M2 Pharma - Policy and Regulations

BioPharma Services awarded WHO's stamp of approval to support pharmaceutical companies in treating HIV/AIDS, TB and malaria

20 November 2018 - BioPharma Services Inc (BioPharma) revealed on Monday that it has successful passed World Health Organization (WHO) GCP/GLP/BE assessment and review of its Toronto, Canada site.The ...

Genmab receives positive opinion from CHMP on split dosing regimen for DARZALEX in EU

20 November 2018 - Genmab A/S (CPH:GEN), a biotechnology company specialising in the creation and development of differentiated antibody therapeutics for the treatment of cancer, announced on Monday t...

Roivant Sciences signs global licensing agreement with iNtRON Biotechnology

20 November 2018 - Roivant Sciences, a company that in-licenses late-stage drug candidates and develops them through subsidiaries, has signed a global licensing agreement with Korea-based iNtRON Biote...

AstraZeneca's Imfinzi fails phase III Mystic lung cancer trial

20 November 2018 - Anglo–Swedish multinational pharmaceutical and biopharmaceutical company AstraZeneca's Imfinzi (durvalumab) monotherapy and the combination of Imfinzi with remelimumab ha...

Novartis' Promacta receives US FDA approval for first-line SAA

20 November 2018 - The US Food and Drug Administration (FDA) has approved the expansion of the label for Switzerland-based Novartis' Promacta (eltrombopag) to include first-line treatment for adu...

Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Opdivo (nivolumab) Plus Low-Dose Yervoy (ipilimumab) as First-Line Treatment for Patients with Intermediate- and Poor-Risk Advanced Renal Cell Carci

20 November 2018 - - The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending approval of the Opdivo (nivolumab) plus low-d...