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 The leading web portal for pharmacy resources, news, education and careers August 2, 2015
Pharmacy Choice - News - Pharmaceutical Development - August 2, 2015

Pharmacy News

 Pharmaceutical Development
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
Articles(s): 1 - 25 of 250     Next >>     Go To Page:

8/2/15 - Basilea reports topline results of isavuconazole phase 3 study in candidemia and other invasive Candida infections [National News Agency (Lebanon)]
-Basilea Pharmaceutica Ltd. announced today topline results from the phase 3 ACTIVE study. The randomized double-blind study evaluated the efficacy and safety of intravenously and orally administered isavuconazole versus a regimen of i.v. caspofungin followed by oral voriconazole, as a potential treatment for adults with candidemia and other invasi
8/2/15 - Cancer patients treated in world-first clinical trial of Canadian viral therapy
By a News Reporter-Staff News Editor at VerticalNews Health& Science Canadian researchers have launched the world's first clinical trial of a novel investigational therapy that uses a combination of two viruses to attack and kill cancer cells, and stimulate an anti-cancer immune response. The clinical trial, which is funded by the Ontario Institu
8/2/15 - CDISC Releases Clinical Research Data Standards for Schizophrenia, Hepatitis C and Dyslipidemia [Daily Star, The (Lebanon)]
-The Clinical Data Interchange Standards Consortium, the Critical Path Institute, and TransCelerate BioPharma, Inc. are pleased to announce that data standards for clinical research in the areas of Schizophrenia, Hepatitis C and Dyslipidemia have been published for use on the CDISC website. The CDISC Hepatitis C project provided a true collabora
8/2/15 - CytoDyn Completes Qualification of PRO 140 Material for Phase 3 [National News Agency (Lebanon)]
-CytoDyn Inc., a biotechnology company focused on the development of new therapies for combating human immunodeficiency virus infection, today announced that the Company's QA/QC expert, Dr. Robert Schiff, has approved for release inventory suitable to satisfy CytoDyn's current Phase 3 trial. Nader Pourhassan, President and CEO, commented: "We are v
8/2/15 - FDA Issues Notice on Generic Drug User Fee-Abbreviated Application
WASHINGTON, Aug. 2 The Department of Health& Human Services published the following notice in the Federal Register from the Food& Drug Administration:. The Food and Drug Administration is announcing the rates for abbreviated new drug applications, prior approval supplements to an approved ANDA, drug master files, generic drug active pharmaceutica
8/2/15 - Galapagos' selective JAK1 inhibitor filgotinib meets key efficacy endpoints, shows ACR70 responses up to 39%, and maintains safety profile after 24... [National News Agency (Lebanon)]
Galapagos' selective JAK1 inhibitor filgotinib meets key efficacy endpoints, shows ACR70 responses up to 39%, and maintains safety profile after 24 weeks of treatment in DARWIN 1 Phase 2 B study. -Galapagos NV announced today that at week 24, patients treated with the selective JAK1 inhibitor filgotinib showed further improvement in signs and sympt
8/2/15 - Galderma Receives FDA Approval for New Antibiotic-Free Treatment Option for Acne Patients
By a News Reporter-Staff News Editor at Medical Letter on the CDC& FDA Galderma Laboratories, L.P. announced that the U.S. Food and Drug Administration approved antibiotic-free Epiduo Forte Gel, 0.3%/ 2.5%, for the once-daily, topical treatment of acne vulgaris. Acne is the most common skin condition in the United States, affecting more than 4
8/2/15 - Germany : FDA Approves Bayer's Finacea (azelaic acid) Foam for the Topical Treatment of the Inflammatory Papules and Pustules of Mild to Moderate... [TendersInfo (India)]
Germany: FDA Approves Bayer's Finacea Foam for the Topical Treatment of the Inflammatory Papules and Pustules of Mild to Moderate Rosacea. Bayer HealthCare today announced that the U.S. Food and Drug Administration has approved Finacea Foam, 15% for the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.
