Entries by Thomas Gabrielczyk

Poor investigator brochures: Resarchers call for standardisation

Human drug trials are compromised by poor reporting and potential bias of animal research. German researchers analysed more than 700 preclinical animal studies and investigator brochures provided by three medical centres. They call to establish documentation standards for IBs/preclinical dossiers.

Ose and Boehringer ink €1.1bn deal in immunoncology

French  Ose Immunotherapeutics SA has licenced global commercialisation rights of its preclinical programme OSE-172 to Boehringer Ingelheim which hopes to complement its immunoncology portfolio with a tumour microenvironment modifier that reactivates effector T cell responses. 

Learning from the small molecule supply chain

Rutger Oudejans, Brand Director at bioLIVE, postulates that the bio supply chain could learn some lessons from the small molecules sector. The bio industry continues to expand at rates above the traditional NCE (New Chemical Entity) sector, yet for the supply chain there are vital synergies that could help further accelerate developments.

Motif Bio to submit NDA for iclaprim

Motif Bio has initiated a NDA rolling submission for iclaprim, a Gram-positive-targeted investigational antibiotic for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in high-risk MRSA (Methicillin-resistant S. aureus) patients. 

Takeda announced bid for Shire

Japanese drug giant Takeda Pharmaceutical Co. Ltd. has confirmed its intention to make a bid for orphan drug leader and neurology specialist Shire plc. The take-over offer has to be made until 25 April.

Roche reports 5 deaths after dosing of Hemlibra

Roche’s US arm Genentech has confirmed a total of 5 deaths in adult patients who were dosed with its 
to-be hemophilia blockbuster emicizumab (Hemlibra), a BITE antibody that mimics the effect of Factor VIII which lack patients with hemophilia A.

Ablynx’ SLE antibody vobarilizumab miss endpoint

Belgian nanobody maker Ablynx’ IL-6 receptor blocker vobarilizumab didn’t met the primary endpoint of  dose response at 24 weeks in a Phase II study enroling 312 patients with severe, active seropositive systemic lupus erythematosus (SLE).