The US FDA has accepted a supplemental BLA to Roche’s existing market approval of the new hemophilia A treatment Hemlibra (emicizumab), which could significantly extend the patient group covered by the label. 

Hikma Pharmaceuticals PLC announces the appointment of Henriette Nielsen to the newly created role of Chief Transformation Officer.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended nine medicines for approval, including two orphan medicines, at its May 2018 meeting.

Despite seemingly insurmountable environmental challenges ahead and the many ‘successes’ flaunted by big biorefinery projects, the wider business community remains stubbornly sceptical about developing business within the bio-based paradigm. Now policymakers are pushing financiers to take a bigger stake in its success. New efforts are underway to drive private investment in bioeconomy ventures.

Sygnature Discovery, thas appointed Dr Bill Marathias as Vice President of Business Development for the US to assist with the company’s international growth plans.

French researchers have found a key driver of chronic epilepsy. 

Bavarian Nordic A/S today announced the appointment of Henrik Juuel to the position of Executive Vice President and Chief Financial Officer. Mr. Juuel is currently the CFO of Orexo AB.

Brain disease specialist Denali Therapeutics will buy all outstanding shares in British F-Star Gamma Ltd from F-Star instead licencing bispecific antibody candidates that can cross the blood-brain barrier (BBB) co-developed under an agreement dating back to 2016.

Nordic Nanovector ASA today announces that Rainer Boehm, MD was elected as a member of its Board of Directors at the company’s Annual General Meeting on 30 May 2018.

Roche announced that atezolimumab plus chemotherapy met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) as first-line treatment of stage IV nonsquamous non small cell lung cancer (NSCLC).