French vac­cine com­pa­ny Val­ne­va and Ger­man CD­MO IDT Bi­ologi­ka have de­cid­ed to ter­mi­nate their man­u­fac­tur­ing col­lab­o­ra­tion for Val­ne­va’s Covid-19 vac­cine.

IDT Bi­ologi­ka was orig­i­nal­ly tasked with mak­ing Val­ne­va’s VLA2001 vac­cine, but the deal has been halt­ed due to “the de­liv­ery of in­ac­ti­vat­ed Covid-19 bulk vac­cine to Val­ne­va.” A state­ment from Val­ne­va al­so lists a lack of or­ders and suf­fi­cient in­ven­to­ry as the oth­er rea­sons.

With the man­u­fac­tur­ing of the vac­cine sus­pend­ed, Val­ne­va will pay €36.2 mil­lion ($35.8 mil­lion) to IDT in com­pen­sa­tion along with €4.5 mil­lion ($4.4 mil­lion) for pur­chas­ing spe­cial­ized equip­ment.

Val­ne­va will con­tin­ue to de­liv­er dos­es of the vac­cine to EU mem­ber states that had al­ready or­dered it and will keep in­ven­to­ry on hand in case of any uptick in de­mand. Val­ne­va al­so said that it is reach­ing out to dif­fer­ent na­tions across the world to ship its re­main­ing eight to 10 mil­lion dos­es over the next year.

The com­pa­ny had ini­tial­ly signed a pur­chas­ing agree­ment with the EU last year to sup­ply 60 mil­lion dos­es. In the sum­mer, how­ev­er, the EU changed its pur­chase to around 1.25 mil­lion dos­es.

Pen­ny stock biotech’s Phase II/III tri­al for ear­ly Covid-19 in­fec­tion fails to reach pri­ma­ry end­point

Well in­to the pen­ny stock zone, Adamis Phar­ma­ceu­ti­cals has hit a ma­jor road­block for its Covid-19 treat­ment.

The San Diego biotech an­nounced Wednes­day its Phase II/III clin­i­cal tri­al eval­u­at­ing the risk of us­ing Tem­pol in high-risk pa­tients with an ear­ly Covid-19 in­fec­tion had failed to hit the pri­ma­ry end­point of “sus­tained clin­i­cal res­o­lu­tion” by day 14.

The Da­ta Safe­ty Mon­i­tor­ing Board (DSMB) al­so rec­om­mend­ed that the tri­al be shut down due to a lack of ef­fi­ca­cy. While Adamis em­pha­sized that no safe­ty con­cerns were raised, it will put a hold on the tri­al and fig­ure out Tem­pol’s next move. Ac­cord­ing to Clin­i­cal­Tri­als.gov, 248 pa­tients par­tic­i­pat­ed in the tri­al.

“We are ob­vi­ous­ly dis­ap­point­ed that the study did not meet its end­points. Much of the pre­clin­i­cal work on Tem­pol for COVID-19 ex­am­ined the ef­fects of the drug on se­vere ill­ness. This tri­al did not meet its pri­ma­ry end­point, but we are ex­plor­ing the pos­si­bil­i­ty that vac­ci­na­tions and the less vir­u­lent vari­ants (Omi­cron) dur­ing the tri­al pe­ri­od may have ob­scured an ef­fect of Tem­pol,” said Adamis CMO Ron Moss in a state­ment.

In­vestors will not be hap­py as the com­pa­ny’s stock price has al­ready dropped even fur­ther in­to the pen­ny stock neb­u­la, where it has been since 2019. The price $ADMP has dropped 44% since Wednes­day’s mar­ket open­ing to $.20, mark­ing an 80% drop since Sep­tem­ber last year.

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 FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

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.