Fast Track Designation granted to decompensated heart failure treatment
The US FDA has granted Fast Track Designation to APD418, which is in development as treatment for decompensated heart failure patients.
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Medicine shortages should be an industry priority, EFPIA says
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has said that medicine shortages may negatively impact patient care and deserves serious action.
NICE requests more data on Keytruda for head and neck cancer treatment
NICE has asked for more information on Keytruda (pembrolizumab) for untreated metastatic or unresectable recurrent squamous cell head and neck cancer due to uncertainty over clinical trial evidence.
Strengthened regulatory systems are needed to improve drug safety, says report
The report reveals practical regulatory reforms that could move the globe closer to the UN’s goal of achieving universal health coverage by 2030.
First living robots, called ‘xenobots’, could be used in drug delivery
Using embryonic stem cells from frogs, scientists have created living robots; called xenobots, these organisms are able to heal after injury and could be the future of drug delivery.
Cyber-security breaches at 67 percent of healthcare organisations last year
A survey has found that a large portion of healthcare organisations in the UK experienced cyber-security incidents last year, which were mostly due to employees sharing data.
FDA issues warning letter to Health Pharma for cGMP violations
An inspection at a manufacturing facility belonging to Health Pharma has revealed breaches of cGMP regulations, causing the FDA to send a warning letter.
HIV treatment Dovato (dolutegravir/lamivudine) approved in Japan
The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted marketing approval for Dovato, a treatment for HIV-1 infection.
Global neoantigen cancer vaccine market to generate $1,826.1m revenue by 2030
A study suggests the global neoantigen cancer vaccine market will grow exponentially due to expected drug launches, new technology reducing costs and currently unmet needs of the market.
FDA issues alert for cancer risk from Belviq (lorcaserin)
The US FDA has announced a warning to healthcare professionals and patients that the weight management drug Belviq may be a cause of cancer.
UK pharmacist who illegally sold drugs sentenced in court
Jasper Ojela, a registered pharmacist who admitted to supplying the black market with drugs including cancer medications, has been given a 28-month prison sentence.
NICE approves palbociclib with fulvestrant on the CDF for treatment of some breast cancers
The NICE committee has made palbociclib with fulvestrant available on the Cancer Drug Fund for patients with hormone receptor-positive, HER2-negative, advanced breast cancer.
Phase III STRENGTH trial for Epanova in mixed dyslipidaemia will close
On recommendations by an independent committee, AstraZeneca will close its STRENGTH trial for Epanova, which has shown low likelihood of being beneficial to patients with mixed dyslipidaemia.
Biodegradable plastic packaging developed for use in pharma
A new ‘green plastic’ alternative that degrades in 10 years has been created, which can be used in the pharmaceutical packaging industry.
Endo agrees opioid settlement payment with Oklahoma for $8.75m
The US state of Oklahoma has agreed to a settlement from Endo International after an investigation into its role in the opioid abuse crisis.
