The flu virus (CDC)

Roche tacks on an­oth­er Xofluza in­di­ca­tion as flu sea­son meets pan­dem­ic

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.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Ron Cooper, Albireo CEO

Al­bireo just ad­vanced down to the 10-yard line at the FDA. And Ron Coop­er’s team is get­ting prepped for the next big play

When Albireo Pharma’s board $ALBO moved to bring in Ron Cooper as the CEO more than 5 years ago, the development-stage company went with an experienced commercial player who had a big-time position on his resume after running Bristol Myers’ commercial ops in Europe.

Now, after successfully navigating a pivotal study, putting them in a foot race with a rival toward an FDA OK, Cooper is getting a boost from regulators on the last drive back to an arena he understands completely.

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Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

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.

Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

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.

Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

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.