Keyword: Food and Drug Administration (FDA)

News

European Price Wars Seen Shaping up Over Hepatitis C Drugs

20.01.2015 - Europe, where about 15 million people are believed to be infected with hepatitis C, could become the next battleground between US drugmakers Gilead Sciences and AbbVie in their...

News

Bayer’s Gadavist Approved by FDA for MRI in Infants

12.01.2015 - Bayer HealthCare's Gadavist (gadobutrol) injection contrast medium has been approved by the US Food and Drug Administration for use with magnetic resonance imaging (MRI) in...

News

Express Scripts to Reimburse AbbVie Hepatitis C Drug

23.12.2014 - The largest pharmacy benefit manager in the US, Express Scripts, has negotiated a cheaper price from AbbVie for its Viekira Pak hepatitis C treatment approved by the US Food and...

Plant Construction & Process Technology

Trust is Good, Control is Better

25.11.2014 - Monitoring process performance is a critical requirement in any manufacturing process as producing quality products within specification reproducibly is a prerequisite of an...

News

Bayer Said to Face US Litigation Over Xarelto Side Effects

16.10.2014 - Bayer soon may find itself regretting its decision to sell its plastics business and become a pure life science player. According to international press reports, the German group's...

Plant Construction & Process Technology

The EXCiPACT Certification Scheme

05.10.2014 - Excipients, together with an active pharmaceutical ingredient (API), are formulated into a final drug that is either prescribed to a patient by a doctor or bought over-the-counter...

Strategy & Management

Discovering the Future of Pharma

30.09.2014 - Dramatic changes to the scientific and business environments have made it impossible for pharmaceutical companies to continue operating as they have in the past. A perceived...

News

Mylan Trims Forecast Due to FDA Approval Delays

12.08.2014 - US generic drugmaker Mylan has shaved the top end of its full-year revenue and earnings forecasts slightly, citing delays in approval from the US Food and Drug Administration for...