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 The leading web portal for pharmacy resources, news, education and careers July 23, 2017
Pharmacy Choice - News - Pharmaceutical Development - July 23, 2017

Pharmacy News

 Pharmaceutical Development
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
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7/16/17 - Illumina Announces FDA-approved Next-Generation Sequencing Cancer Companion Diagnostic Test Kit
By a News Reporter-Staff News Editor at Medical Letter on the CDC& FDA Illumina, Inc. announced its Extended RAS Panel, an FDA- approved next-generation sequencing kit that meets the newly published guidelines for evaluation of colorectal cancer from the American Society for Clinical Pathology, the College of American Pathologists, the Associatio
7/16/17 - Researchers making advancement in HIV/AIDS treatment
By the numbersOver one million people are living with HIV in the United States.One in seven Americans living with HIV do not know they are HIV-positive.HIV/AIDS death rates have fallen by 88 percent since mid-1990.Since the first AIDS cases were reported in the United States in 1981, more than 40 medicines for HIV infection have been approved in th
7/16/17 - Underutilization Of Brain Amyloid Scans Drives Cost And Hurts Alzheimer's Disease Care
LONDON, July 16, 2017/ PRNewswire-USNewswire/ Research reported at the Alzheimer's Association International Conference 2017 in London highlighted the clinical value of amyloid- PET scans, which detect the presence of amyloid-beta plaques in the brain- one of the hallmarks of Alzheimer's disease. Studies also revealed an underutilization of...
7/15/17 - Allena claims orphan status for `devastating` rare disease therapy [Arab Finance (Egypt)]
Allena Pharma has been granted orphan status by the FDA for a drug to treat primary hyperoxaluria, a rare disease that causes kidney and bladder stones and can lead to kidney failure and death. The drugcalled ALLN-177is a non-absorbed formulation of an enzyme designed to break down a substance called oxalate in the gastrointestinal tract.
7/15/17 - AOP Orphan and PharmaEssentia announce latest clinical results for Ropeginterferon alfa-2b in Polycythemia Vera from 3 abstracts presented at the...
AOP Orphan and PharmaEssentia announce latest clinical results for Ropeginterferon alfa-2b in Polycythemia Vera from 3 abstracts presented at the 22nd Congress of the European Hematology Association EHA in Madrid. By a News Reporter-Staff News Editor at Obesity, Fitness& Wellness Week AOP Orphan Pharmaceuticals AG and PharmaEssentia Corporation..
7/15/17 - AXELEAD Begins Operations [Sudan Tribune]
Takeda Pharmaceutical Company and Axcelead Drug Discovery Partners has announced the start of operations for AXCELEAD. This research will assist companies within and outside Japan as part of the firm`s comprehensive integrated drug discovery services and consultation for the Shonan Health Innovation Park at Takeda`s Shonan Research Center.
7/15/17 - EMA validates Gilead Sciences marketing application for BIC/FTC/TAF combination [Arab Times (Kuwait)]
During the Phase III clinical trials, BIC/ FTC/ TAF has shown high rates of virologic suppression and no treatment-emergent resistance through 48 weeks among treatment-nave adult patients, as well as virologically suppressed adult patients who switched regimens. Gilead Sciences chief scientific officer and research and development executive...
7/15/17 - FDA recommends approval for Novartis CTL019 to treat r/r B-cell ALL [Syrian Arab News Agency]
The US Food and Drug Administrations Oncologic Drugs Advisory Committee has unanimously recommended approval of Novartis CTL019 for the treatment of relapsed or refractory B-cell acute lymphoblastic leukaemia. Novartis Oncology CEO Bruno Strigini said: The panel`s unanimous recommendation in favour of CTL019 moves us closer to potentially...
7/15/17 - Genetically Enhanced, Cord-Blood Derived Immune Cells Strike B-Cell Cancers
The University of Texas MD Anderson Cancer Center issued the following news release:. Immune cells with a general knack for recognizing and killing many types of infected or abnormal cells also can be engineered to hunt down cells with specific targets on them to treat cancer, researchers at The University of Texas MD Anderson Cancer Center report
7/15/17 - J&Js psoriasis drug faces crowded market after US approval [Sport360]
The FDA has backed guselkumab, which will be branded as Tremfya, for adults with moderate to severe plaque psoriasis. Valeant bought Siliq from AstraZeneca, which was keen to offload the drug after a risk suicidal ideation emerged in trials something that will likely affect the drugs marketability as the FDA insisted it carried a warning on its box
7/15/17 - Jamaica Cancer Drug Aims For Yearly US$250m Haul [T-break Tech (Middle East)]
Scientist and businessman Dr Henry Lowe is predicting annual sales of US $250 million, the equivalent of around $32 billion, from Cresorol, an anti-cancer drug made from marijuana. The product, which targets acute myeloid leukemia has been designated an `orphan drug` by the US Food and Drug Administration, the FDA, but the American regulator also n
7/15/17 - JAMAICA-MARIJUANA-Government will ensure standards are met in marijuana industry
Prime Minister Andrew Holness, says the Government will be exercising caution in how cannabis is leveraged in the development of Jamaica's nutraceutical industry. The Prime Minister was speaking at a ceremony to announce the United States Food and Drug Administration's award of Orphan Drug Status for' Chrysoeriol', which has been developed by Flavo
7/15/17 - New class of breast cancer drugs deemed well-tolerated [Sport360]
