→ Af­ter kick­ing off a Phase III tri­al test­ing its NM­DA drug in sui­ci­dal bipo­lar de­pres­sion, Neu­roRx has se­cured ac­cess to around $95 mil­lion (HKD$750 mil­lion) to com­plete the pro­gram and fund the man­u­fac­tur­ing ac­tiv­i­ties. New York-based GEM Glob­al Yield has com­mit­ted to pro­vide the cap­i­tal — through pur­chas­ing shares — once Neu­roRx gets list­ed on a pub­lic mar­ket. The biotech, which was found­ed by bio­phar­ma vet Jonathan Javitt and psy­chi­a­try re­searcher Daniel Javitt (the broth­ers are the CEO and chair­man of the sci­en­tif­ic ad­vi­so­ry board, re­spec­tive­ly), can draw as much or as lit­tle of the agreed amount with­in a 30-month term. The plan is to de­vel­op NRX-101 in both the US, where it has a break­through ther­a­py des­ig­na­tion, and Chi­na.

→ Don­ald Trump is fi­nal­ly as­sem­bling his Pres­i­dent’s Coun­cil of Ad­vi­sors on Sci­ence and Tech­nol­o­gy, al­most two years af­ter the group last met in Jan­u­ary 2017 just be­fore his in­au­gu­ra­tion. There’s one biotech ex­ec­u­tive among the first sev­en out of 16 mem­bers named to the group: Sharon Hrynkow, SVP for Med­ical Af­fairs at Cy­clo Ther­a­peu­tics, who had a back­ground in the NIH. Oth­ers on the com­mit­tee in­clude Cather­ine Bessant, CTO for Bank of Amer­i­ca; Dario Gil, di­rec­tor of IBM Re­search; Fisk John­son III, CEO of clean­ing prod­ucts com­pa­ny SC John­son & Son; At­ti­ganal Sreer­am, se­nior vice pres­i­dent of re­search at Dow; Shane Wall, CTO and head of HP Labs; and UC Berke­ley pro­fes­sor Bir­git­ta Wha­ley.

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.