Piero Iamartino coordinates the new AFI’s Pharmaceutical Technology working group, together with professor Andrea Gazzaniga of the University of Milan. He summarizes for Pharma World the history and final goals of the MCS initiative, originally proposed in 2014 by a British university-industry mixed working group led by representatives of three big pharma, Bristol-Myers Squibb, GlaxoSmithKline ...

Zeria Pharmaceutical Co., Ltd. (Headquarters: Chuo-ku, Tokyo; President and CEO: Sachiaki Ibe; “Zeria”) and Astellas Pharma Inc. (Headquarters: Chuo-ku, Tokyo; President and CEO: Masafumi Nogimori; “Astellas Pharma”) announced today that Zeria had submitted the application for marketing approval of the therapeutic agent (nonproprietary name: acotiamide hydrochloride hydrate; “acotiamide”; Zeria...

NEW DRUGS Generic Fludara for Leukemia Bioniche Pharma has received the FDA’s approval for its Abbreviated New Drug Application (ANDA) for fludarabine phosphate injection USP, 25 mg/ mL. The product is packaged in 50-mg/ 2-mL, single-dose vials. Fludarabine is a chemotherapy agent for treating B-cell chronic lymphocytic leukemia (CLL). The product is bioequivalent and therapeutically equivalent...

1Department of Medicine I, Wilhelminenspital Vienna, Vienna, Austria; 2Internal Hematooncological Clinic, Faculty Hospital Brno and Faculty of Medicine MU, Brno, Czech Republic; 3Clinic of Hematology, Faculty Hospital with Policlinic, Kosice, Slovakia; 4Clinical Division of Oncology, Medical University of Vienna, Vienna, Austria; 5Clinical Hospital “Rebro,” Zagreb, Croatia; 6Department of Inter...

The pharmaceutical industry has been receiving greater scrutiny lately due in large part to the many public and private legal enforcement actions taken against pharmaceutical manufacturers. These enforcement actions, along with legal developments such as the OIG Compliance Guidance for Pharmaceutical Manufacturers, the Sarbanes-Oxley Act's statutory guidelines for public corporations, the HIPAA...

Partnering is an ideal field if someone is seeking to move from a scientific to a more business-oriented discipline. Partnering's goal is to identify and acquire external innovation. These discoveries are then included in a company's pipeline and help bring novel treatments to patients. Advanced scientific training is essential in the identification and evaluation of these external assets. Here...

I1 Models of respiratory disease symposium Kathy H Abbott-Banner, Anthony Holmes, Ian Adcock, Navin L Rao, Edward Barrett, Richard Knowles Present address: Verona Pharma plc, Suite 21 Alpha House, 100 Borough High Street, London, SE1 1LB, UK; NC3Rs, Gibbs Building, 215 Euston Road, London, NW1 2BE, UK; National Heart and Lung Institute, Imperial College London, Dovehouse Street, London, SW3 6LY...