MHRA approves cerebral palsy spasticity drug to treat children
Dysport®, a therapy for spasticity in cerebral palsy patients has been granted a license update to treat children aged two years and older.
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Top five pharma companies saw overall decline in Q3 2019
Research has found that the top five pharmaceutical companies averaged a Market Capitalisation decline of five percent in Q3 of 2019.
Acute myeloid leukemia treatment receives FDA Orphan Drug Designation
Orphan drug designation has been approved by the FDA for PRGN-3006 UltraCAR-T™ for patients with acute myeloid leukemia (AML).
Internally-developed vaccines reportedly approved in China
According to a recent article, China has approved a number of home-grown vaccines, offering alternatives to global drugmakers' products.
Astellas has announced its acquisition of Xyphos for $665m
Xyphos Biosciences will become a wholly owned subsidiary of Astellas Pharma following an acquisition made by the latter company.
Funding for AI in drug development, clinical trials and information synthesis hits $5.2bn
A study has suggested that while funding for artificial intelligence in pharma was $5.2bn in 2019, overall investment is slowing.
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.
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.
