FDA adds Guil­lain-Bar­ré syn­drome warn­ing to Glax­o­SmithK­line’s shin­gles vac­cine

The FDA late Wednes­day sent out a safe­ty com­mu­ni­ca­tion to ex­plain that while Glax­o­SmithK­line’s shin­gles vac­cine Shin­grix is a safe vac­cine, it’s now added a new warn­ing to the la­bel not­ing an in­creased risk of a rare but de­bil­i­tat­ing dis­or­der known as Guil­lain-Bar­ré syn­drome (GBS).

“In a post­mar­ket­ing ob­ser­va­tion­al study, an in­creased risk of GBS was ob­served dur­ing the 42 days fol­low­ing vac­ci­na­tion with Shin­grix,” the up­dat­ed Warn­ings and Pre­cau­tions sec­tion of the la­bel now says. The FDA al­so de­ter­mined that the ben­e­fits of vac­ci­na­tion with Shin­grix con­tin­ue to out­weigh its risks.

The FDA said in its safe­ty com­mu­ni­ca­tion that it found the risk by comb­ing through Medicare claims da­ta from more than 3.7 mil­lion vac­ci­na­tions with Shin­grix be­tween Oc­to­ber 2017 and Feb­ru­ary 2020.

“The pri­ma­ry analy­sis (claims-based, all dos­es) found an in­creased risk of GBS dur­ing the 42 days fol­low­ing vac­ci­na­tion with Shin­grix, with an es­ti­mat­ed 3 ex­cess cas­es of GBS per mil­lion dos­es ad­min­is­tered to adults aged 65 years or old­er,” FDA said. “In sec­ondary analy­ses, an in­creased risk of GBS was ob­served dur­ing the 42 days fol­low­ing the first dose of Shin­grix, with an es­ti­mat­ed 6 ex­cess cas­es of GBS per mil­lion dos­es ad­min­is­tered to adults aged 65 years or old­er, and no in­creased risk of GBS was ob­served fol­low­ing the sec­ond dose of Shin­grix.”

Each year in the US, an es­ti­mat­ed 3,000 to 6,000 peo­ple de­vel­op GBS, FDA said, which is about 10 to 20 cas­es of GBS per mil­lion peo­ple each year.

The FDA al­so ac­knowl­edged that it did not iden­ti­fy an in­creased risk for GBS in its eval­u­a­tion of the clin­i­cal tri­als da­ta for Shin­grix, which the agency eval­u­at­ed pri­or to the vac­cine’s ap­proval in 2017.

“Rare ad­verse events, some of which may be se­ri­ous, may be­come ap­par­ent with more wide­spread use of the vac­cine,” the agency said.

GSK told End­points News in a state­ment, “GSK re­mains con­fi­dent in the fa­vor­able ben­e­fit-risk pro­file of SHIN­GRIX for the pre­ven­tion of shin­gles. We will con­tin­ue to com­mu­ni­cate with FDA and CDC on post-mar­ket­ing safe­ty mon­i­tor­ing for SHIN­GRIX.”

The state­ment al­so not­ed that at the Feb­ru­ary 2021 meet­ing of the CDC Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices, the Her­pes Zoster Work Group pre­sent­ed re­sults of a com­pre­hen­sive risk-ben­e­fit analy­sis of Shin­grix that in­clud­ed a re­view of post-mar­ket­ing da­ta. “The analy­sis con­clud­ed: GBS is rare, and da­ta on the risk of GBS fol­low­ing HZ (her­pes zoster or ‘shin­gles’) and vac­ci­na­tion are lim­it­ed. Clin­i­cal tri­als, ob­ser­va­tion­al stud­ies and the risk-ben­e­fit analy­sis con­firm the con­sid­er­able ben­e­fits of RZV (SHIN­GRIX) vac­ci­na­tion in pre­vent­ing HZ, se­vere dis­ease and com­pli­ca­tions.”

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Ex-My­lan em­ploy­ee pleads guilty to in­sid­er trad­ing, il­le­gal­ly deal­ing on FDA ap­provals, earn­ings and Up­john merg­er

A former Mylan IT executive pleaded guilty Friday to an insider trading scheme where he bought and sold stock options on another executive’s advice.

Prosecutors secured the plea from Dayakar Mallu, Mylan’s former VP of global operations information technology, after uncovering the plan. Mallu collaborated with an unnamed “senior manager,” the SEC said, to trade options ahead of Mylan public announcements regarding FDA approvals, revenue reports and its merger with the Pfizer generics subsidiary Upjohn. The two subsequently shared profits.

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Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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