Japan­ese phar­ma Sh­iono­gi’s Covid-19 an­tivi­ral against Omi­cron passed its Phase III tri­al in Asia, meet­ing its pri­ma­ry end­point.

The drug, a pro­tease in­hibitor known as en­sitrelvir, was ad­min­is­tered dai­ly for five days and led to a sig­nif­i­cant re­duc­tion in symp­toms such as stuffy or run­ny nose, sore throat, cough, feel­ing hot or fever­ish, and low en­er­gy or tired­ness with­in 72 hours of its on­set, the com­pa­ny an­nounced Wednes­day. A to­tal of 1,821 most­ly vac­ci­nat­ed pa­tients from Japan, South Ko­rea and Viet­nam were en­rolled in the study.

The me­di­an time for pa­tients to ex­pe­ri­ence re­lief in five Covid-19 symp­toms was sig­nif­i­cant­ly re­duced in the co­hort that was treat­ed with the low dose of en­sitrelvir (the dose lev­el sub­mit­ted for ap­proval in Japan) com­pared to place­bo: 167.9 hours ver­sus 192.2. No sig­nif­i­cant ad­verse ef­fects were not­ed, the com­pa­ny said.

Mean­while, the study al­so hit its sec­ondary end­point — re­duc­tion in vi­ral RNA on day 4 — fol­low­ing the third dose.

The com­pa­ny has sub­mit­ted the topline re­sults of the Phase III tri­al to Japan­ese drug reg­u­la­tors for re­view. Pre­vi­ous­ly, the reg­u­la­to­ry au­thor­i­ties in Japan de­nied emer­gency ap­proval for use of the pill, and asked for more da­ta on its ef­fec­tive­ness, Reuters re­port­ed.

If ap­proved, Sh­iono­gi’s drug could face stiff com­pe­ti­tion with Covid-19 pills from Pfiz­er and Mer­ck’s Covid-19 an­tivi­rals that have al­ready been ap­proved in Japan and in oth­er coun­tries.

Ocu­gen en­ters a deal to com­mer­cial­ize a ‘uni­ver­sal’ in­tranasal covid vac­cine

Penn­syl­va­nia-based Ocu­gen wants to com­mer­cial­ize an in­tranasal­ly de­liv­ered Covid-19 vac­cine in the US, Eu­rope, and Japan.

The com­pa­ny has en­tered a li­cens­ing deal with Wash­ing­ton Uni­ver­si­ty in St. Louis, which de­vel­oped the vac­cine along with In­di­an phar­ma­ceu­ti­cal Bharat Biotech. Ocu­gen claims that the in­tranasal shot could be ef­fec­tive against all vari­ants of Covid-19. This vac­cine is al­ready au­tho­rized for emer­gency use in In­dia, the com­pa­ny said.

“As the ef­fort to end the pan­dem­ic fo­cus­es on ef­fec­tive boost­er op­tions, Ocu­gen is ex­cit­ed about the po­ten­tial for this vac­cine to be a uni­ver­sal boost­er, re­gard­less of pre­vi­ous COVID-19 vac­ci­na­tion his­to­ry,” the com­pa­ny added in a press re­lease.

The vac­cine con­tains spike pro­tein of the SARS-CoV-2 virus, pack­aged in an ade­n­ovirus vec­tor.

Ac­cord­ing to the com­pa­ny, de­liv­er­ing the vac­cine through the nasal route cre­ates strong im­mu­ni­ty against the virus in the nose, mouth, up­per air­ways and lungs, where the virus tends to in­fect the most.

“Be­cause the vac­cine can be de­liv­ered di­rect­ly in­to the nose, it is specif­i­cal­ly de­signed to block in­fec­tion at the por­tal of virus en­try, and we be­lieve it may help pre­vent trans­mis­sion as well as pro­vide pro­tec­tion against new COVID-19 vari­ants,” said Michael Di­a­mond, in­ven­tor of the nasal vac­cine tech­nol­o­gy.

Re­vive’s Covid pill finds a stop sign at the FDA’s doorsteps

Re­vive Ther­a­peu­tics has hit a hilly road with its oral Covid-19 drug.

The FDA has re­ject­ed the pri­ma­ry end­point for the Phase III study of the com­pa­ny’s an­tivi­ral drug bu­cil­lamine. Re­vive is cur­rent­ly study­ing the drug’s an­ti-in­flam­ma­to­ry and an­tivi­ral prop­er­ties in pa­tients with mild to mod­er­ate Covid-19.

Reg­u­la­tors, how­ev­er, have asked the com­pa­ny to sub­mit a meet­ing re­quest to dis­cuss the “ap­pro­pri­ate end­points and jus­ti­fi­ca­tion of the rel­e­vance of the re­vised pri­ma­ry end­point,” the com­pa­ny said in a press re­lease.

Mean­while, the com­pa­ny has de­cid­ed to con­tin­ue with and re­view post-dose se­lec­tion da­ta in around 500 pa­tients.

“Re­gard­less of the out­come, the Com­pa­ny would pro­ceed to seek a meet­ing with the FDA to agree on a pro­posed plan for po­ten­tial reg­u­la­to­ry ap­proval,” Re­vive said in a press state­ment.

Dupixent, the blockbuster anti-inflammatory drug from Sanofi and Regeneron, has cleared a high-stakes Phase III study in chronic obstructive pulmonary disease, the companies announced Thursday morning.

If they hold up in a second, identical trial, the data pave the way for Dupixent to become the first biologic to treat patients whose COPD remains uncontrolled despite being on maximal standard-of-care inhaled therapy — the patient population studied in the pivotal program. The companies had spotlighted this as a key readout as they look to expand the Dupixent franchise and explore its full potential.

Moderna CEO Stéphane Bancel faced a barrage of questions from the Senate health committee on Wednesday but emerged mostly unscathed as he defended the quadrupling of the price of the company’s blockbuster Covid-19 vaccine in the US, from about $26 per dose to $130 per dose.

What’s behind that rise in price, many senators on both sides of the aisle questioned, and Bancel offered a variety of reasons. First and foremost, the company is expecting a 90% reduction in demand for its vaccine next fall, when the FDA is likely to roll out another booster campaign to fight Covid-19.

Incyte touted an accelerated approval for its PD-1 retifanlimab in a rare skin cancer on Wednesday, roughly a year and a half after the drug suffered a rejection in squamous cell carcinoma of the anal canal (SCAC).

Retifanlimab, marketed as Zynyz, was approved for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), a fast-growing skin cancer typically characterized by a single, painless nodule. It’s roughly 40 times rarer than melanoma, according to the nonprofit Skin Cancer Foundation — but incidence is growing, particularly among older adults, Incyte said in its announcement.