FDA be­gins court-man­dat­ed re­lease of thou­sands of pages on Pfiz­er's Covid-19 vac­cine re­view

A court loss for the FDA in a Texas dis­trict court means the agency on Tues­day be­gan to re­lease a mas­sive trove of hun­dreds of thou­sands of doc­u­ments re­lat­ed to its re­view of Pfiz­er’s safe and ef­fec­tive Covid-19 vac­cine.

But what ex­act­ly will be un­cov­ered in each batch of re­leased doc­u­ments is any­one’s guess.

The non­prof­it that won the court case, known as the Pub­lic Health and Med­ical Pro­fes­sion­als for Trans­paren­cy, prompt­ly re­leased the Pfiz­er doc­u­ments on its web­site this week but did not of­fer any sort of or­ga­ni­za­tion or ex­pla­na­tion of what they show.

Some of the doc­u­ments, like one la­beled as a pri­or­i­ty re­view re­quest, in­cludes more than 100 pages worth of anony­mous safe­ty-re­lat­ed ta­bles of da­ta. Or an­oth­er ta­ble of uniden­ti­fied par­tic­i­pants’ gen­der, age and BMI.

Oth­er doc­u­ments are typ­i­cal for any drug or vac­cine ap­pli­ca­tion. For in­stance, one doc­u­ment shows the stan­dard, near­ly $2.9 mil­lion user fee pay­ment to FDA from Pfiz­er. Oth­er doc­u­ments re­leased in­clude the fast track des­ig­na­tion let­ter, which is not typ­i­cal­ly re­leased, the con­fi­den­tial non­clin­i­cal overview for the vac­cine, Pfiz­er’s re­quest for a waiv­er from adding a suf­fix to the vac­cine’s name (al­so not typ­i­cal­ly re­leased), and an­oth­er with a long list of anonymized tri­al sub­jects who didn’t re­ceive the vac­cine as ran­dom­ized.

The sheer vol­ume of pages and doc­u­ment types will give read­ers a good over­all sense of the re­quired doc­u­men­ta­tion nec­es­sary to ap­ply for a drug or vac­cine ap­proval at the FDA. But it’s still un­clear if the doc­u­ments will of­fer any new in­sight in­to the vac­cine’s safe­ty or ef­fi­ca­cy, es­pe­cial­ly giv­en the re­al-world da­ta on the vac­cine that’s al­ready been pub­lished in ma­jor med­ical jour­nals (e.g. Pfiz­er’s vac­cine ef­fec­tive­ness and safe­ty in health care per­son­nel or Is­rael).

An­ti-vax lawyer Aaron Siri, a man­ag­ing part­ner of the firm Siri & Glim­stad who rep­re­sent­ed the non­prof­it, told End­points News, “Our job was to get the doc­u­ments. We leave it to the sci­en­tists and oth­ers to an­a­lyze.”

Pre­vi­ous­ly Siri wrote on his Sub­stack that what drove this suit was that the gov­ern­ment “want­ed to hide the da­ta by wait­ing to ful­ly pro­duce what it re­lied up­on to li­cense this prod­uct un­til al­most every Amer­i­can alive to­day is dead.”

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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Emer Cooke, ICRMA chair (AP Photo/Geert Vanden Wijngaert)

ICM­RA to launch sev­er­al reg­u­la­to­ry pi­lot pro­grams cen­tered around man­u­fac­tur­ing in­spec­tions

As regulatory agencies look to catch up on inspections amid the Covid-19 pandemic, ICMRA is unveiling several pilot programs to address industry applications and inspections.

ICMRA, which is made up of the world’s top drug regulators, is launching multiple pilot programs, including two regulatory pilots addressing facility inspections for chemistry and manufacturing controls (CMC) and post-approval change (PAC) submission assessments and related regulatory actions.

FDA slaps warn­ing let­ter on Min­neso­ta API fa­cil­i­ty af­ter em­ploy­ee de­stroys clean­ing log

A manufacturing facility belonging to the Netherlands-based API producer Fagron Group has entered the FDA’s crosshairs after an employee destroyed a cleaning log, among other violations.

One of its plants in Saint Paul, MN received a warning letter on June 14, following an inspection last November that uncovered cross-contamination concerns.

“In your response, you provided a follow-up cleaning validation report in which you only assessed the carryover of niacin swab samples but not progesterone, which was included in your initial cleaning validation,” FDA says in the letter. “The lack of progesterone (b)(4) [commercially confidential information] is concerning considering the failing residue results you provided to investigators would yield unacceptable levels of progesterone cross-contamination.”

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.

Covid-19 roundup: Ox­ford Bio­med­ica and As­traZeneca ex­tend vac­cine deal; FDA wants boost­ers for new­er vari­ants

An Oxford University spinout and one of the major players in the pharma industry are extending their collaboration on its Covid shot.

Oxford Biomedica and AstraZeneca on Friday announced that they have signed a new three-year agreement on future manufacturing for the AstraZeneca Covid-19 vaccine. According to Oxford Biomedica, this deal is an expansion of the original agreement announced between the two companies during the first waves of the pandemic in September 2020.

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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