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 The leading web portal for pharmacy resources, news, education and careers November 19, 2018
Pharmacy Choice - News - Pharmaceutical Industry Trends and Policy - November 19, 2018

Pharmacy News

 Pharmaceutical Industry Trends and Policy
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11/19/18 - Alvotech and Fuji Pharma Enter into Exclusive Partnership for Development and Commercialization of Biosimilars in Japan
-Partnership gives Fuji Pharma a leading position in the Japanese biosimilar market. TOKYO& REYKJAVIK, Iceland Alvotech and Fuji Pharma today announce that the two companies are entering into an exclusive partnership for the commercialization by Fuji Pharma of Alvotech s biosimilar portfolio in Japan. Under the partnership, Alvotech will be
11/19/18 - Amgen And Provention Bio to Develop Celiac Disease Treatment [Sport360]
On Nov. 5, 2018, Amgen and Provention Bio, a clinical-stage biopharmaceutical company focused on immune-mediated diseases, announced a licensing and co-development agreement for AMG 714, a novel anti-IL-15 monoclonal antibody, for the treatment of gluten-free diet non-responsive celiac disease. Under the terms of the agreement, Provention will cond
11/19/18 - Ascelia Pharma receives positive feedback from FDA on design of the pivotal Phase 3 study with Mangoral
Ascelia Pharma AB today announced that the company has successfully concluded discussions with the US Food and Drug Administration regarding the study design for the single pivotal Phase 3 trial for Mangoral as a contrast agent in patients with focal liver lesions and severe renal impairment. Ascelia Pharma will now complete the preparatory work
11/19/18 - ASIT biotech Launches Its Confirmatory Phase III Clinical Study with gp-ASIT+? in Grass Pollen Rhinitis Prevention Following the Investigator Meeting Hosted in Prague (Czech Republic) on November 16-17, 2018
ASIT biotech, a Belgian biopharmaceutical company specialized in the research and development of innovative allergy immunotherapy products, today announced that it hosted the investigator meeting in Prague on November 16-17, 2018 ahead of the launch of its confirmatory Phase III clinical study with gp-ASIT+? in grass pollen rhinitis prevention.
11/19/18 - Author traces American overdose crisis in new book [The Frederick News-Post, Md.]
Nov. 19 In his new book, journalist Chris McGreal investigated a dark part of American culture and a distinctly U.S. phenomenon: drug overdose. The book draws a line from the Williamson Wellness clinic in West Virginia, which was known for liberally prescribing painkillers, to today's overdose crisis in America, including stories of how Purdue Ph
11/19/18 - Axsome Therapeutics to Participate in 2018 Global Mizuho Investor Conference
Axsome Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system disorders, today announced that Herriot Tabuteau, MD, Axsome s Chief Executive Officer, will conduct investor meetings at the upcoming 2018 Global Mizuho Investor Conference on December 3, 2018.
11/19/18 - Biologic Therapy Market Comprehensive Analysis, Business Planning Research, Resources, Revenue And New Market Opportunities Explored By 2023
An expert on premium research reports, Market Research Future has added a report titled "Biologic Therapy Market Research Report- Global Forecast to 2023" to its offering. The report provides an in-depth analysis of regional data and an accurate projection of the market size and share of the Top 10 market players across the globe. GlaxoSmithKline P
11/19/18 - CASI Pharmaceuticals | CASI Pharmaceuticals To Build GMP Manufacturing Site In Wuxi, China
ROCKVILLE, Md.- CASI Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the development and delivery of high quality, cost-effective pharmaceutical products and innovative therapeutics to patients in China and throughout the world, announces that it has entered into framework agreements to build a state-of-the-art manufacturing site...
11/19/18 - Celltrion Healthcare:Biosimilars Have the Potential to Deliver Dramatic Cost Savings for US and European Healthcare Systems
Celltrion Healthcare outlined their vision of shaping future healthcare by improving access to biosimilars at the 5 th Annual Biosimilars USA Conference in New Jersey, US. According to data provided by IMS Health, biosimilars could lead to cumulative savings of up to 107 billion USD by 2020 in the United States and the top five European Union
11/19/18 - CHMP Issues Positive Opinion on Split Dosing Regimen for DARZALEX (daratumumab)
Copenhagen, Denmark; November 19, 2018 Genmab A/S announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending updating the existing marketing authorization for DARZALEX in the European Union. The recommendation is to update the Summary of Product Character
11/19/18 - Clinical Trial Management Systems Market size and Key Trends in terms of volume and value 2018-2028 [ClickPress (UK)]
Clinical trial management systems are central to eClinical environments, and considering the paramount focus on product safety and efficiency, there is a palpable shift towards better functionality and standardization. The clinical trial management systems market continues to be influenced by a range of factors ranging from macroeconomic to...
