FDA announces new centre to improve compounded drug quality
A new centre has been established by the FDA that will allow the agency to improve the quality and safety of compounded drugs by providing educational programmes to outsourcing facilities.
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Three more companies raise their US drug list prices
Novartis, Merck and Allergan have joined numerous other pharmaceutical companies by increasing the price of certain drugs since the start of 2020.
Adopting new guidelines could get medicines from CID trials to patients faster
The ECMC has published guidelines for Complex Innovative Design trails which could improve the conduct, quality and acceptability of oncology studies, enabling patients to get access to new medications more quickly.
First company awarded market authorisation under new Chinese drug law
The mAb tislelizumab has been granted approval from Chinese authorities, making Boehringer Ingelheim Biopharmaceuticals the first MAH under the new system.
FDA issues warning letter which highlights the importance of a quality unit
Henan Kangdi Medical Devices Co Ltd has been sent a warner letter after an inspection found cGMP violations that included failures of the company’s quality unit.
Epidyolex available to patients through the NHS from today
Epidyolex, which contains cannabidiol, can now be prescribed by doctors to epilepsy patients in the UK through the NHS.
Report indicates seasonal influenza vaccine market in Asia will reach $1bn by 2028
A new report indicates that drug launches and new formulations will drive the growth of the seasonal influenza vaccine market in China, India and Japan from $914m in 2018 to $1.05bn in 2028.
FDA announces US recall of mirtazapine tablets due to mislabelled strength
Aurobindo Pharma USA, Inc. has issued a voluntary nationwide recall of certain mirtazapine tablets as bottles labelled as 7.5mg may contain 15mg tablets.
NICE issues draft guidance, finding negative opinion for volanesorsen
Waylivra (volanesorsen) has not been recommended for treatment of familial chylomicronaemia syndrome, according to draft guidance from NICE.
Over 250 drug list prices increased in 2020, says new report
Drug makers have hiked the price of over 250 drugs in the US so far in 2020, according to new reports.
Lynparza approved by FDA to treat germline BRCA-mutated metastatic pancreatic cancer
The FDA has approved Lynparza as a first-line treatment after it reduced the risk of disease progression or death by 47 percent in patients.
WHO announces first biosimilar medicine pre-qualification
A trastuzumab biosimilar has been pre-qualified by WHO, marking its first, to improve access to the breast cancer treatment.
Intravenous delivery of TB vaccine found to dramatically improve potency in models
New research has shown that intravenous injection of the BCG vaccine dramatically reduces monkey susceptibility to TB bacteria and lung inflammation.
EMA announces launch of collaborative pilot scheme to inspect manufacturers
The EMA will collaborate with other medicine regulatory bodies globally in a pilot programme to inspect sterile medicine manufacturers.
Novadoz Pharmaceuticals receives FDA go-ahead for Febuxostat generic
US-based Novadoz Pharmaceuticals has received FDA approval for their generic version of Febuxostat 40mg and 80mg tablets.
