FDA grants Orphan Drug Designation to Epidermolysis Bullosa treatment
The US Food and Drug Administration has awarded APR-TD011 Orphan Drug Designation, for the treatment of a rare disease.
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Number of illegal diazepam tablets seized doubles in UK
The amount of illegal diazepam tablets commandeered at the border of the UK doubled last year, according to a report.
The first generics of Gilenya have been approved by the FDA
The first three applications for generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of MS have been approved.
Investment in UK cell and gene therapy manufacturing set to continue
An additional 6,000m2 of cell and gene therapy manufacturing space is expected to become available within the next 12 months, according to new data.
Zotiraciclib granted Orphan Drug Designation by FDA and EMA
The FDA and EMA have granted Orphan Drug Designation to zotiraciclib, currently the subject of two separate Phase Ib clinical trials in glioblastoma.
FDA update: additional testing of ranitidine and nizatidine ordered
To further its investigation into the cause of the NDMA impurities found in ranitidine and nizatidine, the FDA has asked manufacturers of these products to expand their testing to include all lots of the medication.
Environmentally friendly pressurised Metered Dose Inhaler to be developed
A pharmaceutical company has announced its intention to create a pressurised Metered Dose Inhaler that will reduce the carbon footprint of the drug delivery system.
Once-a-month oral contraceptive pill one step closer
A new slow-release formulation and delivery system for the oral contraceptive pill has shown success in pre-clinical trials and could be taken once a month.
New opportunities for Indian pharma industry in Philippines, finds study
The Philippines’ 2019 Universal Health Care Act and regulatory tax reforms open new avenues for the Indian pharmaceutical industry, according to new research.
FDA approves new line of methotrexate products for rheumatoid arthritis
RediTrex, a new line of methotrexate products, has been approved by the FDA for the treatment of patients with rheumatoid arthritis.
Astellas enters into definitive agreement to acquire Audentes Therapeutics
Astellas has announced that it will be acquiring Audentes Therapeutics at a total cost of $3 billion.
NICE approves new tablet formulation for olaparib drug
The UK NICE has extended its approval for olaparib, updating its formulation from eight capsules twice a day to two tablets twice daily.
High levels of pharmaceutical pollution found in industrialising counties
A study has revealed that in industrialising and urbanising countries, pharmaceutical pollution in rivers could lead to antimicrobial resistance.
Strategies developed for improving drug delivery for brain tumour treatment
Scientists have proposed combining ultrasound with other techniques to improve drug transport into brain tumours.
Medicinal cannabis product granted approval in Ireland
A medicinal CBD oil has been approved for importation, prescription and supply under the Medical Cannabis Access Programme (MCAP) in Ireland.
