Phase III programme for the use of otilimab for rheumatoid arthritis launched
A Phase III clinical development programme testing otilimab in patients with RA has begun.
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Crystallised drug formulation extends medical device function
A study has shown that crystallising drugs removes localised immune reaction, allowing long-term release of drugs from medical devices.
FDA releases guidance on pharmaceutical product labelling
New guidance drafts have been announced by the FDA to improve patients understanding and keep information consistent.
The Chief Executive of ABPI has announced his retirement
ABPI Chief Executive, Mike Thompson, will retire at the end of 2019.
Clinical trial sponsors called to publish results on EU database
All sponsors of clinical trials conducted in the European Union have been reminded of their obligation to make summaries of trial results.
Global pharmaceutical filler market set to increase 5.7 percent
The filler market is predicted to increase to US$2 billion by 2024, according to a new report.
FDA issues three warning letters to API re-packers
Three API re-packers who failed to meet current good manufacturing practice requirements have received warning letters from the FDA.
Report suggests process for vaccine trials during health crises
A recent report has presented an argument for updating vaccine development during health emergencies to increase efficiency.
New analysis shows that 3,400 drug prices have risen in 2019 so far
The price of over 3400 drugs have been hiked in the first half of 2019, surpassing the number of hikes imposed during the same period last year.
Trump administration sees FDA enforcement actions decline
A study has shown the warning letters the FDA distributes have decreased by a third since Trump came to office.
Macleods Pharmaceuticals issues recall due to NMBA impurities
Macleods has issued a recall of 32 lots of drug products that contained trace amounts of NMBA impurities.
Fasenra receives positive EU CHMP opinion for self-administration and the new Fasenra pen, a pre-filled, single-use auto-injector
AstraZeneca today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion to add a self-administration option for Fasenra (benralizumab) and a new delivery method as a pre-filled, single-use auto-injector (the Fasenra pen) to the medicine’s product information in the European…
FDA approves treatment for rare neurological disorder
An injection to treat NMOSD has been given approval by the FDA and has received orphan drug designation.
Pfizer successfully completes the acquisition of Therachon
Pharmaceutical company, Pfizer, has announced it has completed the acquisition of Therachon for $340 million.
Jet-lag medication approved by MHRA
The MHRA has given marketing authorisation for short-term jet-lag therapy in adults.
