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 The leading web portal for pharmacy resources, news, education and careers May 25, 2017
Pharmacy Choice - News - Pharmaceutical Development - May 25, 2017

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:

5/25/17 - Actinium Pharmaceuticals Granted Orphan Designation from the European Medicines Agency for Actimab-A [Sport360]
Actinium Pharmaceuticals, Inc., a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today that Actimab-A has been granted orphan designation in the European Union by the European Medicines Agency. Actimab-A is intended to be used, upon approval, in patients newly...
5/25/17 - AERI Is Awesome, GWPH Abuzz, FDA Panel Nod For PBYI
LONDON- Today's Daily Dose brings you news about Aerie Pharma's positive efficacy results from phase III study of its glaucoma drug candidate Roclatan; Alnylam's public offering and FDA panel's support for approval of Puma's breast cancer drug Neratinib. Shares of Aerie Pharmaceuticals Inc. climbed more than 27% in extended trading on Wednesday,...
5/25/17 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, SUPPLEMENTARY INFORMATION: The following is a list of FDA information collections recently approved by OMB under section 3507
5/25/17 - Akcea Announces Publication in The New England Journal of Medicine of Data with AKCEA-ANGPTL3-L Rx Showing Favorable Cardiometabolic Effects
Akcea Therapeutics, a wholly owned subsidiary of Ionis Pharmaceuticals, Inc., today announced the publication in The New England Journal of Medicine of key preclinical findings with angiopoietin-like 3- targeting drugs and Phase 1/ 2 clinical study results with AKCEA-ANGPTL3-L Rx. Furthermore, in preclinical studies, we have shown that targeting
5/25/17 - Bronchial thermoplasty helps reduce severe asthma attacks and ER visits [Syrian Arab News Agency]
In a new study presented at the 2017 American Thoracic Society International Conference, adult asthma patients treated with bronchial thermoplasty had fewer severe exacerbations and were able to reduce their ER visits and hospitalizations in the two years following treatment. Approved by the FDA in 2010, BT is a new device-based therapy that uses a
5/25/17 - Cancer resistance firm TP Therapeutics reaps $45M in third round [Arab Finance (Egypt)]
The company was co-founded in 2013 by ex- Pfizer scientist Jean Cui, Ph.D., who was behind the development of the drugmaker`s $560 million drug Xalkori and is hoping to repeat that success with TP`s lead candidate, TPX-0005. Proceeds from the third-round financing, co-led by Lilly Asia Ventures, OrbiMed Advisors, and S.R. If TP`s prediction pans ou
5/25/17 - ContraFect Announces Initiation of Phase 2 Study Evaluating CF-301 in Patients with Staphylococcus aureus Bacteremia
ContraFect Corporation, a biotechnology company focused on the discovery and development of protein and antibody therapeutics for life-threatening, drug-resistant infectious diseases, today announced the initiation of an international Phase 2 study evaluating its first-in-class lysin, CF-301, as a potential treatment of Staphylococcus aureus...
5/25/17 - Curis Announces Presentations Related to CA-170 and CUDC-907 at 2017 ASCO Annual Meeting
Curis, Inc., a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer, today announced the presentation of a poster describing the Phase 1 trial of CA-170, an oral small molecule dual inhibitor of immune checkpoints PD-1 and VISTA, in the treatment of patients wi
5/25/17 - Don't let fake health news impact your family
It appears parents in Vermont are listening. In the current school year, 94 percent of Vermont's children in grades K-12 have received all required vaccines. Prior to approval by the Food and Drug Administration, manufacturers must demonstrate vaccine safety.
5/25/17 - FDA Approves Actemra for Giant Cell Arteritis [Syrian Arab News Agency]
Genentechs tocilizumab subcutaneous injection was approved by the U.S. Food and Drug Administration on Monday for the treatment of Giant Cell Arteritis. This is the sixth FDA approval for Actemra since it was launched in 2010 and the first drug approved to specifically treat patients with GCA. GCA is a chronic and severe autoimmune condition that i
5/25/17 - FDA approves first treatment for giant cell arteritis [T-break Tech (Middle East)]
It is the first drug of its kind to be made available by the Food and Drug Administration to treat adults with this condition, although it is already available in the United States in the same form for patients with severely active rheumatoid arthritis. Announcing the decision, Badrul Chowdhury, director of the division of pulmonary, allergy, and r
5/25/17 - FDA approves Mercks bladder cancer drug [Sport360]
In the first-line setting, Keytruda is now approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy. This indication is approved under accelerated approval based on tumour response rate and duration of response. Continued approval for this indication may
5/25/17 - FDA approves Sanofi and Regenerons Kevzara for adult rheumatoid arthritis [Syrian Arab News Agency]
Sanofi and Regeneron Pharmaceuticals drug Kevzara has received the US Food and Drug Administration approval to treat adult patients affected with moderately to severely active rheumatoid arthritis. Sanofi CEO Olivier Brandicourt said: Despite the many advances made in the treatment of rheumatoid arthritis, patients continue to need new treatment...
