Pharma News

Bayer and Orion Corporation announced the expansion of the global clinical development programme for the investigational androgen receptor (AR) antagonist BAY-1841788 (ODM-201) in the area of prostate cancer. A new phase III study ARASENS will evaluate the compound in combination with standard androgen deprivation therapy (ADT) and the chemotherapy docetaxel in men with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC), who are starting first line hormone therapy.

Novartis announced  that the European Commission has approved Afinitor® (everolimus) tablets for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin in adults with progressive disease. Afinitor is the first approved therapy in all 28 member states of the European Union (EU), plus Iceland and Norway, for this type of lung NET, and one of very few treatment options available for this type of GI NET.

Shire plc, a leading global biotechnology company, completed its previously announced combination with Baxalta Incorporated, creating the leading global biotechnology company focused on serving patients with rare diseases and other highly specialized conditions.

Therabron Therapeutics, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to rhCC10 (recombinant human Club Cell 10 kDa Protein), the company’s lead product candidate,for the prevention of bronchopulmonary dysplasia and chronic respiratory morbidity (CRM) in preterm infants. The Rare Pediatric Disease Designation supplements the Fast Track Designation recently granted by the FDA for rhCC10. This program has also previously been granted Orphan Status by both the US and EU Health Authorities.

As part of Johnson & Johnson’s commitment to combat Ebola, Janssen Pharmaceutica NV  announced that the Idylla™ Ebola Virus Triage Test (Idylla™ EBOV Test) was granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA). The Idylla™ Ebola Virus Triage Test is a diagnostic that detects the presence of the Ebola Zaire virus in patients with signs and symptoms of Ebola virus disease and was jointly developed by Janssen Diagnostics, a division of Janssen Pharmaceutica, Biocartis NV (Biocartis), and the Belgium Institute of Tropical Medicine.

Pixium Vision, a company developing innovative bionic vision systems to allow patients who have lost their sight to lead more independent lives, has received approval from the Medicines & Healthcare products Regulatory Agency (MHRA) in the UK to initiate a clinical trial for patients who have lost sight due to retinitis pigmentosa (RP) with the IRIS II bionic vision system. This system being evaluated includes a mini bio-inspired camera and a 150 electrode epi-retinal implant with an explantable design.

Vertex Pharmaceuticals Incorporated, a global biotechnology company, announced that the US Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for the use of Orkambi (lumacaftor/ivacaftor) in people with cystic fibrosis (CF) ages 6 to 11 who have two copies of the F508del mutation. The FDA granted Vertex's request for Priority Review of this sNDA, and a target review date of September 30, 2016 was set under the Prescription Drug User Fee Act (PDUFA).