Phase III trial

Pfizer and Astellas have announced positive top-line results from the Phase III EMBARK trial evaluating XTANDI (enzalutamide) in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR). Patients enrolled in the trial were randomised to one of three study arms: XTANDI plus leuprolide, placebo plus leuprolide, or XTANDI monotherapy. The study met […]

The combination therapy of niraparib and abiraterone acetate (AA) could become the first dual action tablet (DAT) available in the European Union for metastatic castration-resistant prostate cancer (mCRPC) with BRCA1/2 mutations.  Janssen’s Akeega has been recommended for marketing authorisation when given with prednisone (P) or prednisolone by the Committee for Medicinal Products for Human Use […]

Under a new agreement, Destiny Pharma and Sebela Pharmaceuticals will co-develop NTCD-M3, Destiny’s lead asset for the prevention of Clostridioides difficile infection (CDI) recurrence.  It is anticipated that Sebela will lead and finance the future clinical development and commercialisation activities of NTCD-M3 in North America.   Destiny will keep most rights for Europe and Rest of […]

Covid-19 booster candidate UB-612 has achieved its immunogenicity endpoints in a head-to-head trial against three vaccine platforms: mRNA (Pfizer-BioNTech’s BNT162b2), adenovirus vector (AstraZeneca’s ChAdOx1-S), and inactivated virus (Sinopharm’s BIBP).  The results show UB-612 elicits superior neutralising antibody titers and seroconversion rates against both Wuhan and Omicron BA.5 variants compared to adenovirus vector (ChAdOx1-S) and inactivated […]

Janssen has revealed updated results from the Phase III MAGNITUDE study, which show that a combination therapy including niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, slowed prostate cancer progression.  The drug was investigated in combination with abiraterone acetate plus prednisone (AAP) in patients with metastatic castration-resistant prostate cancer (mCRPC) with or without specific homologous recombination […]

UCB’s Fintepla (fenfluramine) oral solution has been approved in the European Union (EU) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS).  It has received authorisation as an add-on therapy to other anti-epileptic medicines for patients two years of age and older.  The approval was based on safety and efficacy data from a global, […]

News round-up for 6-10 February by DDW Digital Content Editor Diana Spencer.  Clinical drug trials have made the headlines this week, as it was revealed that breast cancer still tops the bill for number of clinical studies and the shortcomings in current methods to ensure representation of patient populations in trials were exposed.  There were two significant […]

Pierre Fabre will commercialise and distribute the first approved allogeneic T cell immunotherapy in Europe following the transfer of the European Commission marketing authorisation of Ebvallo (tabelecleucel) from Atara Biotherapeutics.  Ebvallo is the only approved therapy for the treatment of relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease (EBV+ PTLD) in the EU.  Pierre […]

Why data from a Phase III clinical trial offers promise for patients with a deadly form of brain cancer. A Phase III clinical trial has produced promising results for a cancer vaccine targeting patients with a new or recurrent glioblastoma.  The study, which involved 331 patients, wanted to assess whether or not the DCVax-L vaccine […]

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Takeda’s vaccine candidate Qdenga for active immunisation against dengue infection from four years of age.  Dengue is the fastest spreading mosquito-borne virus and was recognised by the World Health Organization (WHO) in 2019 as one of the top ten threats to […]