Tuesday, April 7, 2020

Tuesday, April 7, 2020

Latest News

GENETECH: FDA Accepts Genentech’s Biologics License Application for Satralizumab for Neuromyelitis Optica Spectrum Disorder

Satralizumab represents a potential new approach to treating neuromyelitis optica spectrum disorder (NMOSD), a rare, debilitating disease often misdiagnosed as multiple sclerosis (MS)

ALKERMES: Biogen and Alkermes Announce FDA Approval of VUMERITY™ (diroximel fumarate) for Multiple Sclerosis

VUMERITY, a New Oral Treatment Option for Relapsing Forms of MS, Offers a Combination of Well-Characterized Efficacy, Safety and Tolerability

ASTELLAS PHARMA: U.S. FDA Grants Fast Track Designation to Astellas for the Development of ASP1128 for Patients at Risk for Acute Kidney Injury

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of ASP1128 for patients at increased risk of developing moderate to severe acute kidney injury (AKI) after coronary artery bypass and/or valve (CABG/V) surgery.

MEDICINE360: FDA Approves Medicines360's LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Six Years, the Longest Approved Duration of Use of Any Hormonal IUDs

Medicines360, a global nonprofit organization with a mission to expand women's access to quality medicines, and Allergan plc (NYSE: AGN), a leading global pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) approved Medicines360's Supplemental New Drug Application (sNDA) to extend the duration of use of LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg for the prevention of pregnancy for up to six years.

BLUEWILLOW: Receives FDA Clearance to Begin Phase 1 Study of its Intranasal Anthrax Vaccine

BlueWillow Biologics®, a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for BW-1010, the company's next-generation anthrax vaccine candidate.

WOLFE EYE CLINIC: U.S. Food & Drug Administration Approves New Wet Age-Related Macular Degeneration Treatment

The highly anticipated approval of Beovu® (brolucizumab) may reduce the frequency of intravitreal injections for wet age-related macular degeneration patients following clinical trials at Wolfe Eye Clinic

ALZHEIMER'S ASSOCIATION: Statement Biogen to Submit Aducanumab Results in Early Alzheimer's to U.S. FDA

On behalf of the more than 5 million Americans living with Alzheimer's and their family members, the Alzheimer's Association is encouraged to learn that Biogen will pursue regulatory approval from the FDA for the investigational drug aducanumab based on Phase 3 clinical trial results from the EMERGE and ENGAGE studies, and other related data, after finding a reduction of cognitive and functional decline in people taking the high dose.

NOVO NORDISK: FDA approves Fiasp® for use in insulin infusion pumps for adults with type 1 or type 2 diabetes

Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has expanded the label for Fiasp® (insulin aspart injection) 100 u/mL to include use in insulin infusion pumps for the improvement of glycemic control in adults with type 1 or type 2 diabetes.1 Fiasp®, a rapid-acting insulin, was approved by the FDA in 2017 for use by intravenous infusion under supervision by a healthcare professional or by subcutaneous multiple daily injection (MDI) in adults with diabetes.

BERGENBIO ASA: Receives FDA Approval of Fast Track Designation for Bemcentinib

BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, today announces that the U.S. Food and Drug Administration (FDA) has approved Fast Track Designation for bemcentinib for the treatment of elderly patients with acute myeloid leukaemia (AML) whose disease has relapsed.

U.S. FDA: Approves new breakthrough therapy for cystic fibrosis

Treatment approved for approximately 90% of patients with cystic fibrosis, many of whom had no approved therapeutic options

SOPHIRIS BIO: Receives Positive Feedback from FDA Regarding Phase 3 Localized Prostate Cancer Clinical Trial Design

Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company studying topsalysin (PRX302), a first-in-class, pore-forming protein, in late-stage clinical trials for the treatment of patients with urological diseases, today announced that following an End of Phase 2/ Pre-Phase 3 meeting with the United States Food and Drug Administration (FDA), there is agreement regarding the design of a single Phase 3 clinical trial to evaluate the potential of topsalysin as a targeted focal therapy to treat patients with intermediate risk localized prostate cancer.

JANSSEN: Announces U.S. FDA Approval of STELARA® (ustekinumab) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis

In the Phase 3 pivotal trial, more than 40 percent of patients receiving STELARA subcutaneous (SC) injections every 8 weeks were in clinical remission at one year and not taking corticosteroids

NEUREN: FDA Grants Orphan Drug Designation for Neuren's NNZ-2591 to Treat Angelman, Phelan-McDermid and Pitt Hopkins Syndromes

Neuren Pharmaceuticals (ASX: NEU) announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to Neuren’s NNZ-2591 for the treatment of Angelman syndrome, Phelan-McDermid syndrome and Pitt Hopkins syndrome.

GENENTECH: Announces FDA Approval of Xofluza (Baloxavir Marboxil) for People at High Risk of Developing Influenza-Related Complications

Single-dose Xofluza is the first and only antiviral medicine indicated specifically for patients at high risk of developing serious complications from influenza (flu)

DAIICHI SANKYO: [Fam-] Trastuzumab Deruxtecan (DS-8201) Granted FDA Priority Review for Treatment of Patients with HER2 Positive Metastatic Breast Cancer

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for [fam-] trastuzumab deruxtecan (DS-8201) and granted Priority Review.

FDA Health News