safety

Astellas reports fourth death in halted gene therapy trial

There has been a fourth patient fatality in Astellas’ clinical trial of its AT132 gene therapy for the rare disease X-linked myotubular myopathy (XLMTM), which has been halted twice due to safety concerns. The latest suspension came after abnormal liver function tests (LFTs) were seen in a boy receiving the gene therapy, who has since …

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FDA slaps clinical hold on BioMarin’s PKU gene therapy

BioMarin Pharma has had another setback in its gene therapy development programme, announcing this morning that the FDA has placed a phase 1/2 trial of its candidate for phenylketonuria (PKU) on hold while it investigates a safety signal. The biotech said that the US regulator ordered the pause on the study after liver tumours were …

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FDA firms up JAK inhibitor warnings after Xeljanz review

The FDA has concluded its safety review of Pfizer’s JAK inhibitor Xeljanz and Xeljanz XR, requiring revised warnings for the drugs as well as others in the class after finding evidence of elevated risks of serious heart-related events. After looking at the data from Pfizer’s long-term, post-marketing safety study – ORAL Surveillance – the US …

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More trouble for Astellas as AT132 gene therapy trial is halted again

Astellas has halted dosing in a study of its AT132 gene therapy for the rare disease X-linked myotubular myopathy (XLMTM) for the second time after another serious adverse event (SAE) linked to possible liver damage. The ASPIRO trial of AT132 has been paused after abnormal liver function tests (LFTs) were seen in a patient receiving …

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AZ says second COVID jab dose isn’t linked to rare clot reaction

A new analysis has suggested that the rare blood clot side effects linked to AstraZeneca’s COVID-19 vaccine Vaxzevria don’t occur after a second dose. The study in The Lancet examined cases of thrombosis with thrombocytopenia syndrome (TTS) from an AZ database encompassing around 5.62 million people who had received two doses of Vaxzevria in the …

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AZ, J&J tweaking COVID shots to reduce clotting risks; report

AstraZeneca and Johnson & Johnson are both exploring ways to modify their COVID-19 vaccines to minimise the risk of severe blood clotting reactions that are seen – albeit rarely – in some people receiving the jabs. At the same time, the UK’s National Institute for Health and Care excellence (NICE) is developing guidance to help …

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Study links AstraZeneca COVID-19 shot to bleeding disorder ITP

Researchers in Scotland have identified a possible link between the Oxford University/AstraZeneca COVID-19 and a mostly mild and generally treatable bleeding disorder. The scientists examined real-world public health data from all individuals in Scotland who received either the AZ or Pfizer/BioNTech vaccines up until 14 April and found a possible association between the AZ shot …

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Novartis halts three trials of Beovu eye drug on safety concerns

Prospects for Novartis’ ophthalmology drug Beovu have taken another dive after the drugmaker reported toxicity issues in a new phase 3 trial in wet age-related macular degeneration (AMD). On the plus side, Beovu (brolucizumab) met its efficacy objectives in the MERLIN study, but that was offset by higher rates of inflammatory reactions in the eyes …

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Belgium halts dosing of J&J COVID vaccine in under 41s after death

Belgium’s Ministry of Health has paused dosing of people under the age of 41 with Johnson & Johnson’s one-shot COVID-19 vaccine, following the death of a woman from what appeared to be a blood clot-related condition.  The unnamed woman – who was under the age of 40 – died on 21 May after being admitted …

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Safety of mRNA COVID-19 jabs backed, despite myocarditis cases

As US and EU health regulators review cases of heart inflammation seen in young people administered mRNA-based COVID-19 vaccines from Pfizer/BioNTech and Moderna, cardiologists have come out in favour of the jabs. The American Heart Association (AHA) and American Stroke Association (ASA) have issued a statement saying that the benefits of the vaccines “enormously outweigh …

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EMA panel probes heart inflammation with Pfizer/BioNTech COVID vaccine

