The U.S. Food and Drug Administration has approved the new drug tecovirimat to treat smallpox, the first drug against the deadly disease since a huge vaccination campaign over three decades ago. To address the risk of bio-terrorism, Congress has taken steps to enable the development and approval of countermeasures to thwart pathogens that
By a News Reporter-Staff News Editor at Pharma Business Week A patent application by the inventor Yamamoto, Akira, filed on February 26, 2018, was made available online on July 5, 2018, according to news reporting originating from Washington, D.C., by NewsRx correspondents. This patent application has not been assigned to a company or institution
By a News Reporter-Staff News Editor at Pharma Business Week A patent application by the inventor ROTUNDA, ADAM M., filed on December 28, 2016, was made available online on July 5, 2018, according to news reporting originating from Washington, D.C., by NewsRx correspondents. This patent application has not been assigned to a company or institutio
Gainers Tonix Pharmaceuticals Holding Corp. rose 29.2 percent to $5.10 in pre-market trading after the company disclosed that it has received Fast Track designation from the U.S. FDA for TNX-102 SL for the treatment of agitation in Alzheimer's disease. Coda Octopus Group, Inc. rose 26 percent to $4.71 in pre-market trading after the company disclos
ABBOTT PARK- Abbott today announced it received approval from the U.S. Food and Drug Administration for a next-generation version of its leading MitraClip heart valve repair device used to repair a leaky mitral valve without open-heart surgery. Abbott received CE Mark for the next-generation device earlier this year, allowing for sale of the device
NORTH CHICAGO- AbbVie, a research-based global biopharmaceutical company, today announced it submitted a supplemental New Drug Application to the U.S. Food and Drug Administration for venetoclax in combination with a hypomethylating agent or in combination with low-dose cytarabine for the treatment of newly diagnosed patients with acute myeloid...
CAMBRIDGE- Acceleron Pharma Inc., a leading biopharmaceutical company in the discovery and development of TGF-beta therapeutics to treat serious and rare diseases, today announced that the United States Food and Drug Administration has granted orphan drug designation for ACE-083, the Company's locally acting' Myostatin+' muscle agent, for the treat
Advaxis Inc. jumped $0.26 to $1.48 in morning trading Friday after it said FDA lifted a clinical hold on a Phase I/II combination study that includes the company's axalimogene filolisbac. Advaxis said Friday it is implementing new guidelines for early detection and treatment of safety-related events. On Tuesday, Advaxis said it has withdrawn the...
SUMMARY: The Food and Drug Administration is announcing that a proposed collection of information has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995.. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed
Agenus Inc., an immuno-oncology company with clinical stage checkpoint antibodies, a pipeline of IND ready antibodies and bispecifics, cancer vaccines, and adoptive cell therapies 1, today announced the appointment of I-O drug development experts into key leadership positions. Gupta and Wijatyk have had successful careers leading the approvals of
LEXINGTON- Aldeyra Therapeutics, Inc., a biotechnology company devoted to the development of next-generation medicines to improve the lives of patients with immune-mediated diseases, announced that the last patient has completed dosing in Aldeyra's randomized, double-masked, vehicle-controlled, multi-center, parallel-group Phase 2 b clinical trial.
By a News Reporter-Staff News Editor at Pharma Business Week Arcus Biosciences, Inc., a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, and Infinity Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing IPI-549, a first-in-class immuno-oncology product candidate that...
'We are pleased that Taiho has decided to exercise their option just as we are initiating our Phase 1/ 1 b program for AB928 in the U.S. and Australia,' said Terry Rosen, Ph.D., CEO at Arcus.' We believe that Taiho's decision to exercise their option to this program at this early stage reflects their recognition that AB928, the first adenosine 2 re
Aspect s new ISO 13485: 2016 certification complies with the requirements of ISO 13485: 2016 and EN ISO 13485: 2016, and includes design, manufacture, control of sales, installation, service, and support of MRI systems. Aspect was previously certified according to the 2003 version of the Standard, which will become obsolete in February 2019, and
Aucta Pharmaceuticals, Inc. announced today that it has begun shipping Vigabatrin for Oral Solution, USP, 500 mg, following final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application. Aucta's commercial partner Upsher-Smith Laboratories, LLC will launch vigabatrin for oral solution under the brand name Viga
RICHMOND, British Columbia& GUILFORD, Conn.& DURHAM- BIOASIS TECHNOLOGIES INC., a biopharmaceutical company developing its xB3 TM proprietary platform technology for the delivery of therapeutics across the blood-brain barrier and the treatment of CNS disorders, and BIOAGILYTIX, a leading provider of contract bioanalytical testing services with...
BioAxone BioSciences Awarded $1.1 Million Phase 2 SBIR Funding for Continued Development of sd-rxRNA Drug Candidate for the Treatment of Spinal Cord Injury. By a News Reporter-Staff News Editor at Biotech Business Week BioAxone BioSciences, Inc. announced that, as part of a collaborative effort with RXi Pharmaceuticals Corporation, it is the reci
PLYMOUTH MEETING, Pa., July 16, 2018/ PRNewswire/ Braeburn announces that the U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act goal date of December 26, 2018 for its New Drug Application for CAM2038, an investigational buprenorphine flexible-dose weekly and monthly subcutaneous depot injection for the treatment of a
Rockwell Medical, Inc. today provided an update regarding Calcitriol, the Company's FDA approved active vitamin D injection for the management of hypocalcemia in patients undergoing chronic hemodialysis. On July 11, 2018, Rockwell Medical received FDA approval of its Prior Approval Supplement for manufacturing Calcitriol. As previously announced,
Camurus announced today that the US Food and Drug Administration assigned a Prescription Drug User Fee Act goal date of December 26, 2018 for its investigational weekly and monthly buprenorphine depots, CAM2038, for the treatment of adults with opioid use disorder. The FDA considers the resubmission of the New Drug Application by Camurus' US part
Cassiopea Announces Very Positive Interim Analysis Phase 2 Results for Breezula in Treating Androgenetic Alopecia. Lainate, Italy- 16 July 2018- Cassiopea SpA, a clinical-stage pharmaceutical company developing and commercializing innovative medical dermatology products, today announced the results of the planned six-month interim analysis from.
By a News Reporter-Staff News Editor at Pharma Business Week CEL-SCI Corporation announced that it has closed its previously announced registered direct offering and concurrent private placement with institutional investors. Therefore, in the Phase 3 study CEL-SCI treats patients who are newly diagnosed with advanced primary squamous cell carcino
From October 2015 until its acquisition by Mallinckrodt plc in early 2018, Mr. Miller was the vice president of finance at Sucampo Pharmaceuticals, Inc., a global biopharmaceutical company. From 2006 to 2015, Mr. Miller was the Senior Director of Accounting, Americas of Qiagen N.V., a world-wide leader in sample and assay technologies, and prior to
Certis Oncology Solutions, Inc., a new precision medicine company focused on individualized patient care, today announced that it has received its CLIA Certificate of Registration for High-Complexity Testing. Certis will utilize the certificate to implement Laboratory Developed Tests for its Patient-Derived Orthotopic Xenograft mouse models..
By a News Reporter-Staff News Editor at Clinical Trials Week Aurora, Colo.- Children's Hospital Colorado has announced that its Mike McMorris Cystic Fibrosis Research and Care Center, one of the largest cystic fibrosis clinical care centers in the U.S., is participating in one of two Phase Three clinical trials related to the development of a pos