Illegal pharmacies are defined as those that operate without certification, prescribe drugs without...
FDA approves expanded indication for Novartis drug Kisqali
Novartis has obtained approval from the US Food and Drug Administration (FDA) for its Kisqali (ribociclib) to treat advanced or metastatic breast cancer patients who are hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-).
AstraZeneca to stockpile medicines in preparation for no-deal Brexit
UK pharmaceutical company AstraZeneca has announced it increasing its stockpiles of medicines in UK and Europe that could be affected as a result of Brexit by approximately 20% in case there is no deal between the UK and the European Union (EU).
SIRION Biotech and Heidelberg University Hospital to Develop AAV Technologies
The viral vector specialist SIRION Biotech has announced the signing of a preferred partnership agreement with Heidelberg University Hospital and adeno-associated virus (AAV) pioneer Professor Dirk Grimm.
Roche gains FDA breakthrough status for Tecentriq combination
Roche has obtained breakthrough therapy designation from the US Food and Drug Administration (FDA) for the combination of Tecentriq (atezolizumab) with Avastin (bevacizumab) to treat hepatocellular carcinoma (HCC), the most common form of liver cancer.
FDA grants orphan drug designation to Asceneuron’s ASN120290
Swiss biotechnology company Asceneuron has announced the US Food and Drug Administration (FDA) has granted its lead drug ASN120290 orphan drug designation for the treatment of rare neurodegenerative disease progressive supranuclear palsy (PSP).
UK Government loses vote on EMA amendment to Brexit bill
The UK Government has unexpectedly lost a vote 301 to 305 on an amendment to the Brexit Trade Bill on ‘UK participation in the European medicines regulatory network’.
FDA approves Janssen’s Symtuza single-tablet regimen for HIV-1
The US Food and Drug Administration (FDA) has granted approval to Janssen Pharmaceutical Companies’ single-tablet regimen Symtuza to treat human immunodeficiency virus type 1 (HIV-1).
EC grants Akcea and Ionis’s inotersen marketing authorisation
Ionis Pharmaceuticals and its affiliate Akcea Therapeutics have announced their drug Tegsedi (inotersen) has received marketing authorisation approval from the European Commission (EC) to treat stage one and two polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR amyloidosis).
Post-Curing on the Reduction of Cyclosiloxanes Contaminates
Drug manufacturers are increasingly concerned about the sources of potential contamination from processing equipment. To give a sense of the scale of this problem, 15% of drug recalls reported by the US Food and Drug Administration (FDA) in the last six months were due to contamination from processing equipment.
Read our magazine
Pharma Technology Focus is the essential reading material for decision-makers in the pharmaceutical industry, bringing you the latest news and analysis in an exciting, interactive format.