A review of side effects reported with coronavirus vaccines by the EMA’s safety committee has uncovered cases of inflammation of the heart in people receiving the Pfizer/BioNTech Comirnaty shot.  The Pharmacovigilance Risk Assessment Committee (PRAC) says it is aware of cases of myocarditis and pericarditis – inflammation of the heart muscle and membrane around the …

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FDA lifts hold on uniQure gene therapy after cancer case review

Dosing can start once again in uniQure’s phase 3 trial of its haemophilia B gene therapy, after the FDA concluded that a case of liver cancer seen in the study was unlikely to be caused by the treatment.  The biotech said that the FDA had concluded that its investigation into the case, conducted in collaboration …

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EU safety regulators clear J&J COVID shot despite tiny clot risk

The benefits of Johnson & Johnson’s COVID-19 vaccine outweigh a tiny risk of unusual blood clots forming, Europe’s drugs regulator has said. In a decision that will allow the rollout of vaccines in certain EU states, the European Medicines Agency’s safety committee said there appears to be a link to unusual blood clots combined with …

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Risk of brain clots higher with COVID than vaccine, study suggests

A study has suggested that the risk of getting a serious brain clot is eight to 10 times higher in people with COVID-19 than those who get a vaccine. There are some big caveats with the research from Oxford University – it was based on data from people in the US who had received either …

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Czech Republic swoops for Denmark’s 2.4m unwanted AZ COVID shots

The Czech Republic wants to buy around 2.4 million doses of the AstraZeneca/Oxford University vaccine ditched by Denmark, which has said it will stop using it because of concerns about rare blood clotting side-effects. Czech deputy prime minister Jan Hamacek said on twitter that he had instructed the country’s ambassador in Denmark to try to …

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UK will offer under-30s alternative to AZ’s COVID jab

The UK drugs regulator has said people aged under 30 should be offered an alternative to the AstraZeneca COVID-19 vaccine, because of evidence linking it to rare blood clots.  Updated figures from the Medicines and Healthcare products Regulatory Agency (MHRA) reveal 79 people experienced blood clots after receiving a dose of Vaxzevria (AZD1222), with 19 …

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Paediatric trial of AZ COVID jab ‘halted as a precaution’

Oxford University has suspended a clinical trial of its AstraZeneca-partnered COVID-19 vaccine in children and adolescents while a possible link to rare cases of blood clotting is investigated by the UK drugs regulator.  Around 300 volunteers have been enrolled into the trial, but investigators have decided to pause dosing with the Oxford/AZ vaccine while they …

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Safety study pushes back phase 3 trial of Newron’s schizophrenia drug

Switzerland’s neurology specialist Newron must hold off starting a phase 3 study of its schizophrenia drug evenamide to complete a small study to show safety at a higher dose, causing a further delay to development. Clinical development has already been delayed by safety issues that arose unexpectedly in 2019 but the FDA agreed a plan …

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EMA backs safety of AZ COVID-19 jab in all age groups

The head of the EMA has reiterated that there is no evidence to limit the use of AstraZeneca’s COVID-19 vaccine in any age group, after Germany and Canada imposed restrictions in younger patients.  “Our position has not changed” from a safety update two weeks ago, said Emer Cooke at an EMA press conference today. “According …

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AZ issues revised efficacy figures for COVID-19 shot

AstraZeneca has issued revised efficacy figures from the US trial of its COVID-19 vaccine following a complaint from independent monitors that figures from an interim analysis published earlier this week were out of date. The new figures from AZ, which developed the vaccine in partnership with Oxford University, give an efficacy at preventing symptomatic COVID-19 …

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States halting AZ jab a ‘disaster’ for EU’s COVID vaccination programme

The decision by around a dozen EU countries to suspend dosing with AstraZeneca’s COVID-19 vaccine is facing criticism, amid fears that it could undermine the response to the pandemic in Europe.  Germany, France, Italy and Spain are among the member states that have announced a suspension of dosing with AZD1222 in the last 24 hours …

