc­to­ber 2018, and El­zon­ris is avail­able for Amer­i­cans aged two and old­er.

Stem­line Ther­a­peu­tics de­vel­oped the drug, but the com­pa­ny is now a part of Ital­ian phar­ma­ceu­ti­cal com­pa­ny The Menar­i­ni Group. Stem­line in­vit­ed con­tro­ver­sy while the drug was still in clin­i­cal tri­als, fail­ing to tip in­vestors off about a pa­tient death in the piv­otal study.

The FDA nonethe­less waved the drug through on a small set of da­ta. El­zon­ris’ OK came af­ter it post­ed wide­ly vary­ing re­sults from two drug co­horts in a tiny sin­gle-arm study.

Hu­mani­gen signs deal to use BAR­DA man­u­fac­tur­ing sites for lenzilum­ab in Covid-19

Hu­mani­gen, a for­mer com­pa­ny of “Phar­ma Bro” Mar­tin Shkre­li, has been de­vel­op­ing its lenzilum­ab can­di­date in con­junc­tion with the De­part­ment of De­fense for Covid-19 since No­vem­ber 2020. Now, the com­pa­ny has ac­cess to new man­u­fac­tur­ing sites.

Hu­mani­gen’s deal with CRA­DA is now co-signed by BAR­DA, al­low­ing the com­pa­ny to pro­duce the ex­per­i­men­tal drug with BAR­DA’s sites. Lenzilum­ab is cur­rent­ly in a Phase III tri­al for Covid-19 and Hu­mani­gen is ex­pect­ed to seek an EUA in the near fu­ture.

Should the can­di­date work as planned, it will pre­vent and treat the cy­tokine storms as­so­ci­at­ed with Covid-19. In Oc­to­ber, the mon­o­clon­al an­ti­body was al­so tapped by the NI­AID to par­tic­i­pate in the AC­TIV-5 Big Ef­fect Tri­al, eval­u­at­ing its ef­fi­ca­cy in com­bi­na­tion with Gilead’s Vek­lury.

Four years ago, when Arena CEO Amit Munshi cut its ties to a troubled weight drug and doubled down on the pipeline, a cannabinoid receptor 2 agonist figured prominently in the biotech’s future. On Tuesday evening, however, Munshi’s high hopes for the drug took a nasty hit after it failed a Phase IIb study for patients with irritable bowel syndrome pain.

Put through a randomized pace with 273 patients, researchers said it flat failed the primary endpoint among the large group with abdominal pain. But they quickly went on to highlight subgroup data, always a tricky and controversial ploy, where they spotlighted a positive p value for patients with moderate to severe pain who received the high dose of the drug — one of 3 provided in the study.

Mesoblast faced rough waters in 2020, but on Monday were thrown a financial lifeline.

The Australian stem cell therapy player has raised $110 million in a private placement, the company announced, offering 60 million shares to the US investor group SurgCenter Development. SurgCenter received the shares at a 6.5% discount from Mesoblast’s closing price on Feb. 25.

Mesoblast plans to use the funds to boost supply of its lead candidate remestemcel-L ahead of what they hope is a potential approval in pediatric GvHD when they return to the FDA, as well as advancing manufacturing and development of their rexlemestrocel-L platform for chronic heart failure and chronic low back pain.

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.