Is­rael, EU drug reg­u­la­tors find no link be­tween Pfiz­er Covid shot and stroke

One week af­ter the FDA and CDC found a po­ten­tial safe­ty con­cern link­ing is­chemic stroke in old­er adults to the up­dat­ed Pfiz­er vac­cine, Is­rael and EU drug reg­u­la­tors an­nounced they had not found a link be­tween the two.

Is­chemic strokes oc­cur when blood clots or oth­er par­ti­cles block the blood ves­sels to the brain.

Reuters first re­port­ed on Thurs­day that an Is­rael health min­istry of­fi­cial said there were no links found be­tween the vac­cine made by Pfiz­er and its Ger­man part­ner BioN­Tech, and strokes.

“We have not turned up such a find­ing, even af­ter we went back and rechecked all our da­ta af­ter the FDA an­nounce­ment,” Salman Zar­ka, the head of Is­rael’s coro­n­avirus task force, said in a video brief­ing sent to Reuters last week.

On Jan. 18, the Eu­ro­pean Med­i­cines Agency al­so told Reuters that it hasn’t found a safe­ty con­cern in the EU with the vac­cine but that it would con­tin­ue to mon­i­tor da­ta.

In a state­ment joint­ly post­ed by the FDA and CDC re­gard­ing the safe­ty sig­nal, the agency not­ed that on­ly one of its mul­ti­ple safe­ty sys­tems, Vac­cine Safe­ty Datalink, found a po­ten­tial prob­lem:

Rapid-re­sponse in­ves­ti­ga­tion of the sig­nal in the VSD raised a ques­tion of whether peo­ple 65 and old­er who have re­ceived the Pfiz­er-BioN­Tech COVID-19 Vac­cine, Bi­va­lent were more like­ly to have an is­chemic stroke in the 21 days fol­low­ing vac­ci­na­tion com­pared with days 22-44 fol­low­ing vac­ci­na­tion.

Fol­lowup analy­ses of the da­ta al­so did not find a safe­ty sig­nal in Pfiz­er-BioN­Tech’s vac­cine, and no is­sues were de­tect­ed with Mod­er­na’s shot, ac­cord­ing to the FDA. The fol­lowup analy­ses in­clud­ed oth­er large vac­cine datasets from Medicare, the Unit­ed States De­part­ment of Vet­er­ans Af­fairs, Pfiz­er’s and BioN­Tech’s own mon­i­tor­ing pro­grams and a vac­cine side-ef­fect re­port­ing col­lec­tion tool known as VAERS.

The FDA and CDC do not rec­om­mend any “change in vac­ci­na­tion prac­tice.”

Ac­cord­ing to da­ta col­lect­ed by the CDC, 69% of the US pop­u­la­tion has com­plet­ed the orig­i­nal vac­cine se­ries, and 16% — about 50 mil­lion peo­ple — have re­ceived the up­dat­ed boost­er.

Any vac­cine car­ries some lev­el of risk or side ef­fect, though typ­i­cal­ly far small­er than the con­se­quences of dis­eases they are meant to guard against.

In an emailed state­ment to End­points News, Pfiz­er said “there is no ev­i­dence to con­clude that is­chemic stroke is as­so­ci­at­ed with the use of the com­pa­nies’ COVID-19 vac­cines.

“Com­pared to pub­lished in­ci­dence rates of is­chemic stroke in this old­er pop­u­la­tion, the com­pa­nies to date have ob­served a low­er num­ber of re­port­ed is­chemic strokes fol­low­ing the vac­ci­na­tion with the Omi­cron BA.4/BA.5-adapt­ed bi­va­lent vac­cine,” the state­ment con­tin­ued. “With hun­dreds of mil­lions of dos­es of the orig­i­nal and Omi­cron BA.4/BA.5-adapt­ed bi­va­lent Pfiz­er-BioN­Tech COVID-19 vac­cine ad­min­is­tered glob­al­ly, the ben­e­fit-risk pro­file of our vac­cines re­mains pos­i­tive for all au­tho­rized in­di­ca­tions and age groups.”

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

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With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Sanofi scraps PhI­II tri­al for Prin­cip­ia drug af­ter re­view­ing com­pe­ti­tion

Months after the FDA placed Phase III trials of Sanofi’s BTK inhibitor on hold, the company is winding down one of the studies.

Sanofi reported in its Q4 earnings that the URSA study “was discontinued after careful evaluation of the emerging competitive treatment landscape in” myasthenia gravis, a rare disease that causes muscle weakness.

The Phase III, placebo-controlled trial was testing tolebrutinib in patients with the moderate-to-severe form of the disease. It started in late 2021, according to records on clinicaltrials.gov, and was originally designed to recruit 154 participants who were receiving the standard of care.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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How to use ex­ter­nal con­trols: FDA spells out think­ing in new draft guid­ance

The use of real-world evidence to inform the FDA’s decision-making continues apace, with the agency releasing new draft guidance yesterday on how sponsors can compare outcomes of trial participants receiving a test treatment with outcomes in a group of people external to the trial.

The practice of externally controlled trials is common, particularly in oncology or other difficult areas where it’s not ethical or feasible to use internal controls.

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The Big Phar­ma axe: Mer­ck cuts chikun­gun­ya vax, Bris­tol My­ers drops Cy­tomX-part­nered pro­gram, and more

As fourth quarter earnings come in, Big Pharmas are disclosing changes to their pipelines during their investor calls, and sometimes more quietly in presentation appendices.

Merck dropped its chikungunya vaccine candidate, which completed a Phase II study. Merck acquired the vaccine through its purchase of Themis Bioscience in 2020. In developing a vaccine for chikungunya, a mosquito-borne virus, Valneva is the frontrunner, as it submitted its vaccine to the FDA at the end of December.

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