Boehringer Ingelheim announced the approval of a new indication for afatinib (Gilotrif), as the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (NDA) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.
Global Blood Therapeutics, Inc. (GBT) (GBT) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to voxelotor (previously called GBT440) for the treatment of sickle cell disease (SCD). Voxelotor is being developed as a disease-modifying therapy for SCD and previously received European Medicines Agency (EMA) Priority Medicines (PRIME) designation for the treatment of SCD.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced that the U.S. Food and Drug Administration (FDA) has approved the use of TRISENOX® (arsenic trioxide) injection in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. The approval was based on a Priority Review by the FDA on data from published scientific literature and a review of Teva’s global safety database for arsenic trioxide
Wave Clinical Platform is the work of ExcelMedical and is a system that monitors patients' vital signs, sending alerts that warn of potentially fatal heart attacks or respiratory failure up to six hours before a patient suffers such an event.
Recent guidance from UK medical device market regulators on human factors engineering (HFE) includes some recommendations that differ from HFE requirements established in Europe, suggesting a more standalone British approach to some areas of device development.
Celgene Corporation (CELG) and Impact Biomedicines today announced the signing of a definitive agreement in which Celgene will acquire Impact Biomedicines, which is developing fedratinib for myelofibrosis and polycythemia vera. Under the terms of the agreement, Celgene will pay approximately $1.1 billion upfront and up to $1.25 billion in contingent payments based on regulatory approval milestones for myelofibrosis. Additional future payments for regulatory approvals in additional indications and sales-based milestones are also possible.
Gene therapies are an undeniably exciting new frontier for medicine. From Kymriah's genetically modified, cancer-hunting immune cells, to Luxturna's vision-restoring healthy gene replacement, these therapies are fundamentally unlike 20th-century medicines which generally require ongoing drug treatment. Gene therapies can be one-off doses that in effect, cure a specific disease.
Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced that its New Drug Application (NDA) for inotersen has been accepted for Priority Review by the U.S. Food and Drug Administration (FDA). Inotersen is an investigational drug for the treatment of patients with hereditary TTR amyloidosis (hATTR). Priority Review is granted by the FDA to drugs with the potential to address a serious condition and, if approved, would provide a significant improvement in safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of July 6, 2018. “TTR amyloidosis is a progressive, fatal disease with very limited treatment options. Receiving Priority Review in the U.S. and Accelerated Assessment in the EU for inotersen shows that the regulatory agencies recognize the high unmet need and the urgency to identify effective therapies to treat patients with this devastating disease,” said Sarah ...
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