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JAK inhibitors increase risk of cardiovascular problems and cancer, warns PRAC
Janus kinase inhibitors used for chronic inflammatory conditions are only safe for certain patients, advises the EMA’s safety committee.
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Clinical Trials
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Clinical success begins early for small molecule drugs
First-in-human clinical verification is one of the first critical milestones in drug development. Abhijeet Sinha, Senior Scientist at Lonza Small Molecules, exemplifies the imperative of solving drug development challenges in the early phases.
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First patient receives new engineered mRNA epigenetic
OTX-2002, a programmable epigenetic medicine is the first mRNA therapy to target MYC dysregulation and could treat hepatocellular carcinoma.
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NICE recommends first oral GnRH antagonist for uterine fibroids
Ryeqo, a one-per-day oral drug for adults with moderate-to-severe symptoms of uterine fibroids has been given the green light by NICE.
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AstraZeneca dual immunotherapy approved for US liver cancer patients
The FDA has approved Imfinzi™ combined with Imjudo for adults with unresectable liver cancer, based on a lower risk of death compared to only sorafenib.
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Steep drop for UK industry clinical trials between 2017 and 2021
COVID-19 has accelerated the decline in late-stage industry clinical research in the UK, compared to its global peers.
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Three-dose vaccine prevents HIV patients getting hepatitis B
Clinical trial results suggest adult HIV patients can be protected against hepatitis B with a three-dose vaccine series.
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Gilead and MacroGenics to develop bispecific cancer antibodies
A collaboration agreement between Gilead and biopharma company MacroGenics aims to develop MGD024, a bispecific antibody for treatment of blood cancers.
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Shingles vaccine offers a decade of protection in older adults
Shingrix can effectively vaccinate adults over 50 years old against shingles for at least 10 years, new data shows.
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First patient receives novel, potentially cancer-stopping pill
City of Hope has developed AOH1996, a promising cancer medicine, for people with reoccurring solid tumours.
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$38 million will fund rare disease research over four-year period
Research for rare diseases including ALS will be supported over the next four years by $38 million in FDA funding.
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Evaluating benefits of outsourcing biopharma R&D
Near-term gains from outsourcing biopharma R&D activities can be offset by slower innovation in the long run, according to a recent paper.
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EC approves CAR T-Cell therapy for B-cell lymphoma
Yescarta approved by EC for the treatment of large B-Cell lypmphoma and high grade B-cell lymphoma.
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CHMP recommends dengue vaccine for children
Takeda’s novel dengue vaccine has received positive opinion from the EMA’s human medicines committee (CHMP), demonstrating the vaccine is safe for patients from four years old.
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Enterin and Parkinson’s UK to partner on dementia study
A new Phase II trial will study the drug ENT-01 for Parkinson’s Disease (PD)-associated dementia at sites in the UK and US.
