By a News Reporter-Staff News Editor at Obesity, Fitness& Wellness Week A patent application by the inventors Perez Figueroa, J. Manuel; Santiesteban, Oscar; Kaittanis, Charalambos, filed on September 19, 2014, was made available online on April 2, 2015, according to news reporting originating from Washington, D.C., by NewsRx correspondents. This
Allergen Research Corp. has appointed Mary Rozenman, PhD, as Senior Vice President, Corporate and Commercial Development, and Mike Holfinger, PhD, as Vice President, Manufacturing. The company said that Dr. Rozenman and Dr. Holfinger fill key functions as ARC prepares for its upcoming Phase 3 clinical trial of the company's lead product, AR 101, a
Anika Therapeutics reported that it has filed an Investigational Device Exemption with the U.S. Food and Drug Administration to conduct a pivotal Phase III clinical trial for Hyalofast, a biodegradable, 3 D, HA-based scaffold with autologous bone marrow aspirate concentrate. Hyalofast is CE Marked in Europe for the entrapment of mesenchymal stem ce
Blue Ridge Cancer Care reported it is now offering radiation clinical trials to cancer patients in Southwest Virginia. The trials are a collaborative effort among BRCC, NRG Oncology and US Oncology Research. With the addition of these novel trials, BRCC reported that its presence is expanding in Southwest Virginia, providing referring physicians th
DSG has teamed with Soligenix to provide EDC, IWRS Web-based patient randomization and data management services for their current Phase 3 clinical study of SGX301 coupled with visible light activation in the treatment of Cutaneous T-Cell Lymphoma. The Company reported that eCaseLink IWRS, an integrated component in the EDC software, will help Solig
Eagle Pharmaceuticals reported that the United States Patent and Trademark Office has granted Patent No. 9,000,021 for the use of bendamustine for treating patients requiring restricted fluid and/or sodium intake. In a release, the Company noted that on February 13, it submitted a New Drug Application to the U.S. Food and Drug Administration for...
Enanta Pharmaceuticals, a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, reported abstracts of research on regimens containing either one of Enanta's two protease inhibitors for hepatitis C virus identified and developed in its ongoing collaboration with...
With the completion of the deal, the company said, PPD-SNBL is one of the largest clinical development service providers in Japan, both for clients seeking to conduct global clinical trials and for trials based solely in Japan. Those areas comprise SNBL's early stage businesses, Phase I services in the United States for Japanese bridging studies, s
Prolong Pharmaceuticals reported that the U.S. The company said the FDA defines rare diseases as those affecting fewer than 200,000 people in the United States. "Our Orphan Drug Designation has been issued based in part on SANGUINATE's unprecedented ability to un-sickle sickle cells," stated Glenn Kazo, president of Prolong Pharmaceuticals.
