Genentech announced that the U.S. FDA approved Perjeta (pertuzumab), in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence.
The last several years has shown a particular focus on immuno-oncology therapies, probably as close to miracle cures as anything seen in recent years. Arpita Dutt, writing for Zacks, predicts what the three hot areas for approvals are likely to be in 2018.
Orchard Therapeutics said it raised $110 million in the second round of funding as the drug developer looks to launch its gene therapy to treat a rare inherited disorder and beef up manufacturing facilities.
The FDA approved Aerie Pharmaceuticals Inc.’s eyedrop Rhopressa as a treatment for glaucoma, two months ahead of the expected date.
Novartis picked up a priority review voucher in a $130 million deal with California-based Ultragenyx Pharmaceutical Inc. The PRV is for rare pediatric diseases.
Allergan and Gedeon Richter’s drug cariprazine to treat severe bipolar depression in adults met the main goal of a late-stage study.
US FDA Accepts Regulatory Submission for Tagrisso in First-Line EGFR-Mutated Non-Small Cell Lung Cancer
AstraZeneca announced that the U.S. Food and Drug Administration accepted a supplemental New Drug Application for the use of Tagrisso (osimertinib) – a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor with clinical activity against central nervous system metastases – in the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have EGFR mutations.
Athersys Inc. and Mesoblast Ltd. are beginning final-stage trials in hundreds of patients that they – along with loyal investors – say could change the course of devastating stroke and heart failure.
Roche’s patent dispute with London-listed Shire over the Swiss drugmaker’s new hemophilia drug Hemlibra escalated, with Shire filing a new motion in a U.S. court that Roche says aims to stop some patients from getting its medicine.
The U.S. FDA approved two doses of Pfizer Inc.’s medicine Xeljanz for treating active psoriatic arthritis.