Xofluza was her­ald­ed as the first new flu drug in 20 years when it got the FDA OK back in 2018. But even so, Roche saw tough com­pe­ti­tion from cheap­er Tam­i­flu gener­ics that ap­peared to be near­ly as — if not just as — ef­fec­tive.

Now, the phar­ma says the drug al­so can be used to pre­vent in­fluen­za af­ter ex­po­sure, snag­ging a new ap­proval and adding to Xofluza’s ap­peal as flu sea­son meets the pan­dem­ic.

“With to­day’s ap­proval, Xofluza is now avail­able as the first sin­gle-dose, post-ex­po­sure pre­ven­tive treat­ment for in­fluen­za,” Genen­tech CMO and head of glob­al prod­uct de­vel­op­ment Levi Gar­raway said in a state­ment.

In the Phase III BLOCK­STONE study con­duct­ed in Japan, Xofluza was eval­u­at­ed against a place­bo as a pre­ven­ta­tive treat­ment for adults and chil­dren over 12 who were liv­ing in the same house­hold as some­one with the flu. Par­tic­i­pants were re­quired to have lived with that flu-in­fect­ed house­hold mem­ber for more than 48 hours be­fore re­ceiv­ing ei­ther the treat­ment or place­bo. And those with the flu had to have an on­set of symp­toms of less than 48 hours. Re­sults showed that 1% of those in the treat­ment arm end­ed up con­tract­ing the flu, com­pared to 13% in the place­bo group, Roche said.

The most com­mon side ef­fects in­clud­ed di­ar­rhea (3%), bron­chi­tis (3%), nau­sea (2%), si­nusi­tis (2%) and headache (1%).

Roche li­censed Xofluza from Sh­iono­gi, which holds the rights in Japan and Tai­wan. Its 2018 ap­proval was much-need­ed for Roche, whose Tam­i­flu was bat­tered by cheap­er gener­ics. Like Tam­i­flu, Xofluza re­duced flu symp­toms, but did not cure the ill­ness. The com­pa­ny tout­ed sin­gle-dose Xofluza’s con­ve­nience com­pared to Tam­i­flu, which re­quires 10 dos­es over 5 days. But with sim­i­lar ef­fi­ca­cy da­ta, some con­sumers opt­ed for the cheap­er price tag on Tam­i­flu gener­ics.

And last year, a study in Na­ture con­firmed that Xofluza was linked to spe­cif­ic mu­ta­tions with re­duced sus­cep­ti­bil­i­ty. “In a worst case sce­nario, these mu­ta­tions could ren­der the drug en­tire­ly use­less,” An­drew Pekosz, a mol­e­c­u­lar bi­ol­o­gist at Johns Hop­kins who was not in­volved in the study, told End­points News last No­vem­ber. “They haven’t yet, and it’s not clear why that’s been the case.”

Last Oc­to­ber, Roche ex­pand­ed Xofluza’s la­bel to in­clude those at high risk of de­vel­op­ing flu-re­lat­ed com­pli­ca­tions. It’s al­so ap­proved in the US and abroad for the treat­ment of in­fluen­za types A and B, and in the US for acute, un­com­pli­cat­ed in­fluen­za in those 12 and old­er.

Next up, Roche is seek­ing po­ten­tial ap­proval for acute un­com­pli­cat­ed in­fluen­za in chil­dren from 1 to 12 years old, and for pre­ven­tion for pa­tients in the same age group who have been ex­posed to in­fluen­za.

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.