8/2/15 - HC verdicts not in favor of watchdog in pharma transparency lawsuit [National Iraqi News Agency (Iraq)]
A judicial review brought by a clinical research company against the Health Research Authority, challenging the steps that the clinical trials regulator took to monitor the registration of clinical trials, has been upheld by a High Court judge in a judgement published on 28 July 2015. The ruling means that companies sponsoring phase I clinical tria
8/2/15 - Lixisenatide (Lyxumia) royalty revenue increased in Q2 2015 as Sanofi confirms the submission of a NDA in the US [Saudi Press Agency (Saudi Arabia)]
-Royalty revenue to Zealand from Sanofi's ex-US sales of lixisenatide amounted to DKK 7.1 million in Q2 2015, a 65% increase over Q2 2014. Sanofi has in late July 2015 submitted a New Drug Application for lixisenatide to the Food and Drug Administration for regulatory approval in the US. Copenhagen, 30 July 2015 Zealand announces that royalty re
8/2/15 - Nasdaq Welcomes vTv Therapeutics Inc. to The Nasdaq Stock Market [Cihan News Agency (Turkey)]
-Nasdaq announced that trading of vTv Therapeutics Inc., a clinical-stage biopharmaceutical company, commenced on The Nasdaq Stock Market on July 30, 2015. vTv Therapeutics Inc. is engaged in the discovery and development of orally administered small molecule drug candidates to fill significant unmet medical needs. vTv has a pipeline of clinical dr
8/2/15 - Newron Receives FDA Orphan Drug Designation for Sarizotan for the Treatment of Rett Syndrome
By a News Reporter-Staff News Editor at Medical Letter on the CDC& FDA Newron Pharmaceuticals S.p.A., a research and development company focused on novel central nervous system and pain therapies, announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to Newron's New Chemical Entity sarizotan for treatment of Ret
8/2/15 - Onxeo Reports First Half 2015 Business Update and Consolidated Accounts [National News Agency (Lebanon)]
Onxeo S.A., an innovative company specializing in the development of orphan oncology drugs, today reported its consolidated half-year accounts as of June 30, 2015 and provided an update on the key operational and clinical milestones achieved during the first six months of the year. The first half year of 2015 has been extremely active for Onxeo.
8/2/15 - Sunesis Pharmaceuticals Reports Second Quarter 2015 Financial Results and Recent Highlights [Jerusalem Post (Israel)]
-Sunesis Pharmaceuticals, Inc. today reported financial results for the second quarter ended June 30, 2015. Loss from operations for the three and six months ended June 30, 2015 was $10.6 million and $19.4 million, respectively. As of June 30, 2015, cash, cash equivalents and marketable securities totaled $39.6 million.
8/2/15 - The Vision Enhancing Bionic Eye Deemed Safe For Long Term Use After Three Year Clinical Trial [Qatar Tribune]
Ghassan Zein, medical director and Femto-LASIK eye surgeon at the Beverly Hills Medical Center of Kuwait. After undergoing a Functional Low-vision Observer Rated Assessment, an FDA mandated visual function test, 89 percent of the trial subjects were found to perform significantly better on computer screen and field tests using the bionic eye.
8/2/15 - VetStem Biopharma Successfully Completes Large Milestone Efficacy Study for its Flagship Canine Osteoarthritis Stem Cell Product [Moj News Agency (Iran)]
-Leading regenerative veterinary medicine company, VetStem Biopharma, announced the successful completion of a field clinical study of its canine osteoarthritis stem cell product, currently under development for FDA approval. The product is being developed together with Aratana Therapeutics and will be marketed in the US by Aratana.
8/2/15 - Vision-restoring gene therapy also strengthens visual processing pathways in brain
By a News Reporter-Staff News Editor at VerticalNews Health& Science PHILADELPHIA Since 2007, clinical trials using gene therapy have resulted in often-dramatic sight restoration for dozens of children and adults who were otherwise doomed to blindness. Now, researchers from the Perelman School of Medicine at the University of Pennsylvania and T
8/1/15 - Aequus Pharmaceuticals Announces It Has Entered Into a Definitive Agreement to Acquire TeOra Health and Intends to Promote Its First Commercial...
