Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) submitted by Samsung Bioepis Co., Ltd. for SB2 (infliximab), an investigational biosimilar candidate of Remicade.
Profound Medical Corp. announced that it has been granted Investigational Device Exemption (“IDE”) approval from the U.S. Food and Drug Administration (“FDA”), for a multicenter Pivotal Clinical Trial (“Pivotal Trial”). The objective of this trial is to evaluate the efficacy of the TULSA-PROTM System in patients with localized prostate cancer.
Pain Therapeutics, Inc. announced that an Advisory Committee of the U.S. Food and Drug Administration (FDA) will review the REMOXY® New Drug Application (NDA), tentatively scheduled for Friday, August 5, 2016. This is intended to be a joint meeting of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee.
Millennium Dental Technologies (MDT) is pleased to announce a first-of-its-kind 510(k) clearance from the Food and Drug Administration (FDA) for periodontal regeneration – true regeneration of the attachment apparatus (new cementum, new periodontal ligament, and new alveolar bone) on a previously diseased root surface when used specifically in the LANAP® protocol.
VM BioPharma, the United States division of ViroMed Co., Ltd. in Seoul, South Korea announced that the U.S. Food and Drug Administration FDA has granted Fast Track designation for the Companys lead investigational drug, VM202, a Phase 2 novel gene therapy for the potential treatment of Amyotrophic Lateral Sclerosis, ALS.
ViroMed is anticipating the publication of data from the Phase 1/2 trial of VM202 in ALS in the second half of the year. The primary endpoint of the trial was the safety and tolerability of VM202, and measures of the ALS Functional Rating Scale (ALSFRS-r) and other efficacy parameters were studied as secondary endpoints.
"We are very pleased to announce that the FDA has granted Fast Track designation for VM202 in the potential treatment of ALS. This status underscores the need to expedite potentially new and important treatment options for the ALS community," said Dr. Seungshin Yu, head of new business development of ViroMed Co., Ltd. "The Fast Track designation, coupled with the recent Orphan Drug designation from the FDA, provides even more momentum in our work to address the urgent and significant unmet medical need that remains in the treatment of people with ALS."
Through the Fast Track program, a product may be eligible for priority review at the time of a new drug application (NDA) filing and may also be eligible to submit completed sections of the NDA on a rolling basis before the complete application is submitted. These expedited processes can significantly cut down the development time and cost associated with bringing a drug to market, and the orphan-drug designation also allows for 7 years of market exclusivity even after expiration of related patents.
Neos Therapeutics, Inc. announced that Adzenys XR-ODT™ is in distribution channels and is now available to prescribe to patients with ADHD in the United States. Adzenys XR-ODT was approved by the U.S. Food and Drug Administration (FDA) in January for the treatment of ADHD in patients six years and older and is the first and only extended-release orally disintegrating tablet (XR-ODT) for the treatment of ADHD. Adzenys XR-ODT is bioequivalent to Adderall XR®, one of the most commonly prescribed medications for the treatment of ADHD.
H3 Biomedicine Inc., announced that the U.S. Food and Drug Administration (FDA) accepted the company’s Investigational New Drug (IND) application to begin Phase 1 clinical trials for its lead oncology drug candidate H3B-8800. The compound is an oral and selective small molecule modulator of splicing factor 3b subunit 1 (SF3B1), which is being developed by H3 Biomedicine as an anticancer therapeutic agent for the potential treatment of select hematologic malignancies.
AstraZeneca announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for the investigational MEK 1/2 inhibitor, selumetinib (AZD6244, ARRY-142886) for adjuvant treatment of patients with stage III or IV differentiated thyroid cancer (DTC). AstraZeneca acquired exclusive worldwide rights to selumetinib from Array BioPharma Inc. in 2003.
The U.S. Food and Drug Administration finalize rule that revises its annual reporting requirements for drug sponsors of all antimicrobials sold or distributed for use in animals intended for human consumption or food-producing animals. The new sales data will improve the agency’s understanding of how antimicrobials are sold and distributed for use in major food-producing species and help further target efforts to ensure judicious use of medically important antimicrobials.
Allena Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Allena’s investigational therapy oxalate decarboxylase for the treatment of pediatric hyperoxaluria.
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