EMA finds link be­tween ‘very rare’ but some­times fa­tal blood clots and As­traZeneca vac­cine

The EMA said Wednes­day that very rare but some­times fa­tal blood clots should be list­ed as a side ef­fect for As­traZeneca’s Covid-19 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.

De­spite the rare side ef­fects for the vac­cine, known as Vaxzevria, EMA ex­ec­u­tive di­rec­tor Emer Cooke said in a press con­fer­ence on Wednes­day that the ben­e­fits of the vac­cine still out­weigh the risks.

“The risk of mor­tal­i­ty from Covid is much greater than the risk of mor­tal­i­ty from these side ef­fects,” Cooke said.

The safe­ty com­mit­tee said it can­not make any rec­om­men­da­tions to re­duce the risk of the rare side ef­fects. Sabine Straus, chair of the EMA’s Phar­ma­covig­i­lance Risk As­sess­ment Com­mit­tee, said the re­port­ed rate of CVST is be­tween 1 and 2 per 100,000 peo­ple.

“One plau­si­ble ex­pla­na­tion for the com­bi­na­tion of blood clots and low blood platelets is an im­mune re­sponse, lead­ing to a con­di­tion sim­i­lar to one seen some­times in pa­tients treat­ed with he­parin,” EMA said.

As of April 4, EMA said a to­tal of 169 cas­es of CVST and 53 cas­es of splanch­nic vein throm­bo­sis were re­port­ed to the data­base, among 34 mil­lion peo­ple who have been vac­ci­nat­ed with in the EEA and UK. By com­par­i­son, Straus not­ed that for the J&J vac­cine, 3 CVST cas­es were found among 4.5 mil­lion vac­ci­nat­ed in the EU/EEA, 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.

“EMA is re­mind­ing health­care pro­fes­sion­als and peo­ple re­ceiv­ing the vac­cine to re­main aware of the pos­si­bil­i­ty of very rare cas­es of blood clots com­bined with low lev­els of blood platelets oc­cur­ring with­in 2 weeks of vac­ci­na­tion. So far, most of the cas­es re­port­ed have oc­curred in women un­der 60 years of age with­in 2 weeks of vac­ci­na­tion. Based on the cur­rent­ly avail­able ev­i­dence, spe­cif­ic risk fac­tors have not been con­firmed,” the agency said.

Sep­a­rate­ly on Wednes­day, the UK’s med­i­cines reg­u­la­tor MHRA an­nounced that those un­der the age of 30 should not re­ceive the As­traZeneca vac­cine. As of March 31, 20.2 mil­lion dos­es of the As­traZeneca vac­cine had been ad­min­is­tered in the UK, mean­ing the over­all risk of these blood clots is ap­prox­i­mate­ly 4 peo­ple in a mil­lion who re­ceive the vac­cine, the MHRA said.

As­traZeneca said in a state­ment that it “has been ac­tive­ly col­lab­o­rat­ing with the reg­u­la­tors to im­ple­ment these changes to the prod­uct in­for­ma­tion and is al­ready work­ing to un­der­stand the in­di­vid­ual cas­es, epi­demi­ol­o­gy and pos­si­ble mech­a­nisms that could ex­plain these ex­treme­ly rare events.”

The World Health Or­ga­ni­za­tion added in a state­ment, “Based on cur­rent in­for­ma­tion, a causal re­la­tion­ship be­tween the vac­cine and the oc­cur­rence of blood clots with low platelets is con­sid­ered plau­si­ble but is not con­firmed. Spe­cialised stud­ies are need­ed to ful­ly un­der­stand the po­ten­tial re­la­tion­ship be­tween vac­ci­na­tion and pos­si­ble risk fac­tors.”

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Sijmen de Vries, Pharming CEO

FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.