Opin­ion: US and EU re­views of blood clots and J&J’s Covid vac­cine show why a trans­par­ent process mat­ters

When the CDC’s top ad­vi­so­ry com­mit­tee met last week to re­view whether a hand­ful of very rare but po­ten­tial­ly fa­tal blood clots with low platelets might be linked to J&J’s Covid-19 vac­cine, the as­sump­tion was that the com­mit­tee would, at the very least, fol­low its own agen­da and vote on whether to wait for more da­ta, or make in­ter­im age- or risk-based rec­om­men­da­tions for the vac­cine.

In­stead, the com­mit­tee did nei­ther, punt­ing its vote un­til this Fri­day when it can hold a longer dis­cus­sion with the lat­est da­ta. None of the ACIP mem­bers raised ma­jor con­cerns with the de­ci­sion, or lack there­of, de­spite some calls to not pause the vac­cine in­def­i­nite­ly.

But the in­ac­tion al­so raised con­cerns about whether the CDC and FDA were shirk­ing their re­spon­si­bil­i­ties and un­nec­es­sar­i­ly de­lay­ing J&J vac­ci­na­tions as the race to slow the spread of the coro­n­avirus con­tin­ues.

In con­trast, the Eu­ro­pean Med­i­cines Agency’s safe­ty com­mit­tee quick­ly con­clud­ed its re­view of the blood clots and the J&J vac­cine on Tues­day, de­cid­ing the vac­cine’s ben­e­fits out­weigh the risks, while adding a warn­ing to the vac­cine’s la­bel, even as no one in Eu­rope has re­ceived the vac­cine yet. Fol­low­ing the com­mit­tee’s an­nounce­ment, J&J said it would re­sume ship­ments of the vac­cine.

At first blush, the EMA, which just went through a sim­i­lar re­view with As­traZeneca’s vac­cine and came to a sim­i­lar con­clu­sion, seems to have been the more proac­tive reg­u­la­tor. The EMA made a quick de­ci­sion on the avail­able da­ta and re-start­ed the process for get­ting more shots in­to arms.

But be­yond the head­line and fi­nal de­ci­sion lies a very dif­fer­ent sto­ry.

In the case of the CDC’s com­mit­tee, any mem­ber of the pub­lic (any­where in the world) could turn on a com­put­er and watch the pro­ceed­ings, lis­ten to the se­ri­ous­ness of the de­tails, hear the ar­gu­ments and see the slides that each of the com­mit­tee mem­bers re­view. The pub­lic even has an op­por­tu­ni­ty to weigh in at the CDC meet­ing, al­though it’s un­clear how those com­ments are ac­tu­al­ly used.

The ACIP de­ci­sion to de­lay ac­tion and wait for more da­ta on the blood clots may seem like an al­most neg­li­gent re­sponse, es­pe­cial­ly giv­en the EMA’s snap de­ci­sion, when time is of the essence. But the risk cal­cu­la­tions for the two re­gions are very dif­fer­ent. The US has more of the Pfiz­er and Mod­er­na Covid vac­cines than the EU to fill the gap left by the J&J pause. The US al­so has about 10 mil­lion dos­es of the J&J vac­cine wait­ing on shelves so if the FDA and CDC of­fer a green­light, those dos­es will im­me­di­ate­ly be ad­min­is­tered.

Al­so, the EMA’s safe­ty com­mit­tee com­plet­ed its analy­sis of the J&J and As­traZeneca vac­cine da­ta be­hind closed doors, on­ly of­fer­ing a peek in­to what oc­curred via lim­it­ed press re­leas­es and press con­fer­ences that usu­al­ly lead to as many new ques­tions as an­swers.

Pe­ter Ar­lett

For in­stance, at each of the EMA press con­fer­ences on the vac­cine la­bel up­dates, Pe­ter Ar­lett, the head of phar­ma­covig­i­lance at the EMA, has un­veiled new fig­ures on the cas­es of blood clots with low platelets for each of the vac­cines au­tho­rized in the EU.

But in do­ing so, Ar­lett fails to of­fer any fur­ther in­for­ma­tion on how many to­tal dos­es of the vac­cines have been ad­min­is­tered or where these new cas­es oc­curred. At least twice now, ei­ther Ar­lett or some­one else at the EMA has had to cor­rect or clar­i­fy what the num­bers mean, or where the cas­es did or did not oc­cur.

If the EMA is go­ing to re­lease these num­bers, why not put them in a press re­lease and ful­ly ex­plain them? In­stead, the agency leaves it to the pub­lic to de­cide on what they might mean, which is con­cern­ing as they are not ap­ples-to-ap­ples com­par­isons. Pfiz­er see­ing 25 cas­es of the blood clots and low platelets ver­sus J&J see­ing 8 cas­es are not com­pa­ra­ble con­sid­er­ing how many tens of mil­lions of more dos­es of the Pfiz­er vac­cine have been ad­min­is­tered.

In oth­er in­stances (e.g. re­leas­ing clin­i­cal tri­al re­sults), the EMA has tak­en a lead­ing role in show­ing the world how trans­paren­cy works. But in this case, even with the FDA and CDC tak­ing ex­tra days to make its de­ci­sion, and even if the de­ci­sion is to re­strict the use of the J&J vac­cine to a spe­cif­ic pop­u­la­tion, the im­por­tance of trans­paren­cy is clear.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

Ankit Mahadevia, Spero CEO

Spero’s UTI can­di­date gets the CRL ham­mer as the com­pa­ny falls in­to pen­ny stock sta­tus

Spero Therapeutics has been struggling in the past few years, dealing with FDA holds and staff reductions amidst a rough biotech market, and the latest news from the Massachusetts-based company confirms what it anticipated in May: a CRL.

The company was slapped with the no-go for its NDA, the biotech disclosed Monday. The company was seeking approval for tebipenem HBr oral tablets, intended for the treatment of adult patients with complicated urinary tract infection, or cUTI, including pyelonephritis. The FDA had set a PDUFA date of June 27.

(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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Herriot Tabuteau, Axsome CEO (Owen Hoffmann/Patrick McMullan via Getty Images)

Ax­some's long de­layed de­pres­sion drug is back up for la­bel dis­cus­sions at the FDA, trig­ger­ing a big spike in the share price

Axsome’s on-and-off quest to obtain an FDA approval for their depression drug AXS-05 is back on again.

After the markets closed on Monday, the biotech issued a short, simple alert in an SEC filing saying the team had “received from the U.S. Food and Drug Administration (the “FDA”) proposed labeling for the Company’s AXS-05 product candidate with respect to its New Drug Application (the “NDA”) for AXS-05 for the treatment of major depressive disorder. The Company is reviewing the proposed labeling and will reply to the FDA to secure final labeling agreement.”

New Charles River Laboratories High Quality (HQ) Plasmid DNA Centre of Excellence at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. (Charles River)

Charles Riv­er Lab­o­ra­to­ries to start cell and gene ther­a­py man­u­fac­tur­ing at UK site in Sep­tem­ber

While Massachusetts-based Charles River Laboratories has been on an acquisition spree, they are not against planting their flag. The latest move by the company sees them crossing the pond to establish a manufacturing site in the UK.

The company on Tuesday opened its cell and gene therapy manufacturing center at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. The expansion follows Charles River’s acquisition of Cognate BioServices and Cobra Biologics in 2021 for $875 million. Cognate is a plasmid DNA, viral vector and cell therapy CDMO.