Medicine regulators should increase collaboration, says new report
The US National Academies of Sciences, Engineering, and Medicine have released a report that suggests regulators need to collaborate more to ensure drug quality.
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First treatment for inherited rare disease approved by the FDA
Givlaari (givosiran) has been approved by the FDA for the treatment of adult patients with the rare genetic disorder, acute hepatic porphyria.
EC approves two new regimens of Keytruda for HNSCC
The European Commission has given its approval to Keytruda to treat head and neck squamous cell carcinoma as a monotherapy or in combination with a chemotherapy.
Precision Dose voluntarily recalls ranitidine oral solution
The FDA has announced that Precision Dose Inc is voluntarily recalling five lots of its ranitidine oral solution in the US.
Healthcare sector often fails to implement new digital initiatives, finds report
A new report has found that even though ambitions are high in the healthcare sector to invest in digital initiatives, the rate of implementing these initiatives are low.
UK authorisation granted for first in-human CAR-Treg cell therapy study
Authorisation has been granted in the UK for the STEADFAST clinical study of TX200, which is the first-in-human trial to evaluate a CAR-Treg cell therapy.
White House announces plan to increase US drug price transparency
Donald Trump has issued a statement outlining a plan to make drug costs in the US clearer for patients, which could also help to drive competition.
Enzyme-coated protocells could be used as targeted drug-delivery system
A study has shown that using certain enzymes on liposomes could be an effective form of directed drug delivery.
Ninety-seven percent response rate reported in advanced prostate cancer treatment study
A Phase III study of oral relugolix has met its primary efficacy endpoint in men with advanced prostate cancer, supporting a New Drug Application submission to the FDA.
Purdue to pay states’ legal fees and urged to help opioid victims
Purdue Pharma is to reimburse the legal fees for states that backed its proposed $10 billion settlement of opioid lawsuits, but with a condition meant to help victims of the addiction crisis.
Keytruda overtakes Opdivo in Q3 sales to reach $3.1bn
Sales of Merck’s drug Keytruda have grown beyond those of Bristol-Myers Squibb’s Opdivo, to become the global leading PD-1 inhibitor.
Fast Track Designation received for Prader-Willi syndrome treatment
Levo Therapeutics has received Fast Track Designation from the FDA for LV-101 (intranasal carbetocin) for the treatment of Prader-Willi syndrome.
Primary endpoint met in drug study for worsening chronic heart failure
A study evaluating the efficacy and safety of vericiguat, a treatment for patients with worsening chronic heart failure, has met the primary efficacy endpoint.
Leaked document reveals ‘unprecedented’ medicine shortages in NHS
A document from the DHSC has reportedly advised NHS doctors to ration certain medicines after outlining dozens of drugs that are in shortage, as published in a report.
Therapy approved for patients with sickle cell disease complication
Adakveo has been approved by the FDA to reduce the frequency of vaso-occlusive crisis, a painful complication of sickle cell disease.