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EU probes low platelet safety issue with COVID-19 shots

EU regulators are reviewing reports of low blood platelets in patients who received any of the three approved COVID-19 vaccines from Pfizer/BioNTech, AstraZeneca and Moderna. The experts have also recommended a safety update on the label of Oxford University/AstraZeneca’s COVID-19 vaccine, which has been linked to anaphylactic reactions, in what has turned out to be …

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EU regulators probe safety of AstraZeneca vaccine batch after blood clot reports

European safety regulators have launched an investigation into the safety of a batch of the Oxford University/AstraZeneca COVID-19 vaccine, as countries including Denmark suspended its use as a precaution following reports of blood clots. Initial findings showed no issue with the shots suspended by Austrian authorities after a person was diagnosed with severe blood clotting …

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bluebird seeks gene therapy trial restart after cancer scare

bluebird bio is to ask regulators to restart clinical studies of its LentiGlobin for sickle cell disease, after an investigation concluded that a case of acute myeloid leukaemia (AML) was “very unlikely” to be caused by the gene therapy. Known as Zynteglo in Europe where it is approved to treat the rare blood disorder beta-thalassemia, …

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Zynteglo halt re-ignites viral vector safety concerns; analysts

Bluebird Bio’s decision to hit pause on the launch of Zynteglo for beta thalassaemia after two cases of cancer were seen in a clinical trial could see fears over the safety of viral vectors used to deliver gene therapies resurface.  That’s the view of analysts at Jefferies, who suggest it could “re-ignite concerns over the …

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FDA holds back from action over Xeljanz safety study

The FDA has said it will wait for additional results from last week’s trial showing an increased risk of cardiac side effects with Pfizer’s arthritis blockbuster Xeljanz before deciding on further action. The post-marketing ORAL Surveillance safety study showed that JAK inhibitor Xeljanz (tofacitinib) was associated with a higher rate of heart attacks and cancer …

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Bad news for Pfizer as blockbuster Xeljanz flunks safety study

JAK inhibitor Xeljanz is one of Pfizer’s top-selling drugs, despite a ‘black box’ warning for blood clots and cancers added to its label in 2019. Now, a study designed to prove its safety has achieved the opposite. The post-marketing safety study showed that Xeljanz (tofacitinib) – used to treat rheumatoid arthritis (RA) – was associated …

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Bad news for Pfizer as blockbuster Xeljanz flunks safety study

JAK inhibitor Xeljanz is one of Pfizer’s top-selling drugs, despite a ‘black box’ warning for blood clots and cancers added to its label in 2019. Now, a study designed to prove its safety has achieved the opposite. The post-marketing safety study showed that Xeljanz (tofacitinib) – used to treat rheumatoid arthritis (RA) – was associated …

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Coronavirus vaccine may have allergy warning in US, says expert

The US government’s coronavirus vaccine chief has said that Pfizer/BioNTech’s vaccine could carry a warning that it should be avoided by people who are prone to serious allergic reactions. Moncef Slaoui, co-head of the US government’s Operation Warp Speed COVID-19 vaccine programme, made the comments after the UK drugs regulator advised those with severe allergies …

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FDA puts Bellicum’s cancer cell therapy trial on hold

The FDA has placed a clinical hold on a phase 1/2 trial of Bellicum’s cancer cell therapy BPX-601, following a patient death. Houston, Texas-based Bellicum said that the regulator had placed recruitment and dosing on hold in the dose-escalation trial in patients with previously treated metastatic pancreatic cancer or prostate cancer. Bellicum is hoping to …

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AZ’s COVID-19 vaccine trial ready to resume – reports

AstraZeneca’s COVID-19 vaccine trial could be ready to resume this week in the US after a seven-week hiatus while the FDA completed its review of a serious illness, according to reports. Citing four sources, Reuters said that the FDA is about to allow the large-scale trial of the shot to resume after it was put …

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