By a News Reporter-Staff News Editor at Health& Medicine Week A patent application by the inventors Bagchi, Saumitra; Vuppala, Murali K., filed on October 29, 2015, was made available online on May 12, 2016, according to news reporting originating from Washington, D.C., by NewsRx correspondents. This patent application has not been assigned to a
By a News Reporter-Staff News Editor at Drug Week The Food and Drug Administration's Office of Hematology and Oncology Products, in co-sponsorship with the Critical Path Institute's Patient-Reported Outcome Consortium, is holding a public meeting titled "Workshop on Clinical Outcome Assessments in Cancer Clinical Trials" on Tuesday, April 26, 7:3
By a News Reporter-Staff News Editor at Health& Medicine Week Ampio Pharmaceuticals, Inc. announced that patient dosing has begun in the initial clinical trial of Ampion? for the treatment of pain due to osteoarthritis of the hand. Michael Macaluso, Ampio's CEO, noted: "The World Health Organization has determined that Osteoarthritis will be th
LONDON- AstraZeneca said that the US Food and Drug Administration has issued a Complete Response Letter or CRL regarding the New Drug Application or NDA for sodium zirconium cyclosilicate, the investigational medicine being developed for the treatment of hyperkalaemia by ZS Pharma, a wholly-owned subsidiary of AstraZeneca. AstraZeneca and ZS Pharma
AstraZeneca today announced that the US Food and Drug Administration has issued a Complete Response Letter regarding the New Drug Application for sodium zirconium cyclosilicate, the investigational medicine being developed for the treatment of hyperkalaemia by ZS Pharma, a wholly-owned subsidiary of AstraZeneca. AstraZeneca and ZS Pharma are...
AstraZeneca today announced positive results from the Phase III FALCON trial comparing Faslodex 500 mg to Arimidex 1 mg for the treatment of locally-advanced or metastatic breast cancer, in post-menopausal women who have not had prior hormonal treatment for hormone-receptor-positive breast cancer. Sean Bohen, Executive Vice President, Global...
Baxalta Incorporated, Velocity Pharmaceutical Development, LLC and Astellas Pharma Inc today announced that Thunderbolt, Inc., a company established by Vitesse Biologics, acquired all rights to the Astellas BAFF/APRIL dual antagonist program through an asset purchase agreement. We are pleased to have created this first company as a result of the no
Studies from F. Lhospice et al in the Area of Immunoglobulins Described. By a News Reporter-Staff News Editor at Drug Week Researchers detail new data in Immunology. According to news reporting out of Marseille, France, by NewsRx editors, research stated, "Antibody-drug conjugates have demonstrated clinical benefits that have led to the recent FD
AstraZeneca said its faslodex drug met its primary endpoint for treating advanced breast cancer. Sean Bohen, executive vice president for global medicines development and chief medical officer at AstraZeneca, said the results from the trial bring AstraZeneca closer to offering more and earlier treatment options for post-menopausal women suffering..
Cryoport, the globe's prime cryogenic logistics firm for the life sciences industry, declared that it will deliver international logistics backing to International Stem Cell Corporation's for its Phase I clinical trial in Australia for the cure of moderate to major Parkinson's disease. 2 of Cryoport's strategically located depots, in southern...
Janssen Pharmaceuticals, Inc., today announced the U.S. Food and Drug Administration has approved INVOKAMET, a fixed-dose combination therapy of INVOKANA and metformin hydrochloride, for first-line treatment of adults with type 2 diabetes. INVOKAMET, the first combination of a sodium glucose cotransporter 2 inhibitor and metformin available in the.
