Mer­ck is seek­ing a reeval­u­a­tion of the Eu­ro­pean Med­i­cines Agency’s (EMA) re­jec­tion of the phar­ma’s block­buster Covid-19 pill, known as Lagevrio (mol­nupi­ravir), which has served as a sec­ond op­tion to Pfiz­er’s Paxlovid (nir­ma­trelvir/ri­ton­avir).

The EMA an­nounced its long-await­ed re­jec­tion in late Feb­ru­ary, say­ing pub­licly:

Based on the to­tal­i­ty of da­ta, it was not pos­si­ble to con­clude that Lagevrio can re­duce the risk of hos­pi­tal­i­sa­tion or death or short­en the du­ra­tion of ill­ness or time to re­cov­ery in adults at risk of se­vere dis­ease. Fur­ther­more, it was not pos­si­ble to iden­ti­fy a spe­cif­ic group of pa­tients in whom a clin­i­cal­ly rel­e­vant ben­e­fit of Lagevrio could be demon­strat­ed.

In the US, Mer­ck’s Covid drug has been avail­able un­der emer­gency use au­tho­riza­tion since Dec. 2021, with the US re­port­ing more than 1.2 mil­lion cours­es of the drug ad­min­is­tered so far and an­oth­er 1.7 mil­lion cours­es have been de­liv­ered to states.

The FDA in late Feb­ru­ary, ac­cord­ing to a re­view memo, took an­oth­er look at Lagevrio’s EUA af­ter Michael Lin, Stan­ford Uni­ver­si­ty as­so­ciate pro­fes­sor, re­quest­ed a re-re­view fol­low­ing the re­lease of a preprint ar­ti­cle un­cov­er­ing “a sig­na­ture of mol­nupi­ravir mu­ta­ge­n­e­sis” that can be seen “in glob­al se­quenc­ing data­bas­es, in some cas­es with on­wards trans­mis­sion.”

Mol­nupi­ravir hype: use­ful an­tivi­ral drug, won't cre­ate vi­able vi­ral mu­tants

Mol­nupi­ravir re­al­i­ty: use­less an­tivi­ral drug, cre­ates vi­able vi­ral mu­tants@FDACDERDi­rec­tor please re­con­sid­er the EUA, for the sake of pub­lic health

— Michael Lin, MD PhD 🧬 (@michael­zlin) Feb­ru­ary 22, 2023

But the FDA, mean­while, took a look and all but dis­missed the ar­ti­cle, ac­knowl­edg­ing in its re­view memo that while it’s “plau­si­ble that MOV [mol­nupi­ravir] use could con­tribute to mu­ta­tion­al pat­terns in SARS-CoV2 se­quences, there are some un­cer­tain­ties re­gard­ing the au­thors claims and the pub­lic health im­pli­ca­tions of their re­sults that are trans­mis­si­ble re­mains chal­leng­ing to quan­ti­fy.”

Mer­ck al­so not­ed, ac­cord­ing to the memo, that the au­thors of the preprint “as­sume that the ob­served SARS-CoV-2 mu­ta­tions are as­so­ci­at­ed with MOV treat­ment, re­ly­ing on cir­cum­stan­tial as­so­ci­a­tions be­tween vi­ral se­quence ori­gin and time­frame of se­quence col­lec­tion in coun­tries where MOV is avail­able, with no di­rect ev­i­dence that the vi­ral se­quences arose from MOV use.”

In 2022, Mer­ck sold about $5.7 bil­lion of Lagevrio world­wide. And the big bio­phar­ma com­pa­ny pre­dicts an­oth­er $1 bil­lion in sales for this year.

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.

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.

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.

In a first, Merck has secured a full approval for Keytruda in a tumor agnostic setting — as a treatment for any unresectable or metastatic solid tumors that are classified as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).

The FDA granted Keytruda accelerated approval in this indication in 2017, and GSK’s Jemperli followed suit in 2021. But now it’s converted to a full approval for Keytruda. Before prescribing, doctors would have to make sure patients carry this biomarker, using an FDA-approved test.