5/25/17 - FDA Clears Sciex`s Mass Spec-Based Vitamin D Test [Sport360]
The test, which will be offered through the company`s Sciex Diagnostics division, is the only FDA- cleared LC-MS-based Vitamin D assay kit currently on the market, Sciex said. According to Sciex, the Office of Inspector General "recently reported Vitamin D as one of the top five laboratory assays reimbursed by Medicare, accounting for 8.7 million l
5/25/17 - First Results Announced from Second Phase III Trial of Oral Ozanimod in People with Relapsing MS
*The results of the RADIANCE trial were announced in a May 22, 2017 press release from Celgene Corporation. *In a pooled analysis of both phase III studies, ozanimod was not shown to slow disability progression significantly more than Avonex. *According to the press release, the company will present detailed results from both studies at an upcoming
5/25/17 - Fresh off two new FDA nods, Merck`s high-flying Keytruda nets priority status in stomach cancer [Syrian Arab News Agency]
In a month that`s featured three FDA approvals for Keytruda, the immuno-oncology med has netted a speedy review for the therapy in stomach cancer. The FDA will hand down an approval decision by September 22, it said. Five checkpoint inhibitorsKeytruda; Opdivo; Roches Tecentriq; Pfizer and Merck KGaAs Bavencio; and AstraZenecas Imfinzinow boast at l
5/25/17 - Gainers & Losers Of May 24: PBYI, INO, NVCR, AKAO, NBIX...
News: The FDA panel has supported approval of the Company's breast cancer drug Neratinib. The FDA panel voted 12- 4 to recommend approval of Neratinib for the extended adjuvant treatment of HER2-positive early stage breast cancer. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.
5/25/17 - GW Pharmaceuticals and its U.S. Subsidiary Greenwich Biosciences Announce Publication of Groundbreaking Study of Epidiolex (cannabidiol) in The New England Journal of Medicine
-First well-controlled clinical study of cannabidiol in Dravet syndrome, a rare, severe type of epilepsy with no FDA- approved treatments-. GW Pharmaceuticals plc, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, along with its U.S. subsidiary...
5/25/17 - Keytruda is first FDA-approved drug for molecular indication [T-break Tech (Middle East)]
The cancer drug has become the first to be approved by the FDA to treat all cancers with a specific tumour biomarker. The US regulator`s head of haematology and oncology products, Richard Pazdur, said the development is "an important first for the cancer community" as until now cancer drugs have always been approved based on where the cancer starte
5/25/17 - MabVax Therapeutics to Present Phase I Clinical Trial Results of MVT-5873 for the Treatment of Advanced Pancreatic Cancer in Poster Presentation at the 2017 ASCO Annual Meeting
MabVax Therapeutics Holdings, Inc., a clinical-stage biotechnology company with a fully human antibody discovery platform focused on the rapid translation into clinical development of products to address unmet medical needs in the treatment of cancer, announced today that results from the Phase I clinical trial of MabVax's therapeutic antibody...
5/25/17 - Merck Gets Booster from Chinese HPV Vaccine Approval [Syrian Arab News Agency]
The GSK product is not yet available in the China market. It hired Chongqing- based Zhifei Biological Products Co. as an exclusive dealer, in charge of all marketing and sales in China. For now, there is not an HPV vaccine available in China, a decade after the United States was the first to have it introduced in 2006..
5/25/17 - Merck`s Keytruda wins first FDA nod to treat genetically-ID`d tumors anywhere in the body [Syrian Arab News Agency]
Mercks Keytruda nabbed its third FDA approval in two weeks on Tuesday, becoming the first checkpoint inhibitor to pick up an approval to treat microsatellite instability-high cancer, a rare tumor type identified with genetic testing. MSI-H tumors contain abnormalities that affect proper repair of DNA inside cells, the FDA said, and theyre most comm
5/25/17 - miRagen Therapeutics Receives EU Orphan Medicinal Product Designation for MRG-106 for the Treatment of Cutaneous T-cell Lymphoma [Syrian Arab News Agency]
miRagen Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today announced that the European Commission granted orphan medicinal product designation to miRagens product candidate, MRG-106, for the treatment of cutaneous T-cell lymphoma. /EIN News/ The U.S. Food and Dr
5/25/17 - Novartis receives FDA approval for first-of-its-kind Kisqali Femara Co-Pack for initial treatment of HR+/HER2- advanced or metastatic breast cancer
By a News Reporter-Staff News Editor at Women's Health Weekly Novartis announced that the US Food and Drug Administration has approved the Kisqali Femara Co-Pack for the treatment of hormone receptor-positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer in postmenopausal women1. With this FDA appro
5/25/17 - Orbita, ERT seek to improve voice-first data capture [T-break Tech (Middle East)]
The partnership will combine their technologies to develop a voice-based solution capable of effectively gathering trial participant feedback. ERT says its EXPERT platform has been used to collect data in over 50% of drug trials that have led to FDA approval in the past four years. Andrea Valente, executive vice president and chief development offi
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