European patent upheld for foundational CRISPR intellectual property
Arguments filed in opposition to a patent for foundation CRISPR-Cas9 intellectual property have been rejected by the European Patents Office.
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EMA announces restrictions to cyproterone use due to meningioma risk
After a review of cyproterone, the EMA has recommended that the drug only be prescribed once other treatment options have failed, due to an increased meningioma risk.
Biotech company Promedior merges with Roche
Roche has successfully completed its purchase of Promedior, Inc. along with its entire portfolio of fibrotic disease therapeutics.
FDA and India prevented 500 unapproved drug shipments entering US in January
A collaborative effort between the FDA and Government of India stopped shipments of illegal drugs from reaching patients in the US in Operation Broadsword.
Voltaren approved for arthritis pain over-the-counter in the US
Voltaren Arthritis Pain has been approved by the FDA as an over-the-counter product for the temporary relief of arthritis pain.
Updated restrictions announced for multiple sclerosis treatment
A revised indication, additional contraindications and strengthened monitoring requirements has been recommended for Lemtrada (alemtuzumab) following a review.
Researchers develop method to produce protein drugs from lettuce
Scientists have divised a way to manufacture protein drugs using lettuce leaves, which has presented a potential drug for pulmonary arterial hypertension.
In silico techniques – a JPAG event
European Pharmaceutical Review attended a JPAG event, exploring the plethora of uses for in silico techniques in the pharmaceutical industry.
New innovation centre for biopharma technologies opens
A facility has opened in Ireland which will allow the biopharma industry to trial and simulate the latest bioprocessing and quality control technologies in a GMP environment.
Keytruda® (pembrolizumab) with chemotherapy meets Phase III PFS endpoint
The drug’s developers reveal Keytruda increased progression-free survival (PFS) in patients with metastatic triple-negative breast cancer (mTNBC) expressing PD-L1.
Combining crotoxin with silica enables safe administration in animals
The toxicity of crotoxin has been significantly reduced by combining it with nanostructured SBA-15 silica, used in vaccine formulations.
FDA requests market withdrawal of weight-loss drug Belviq
After clinical trials showed an increased risk of cancer in patients taking Belviq, the FDA has recommended the withdrawal of the drug from the US market.
US biopharmaceutical industry generates more than $1.1 trillion in revenue
According to a new report, the US biopharmaceutical industry supports more than four million jobs and is a major driver of the country's economic growth.
Insight into 2020’s clinical trials landscape
Oncology, industry-sponsored and a combination of the two, will account for the majority of clinical trials categories over the course of the coming year.
Medicines and Medical Devices Bill introduced in UK
A new bill is now effective in the UK which aims to improve regulation for medical devices and ensure patient safety, as well as allow hospitals to develop personalised medicines.
