Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Lead­ing the way to in­crease ac­cess to cheap­er drugs world­wide, Pfiz­er said Wednes­day it will pro­vide all cur­rent and fu­ture patent-pro­tect­ed med­i­cines and vac­cines avail­able in the US or EU on a not-for-prof­it ba­sis to about 1.2 bil­lion peo­ple in 45 low­er-in­come coun­tries.

Rwan­da, Ghana, Malawi, Sene­gal and Ugan­da are the first five coun­tries to sign on to this ac­cord, which will al­so seek to blaze new paths for quick and ef­fi­cient reg­u­la­to­ry and pro­cure­ment process­es to re­duce the usu­al de­lays in mak­ing new med­i­cines and vac­cines avail­able in these coun­tries.

“Com­bined with ad­di­tion­al in­vest­ments in strength­en­ing Africa’s pub­lic health sys­tems and phar­ma­ceu­ti­cal reg­u­la­tors, the Ac­cord is an im­por­tant step to­ward sus­tain­able health se­cu­ri­ty for coun­tries at every in­come lev­el,” Pres­i­dent of Rwan­da Pres­i­dent Paul Kagame said in a state­ment.

Pfiz­er says so far it’s com­mit­ted to pro­vid­ing 23 med­i­cines and vac­cines that treat var­i­ous in­fec­tious dis­eases, can­cers, and rare and in­flam­ma­to­ry dis­eases, which col­lec­tive­ly could save about one mil­lion lives each year in these coun­tries, as well as help at least 500,000 more bat­tling chron­ic dis­eases that sig­nif­i­cant­ly im­pact qual­i­ty of life.

The Bill & Melin­da Gates Foun­da­tion is al­so help­ing out, fund­ing Pfiz­er’s work around new vac­cine can­di­dates for the pre­ven­tion of Group B Strep­to­coc­cus, which is a lead­ing cause of still­birth and new­born mor­tal­i­ty in low-in­come coun­tries. The two sides are al­so dis­cussing op­por­tu­ni­ties to sup­port RSV vac­cine de­vel­op­ment, an­oth­er ma­ter­nal vac­cine.

Pfiz­er’s in­ves­ti­ga­tion­al RSV vac­cine can­di­date builds on dis­cov­er­ies made at the NIH, which de­tailed the crys­tal struc­ture of pre­fu­sion F, a key form of the vi­ral fu­sion pro­tein that RSV us­es to at­tack hu­man cells. In March, Pfiz­er’s vac­cine can­di­date re­ceived a break­through des­ig­na­tion from the FDA for the pre­ven­tion of RSV-as­so­ci­at­ed low­er res­pi­ra­to­ry tract dis­ease in in­fants from birth up to six months of age by ac­tive im­mu­niza­tion of preg­nant women.

Pfiz­er CEO Al­bert Bourla told the Fi­nan­cial Times in an in­ter­view at the World Eco­nom­ic Fo­rum in Davos, Switzer­land that this ac­cord is not linked to Pfiz­er’s op­po­si­tion to a pro­pos­al at the WTO to pro­vide patent flex­i­bil­i­ties around Covid-19 vac­cines.

“I don’t con­nect the two at all. Frankly, I think it is some­thing that is the right thing to do,” Bourla said.

Mean­while, on the Covid-19 front, he said he’s wor­ried about the com­pla­cen­cy world­wide, warn­ing that con­se­quences could be seen in three to six months.

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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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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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.

No­var­tis to re­sume the pro­duc­tion of two ra­di­oli­gand ther­a­pies af­ter re­solv­ing qual­i­ty is­sues

Earlier this year, Novartis touted its radioligand as a major piece to counter competition in the cancer space. However, the physical production of its products has had anything but a smooth ride.

In May, Novartis had to suspend production of Lutathera and Pluvicto, its two primary radiotherapies. According to the company, this was done out of an abundance of caution as a result of potential quality issues identified in its manufacturing. The production suspension impacts the commercial and clinical trial supply of the products.

Roche, Pfiz­er top list of ESG lead­ers in pa­tient group­s' view, but many still think phar­mas can do bet­ter

The rise of pharma environmental, social and governance (ESG) efforts in the past two years has been meteoric as investors turn their attention to sustainable funding. However, investors aren’t the only ones watching. Patients are beginning to tune into pharmas’ ESG promises too.

Patient advocacy groups familiar with ESG regard it as an important issue and want to be included in helping pharma companies set ESG policies and targets, according to a new report from PatientView. That’s quite different from what the investment community wants across a variety of Gartner’s defined financial, competitive, strategic and perception goals.