Adar Poonawalla, Serum Institute of India CEO (Dhiraj Singh/Bloomberg via Getty Images)

Covid-19 roundup: Serum In­sti­tute eyes Africa for glob­al ex­pan­sion — re­port; Jun­shi an­tivi­ral hits pri­ma­ry end­point in late-stage tri­al

Af­ter Serum In­sti­tute CEO Adar Poon­awal­la an­nounced last month that the world’s largest vac­cine mak­er stopped pro­duc­ing dos­es of Covid-19 vac­cines back in De­cem­ber, the in­sti­tute is look­ing to ex­pand.

The CEO told Reuters Mon­day that the com­pa­ny is con­sid­er­ing es­tab­lish­ing its first man­u­fac­tur­ing plant in Africa in its next step to­ward glob­al ex­pan­sion af­ter suc­cess­ful­ly mass pro­duc­ing and sell­ing hun­dreds of mil­lions of Covid-19 vac­cine dos­es out of its In­dia-based fa­cil­i­ties.

Reuters not­ed that Africa was the on­ly con­ti­nent that did not have its own man­u­fac­tur­ing ca­pa­bil­i­ties for COVID shots, and Poon­awal­la did not act shy about his am­bi­tions for the vac­cine mak­er.

“It’s nev­er been a bet­ter time to be a vac­cine man­u­fac­tur­er. I’m look­ing at ex­pand­ing our man­u­fac­tur­ing across the globe,” Poon­awal­la said in an in­ter­view at the World Eco­nom­ic Fo­rum in Davos, adding, “There are some great coun­tries out there: South Africa, Rwan­da, you know, to name a few that we’re look­ing at.”

Poon­awal­la said he was meet­ing some African of­fi­cials while in Davos to dis­cuss his plans. And when asked about pos­si­ble in­vest­ments, Poon­awal­la said a project like this would typ­i­cal­ly re­quire at least a ball­park fig­ure of $300 mil­lion.

Poon­awal­la’s plans put him in di­rect com­pe­ti­tion with Mod­er­na, which has al­so been look­ing at es­tab­lish­ing its own vac­cine man­u­fac­tur­ing site in Africa. Mod­ern en­tered a mem­o­ran­dum of un­der­stand­ing with the Kenyan gov­ern­ment ear­li­er this year for its first man­u­fac­tur­ing fa­cil­i­ty on the con­ti­nent.

Jun­shi, Vigonvi­ta’s Covid-19 drug hits pri­ma­ry end­point in PhI­II tri­al

Jun­shi Bio­sciences has been work­ing on co-de­vel­op­ing an oral Covid-19 drug along­side Chi­nese biotech Vigonvi­ta Life Sci­ences— and as of this week, the drug met the pri­ma­ry end­point in a reg­is­tra­tion tri­al.

The biotech an­nounced that the oral nu­cle­o­side ana­log can­di­date, called VV116, reached the pri­ma­ry end­point of “time to sus­tained clin­i­cal re­cov­ery”  in a head-to-head bat­tle with Pfiz­er’s Paxlovid pill for “ear­ly treat­ment of mild to mod­er­ate Covid-19.”

Jun­shi al­so added that it will com­mu­ni­cate with a reg­u­la­to­ry au­thor­i­ty re­gard­ing an NDA sub­mis­sion “soon” be­cause of the read­out — but no oth­er de­tails on tim­ing were pro­vid­ed.

The col­lab­o­ra­tion be­tween Jun­Top Bio­sciences — a Jun­shi sub­sidiary — and Vigonvi­ta start­ed back in Sep­tem­ber, when they signed a de­vel­op­ment agree­ment to joint­ly work on both clin­i­cal de­vel­op­ment and com­mer­cial­iza­tion.

The “co­op­er­a­tion ter­ri­to­ry” that the two biotechs agreed to is the whole world, ex­clud­ing 31 coun­tries, such as 19 in the Mid­dle East, and Rus­sia.

Ac­cord­ing to Jun­shi, sev­er­al clin­i­cal stud­ies for pa­tients with mild to mod­er­ate and mod­er­ate to se­vere Covid-19 are in progress, and some oth­er mul­ti-cen­ter, in­ter­na­tion­al Phase III tri­als will be un­der­way. If those in­ter­na­tion­al tri­als pan out, it could be the in-road to nab ap­proval in coun­tries such as the US, as the FDA has put its foot down on Chi­na-on­ly da­ta for can­cer drugs, al­though it re­mains un­known if that new pol­i­cy ex­tends to Covid-19 too.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

One of Sanofi CEO Paul Hudson’s top picks in the pipeline — picked up in a $3.7 billion buyout 2 years ago — has just been sidelined in the US by a safety issue.

The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.

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Phar­ma re­acts to post-Roe; Drug­mak­ers beef up cy­ber de­fense; Boehringer, Roche qui­et­ly axe drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As a reminder, we are off on Monday for the Fourth of July. I hope this recap will kick off your (long) weekend well and that the rest of it will be just what you need. See you next week for a shortened edition!

