EMA initiates rolling review of CureVac’s CVnCoV COVID-19 vaccine
The rolling review will assess CVnCoV’s efficacy and immunogenicity data as it becomes available, speeding the decision process for an eventual marketing authorisation application.
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Fresenius Kabi Oncology Ltd to pay $50mn for destroying records ahead of an FDA Inspection
The Indian drug company pleaded guilty to concealing and destroying records containing evidence of its Kalyani plant manufacturing drugs in contravention to FDA requirements prior to a 2013 inspection.
EC approves first high concentration, low-volume adalimumab biosimilar
YuflymaTM (CT-P17) has been approved for the treatment of thirteen chronic inflammatory diseases, including rheumatoid arthritis, ulcerative colitis and psoriatic arthritis, in Europe.
Two new developments in kidney cancer treatments
Studies suggest there are better treatment options than sunitinib for kidney cancers; cabozantinib in metastatic papillary kidney cancer and lenvatinib/pembrolizumab for renal cell carcinoma.
February Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) began two new reviews and wrote guidance for healthcare professionals on the potential side effects of Strimvelis, Venclyxto and Zolgensma.
Novel ionic liquid enables uniform chemotherapy delivery in solid tumours
Co-injecting doxorubicin with LATTE, a novel ionic liquid formulation, resulted in uniform chemotherapy delivery and successful ablation in solid tumours.
![Male Thai child receiving oral polio vaccine from healthcare worker [Credit: frank60 / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Oral-vaccine-300x278.jpg)
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Therapeutic proteins and oral vaccines market to surpass $300,000mn by 2027
The market is expected to grow at a 6.7 percent CAGR, driven by the increasing prevalence of cancer and cardiovascular diseases, as well as growing interest in biologics.
EC approves Ogluo™ (glucagon) injection for the treatment of severe hypoglycaemia
The approval makes Ogluo™ Europe’s first ready-to-use liquid glucagon for rescuing diabetic patients from severe hypoglycaemic events.
Disinformation and safety concerns could prevent successful COVID-19 vaccination campaigns
Research suggests at least a fifth of the US population are resistant to receiving a COVID-19 vaccine, reports suggest this could be due to disinformation and safety concerns.
DECODR app identifies unintentional DNA mutations from CRISPR gene therapies
The DECODR app was developed to accelerate the development of CRISPR gene therapies, producing similar data as deep sequencing processes in a shorter timeframe and at less cost.
The global smart syringe market should surpass $15,500mn by 2027, finds report
The smart syringe market should grow due to increasing public awareness surrounding vaccination and the increasing popularity of safety injection devices with manufacturers and healthcare professionals.
First immunotherapy for advanced basal cell carcinoma approved in US
In trials Libtayo® caused clinically meaningful and durable responses, resulting in the drug being fully approved for advanced basal cell carcinoma resistant to other treatments.
Semaglutide: “a significant advance in the treatment of obesity,” say scientists
After 75 percent of obese patients treated with semaglutide lost at least 10 percent of their body weight, the drug has been submitted for regulatory approval in the UK, Europe and US.
Zyesami™ shows promise in critical COVID-19 patients with respiratory failure
Preliminary data indicate that Zyesami reduces the length of hospital stay in critical COVID-19 patients treated with High Flow Nasal Cannula (HFNC) therapy or mechanical ventilation.
Global anti-Parkinson’s drugs market to be worth over $5bn by 2023
Research suggests that despite a COVID-19 slump, the anti-Parkinson’s drugs market will recover due to rising numbers of Parkinson’s diagnoses and increasing investment in R&D.