Aequus Pharmaceuticals Announces It Has Entered Into a Definitive Agreement to Acquire TeOra Health and Intends to Promote Its First Commercial Product in Canada in 2015. By a News Reporter-Staff News Editor at Obesity, Fitness& Wellness Week Highlights: Transforms Aequus into a commercial-stage specialty pharmaceutical company earlier than previ
8/1/15 - Juno Announces FDA Clearance of Investigational New Drug Application for JCAR015 in Adult Relapsed/Refractory Acute Lymphoblastic Leukemia [Jerusalem Post (Israel)]
-Juno Therapeutics, Inc., a biopharmaceutical company focused on re-engaging the body's immune system to revolutionize the treatment of cancer, today announced the U.S. Food and Drug Administration cleared the Company's investigational new drug application for JCAR015 for treatment of adult patients with relapsed/refractory acute lymphoblastic...
8/1/15 - Nasdaq Welcomes vTv Therapeutics Inc. to The Nasdaq Stock Market [Jerusalem Post (Israel)]
-Nasdaq announced that trading of vTv Therapeutics Inc., a clinical-stage biopharmaceutical company, commenced on The Nasdaq Stock Market on July 30, 2015. vTv Therapeutics Inc. is engaged in the discovery and development of orally administered small molecule drug candidates to fill significant unmet medical needs. vTv has a pipeline of clinical dr
8/1/15 - Ocera Therapeutics Secures $20 Million Debt Facility from Oxford Finance and Silicon Valley Bank [Jerusalem Post (Israel)]
-Ocera Therapeutics, Inc., a clinical stage biopharmaceutical company focused on acute and chronic orphan liver diseases, today announced that it secured a $20 million debt facility from Oxford Finance LLC and Silicon Valley Bank. This facility provides additional financial strength and flexibility at an attractive cost of capital with the initi
8/1/15 - Sunesis Pharmaceuticals Reports Second Quarter 2015 Financial Results and Recent Highlights [Jerusalem Post (Israel)]
-Sunesis Pharmaceuticals, Inc. today reported financial results for the second quarter ended June 30, 2015. Loss from operations for the three and six months ended June 30, 2015 was $10.6 million and $19.4 million, respectively. As of June 30, 2015, cash, cash equivalents and marketable securities totaled $39.6 million.
8/1/15 - United States : US FDA approves Sofgen's Nimodipine 30mg capsule [TendersInfo (India)]
ANI Pharmaceuticals, Inc. disclosed that its ANDA collaboration partner Sofgen has obtained approval from the US Food and Drug Administration for its Abbreviated New Drug Application for Nimodipine 30 mg capsules. According to IMS Health, trailing twelve-month sales for the product are $25 million with two current competitors. Arthur S. Przybyl, pr
7/31/15 - "Systems, Methods, and Devices for Sterilizing Antiseptic Solutions" in Patent Application Approval Process
By a News Reporter-Staff News Editor at Drug Week A patent application by the inventors DEGALA, Satish; MCGINLEY, Christopher Matthew; THURMOND, II, Kenneth Bruce, filed on March 5, 2014, was made available online on July 16, 2015, according to news reporting originating from Washington, D.C., by NewsRx correspondents. This patent application is
7/31/15 - Alnylam Introduces Phase 1/2 Clinical Trial for ALN-AAT [Professional Services Close - Up]
Alnylam Pharmaceuticals reported that it has initiated a Phase 1/ 2 clinical trial with ALN-AAT, a subcutaneously administered investigational RNAi therapeutic targeting alpha-1 antitrypsin for the treatment of AAT deficiency-associated liver disease. Initiation of this trial is based on encouraging pre-clinical data presented at the Digestive...
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