FDA – Page 13

GBT Receives FDA Breakthrough Therapy Designation for Voxelotor for Treatment of Sickle Cell Disease (SCD)

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.

Source: finance.yahoo
540
January 16, 2018

Teva Announces U.S. FDA Approval of TRISENOX (arsenic trioxide) Injection for First Line Treatment of Acute Promyelocytic Leukemia

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

Source: finance.yahoo
551
January 16, 2018

APL arsenic trioxide FDA New Approvals Teva TRISENOX

Newly FDA-Approved Platform Will Rapidly “Manufacture” Stem Cells to Repair Our Bodies

Stem cells have the unique capability to transform into any sort of specialized cell needed in the body, making them especially promising for medicine that replaces nonfunctional or dead cells.

Source: Futurism
490
January 16, 2018

FDA New Approvals stem cells

FDA approves algorithm that predicts sudden patient deaths to help prevent them

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.

Source: Digital Trends
509
January 16, 2018

FDA healthcare technology New Approvals

UK Takes Stricter Stance on Human Factors Engineering for Medical Devices

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.

Source: Emergo
587
January 15, 2018

FDA medical device Policy

Celgene to Acquire Impact Biomedicines, Adding Fedratinib to Its Pipeline of Novel Therapies for Hematologic Malignancies

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.

Source: finance.yahoo
510
January 12, 2018

Celgene FDA Fedratinib Impact Market Views myelofibrosis

Is the $850,000 price tag for a blindness-curing gene therapy a sign of future medical costs?

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.

Source: New Atlas
446
January 11, 2018

FDA Gene therapy Market Views

Ionis’ Inotersen NDA Accepted for Priority Review by the FDA

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 ...

Source: Prnewswire;
477
January 10, 2018

FDA hATTR New Approvals TTR amyloidosis

FDA approves Mevion’s Hyperscan pencil beam scanning technology

Mevion S250i is a compact proton therapy system that has the capacity to deliver conformal radiation therapy treatments with the support of Hyperscan pencil beam scanning technology.

Source: MDBR
543
January 8, 2018

Company Insight FDA medical device

Sangamo partners with Pfizer to develop gene therapy for ALS

Sangamo Therapeutics Inc and Pfizer Inc said on Wednesday they would work together to develop a gene therapy to treat ALS

Source: Reuters
502
January 4, 2018

ALS Company Insight FDA Gene therapy Pfizer

GBT Receives FDA Breakthrough Therapy Designation for Voxelotor for Treatment of Sickle Cell Disease (SCD)

Teva Announces U.S. FDA Approval of TRISENOX (arsenic trioxide) Injection for First Line Treatment of Acute Promyelocytic Leukemia

Newly FDA-Approved Platform Will Rapidly “Manufacture” Stem Cells to Repair Our Bodies

FDA approves algorithm that predicts sudden patient deaths to help prevent them

UK Takes Stricter Stance on Human Factors Engineering for Medical Devices

Celgene to Acquire Impact Biomedicines, Adding Fedratinib to Its Pipeline of Novel Therapies for Hematologic Malignancies

Is the $850,000 price tag for a blindness-curing gene therapy a sign of future medical costs?

Ionis’ Inotersen NDA Accepted for Priority Review by the FDA

FDA approves Mevion’s Hyperscan pencil beam scanning technology

Sangamo partners with Pfizer to develop gene therapy for ALS

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