Entries by Thomas Gabrielczyk

Roche set to extend Hemlibra label

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. 

EMA recommends nine drugs for approval

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.

Follow the money – from niche to norm

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.

Denali bags F-Star Gamma

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.

Roche mets endpoints in first-line NSCLC study

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).

Janssen ends combo with daratumumab

Following reports of an increase in mortality in a study that combined Genmab’s anti-CD38 daratumumab with a PD-L1 blocker, Genmab’s partner Janssen has stopped a study combining daratumumab with its PD1 blocker JNJ-63723283 in multiple myeloma.