Actelion receives FDA approval for 32mg Tracleer to treat paediatric PAH patients
Actelion Pharmaceuticals US, a Janssen Pharmaceutical Company of Johnson& Johnson, has received US Food and Drug Administration (FDA) approval for Tracleer (bosentan) to be used in paediatric patients with idiopathic or congenital pulmonary arterial … (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - September 6, 2017 Category: Pharmaceuticals Source Type: news
Sanofi and Axxam start new CNS research collaboration
French pharmaceutical company Sanofi and Italian biotech firm Axxam have entered a new research collaboration in the field of neurodegenerative disorders. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - September 6, 2017 Category: Pharmaceuticals Source Type: news
Merck to buy German biotech Rigontec for €115m
Merck is set to acquire German biotechnology firm Rigontec for an upfront cash payment of €115m. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - September 6, 2017 Category: Pharmaceuticals Source Type: news
Case Study: Distributing Light-Sensitive, Fragile Ampoules for a Double Blind Clinical Study
One of the major pharmaceutical companies approached Fisher Clinical Services to discuss a complex request. The company were conducting a double blind study with a light sensitive drug in extremely fragile ampoules. It wanted Fisher Clinical Services … (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - September 6, 2017 Category: Pharmaceuticals Source Type: news
Catalent to Manufacture Opiod Discontinuation Treatment Iofexidine
Catalent Pharma Solutions has announced it has entered an exclusive agreement with US WorldMeds for the commercial manufacture of lofexidine, an investigational drug under development to mitigate symptoms associated with opioid withdrawal and facilit … (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - September 6, 2017 Category: Pharmaceuticals Source Type: news
New 787 Routes from Vancouver Coming in 2018
Air Canada Cargo has announced it will be launching three new routes from Vancouver in 2018, all operated by 787 Dreamliner aircraft. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - September 6, 2017 Category: Pharmaceuticals Source Type: news
Over-the-Counter User Fees? OMUFA?
If the Over-the-Counter (OTC) Monograph User Fee Programme (OMUFA) is passed, it will include pre-submission meetings for proposed monograph changes. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - September 6, 2017 Category: Pharmaceuticals Source Type: news
Navesta Pharmaceuticals' Sterile Pharmaceutical Manufacturing Plant
Sri Lanka-based company Navesta Pharmaceuticals has opened a sterile manufacturing facility in the town of Horana in August 2017. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - September 5, 2017 Category: Pharmaceuticals Source Type: news
UK NICE issues second draft ‘no’ on Ninlaro to treat myeloma patients
The UK National Institute for Health and Care Excellence (NICE) has issued a second draft ‘no’ on Takeda’s Ninlaro (ixazomib) for the treatment of patients with relapsed or refractory myeloma. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - September 5, 2017 Category: Pharmaceuticals Source Type: news
TiGenix obtains production licence for expanded adipose-derived stem cells in Spain
Belgian biopharmaceutical company TiGenix has received a licence for the commercial production of expanded adipose-derived stem cells (eASCs) at its extended manufacturing facility in Madrid, Spain. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - September 5, 2017 Category: Pharmaceuticals Source Type: news
FDA grants rare paediatric disease designation for Novimmune ’s HLH emapalumab treatment
Swiss biopharmaceutical company Novimmune has received rare paediatric disease designation for its lead drug emapalumab from the US Food and Drug Administration (FDA) to treat patients with primary haemophagocytic lymphohistiocytosis (HLH). (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - September 5, 2017 Category: Pharmaceuticals Source Type: news
Abiogen Pharma-R & D, Production, Contract Manufacturing, and Marketing of Pharmaceutical Drugs
Abiogen Pharma is a specialist pharmaceutical company that focuses on bone metabolism and rare diseases. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - September 5, 2017 Category: Pharmaceuticals Source Type: news
A Guide Accross the Regulatory and Scientific Terrain
Pharmaceutical Development Group (PDG) is a drug and medical device consultant that continuously engages in meetings and interactions with the US Food and Drug Administration (FDA). (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - September 5, 2017 Category: Pharmaceuticals Source Type: news
Fixed-Dose Combinations for Prevention and Nutrition
Procaps is a global pharmaceutical group dedicated to delivering innovation, health, and nutrition. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - September 5, 2017 Category: Pharmaceuticals Source Type: news
Manufacturers and Contract Packagers May Miss Serialisation Deadlines
Industry research conducted in May this year revealed that more than one third (36%) of pharmaceutical manufacturers and contract packagers were not preparing for global serialisation requirements, despite impending deadlines. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - September 5, 2017 Category: Pharmaceuticals Source Type: news
