Mer­ck’s block­buster can­cer treat­ment Keytru­da has been hand­ed an­oth­er in­di­ca­tion by the FDA.

The US reg­u­la­tor an­nounced on Thurs­day that it has ap­proved Keytru­da to serve as an ad­ju­vant treat­ment for non-small cell lung can­cer (NSCLC), which is its fifth in­di­ca­tion in NSCLC and 34th in­di­ca­tion over­all.

Ac­cord­ing to a Mer­ck re­lease, the ap­proval is based on da­ta from a Phase III tri­al, dubbed Keynote-091, which mea­sured dis­ease-free sur­vival in pa­tients who re­ceived chemother­a­py fol­low­ing surgery. The da­ta from Mer­ck dis­played that Keytru­da cut down on the risk of dis­ease re­cur­rence or death by 27% ver­sus place­bo.

The FDA stat­ed that ad­verse re­ac­tions were about the same be­tween the drug and con­trol arms, with cas­es of hy­pothy­roidism and pneu­moni­tis be­ing re­port­ed. There were two fa­tal re­ac­tions of my­ocardi­tis re­port­ed in the tri­al as well.

“With this ap­proval, KEYTRU­DA of­fers a new, im­por­tant im­munother­a­py treat­ment op­tion for stage IB (T2a ≥4 cm), II, or II­IA pa­tients with non-small cell lung can­cer fol­low­ing surgery and ad­ju­vant chemother­a­py. This pro­vides, for the first time, an ad­ju­vant im­munother­a­py treat­ment op­tion for non-small cell lung can­cer pa­tients with stage IB dis­ease and re­gard­less of PD-L1 ex­pres­sion,” Mer­ck said in an email to End­points News.

Keytru­da is not stop­ping there as, ac­cord­ing to Mer­ck’s email to End­points, the drug has been ac­cept­ed for pri­or­i­ty re­view in com­bi­na­tion with Pad­cev for treat­ing pa­tients with ad­vanced or metasta­t­ic urothe­lial can­cer who are not el­i­gi­ble for re­ceiv­ing chemo. The PDU­FA date for that is set for April 21.

The good news has kept rolling in for Mer­ck’s top sell­er. To­ward the end of 2022, the an­ti-PD-1 an­ti­body had a less-fre­quent dos­ing reg­i­men, pre­vi­ous­ly cleared by the FDA un­der ac­cel­er­at­ed ap­proval, con­vert­ed in­to full ap­proval. That ac­cel­er­at­ed ap­proval al­lowed for the dos­ing of pa­tients once every six weeks with 400 mg of the drug as op­posed to 200 mg every three weeks.

On the sales front, Keytru­da sales grew to $5.4 bil­lion on Mer­ck’s Q3 re­port, but a pre­view re­port from Eval­u­ate showed that Keytru­da sales are ex­pect­ed to add al­most $3 bil­lion. This is on top of the $20.89 bil­lion in 2022 sales.

Ed­i­tor’s Note: An ear­li­er ver­sion of this sto­ry stat­ed that Keytru­da has 33 in­di­ca­tions. The ar­ti­cle has been cor­rect­ed to note that the lat­est in­di­ca­tion brings the to­tal to 34.

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Thermo Fisher Scientific is putting down more roots in the Bay Area.

The manufacturer opened the doors to a new cell therapy manufacturing facility next to the University of California-San Francisco Medical Center’s Mission Bay campus and on the university’s campus.

UCSF and Thermo Fisher have had a partnership since 2021, with the new site focusing on manufacturing cell therapeutics for certain cancers, including glioblastoma and multiple myeloma. The new site plans to use Thermo Fisher’s expertise in manufacturing services to help UCSF accelerate the development of cell therapies and eventually get them into the clinic, said Dan Herring, the general manager of cell therapy services at Thermo Fisher, in an interview with Endpoints News.

Dallas-based biotech Nanoscope Therapeutics unveiled Phase II results on its gene therapy for a rare eye disease Thursday morning.

In the RESTORE trial, 18 patients with retinitis pigmentosa got a gene therapy called MCO-010 while nine got placebo. On a vision test called the MLYMT, the treatment group had a one-point greater change over one year in their score compared to the placebo group, the primary endpoint of the study. However, the 95% confidence interval was 0.0 to 3.0, meaning the result was not statistically significant. The p-value was not provided.

When Vigil Neuroscience filed its IPO papers in late 2021, the biotech revealed that the FDA had just cleared its Phase I trial — but with a partial clinical hold that limited dosing to under a certain level.

More than a year later, the FDA has lifted the hold.

Vigil is now free to dose VGL101, an antibody targeting TREM2, at levels higher than 20 mg/kg in its ongoing and future clinical trials in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), an inherited condition that affects the brain and spinal cord.

Catalent will be manufacturing a low-cost version of the opioid overdose treatment naloxone as part of a contract with Harm Reduction Therapeutics.

Catalent plans to manufacture the treatment at its facility in Morrisville, NC. No financial details on the deal were disclosed.

Harm Reduction was granted priority review status for the NDA on its spray last year. The company has been working on a naloxone product since 2017. It is anticipating approval in July of this year and a US launch in early 2024.

Last year, South African-based vaccine manufacturer Aspen Pharmacare was facing reports that it had not received a single order for its manufactured Covid-19 shots and that manufacturing lines were sitting idle. But now the vaccine producer is looking to turn things around.

Aspen’s disclosure of its financial results in March unveiled that manufacturing revenue had decreased by 12% to R 603 million ($33.8 million), which Lorraine Hill, Aspen Group’s COO, said is attributable to lower Covid vaccine sales.