The gener­ics pro­duc­er Glen­mark Phar­ma­ceu­ti­cals has been hand­ed a warn­ing let­ter by US reg­u­la­tors.

The let­ter, which was sent to the man­u­fac­tur­er on Nov. 22, not­ed is­sues from an in­spec­tion over the sum­mer at Glen­mark’s fa­cil­i­ty in the town of Colvale, In­dia, in the state of Goa.

Ac­cord­ing to the let­ter, the FDA found that Glen­mark’s in­ves­ti­ga­tion of re­ject­ed batch­es of drugs “failed to ex­tend to oth­er batch­es, dosage strengths, and drug prod­ucts.” The warn­ing let­ter al­so not­ed that the site had failed to es­tab­lish “ad­e­quate writ­ten pro­ce­dures” for pro­duc­tion and process con­trol to en­sure drugs have the cor­rect strength, qual­i­ty and pu­ri­ty.

Glen­mark al­so lacked “ap­pro­pri­ate pro­ce­dures” for re­view­ing “chro­mato­graph­ic da­ta pro­cess­ing,” and was found to have in­com­plete batch records, with batch-spe­cif­ic da­ta left out, ac­cord­ing to the FDA.

The let­ter states:

There were two in­ves­ti­ga­tions where non-con­form­ing tablets were found and did not meet the hard­ness spec­i­fi­ca­tions. In each of the in­ves­ti­ga­tions the im­pact as­sess­ment con­clud­ed that since the au­to­mat­ic weight con­trol or com­paction force con­trol was turned on, the risk of find­ing tablets that did not meet spec­i­fi­ca­tion was low. How­ev­er, the in­ves­ti­ga­tions did not de­ter­mine if the re­jec­tion lim­its were set ap­pro­pri­ate­ly. There was a lack of as­sur­ance to en­sure the com­pres­sion ma­chine was cor­rect­ly re­ject­ing tablets that did not meet spec­i­fi­ca­tions.

Glen­mark has 15 days to re­spond to the let­ter. End­points News reached out to Glen­mark for fur­ther com­ment but did not re­ceive a re­sponse by press time.

Glen­mark is not the on­ly man­u­fac­tur­er un­der pres­sure from the FDA in Goa. Lupin was hand­ed a let­ter in the sum­mer for a lack of clean­li­ness at a fac­to­ry in the In­di­an state. A Cipla fa­cil­i­ty was al­so giv­en a 483 re­port in Sep­tem­ber for QC is­sues and clean­li­ness.

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 hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

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.