United States

CSL Behring receives Orphan Drug exclusivity for Haegarda

Monday, July 24, 2017

CSL Behring announced that the FDA has granted the company seven years of orphan drug exclusivity for Haegarda (C1 Esterase Inhibitor Subcutaneous [Human]), the first and only subcutaneous treatment option for prevention of hereditary angioedema (HAE) attacks. Haegarda was approved by the FDA on June 22, 2017 for routine prophylaxis to prevent HAE attacks in adolescent and adult patients, and marketing exclusivity will continue through June 22, 2024.

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FDA accepts Amgen’s Aimovig BLA for migraine

Monday, July 24, 2017

Amgen announced that the FDA has accepted for review the Biologics License Application (BLA) for Aimovig (erenumab) for the prevention of migraine in patients experiencing four or more migraine days per month. If approved, Aimovig is expected to be the first-and-only monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) receptor, specifically designed for the prevention of migraine.

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Crohn’s & Colitis Foundation launches IBD Clinical Trials Community

Monday, July 24, 2017

Clinical trial recruitment is a challenging step toward FDA approval of new treatments for patients across all disease states; this is especially true for inflammatory bowel diseases (IBD). The Crohn’s & Colitis Foundation launched a dedicated Clinical Trials Community for IBD. The Community is designed to educate patients, caregivers, and healthcare providers about the clinical trial process, its value, and how to address barriers that exist in enrollment.

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FDA Accepts Otonomy’s Otiprio sNDA filing for acute otitis externa

Wednesday, July 19, 2017

Otonomy, a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, announced that its Supplemental New Drug Application (sNDA) for the approval of OTIPRIO as a treatment of acute otitis externa (AOE) has been accepted for filing by the FDA and been assigned a Prescription Drug User Fee Act (PDUFA) action date of March 2, 2018. The acceptance of the sNDA indicates that the application is sufficiently complete to permit a substantive review by the FDA.

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Sangamo receives FDA Fast Track for SB-318a SB-913

Monday, July 17, 2017

Sangamo Therapeutics announced that the FDA has granted Fast Track designation to SB-318 and SB-913, the company’s clinical stage in vivo genome editing product candidates for the treatment of Mucopolysaccharidosis Type I (MPS I) and MPS II, respectively. The FDA’s Fast Track designation is designed to facilitate the development and expedite the review of drugs and biologics to treat serious conditions and fill an unmet medical need. Once a drug receives Fast Track designation, early and frequent communication with the FDA is encouraged throughout the development and review process. The frequency of communication is designed to ensure that questions and issues are resolved quickly, potentially leading to earlier drug approval and access by patients.

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Helius, USAMRMC enroll last subject enrolled in TBI trial

Monday, July 17, 2017

Helius Medical Technologies, a medical technology company focused on the treatment of neurological symptoms caused by disease or trauma, and the United States Army Medical Research and Materiel Command (USAMRMC) announce that the last subject has been enrolled in the registrational clinical trial to investigate the safety and effectiveness of the Portable Neuromodulation Stimulator (PoNS) device for the rehabilitation of chronic balance deficits caused by mild-to-moderate Traumatic Brain Injury (mTBI). The trial is intended to serve as the basis for Helius to submit applications for marketing clearance in the U.S., Canada and Europe for the PoNS device.

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Clinical Trial Finder launches online

Monday, July 17, 2017

Clinical trials are the key to new cancer treatments. However, less than 3% of cancer patients participate in these types of studies. In the case of colorectal cancer, the number is less than half of that.

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Innovation Initiative to modernize the FDA

Monday, July 17, 2017

New FDA Commissioner Scott Gottlieb intends to release a far-reaching plan aimed at modernizing regulatory processes and speeding approvals for new drugs and devices, which could allow greater patient access to new medicines through unprecedented scientific and technological advancements.

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