First Zantac cancer case dropped before trial, without settlement
The first lawsuit claiming that gastrointestinal drug Zantac causes cancer has been voluntarily dismissed a week before it was due to come to trial, in […]
The first lawsuit claiming that gastrointestinal drug Zantac causes cancer has been voluntarily dismissed a week before it was due to come to trial, in […]
GSK, its consumer health spin-off Haleon and Sanofi could be on the hook for billions of dollars in potential damages over Zantac, a gastrointestinal drug […]
One of the main assets of Sanofi’s $3.7 billion buyout of Principia Biopharma has run into trouble, after the FDA placed it on partial clinical […]
The safety of Astellas’ gene therapy portfolio has been thrust into the spotlight once again, after the FDA placed a clinical hold on a trial […]
Shares in Sarepta came under pressure after the biotech said it had temporarily halted a clinical trial of its new-generation Duchenne muscular dystrophy candidate, after […]
Babies born to mothers who contracted COVID-19 during seem to be at slightly higher risk of neurodevelopmental delays, say US researchers, although they caution their […]
German drugmaker Boehringer Ingelheim has sold an artificial intelligence-powered software platform it developed to monitor drug safety data to ArisGlobal, which provides cloud software to […]
Astellas has said it will book a $170 million impairment charge in its fourth quarter results as a result of a decision to halt the […]
Gilead Sciences can restart pivotal trials of its cancer antibody magrolimab – the centre piece of its $4.9 billion acquisition of Forty Seven in 2020 […]
There is no evidence that vaccination with either the Pfizer/BioNTech or Moderna’s mRNA-based COVID-19 vaccines led to the death of patients, says a study by […]
It looks like GlaxoSmithKline’s concerns about its respiratory syncytial virus (RSV) vaccine in pregnant women aren’t going to be resolved quickly. After suspending three trials […]
GlaxoSmithKline has a lot riding on its respiratory syncytial virus (RSV) vaccine, which it thinks could be a $4 billion product at peak, so investors […]
German drugmaker Merck KGaA has reached an agreement to pilot an artificial intelligence platform developed by Quris that aims to identify potential safety problems with […]
With the safety of gene therapies thrown into the spotlight by a series of FDA clinical holds, Astellas has said that an interim readout in […]
The FDA has placed a partial clinical fold on clinical trials of Gilead Sciences’ magrolimab, the centre piece of its $4.9 billion acquisition of Forty […]
A survey by the Service Employees International Union found that 89% of polled nurses and healthcare workers at HCA Healthcare feel staff shortages at their […]
Roche’s idiopathic pulmonary fibrosis (IPF) therapy Esbriet is already being squeezed by its main rival in the market, and could come under renewed pressure if […]
Pfizer has called a halt to a clinical trial of its gene therapy for Duchenne muscular dystrophy as it investigates the unexpected death of a […]
Johnson & Johnson’s also-ran COVID-19 vaccine has been cleared in the EU as a booster shot, although its role in the US could be impacted […]
The FDA has said it needs more time to review Moderna’s application for emergency use of its COVID-19 vaccine mRNA-1273 in children aged 12 to […]
A phase 1 trial of Allogene’s of-the-shelf CAR-T for lymphoma has been placed on hold by the FDA, after a “chromosomal abnormality” was seen in […]
Japanese drugmaker Takeda has suspended dosing in phase 2 trials of its orexin agonist TAK-994, saying it had encountered a “safety signal” in the study. […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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. […]
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 […]
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 […]
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 […]
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 […]
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. […]
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. […]
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 […]
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 […]
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 […]
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