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Eric Hughes, incoming Teva EVP of global R&D and CMO

Te­va chief raids Ver­tex for his new glob­al head of re­search and de­vel­op­ment

Teva CEO Kåre Schultz has found his new R&D chief and CMO in Vertex’s ranks.

The global generics giant, which has some 3,500 staffers in the R&D group, has named Eric Hughes to the top research spot in the company. He’ll be replacing Hafrun Fridriksdottir, who held the role for close to five years, on Aug. 1.

Hughes hasn’t been at Vertex for long, though. He jumped from Novartis less than a year ago, after heading the immunology, hepatology & dermatology global development unit. Before that, he completed a five-year stint as head of early clinical research for the specialty discovery medicine department in the exploratory clinical & translational research group at Bristol Myers Squibb, according to his LinkedIn profile.

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#BIO22: Man­ag­ing a biotech in tur­bu­lent times. 'There's a per­fect shit­show out there'

On Tuesday, June 14, Endpoints News EIC John Carroll sat down with a group of biotech execs to discuss the bear market for industry stocks and how they were dealing with it. Here’s the conversation, which has been lightly edited for brevity.

Martin Meeson, sponsor opening:

Thank you, John. Hello everyone. My name’s Martin Meeson, I’m the CEO of Fujifilm Diosynth. For those of you who don’t know Fujifilm Diosynth, we operate in the development of clinical and commercial product scale up, we have facilities in Europe and the US, and around about 4,000 employees. We run on average about 150 programs, so when it comes to managing in turbulent times over the last two years, we’ve had quite a lot of experience of that. Not just keeping the clinical pipelines and the commercial pipelines open, but also our response to the pandemic and the molecules that we’ve had within there. One of the phrases that I coined probably about a year ago when we were talking at JP Morgan, was I talked about managing through turbulent times. Well, it’s become the fact that we are not managing and leading through these times, we are managing in them, which is why that’s really the purpose of and the topic that we’ve got today.

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Albert Bourla (Photo by JOHN THYS/POOL/AFP via Getty Images)

As boost­er sea­son awaits, US re-ups sup­ply of Pfiz­er Covid-19 vac­cine with new $3.2B deal

The US government said late Wednesday that it will pay Pfizer and its partner BioNTech $3.2 billion upon receipt of the first 105 million Covid-19 vaccine doses, potentially the new Omicron-adapted boosters pending EUA.

Under this agreement, the US government also has the option to purchase up to 195 million additional doses, bringing the total number of potential new doses to 300 million. The US has now spent almost $15 billion on Pfizer’s Covid-19 vaccine.

Amgen's taking social media followers around the globe as it introduces the many different

From Tam­pa to Mu­nich, Am­gen’s ‘Places’ cam­paign in­tro­duces its lo­ca­tions around the world

Amgen is taking social media followers around the world with its latest corporate campaign. Called “Places of Amgen,” the twice monthly posts highlight the biopharma’s different offices and sites – and the people who work there.

Each post runs on LinkedIn, Facebook and Instagram with details about the work Amgen does in that location, when it was established, comments from people who work there and other interesting facts. The most recent one about Paris, France, for example, notes that Amgen France last year signed a French association charter committed to the inclusion of LBGT+ people in the workplace.

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On Friday, Lonza announced plans to construct a large-scale commercial drug product fill and finish facility in the town of Stein, Switzerland.

Lon­za to in­vest $500M+ on fill-fin­ish fa­cil­i­ty on its home turf

Lonza has been expanding its reach across the globe, bringing sites in China and the US online this year, but now they are looking closer to home for their next major investment.

The Swiss manufacturer on Friday announced plans to construct a large-scale commercial drug fill and finish facility in the town of Stein, Switzerland. The new facility will be delivered through an investment of approximately CHF 500 million, or $519 million, and is expected to be completed in 2026. The facility will also be constructed on the same campus as Lonza’s current clinical drug product facility.

Credit: Shutterstock

Bio­haven takes mi­graine cam­paign to pa­tients' Twit­ter feeds, months ahead of Pfiz­er takeover

Two weeks ago, Biohaven hit an all-time high in weekly Nurtec prescriptions. CEO Vlad Coric attributes at least some of that success to a new interactive Twitter campaign that encourages patients to free their feed of potential migraine triggers.

Earlier this month, Biohaven in partnership with Twitter launched the #RelieveYourFeed campaign that allows users to customize their app settings based on their migraine triggers.

Oncologists on Twitter are talking up ASCO studies, health equity and burnout, according to new deep dive research from Harris Poll (via Shutterstock)

What’s been on in­flu­en­tial on­col­o­gist­s' minds? Most­ly AS­CO, but al­so health eq­ui­ty, ac­cord­ing to new Har­ris Poll re­search

Over the past few months, oncologists have been talking a lot about the ASCO conference. Not surprising considering its import and the study data presented, but what may be less expected is the second most talked about topic of health equity.

That’s according to data from The Harris Poll and the new expert network the researcher is building out. While the company has been doing deep data dives into specific health issues or conditions for pharma clients, it’s now monitoring influencer networks of therapy area specialists to find out what experts are really thinking about.