11/19/18 - ContraFect to Present at Piper Jaffray Health Care Conference
ContraFect Corporation, a clinical-stage biotechnology company focused on the discovery and development of protein and antibody therapeutics for life-threatening, drug-resistant infectious diseases, today announced that Steven C. Gilman, Ph.D., the Company's Chairman and Chief Executive Officer, will participate in a fireside chat at the Piper Ja
11/19/18 - Court upholds acquittal of ex-Novartis employee for bait advertising
The Tokyo High Court on Monday upheld a lower court decision that acquitted a former employee of the Japanese unit of Swiss pharmaceutical giant Novartis AG over a charge of exaggerating advertising claims for the blood pressure drug Diovan. In the case linked to the drug, which Novartis started selling in Japan in 2000, Nobuo Shirahashi, 67, was c
11/19/18 - CStone initiates a bridging Phase I clinical trial for PD-1 antibody CS1003 with first patient dosed in China
CStone Pharmaceuticals today announced that a first patient has been enrolled and dosed in a Phase I clinical trial in China for the recombinant humanized anti-programmed death-1 monoclonal antibody CS1003. Frank Jiang, Chairman and CEO of CStone, "We are happy to see Phase I trial get under way in China. We plan to carry out global development f
11/19/18 - CytoDyn Completes Acquisition of ProstaGene and Names Dr. Richard G. Pestell to Board of Directors
CytoDyn Inc., a biotechnology company developing a novel humanized CCR5 monoclonal antibody for multiple therapeutic indications, announces that on Friday November 16, 2018 it completed the previously announced acquisition of privately held ProstaGene, LLC. Concurrently, Richard G. Pestell, M.D., Ph.D., M.B.A., F.A.C.P., F.R.A.C.P., founder and f
11/19/18 - Eagle Pharmaceuticals, Inc. to Present at 30th Annual Piper Jaffray Healthcare Conference
Eagle Pharmaceuticals, Inc. today announced that Scott Tarriff, Chief Executive Officer, and Pete Meyers, Chief Financial Officer, will present at the 30th Annual Piper Jaffray Healthcare Conference as follows:. About Eagle Pharmaceuticals, Inc. Eagle is a specialty pharmaceutical company focused on developing and commercializing injectable product
11/19/18 - Eloxx Pharmaceuticals To Present at the Evercore ISI HealthCONx Conference on Tuesday, November 27, 2018
Eloxx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel therapeutics to treat cystic fibrosis, cystinosis, inherited retinal disorders, and other diseases caused by nonsense mutations limiting production of functional proteins, today announced that Robert E. Ward, Chairman and CE
11/19/18 - FDA Approves AEMCOLO? (Rifamycin), the First Antibiotic Approved for the Treatment of Travelers Diarrhea in Over a Decade
Dublin, Ireland- November 19, 2018- Cosmo Pharmaceuticals N.V. announced that the U.S. Food and Drug Administration has approved AEMCOLO?, containing 194 mg of Rifamycin as delayed-release tablets, a new minimally-absorbed antibiotic that is delivered to the colon, for treatment of Travelers' Diarrhea caused by non-invasive strains of Escherichia
11/19/18 - FDA approves antibacterial drug to treat travelers` diarrhea [Tehran Times (Iran)]
"Travelers` diarrhea affects millions of people each year and having treatment options for this condition can help reduce symptoms of the condition," said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA`s Center for Drug Evaluation and Research. The highest-risk destinations are in most of Asia as well as the M
11/19/18 - FDA Approves New Drug to Treat Travelers Diarrhea [Syrian Arab News Agency]
"Travelers` diarrhea affects millions of people each year and having treatment options for this condition can help reduce symptoms of the condition," said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDAs Center for Drug Evaluation and Research. The highest-risk destinations are in most of Asia as well as the Middle
11/19/18 - FDA approves treatment for peripheral T-cell lymphoma
The US Food and Drug Administration has approved first-line treatment for newly diagnosed peripheral T-cell lymphoma using a new review program... The post FDA approves treatment for peripheral T-cell lymphoma appeared first on European Pharmaceutical Review.
11/19/18 - FDA made wrong call on this opioid
The Food and Drug Administration may be a scientific agency, but that doesn t mean it always lives up to medical science. Too often it makes the wrong call on products that might exacerbate problems facing our country, such as the opioid epidemic. One of us leads the FDA s advisory committee on anesthetic and analgesic drug products.
11/19/18 - Federal Register Table of Contents
Elizabeths Master Plan Amendment No. 2, 58251 Health and Human Services Department See Centers for Disease Control and Prevention See Centers for Medicare& Medicaid Services See Food and Drug Administration See Health Resources and Services Administration See National Institutes of Health See Substance Abuse and Mental Health Services...
11/19/18 - Formosa Lab enters a new era of growth with Formosa Pharma, expanded CDMO service [T-break Tech (Middle East)]
These initiatives are all part of efforts to become a full-fledged integrated pharmaceutical company, says Dr Cheng Chen- yu, chairman and president of Formosa Lab. Through its biopharmaceutical subsidiary Formosa Pharmaceuticals, Formosa Lab ventured into new drug development, and is centred on the indications of ophthalmology, oncology,...
11/19/18 - Genotyping Market Projected to Boost Market Growth at a 22.5% CAGR by 2023 | Rising in Healthcare Research and Development Activities and Trends
Global Genotyping Market: The increasing demand for personalized medicines along with rising in healthcare research and development activities are projected to boost market growth at a 22.5% CAGR by 2023. Global Genotyping Market: The increasing demand for personalized medicines along with rising in healthcare research and development activities ar
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