Allergan plc has announced that the U.S. Food and Drug Administration has approved for standard review the New Drug Application filing for oxymetazoline HCl cream 1.0%, an investigational topical prescription product to treat persistent facial erythema associated with rosacea in adults. The company said the Prescription Drug User Fee Act date would
By a News Reporter-Staff News Editor at Politics& Government Week A patent application by the inventor Boyd, James Palmer, filed on October 16, 2015, was made available online on May 12, 2016, according to news reporting originating from Washington, D.C., by VerticalNews correspondents. "Current protocol for a dentist to deliver an FDA cleared m
AcelRx Pharmaceuticals, Inc. today announced that the Company and its investigators will be presenting Phase 3 SAP301 study results at Euroanaesthesia 2016, which is taking place in London, UK on May 28-30, 2016. Euroanaesthesia is Europe's largest annual event showcasing the latest and the most relevant information in the fields of anesthesia,..
Akari Therapeutics, an emerging growth, clinical-stage biopharmaceutical company, today announced that Gur Roshwalb, MD, Chief Executive Officer, will present and participate in a question-and-answer session at the Jefferies 2016 Healthcare Conference on Thursday, June 9, 2016 at 10:00 a.m. ET.. Akari is a clinical-stage biopharmaceutical company
By a News Reporter-Staff News Editor at Women's Health Weekly Allergan Plc and Gedeon Richter Plc. announced positive results from Venus I, one of two pivotal Phase III clinical trials evaluating the efficacy and safety of ulipristal acetate in women with uterine fibroids. The study included 157 patients, with 101 patients randomized to uliprista
Allied Minds announces successful completion of ABLS II drug candidate feasibility programme and approval of up to $15 million to fund further drug development. It is intended that ABLS Capital, LLC, which includes Allied Minds, Woodford Investment Management and Invesco Asset Management among its investors, will fund 80% of this phase of developme
BeyondSpring Pharmaceuticals, a clinical stage biopharmaceutical company focused on the development of innovative cancer therapies, including a Phase III immuno-oncology compound and strong pipeline in collaboration with the Fred Hutchinson Cancer Research Center, announced today that the American Society of Clinical Oncology has selected the...
"Budiodarone is an important addition to our pipeline, which along with our lead candidate, tecarfarin, enables us to further leverage our substantial expertise in investigating and developing products that may help to address unmet needs in cardiovascular diseases," stated Sanjay Kakkar, MD, Armetheon's Chief Executive Officer. "Armetheon seeks t
Aviragen Therapeutics, Inc., a pharmaceutical company that is developing the next generation of antivirals, today announced that it has voluntarily decided to delay further enrollment in the Phase 2 a trial of BTA585 for the treatment of RSV infections being conducted in the U.K. This decision emanated from a lab report from one subject showing a
Braeburn Pharmaceuticals announces that the U.S. Food& Drug Administration approved Probuphine, the first implant for the maintenance treatment of opioid dependence in patients who have sustained clinical stability on low-to-moderate doses of buprenorphine, specifically 8 mg or less per day. Opioid addiction is a chronic disease and should be tre
The United States Food and Drug Administration has now cleared Capillus laser caps for the treatment of androgenetic alopecia in both men and women. To date, the company is the first and only manufacturer of low level laser therapy at-home laser caps with FDA clearance for any adult who suffers with androgenetic alopecia. Capillus, LLC manufactu
Cellceutix Corporation, a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, antibiotic, and anti-inflammatory applications, today provides additional insight into the successfully completed Phase 2 trial of Prurisol as a new oral therapy for mild to moderate plaque psoriasis.
-Cellectar Biosciences, Inc., an oncology-focused biotechnology company, today announces that the United States Patent and Trademark Office has issued U.S. Patent No. 9,345,718 on May 24, 2016, which covers CLR 1603, a phospholipid ether-paclitaxel conjugate. This first issued patent under our CLR CTX Chemotherapeutic program provides Cellectar and
Celyad, a leader in the discovery and development of engineered cell therapies, with clinical programs in cardiovascular disease and immuno-oncology, today announced the completion of the 21- day safety follow-up of the last patient enrolled in the third dose level cohort in its Phase I/IIa clinical trial evaluating the safety and feasibility of it