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.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,600+ biopharma pros reading Endpoints daily — and it's free.

FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

The latest numbers reveal that for a second straight quarter in 2021, the FDA has met its user fee goal dates for 93% of original new drug applications, which compares with 94% and 98% for the previous two quarters in 2020, respectively.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

UP­DAT­ED: Pfiz­er hits the brakes on their piv­otal tri­al for a BC­MA/CD3 bis­pe­cif­ic on safe­ty con­cerns while FDA road­block is hold­ing up Duchenne MD PhI­II

Pfizer’s ambitious plan to take a Phase II study of its BCMA CD3-targeted bispecific antibody elranatamab (PF-06863135) and run it through to an accelerated approval has derailed.

The pharma giant said in a release this morning that they have halted enrollment for their MagnetisMM-3 study after researchers tracked three cases of peripheral neuropathy in the ongoing Phase I. They are now sharing info with the FDA as they explore the red safety flag.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,600+ biopharma pros reading Endpoints daily — and it's free.

Ngozi Okonjo-Iweala, Director general of WTO (AP Photo/Keystone/Alessandro Della Bella)

Opin­ion: Waiv­ing Covid-19 vac­cine IP could save lives, but where is the man­u­fac­tur­ing ca­pac­i­ty?

Droves of House Democrats in Washington and members of the European Parliament have now glommed onto a major push by India and South Africa at the WTO to abolish all IP around Covid-19 vaccines.

At first blush, waiving this IP sounds like an easy win: More Covid-19 vaccines made locally for more people means more lives saved. Simple enough, especially as low-income countries have received just a tiny fraction of the world’s vaccine allotment so far.

Thomas Schall, ChemoCentryx CEO (file photo)

Chemo­Cen­tryx plunges as FDA rais­es ques­tions about rare dis­ease drug ahead of ad­comm

ChemoCentryx’s stock price on Wednesday was cut in half by the release of FDA briefing documents ahead of a Thursday adcomm, raising questions on the company’s clinical data to support avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

ANCA-associated vasculitides (AAV) affect small to medium-size blood vessels that can be fatal in less than a year if left untreated, according to FDA. Only Roche’s Rituxan is currently FDA-approved for the treatment of AAV, while glucocorticoids are approved for the broader indication of vasculitis.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,600+ biopharma pros reading Endpoints daily — and it's free.

Stéphane Bancel at the Endpoints #JPM20 breakfast panel in San Francisco, January 2020 (Photo: Jeff Rumans, Endpoints News)

Mod­er­na says Covid-19 vac­cine boost­er in­creased im­mune re­sponse against vari­ants of con­cern

About a month after announcing their variant-specific Covid-19 vaccine boosters showed promising results in mice, Moderna says it now has some human data to back it up.

Volunteers given a booster shot about six to eight months after receiving their second dose saw increased antibody levels against SARS-CoV-2 and two variants of concern: B.1.351, which was first identified in South Africa, and P.1, first identified in Brazil, the company said on Wednesday.

Cynthia Butitta (L) and Joe Jimenez

Is that an­oth­er IPO in the mak­ing? Ex-No­var­tis CEO Joe Jimenez and a lead Kite play­er take up new posts at an off-the-shelf ri­val to 2 pi­o­neer­ing drugs

Right on the heels of taking on a $160 million crossover round in a likely leap to Nasdaq, Century Therapeutics CEO Lalo Flores is now pushing ahead with the high-profile ex-Novartis chief Joe Jimenez as chairman.

Jimenez’s greatest fame at Novartis was earned for one of its weakest products, as their pioneering personalized CAR-T Kymriah won the honors for the first such drug to make it to the market. Now a host of players, including Century, are barreling in behind the frontrunners with allogeneic rivals that can be created for off-the-shelf use.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,600+ biopharma pros reading Endpoints daily — and it's free.