The U.S. Food and Drug Administration recently approved the first CDK inhibitor palbociclib or Ibrance, in February 2015 and ribociclib or Kisqali in March 2017. "CDK inhibitors have changed the landscape of management of HR+ breast cancer," Aditya Bardia, a specialist in breast cancer at the Massachusetts General Hospital Cancer Center in Boston,
7/15/17 - Novartis stellar CAR-T efficacy data steamrolls safety doubts to power landmark cancer therapy toward approval [Arab Times (Kuwait)]
Many of these issues will need close monitoring if, as expected, Novartis and, a little later, Kite Pharma bring CAR-T therapies to market. And some of the concerns provide opportunities for members of the chasing pack such as Juno Therapeutics and its defined cell composition product and Cellectis and its off-the-shelf candidate to muscle in on th
7/15/17 - OBI Pharma signs agreement with Abzena for ADC linker technology [Sport360]
UK- headquartered drug development technology and services provider Abzena plc, has signed a licensing agreement and a master services and clinical supply agreement with Taipei, Taiwan biotech OBI Pharma for its novel site-specific ThioBridge antibody drug conjugate linker technology to develop OBIs proprietary ADC, OBI-999 and a series of further
7/15/17 - Pfizer Xeljanz Label Expansion Application Accepted by FDA [Sudan Tribune]
Pfizer Inc. `s PFE supplemental new drug application for Xeljanz has been accepted for review by the FDA. Xeljanz, a JAK inhibitor, is presently approved in the U.S. as a second-line treatment for moderate-to-severely active rheumatoid arthritis in patients who have had an inadequate response to or cannot tolerate methotrexate. A response from the
7/15/17 - Roche`s hold on Avastin, Herceptin sales loosens as FDA panel backs Amgen and Mylan biosims [Arab News (Saudi Arabia)]
Roche took a blockbuster double hit Thursday as the FDAs Oncologic Drugs Advisory Committee recommended an Amgen biosimilar to Avastin in the morning, and then a Mylan biosim to Herceptin in the afternoon. The committee voted 17-0 to recommend FDA approval for Amgens ABP 215, an Avastin biosimilar, in each of the approved indications for the refere
7/15/17 - Shire submits NDA to FDA for Hemophilia A Gene Therapy Candidate [Sudan Tribune]
Shire plc has announced the submission of an investigational new drug application to the U.S. Food and Drug Administration for SHP654, also designated as BAX 888, an investigational factor VIII gene therapy for the treatment of hemophilia A. SHP654 aims to protect hemophilia A patients against bleeds through the delivery of a long-term, constant le
7/15/17 - UNE College of Pharmacy's Edward Li Testifies at FDA Advisory Committee on Breast Cancer Treatment Drug
The University of New England issued the following news release:. Edward Li, M.P.H., BCOP, professor in the College of Pharmacy, has testified at the Open Public Hearing portion of the July 13, 2017 Oncologic Drugs Advisory Committee. Biosimilars are a type of biological product that are licensed by the FDA because they are highly similar to an alr
A panel of the United States Food and Drug Administration has unanimously recommended approval for the biosimilar breast-cancer drug of Biocon. The recommendation takes Biocon closer to. Biocon and Mylan now have to get final approval from the US FDA to commercially launch the product.
7/14/17 - "Novel Pharmaceutical Compositions of Benzenesulfonamide Derivatives for Treatment of Adenoid Cystic Carcinoma" in Patent Application Approval...
"Novel Pharmaceutical Compositions of Benzenesulfonamide Derivatives for Treatment of Adenoid Cystic Carcinoma" in Patent Application Approval Process. By a News Reporter-Staff News Editor at Drug Week A patent application by the inventors YANG, Chuan-Ching; ZHONG, Nanshan; LIN, Mao-Yuan; TU, Chi-Chiang; CHEN, Kun-Hung; HSIAO, Chia-Yen, filed on
7/14/17 - Amgen Receives FDA Approval For BLINCYTO [All Iraq News Agency (AIN)]
Today, Amgen announced that it had received FDA approval for its drug BLINCYTO. The FDA had approved the Supplemental Biologics License Application sBLA for BLINCYTO, because of results from two positive clinical trials. The drug was approved because of results from a phase 3 study, known as the TOWER study.
7/14/17 - Amgen Submits Applications In US, Europe To Include OS Data In KYPROLIS Label
THOUSAND OAKS- Amgen said that it submitted a supplemental New Drug Application or sNDA to the U.S. Food and Drug Administration and a variation to the marketing application to the European Medicines Agency to include overall survival data from the Phase 3 head-to-head ENDEAVOR trial in the product information for KYPROLIS or carfilzomib.
7/14/17 - Amgen Submits Regulatory Applications In US And Europe To Include Overall Survival Data In KYPROLIS (Carfilzomib) Label
Amgen today announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration and a variation to the marketing application to the European Medicines Agency to include overall survival data from the Phase 3 head-to-head ENDEAVOR trial in the product information for KYPROLIS . These results were presented ea
7/14/17 - Apexian Pharmaceuticals Announces FDA Agreement For Inclusion of Chemotherapy Induced Peripheral Neuropathy (CIPN) Indication Under Currently Approved IND [Sudan Tribune]
Apexian Pharmaceuticals, a clinical stage biotechnology company developing novel compounds to treat cancer, today announced that it has received FDA agreement that the currently approved IND can be used to examine Chemotherapy Induced Peripheral Neuropathy as an indication in addition to its anti-tumor effects. Mark Kelley, Apexian`s CSO, has recei
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