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 The leading web portal for pharmacy resources, news, education and careers April 18, 2015
Pharmacy Choice - News - Pharmaceutical Development - April 18, 2015

Pharmacy News

 Pharmaceutical Development
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4/17/15 - A non-surgical intervention for double chins ~ a study published in the Journal of Drugs in Dermatology
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
4/17/15 - AACR honors scientific work and mentorship of Dr. Lucile Adams-Campb
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
4/17/15 - Aeterna Zentaris Files Additional Patent Application to Strengthen IP Protection of Zoptarelin Doxorubicin
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
4/17/15 - Aldeyra Therapeutics Announces First Patient Enrolled in Noninfectious Anterior Uveitis Phase II Clinical Trial [Daily Tribune (Bahrain)]
-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
4/17/15 - AMERIGEN Announces Tentative Approval of Generic Bystolic
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,
4/17/15 - Approved Pfizer breast cancer drug impresses in latest study [Egypt Independent]
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
4/17/15 - AstraZeneca -Medimmune and Immunocore announce new collaboration to conduct immuno-oncology combination trials in melanoma
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.
4/17/15 - AstraZeneca Says FDA Grants Orphan Drug Designation For Selumetinib
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
4/17/15 - AstraZeneca Says Selumetinib Gets Orphan Drug Designation In US
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
4/17/15 - Athersys Announces Results From Phase 2 Study of MultiStem(R) Cell Therapy for Treatment of Ischemic Stroke
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...
4/17/15 - Bharat Book Bureau: Monoclonal Antibodies Market in Rheumatoid Arthritis to 2018 - Market Characterized by Large and Diversified Pipeline and Low Threat of Biosimilar Sales Erosion
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
4/17/15 - Biotech sector continues to outperform - strengthened balance sheets will sustain the industry's solid growth
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
4/17/15 - C-FDA OKs IND for D-Pharm's Anti-Epileptic Drug, DP-VPA in China [Health & Beauty Close - Up]
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
4/17/15 - Cavion Collaborators Present Data at AACR
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
4/17/15 - CELLECTAR BIOSCIENCES, INC. FILES (8-K) Disclosing Regulation FD Disclosure, Financial Statements and Exhibits
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
4/17/15 - Certara Launches its Cardiac Safety Simulator V2.0
By a News Reporter-Staff News Editor at Drug Week Certara , the global biosimulation technology-enabled consultancy, announced the launch of version 2.0 of its Cardiac Safety Simulator, which has become a standalone product for the first time. CSS is currently being used by several leading pharma companies, two of which collaborated with Certar
4/17/15 - CheckMate -057, a Pivotal Phase III Opdivo (nivolumab) Lung Cancer Trial, Stopped Early
Bristol-Myers Squibb Company today announced that an open-label, randomized Phase III study evaluating Opdivo versus docetaxel in previously treated patients with advanced non-squamous non-small cell lung cancer was stopped early because an assessment conducted by the independent Data Monitoring Committee concluded that the study met its...
4/17/15 - CiRA Enters into Co-Development Agreement with Takeda Pharma
The Takeda- CiRA joint program for iPS cell applications is designed to expedite multiple research projects for drug discovery and cell therapy using iPS cells. CiRA director Shinya Yamanaka, for his work on iPS cells, will direct the program, while Takeda provides long-term funding, recommendations on research management, and facilities at its Sho
4/17/15 - Debiopharm International SA announces results of 2 key oncology programs at 2015 AACR Conference
Release date- 16042015- Lausanne, Switzerland Debiopharm International SA, part of Debiopharm Group, a Swiss-based global biopharmaceutical company developing prescription drugs that target unmet medical needs as well as companion diagnostics, today announced that preclinical data on the investigational compounds Debio 1143 and Debio 1347/ CH5183
4/17/15 - EFPIA Welcomes WHO Statement on Clinical Trials Data Disclosure
Release date- 16042015- EFPIA welcomes theWorld Health Organization's Statement on Public Disclosure of Clinical Trial Results and is supportive of its assertion that' the registration of all interventional trials is a scientific, ethical and moral responsibility'. Patient-level clinical trial data, study-level clinical trial data, full clinical st
4/17/15 - Envisia Therapeutics Appoints Dr. Rhett Schiffman Chief Medical Officer [Health & Beauty Close - Up]
Prior to Envisia, Dr. Schiffman was the Chief Medical Officer at Neurotech Pharmaceuticals where he led the company's NT-503 program, a cell-based therapy for wet age-related macular degeneration, through its phase 1/ 2 studies. Prior to Neurotech, Dr. Schiffman was Vice President of Global Drug Development and Therapeutic Area Head of Ophthalmolog
4/17/15 - Evidence grows that melanoma drugs benefit some lung cancer patients [Global Data Point]
Oliver Gautschi, a medical oncologist from Lucern Cantonal Hospital in Switzerland, presented the results of the retrospective EURAF cohort study, which included lung cancer patients whose tumours carried specific mutations in the BRAF gene. The study was conducted by a network of European oncologists, without company involvement.&# x0D;.
4/17/15 - FDA approves generic version of top-selling MS drug Copaxone
The generic, called Glatopa, is made by Sandoz, a unit of Swiss drug company Novartis AG, and U.S.-based Momenta Pharmaceuticals. Shares of Teva, which have been trading around all-time highs, fell 3.8 percent on the day. That's when a key patent on Copaxone will expire, although Teva has introduced a newer formulation of the drug to extend its pat
4/17/15 - FDA Approves Only ICD with Ultra-High Energy on the First Shock
BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced today that the Food and Drug Administration has approved the only implantable cardioverter defibrillator* that can deliver ultra-high energy on the first shock. "Most physicians already understand the benefit of having an ICD that can deliver dual-chamber diagnostics
4/17/15 - FDA Grants Fast Track Designation for MediciNova's MN-001 (tipelukast) for the Treatment of NASH with Fibrosis [Construction Machinery Middle East (United Arab E]
-MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market and the JASDAQ Market of the Tokyo Stock Exchange, today announced that it has received Fast Track designation from the U.S. Food and Drug Administration for MN-001 for the treatment of patients with nonalcoholic steatohepatitis with fibrosis. In January 2015, MediciN
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