A growing client base in the US and healthy demand for highly potent active pharmaceutical ingredients (HPAPIs) are driving expansion at the UK-based CDMO Sterling Pharma Solutions.
Mylan says ‘minor deficiencies’ in its abbreviated new drug application for its proposed generic version of GSK’s Advair Diskus have prompted the US FDA to issue a complete response letter.
DSP has released its generic Atorvastatin drug product within the EU with additional markets to be added later this year the firm looks to become a full-service generics company.
A lack of ‘basic documentation’ and ‘dubious’ environmental control system reports at Taiwan Biotech’s manufacturing plant were cited in the US FDA warning letter.
The Republic of Ireland’s competitive corporate tax rate represents a ‘stability’ that may not be found in other economies, says IDA Ireland executive.
Oral tolerability concerns have prompted the US biotech to close Ph II clinical trial investigations of FLX-787 in amyotrophic lateral sclerosis (ALS) and Charcot-Marie-Tooth (CMT).
Alcami began work on Flexion Therapeutics's ZILRETTA in the fall of 2014 and today announced that it will further support commercial supply of the product, which is approved for the treatment of OA-related knee pain.
Cambrex’s news that it will be constructing a research and development laboratory at its Italy-based site follows on the heels of its recently announced plans to begin a $5m expansion in Sweden.
