Emer Cooke, Shutterstock

UP­DAT­ED: EMA in­ves­ti­gat­ing 4 'se­ri­ous cas­es' of blood clots fol­low­ing J&J vac­ci­na­tions

The Eu­ro­pean Med­i­cines Agency’s safe­ty com­mit­tee said last Fri­day that it has ini­ti­at­ed a re­view of 4 “se­ri­ous cas­es of un­usu­al blood clots with low blood platelets,” in­clud­ing one death, re­port­ed af­ter peo­ple re­ceived the J&J vac­cine in the US.

The agency of­fered an up­date on Wednes­day that it is ex­pe­dit­ing this eval­u­a­tion and cur­rent­ly ex­pects to is­sue a rec­om­men­da­tion next week. “While its re­view is on­go­ing, EMA re­mains of the view that the ben­e­fits of the vac­cine in pre­vent­ing COVID-19 out­weigh the risks of side ef­fects,” the agency said in a state­ment. J&J an­nounced on Tues­day that it would pause the dis­tri­b­u­tion of its vac­cine across Eu­rope un­til the in­ves­ti­ga­tions are com­plete.

The EMA said the cas­es point to a “safe­ty sig­nal” but it’s un­clear if there is a causal as­so­ci­a­tion be­tween the J&J vac­cine and these con­di­tions. One of the cas­es oc­curred in a clin­i­cal tri­al.

The J&J vac­cine, which is giv­en as a sin­gle shot and is cur­rent­ly on pause in the US while a sep­a­rate in­ves­ti­ga­tion in­to 6 of the rare blood clots, has not been used in Eu­rope yet, al­though the Eu­ro­pean Com­mis­sion au­tho­rized its use on March 11.

The EMA’s and FDA’s re­view of the J&J vac­cine fol­lows a re­view of the As­traZeneca Covid-19 vac­cine that con­clud­ed ear­li­er last week, with the EMA rec­om­mend­ing that the very rare but some­times fa­tal blood clots should be list­ed as a side ef­fect for the vac­cine.

The EMA’s safe­ty com­mit­tee said the change to the vac­cine la­bel is part of an in-depth re­view of 62 cas­es of cere­bral ve­nous si­nus throm­bo­sis (CVST) and 24 cas­es of splanch­nic vein throm­bo­sis re­port­ed in the EU drug safe­ty data­base as of March 22. Eigh­teen of the cas­es were fa­tal.

The com­mit­tee al­so said last Fri­day that it’s re­view­ing an­oth­er safe­ty sig­nal that hasn’t been con­firmed as causal­ly linked to the As­traZeneca vac­cine. This one is to as­sess 5 re­ports of cap­il­lary leak syn­drome in peo­ple who were vac­ci­nat­ed with the As­traZeneca vac­cine. Sep­a­rate­ly, the agency al­so said Wednes­day that it’s in­ves­ti­gat­ing whether to up­date rec­om­men­da­tions for a sec­ond dose of the As­traZeneca vac­cine in those who have al­ready re­ceived the first dose.

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.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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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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FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Albert Bourla, Pfizer CEO (Evan Vucci, AP Images)

Covid-19 roundup: Pfiz­er tees up 500M vac­cine dos­es for do­na­tion in ex­pand­ed US pact; Ear­ly remde­sivir helps stave off hos­pi­tal­iza­tions — study

Pfizer and BioNTech will sell 500 million doses of their Comirnaty Covid-19 vaccine to the US at cost as part of an expanded agreement to drive donations to low- and middle-income nations, the drugmaker said Wednesday.

The expanded pact doubles Pfizer/BioNTech’s commitment to the US effort, which will ship donations to COVAX, a global clearinghouse for up to 92 target nations, as well as the 55 member states of the African Union, Pfizer said. Deliveries started in August and are expected to run through September 2022.

Bob Duggan, Summit CEO (via Summit Investments)

The FDA ob­jects to biotech bil­lion­aire Bob Dug­gan’s PhI­II plans — and he’s not budg­ing

Summit Therapeutics, the Cambridge, MA-based biotech run by billionaire investor Bob Duggan, has found itself in the FDA’s crosshairs.

Last month, Summit announced its intent to combine two Phase III studies for its experimental C. difficile treatment, ridinilazole, into one trial in a process that involved changing the primary endpoint. But regulators do not agree with the new endpoint, the biotech revealed in an SEC filing Tuesday, raising questions about ridinilazole’s ongoing development.

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Jean Bennett (Brent N. Clarke/Invision/AP Images)

Lux­tur­na in­ven­tor Jean Ben­nett starts a new gene ther­a­py com­pa­ny to tack­le rare dis­eases left be­hind by phar­ma, VCs

A few years ago Jean Bennett found herself in a surprising place for a woman who invented the first gene therapy ever approved in the United States: No one, it seemed, wanted her work.

Bennett, who designed and co-developed Luxturna, approved in 2018 for a rare form of blindness, had kept building new gene therapies for eye diseases at her University of Pennsylvania lab. But although the results in animals looked promising, pharma companies and investors kept turning down the pedigreed ophthalmology professor.

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