AstraZeneca today announced that the US Food and Drug Administration has granted Orphan Drug Designation for the MEK inhibitor selumetinib, for the treatment of uveal melanoma. The Orphan Drug Designation is an important regulatory advancement as we further our development plans for selumetinib in uveal melanoma, "said Antoine Yver, Head of Oncolog
By a News Reporter-Staff News Editor at Health& Medicine Week The Journal of Drugs in Dermatology is pleased to publish findings on a new injectable drug currently under development by Kythera Biopharmaceuticals, Inc. that may provide a non-surgical alternative for people with double chins. In "A Phase I Safety and Pharmacokinetic Study of ATX-10
By a News Reporter-Staff News Editor at Health& Medicine Week PHILADELPHIA Lucile L. Adams-Campbell, PhD, professor of oncology, associate director of minority health and disparities research, and associate dean of community health and outreach at the Georgetown Lombardi Comprehensive Cancer Center at Georgetown University Medical Center in Was
ENP Newswire- 17 April 2015. Release date- 16042015- Quebec City, Canada,- Aeterna Zentaris Inc. today announced that it has filed an application for a patent on a novel method of manufacturing zoptarelin doxorubicin, its hybrid cytotoxic molecule that is the subject of a pivotal ZoptEC Phase 3 clinical study in women with advanced, recurrent or me
-Aldeyra Therapeutics, Inc., a biotechnology company focused on the development of products to treat diseases related to free aldehydes, today announced that it has enrolled the first patient in its Phase II clinical trial of NS2 for the treatment of noninfectious anterior uveitis. Stephen Foster, a recognized clinical expert in ocular inflammation
Pursuant to a 2013 settlement agreement with Forest Laboratories, and subject to FDA final approval of its ANDA, Amerigen may launch its generic product on the date that is the later of three calendar months prior to the expiration of U.S. Amerigen Pharmaceuticals is a group of companies engaged in all phases of the generic pharmaceutical business,
Pfizer Inc said on Wednesday the first formal late-stage trial of its approved treatment for advanced breast cancer, Ibrance, was stopped early after the medicine met its goal of delaying progression of the disease in previously treated patients. Pfizer said the Phase 3 study, called Paloma 3, was halted after an independent data monitoring board d
Under the terms of the agreement, Immunocore will conduct a Phase Ib/II clinical trial combining MedImmune's investigational checkpoint inhibitors MEDI4736 and/or tremelimumab with IMCgp100, Immunocore's lead T-cell receptor-based investigational therapeutic, for the potential treatment of patients with metastatic melanoma.
LONDON- AstraZeneca announced that the US Food and Drug Administration or FDA has granted Orphan Drug Designation for the MEK inhibitor selumetinib, for the treatment of uveal melanoma. In addition to uveal melanoma, selumetinib is being investigated in Phase III studies in KRAS mutation positive lung cancer and thyroid cancer and in Phase II in ch
LONDON- AstraZeneca PLC on Friday said the US Food and Drug Administration has granted orphan drug designation for its selumetinib treatment for uveal melanoma. Uveal melanoma is a rare disease in which cancer cells form in the tissues of the eye, AstraZeneca said. The Orphan Drug Designation is an important regulatory advancement as we further our
Athersys, Inc. today announced interim results from its exploratory Phase 2 clinical study of the intravenous administration of MultiStem cell therapy to treat patients who have suffered an ischemic stroke. The study results demonstrate favorable safety and tolerability for MultiStem, consistent with prior studies. David Hess, lead clinical...
The leading business intelligence provider, has released its latest research, "Monoclonal Antibodies Market in Rheumatoid Arthritis to 2018- Market Characterized by Large and Diversified Pipeline and Low Threat of Biosimilar Sales Erosion". -The current therapeutic environment in the treatment of RA across the top seven developed markets, including
BB BIOTECH AG/ Biotech sector continues to outperform- strengthened balance sheets will sustain the industry's solid growth. Interim report of BB Biotech AG as of March 31, 2015 Positive clinical trial data, takeovers and a reduction in BB Biotech's discount lead to another strong performance by the investment company in the opening quarter of 2015
D-Pharm has been notified by its co-development partner, Jiangsu Nhwa Pharmaceutical Co.,, that they received an approval letter from the Chinese Food and Drug Administration that allows clinical development of DP-VPA, through Phase 3, for epilepsy. According to a media release, the specific clinical protocols will be communicated to the C-FDA befo
Cavion LLC, a pharmaceutical company developing T-type calcium channel inhibitors for the treatment of solid tumors and neurologic diseases, announced today that its University of Virginia collaborators Barbara Dziegielewska, Ph.D., and Jaroslaw Dziegielewski, Ph.D., will present data at the Annual Meeting of the American Association for Cancer Res
ITEM 7.01 REGULATION FD DISCLOSURE. On April 15, 2015, we issued a press release announcing the initiation of patient dosing in a proof-of-concept trial of I-131- CLR1404 in patients with relapsed or refractory multiple myeloma, an indication for which I-131- CLR1404 previously received orphan drug designation from the U.S. Food and Drug Administra