UP­DAT­ED: J&J paus­es vac­cine roll­out as feds probe rare cas­es of blood clots

The FDA and CDC have joint­ly de­cid­ed to stop ad­min­is­ter­ing J&J’s Covid-19 vac­cine af­ter re­view­ing da­ta in­volv­ing six re­port­ed US cas­es of a rare and se­vere type of blood clot in in­di­vid­u­als af­ter re­ceiv­ing the vac­cine.

CDC will con­vene a meet­ing of its Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices on Wednes­day to fur­ther re­view these cas­es and as­sess their po­ten­tial sig­nif­i­cance. “FDA will re­view that analy­sis as it al­so in­ves­ti­gates these cas­es. Un­til that process is com­plete, we are rec­om­mend­ing a pause in the use of this vac­cine out of an abun­dance of cau­tion,” Pe­ter Marks, di­rec­tor of the FDA’s Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search and Anne Schuchat, Prin­ci­pal Deputy Di­rec­tor of the CDC, said in a joint state­ment Tues­day morn­ing.

Marks said in a me­dia call that the prob­a­ble cause may be a sim­i­lar mech­a­nism seen in oth­er ade­n­ovirus vec­tor vac­cines, like the As­traZeneca Covid-19 vac­cine, which un­der­went a sim­i­lar safe­ty re­view in Eu­rope. He said one per­son has died and one per­son is in crit­i­cal con­di­tion from the blood clots. FDA act­ing com­mis­sion­er Janet Wood­cock added that the time­frame for this re­view of the J&J vac­cine “will be a mat­ter of days.”

J&J said in a state­ment on Tues­day that it has made the de­ci­sion to proac­tive­ly de­lay the roll­out of its vac­cine in Eu­rope. “The safe­ty and well-be­ing of the peo­ple who use our prod­ucts is our num­ber one pri­or­i­ty,” the com­pa­ny said.

“All six cas­es oc­curred among women be­tween the ages of 18 and 48, and symp­toms oc­curred 6 to 13 days af­ter vac­ci­na­tion,” they not­ed, adding that al­most 7 mil­lion dos­es of the vac­cine have now been ad­min­is­tered in the US. The CDC and FDA said that peo­ple who have re­ceived the J&J vac­cine and who de­vel­op se­vere headache, ab­dom­i­nal pain, leg pain, or short­ness of breath 3 weeks af­ter vac­ci­na­tion should con­tact their health care provider.

Treat­ment of this spe­cif­ic type of blood clot is dif­fer­ent from he­parin, which is the treat­ment that might typ­i­cal­ly be ad­min­is­tered, as in this set­ting, CDC and FDA said, “ad­min­is­tra­tion of he­parin may be dan­ger­ous, and al­ter­na­tive treat­ments need to be giv­en.”

Sen­a­tors on Tues­day be­gan weigh­ing in on what the FDA should do with its re­view.

Jeff Zients, White House Covid-19 re­sponse co­or­di­na­tor, said in a state­ment that the Biden ad­min­is­tra­tion is work­ing with states to resched­ule J&J ap­point­ments for Morder­na or Pfiz­er vac­cines. New York said all ap­point­ments for J&J vac­cines to­day at New York State mass vac­ci­na­tion sites will be hon­ored with the Pfiz­er vac­cine.

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

As of April 4, EMA said a to­tal of 169 cas­es of cere­bral ve­nous si­nus throm­bo­sis (CVST) and 53 cas­es of splanch­nic vein throm­bo­sis were re­port­ed to the data­base, among 34 mil­lion peo­ple who have been vac­ci­nat­ed with the As­traZeneca vac­cine in the EEA and UK. By com­par­i­son, the agency not­ed that for the J&J vac­cine, 3 CVST cas­es were found among 4.5 mil­lion vac­ci­nat­ed world­wide, for Pfiz­er, 35 CVST cas­es world­wide were found and 54 mil­lion re­ceived the vac­cine in the EEA, and for Mod­er­na, 5 CVST cas­es world­wide were among 4 mil­lion vac­ci­nat­ed in the EEA.

Mod­er­na said in a state­ment on Tues­day that more than 64.5 mil­lion dos­es of its vac­cine have been ad­min­is­tered glob­al­ly and its as­sess­ment of the da­ta “does not sug­gest an as­so­ci­a­tion with cere­bral ve­nous si­nus throm­bo­sis (CVST) or throm­bot­ic events.”

Anne Schuchat, prin­ci­pal deputy di­rec­tor at the CDC, al­so said on the me­dia call that they are not see­ing con­cerns with these clot­ting events for the Mod­er­na or Pfiz­er vac­cines.

How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

Ryan Watts, Denali CEO

De­nali slips as a snap­shot of ear­ly da­ta rais­es some trou­bling ques­tions on its pi­o­neer­ing blood-brain bar­ri­er neu­ro work

Denali Therapeutics had drummed up considerable hype for their blood-brain barrier technology since launching over six years ago, hype that’s only intensified in the last 14 months following the publications of a pair of papers last spring and proof of concept data earlier this year. On Sunday, the South San Francisco-based biotech gave the biopharma world the next look at in-human data for its lead candidate in Hunter syndrome.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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Frank Pallone (Kevin Dietsch/Pool via AP Images)

House com­mit­tee seeks more from FDA on in­spec­tion back­log, when to restart work on for­eign sites

House Energy & Commerce committee leaders are raising fresh questions about the FDA’s ability to conduct foreign manufacturing site inspections and bring down its growing backlog.

“While we understand that the emergence of COVID-19 required the agency to suspend in-person inspection activities temporarily, we remain concerned that more than one year into the pandemic, the strategy for resuming all inspections and addressing the backlog of delayed inspections remains unclear,” E&C chair Frank Pallone (D-NJ) and a group of five other bipartisan leaders of the committee wrote to FDA acting commissioner Janet Woodcock.

Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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UP­DAT­ED: Pan­el of neu­ro­science ex­perts lays out the com­pli­ca­tions with us­ing Bio­gen's new Alzheimer's drug

Treatment of early Alzheimer’s patients with Biogen’s new drug Aduhelm should closely resemble how the drug was studied in its pivotal clinical trials, according to new recommendations from a panel of neuroscience experts led by UNLV’s Jeffrey Cummings.

“Those considering aducanumab therapy should understand that the expected benefit is slowing of cognitive and functional decline; improvement of the current clinical state is not anticipated,” they wrote Tuesday in The Journal of Prevention of Alzheimer’s Disease, noting that some of their recommendations are more specific or more restrictive than the information provided in the FDA’s prescribing information.

Covid-19 roundup: Till­man Gern­gross inks deal to bring an­ti­body can­di­date to In­dia; At FDA's re­quest, mR­NA vac­cine mak­ers will ex­pand tri­als for chil­dren ages 5-11

A week after it was reported that India’s Covid-19 death toll could be in the millions, antibody legend Tillman Gerngross has inked a deal to develop Adagio’s lead candidate for the treatment and prevention of the virus in southern Asia.

Adagio is joining hands with Biocon Biologics to manufacture and commercialize a treatment based on ADG20 in India and “select emerging markets,” the companies announced on Monday. Under the agreement, Adagio will provide Biocon with materials and know-how to make the therapy, including data from ongoing Phase II/III trials and (if all goes well) access to its potential EUA package.