Register Now
Why register?
Login
 The leading web portal for pharmacy resources, news, education and careers August 25, 2016
Pharmacy Choice - News - Pharmaceutical Development - August 25, 2016

Pharmacy News

 Pharmaceutical Development
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
Articles(s): 1 - 25 of 223     Next >>     Go To Page:

8/25/16 - Abbreviated New Drug Application SubmissionsRefuse To Receive for Lack of Justification of Impurity Limits; Guidance for Industry; Availability
SUMMARY: The Food and Drug Administration is announcing the availability of a guidance for industry entitled "Abbreviated New Drug Application SubmissionsRefuse to Receive for Lack of Justification of Impurity Limits." This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications and prior approval...
8/25/16 - Adocia Announces Topline Results of Indian Phase 3 Trial of BioChaperone PDGF for Diabetic Foot Ulcer
Adocia, a clinical stage biopharmaceutical company focused on the treatment of diabetes with innovative formulations of approved proteins, today announced topline results from a Phase 3 clinical trial of BioChaperone PDGF in the treatment of diabetic foot ulcer, which was conducted in India. Therefore, we have initiated a thorough review of the stu
8/25/16 - ARENA PHARMACEUTICALS INC FILES (8-K) Disclosing Other Events
We and Eisai Inc. have received a "Paragraph IV certification" notification with respect to patents for BELVIQ listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book. The certification was from an Abbreviated New Drug Application for a proposed generic version of BELVIQ . In accordance with the.
8/25/16 - Armetheon Announces Positive Results of Pharmacokinetics Study of Tecarfarin versus Warfarin
Armetheon, Inc., a specialty pharmaceutical company developing novel small molecule drugs for cardiovascular diseases, today announced results from its Phase 1 clinical trial evaluating the effect of severe chronic kidney disease on the pharmacokinetics of tecarfarin, Armetheon's lead candidate, and of warfarin, the current standard of care in...
8/25/16 - BeiGene Appoints Amy Peterson, M.D. as Chief Medical Officer, Immuno-oncology [Kuwait News Agency]
Eric Hedrick, currently serving as the Interim Chief Medical Officer, will continue to oversee global clinical hematology development including the program for BGB-3111, BeiGenes BTK inhibitor, and will remain serving as an advisor as BeiGene continues to expand its global clinical development capabilities. We are delighted to have Dr. Peterson joi
8/25/16 - Bioblast Pharma Reports Second Quarter 2016 Financial Results
The Company reported a net loss of $3.685 million for the period,$. 22 per share, as compared to $3.686 million,$. 26 per share for the second quarter of 2015. The Company announced its intention to initiate enrollment of more than 70 patients in a double-blind, placebo-controlled Phase 2 b clinical trial of trehalose 90 mg/mL IV solution in patien
8/25/16 - Cempra's Pivotal Phase 3 SOLITAIRE-IV Study of IV to Oral Solithromycin Published in Clinical Infectious Diseases
Cempra, Inc., a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced the publication of its pivotal Phase 3 study, SOLITAIRE-IV, comparing the efficacy and safety of intravenous-to-oral solithromycin to intravenous-to-oral...
8/25/16 - Chris Molloy appointed new CEO of Medicines Discovery Catapult [Kuwait News Agency]
Chris Molloy, who has more than 25 years experience in the international life science industry, will lead the MDC in developing new approaches for the discovery and early development of new medicines. He will join MDC in November and work with the MDCs Board to develop and implement the Catapults initial five year business plan, which will be agree
8/25/16 - Clinical Trial Supplies
Clinical Trial Supplies 2nd Annual Symposium will be held in Brussels on the 20th and 21st of October 2016. With capacity of 120+ attendees, CTS will be held along with the 4th Annual Clinical Outsourcing Strategies Symposium, sharing the same days, venue and exhibition area. The Clinical Trial Supplies conference is an annual event and a dedicat
8/25/16 - Clinical Trial Supplies Conference Is Based in Brussels on the 20th and 21st October 2016
The 2nd Annual Clinical Trial Supplies Conference will be held in Brussels on the 20th and 21st of October 2016. The Conference will be co-held with the 4th Annual Clinical Outsourcing Strategies Symposium.London, UK 08/25/2016 Clinical Trial Supplies 2nd Annual Symposium will be held in Brussels on the 20th and 21st of October 2016. The Spea
8/25/16 - Company Pipeline Analysis and Sales Projections for the Top 25 Pharmaceutical Companies 2016-2025 - Research and Markets
Research and Markets has announced the addition of the "Top 25 Pharmaceutical Company Pipeline Analysis and Sales Projections to 2025" report to their offering. Top 25 Pharmaceutical Company Pipeline Analysis and Sales Projections to 2025 examines the leaders in the pharmaceutical industry, including the late-term pipeline of major companies.
8/25/16 - Corium Announces Streamlined Bioequivalence Development Path for Transdermal Corplex Memantine [Qatar Tribune]
-Corium International, Inc., a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, today announced receiving favorable written feedback from the U.S. Food and Drug Administration on the companys Pre-Investigational New Drug Application submission for...
8/25/16 - Data from Phase III CASTOR Study of Daratumumab Published in The New England Journal of Medicine
The New England Journal of Medicine published data from the Phase III CASTOR study of daratumumab in relapsed or refractory multiple myeloma Study data initially presented at the 2016 ASCO Annual Meeting and the 21 st Congress of EHA. Copenhagen, Denmark; August 25, 2016 Genmab A/S announced today The New England Journal of Medicine has publishe
8/25/16 - Denali Therapeutics Announces First Clinical Trial Application, Key Collaborations And $130M Series B
SOUTH SAN FRANCISCO, Calif., Aug. 25, 2016/ PRNewswire-USNewswire/ Denali Therapeutics Inc. today announced several critical milestones in the company's growth, including its first Clinical Trial Application to initiate a Phase 1 trial, previously undisclosed collaborations and licensing deals, and a $130 million Series B equity financing.
8/25/16 - EMA accepts to review Mylan and Biocon's cancer biosimilar
Mylan and Biocon, who co-developed this proposed biosimilar, anticipate that this may be the first MAA for a trastuzumab biosimilar accepted by the EMA...
8/25/16 - Equon Pharmaceuticals, Inc's mission is to develop innovative pharmaceuticals offering symptomatic relief from the swelling, tissue damage and pain caused by a variety of inflammatory conditions including Late Phase Asthmatic Response and Rheumatoid
Equon's mission is to develop innovative pharmaceuticals offering symptomatic relief from the swelling, tissue damage and pain caused by a variety of inflammatory conditions including Late Phase Asthmatic Response and Rheumatoid Arthritis. Equon is primed to move its antibodies into pre-clinical trials in preparation for FDA approval treating both.
8/25/16 - FDA Approves Minimally Invasive Valve Replacement (TAVR) for New Group of Patients
Morton Plant Hospital has been participating in the FDA trial for intermediate risk patients since 2012.. Now, with the latest FDA approval, we will be able to offer TAVR to any intermediate risk patients with severe symptomatic aortic stenosis, "said Joshua Rovin, MD, FACS, cardiovascular surgeon and medical director, for the Center for Advanced V
8/25/16 - Fighting Post-Operative Infection: New Funding for Development of Bio-active Implants that Speed Recovery
Innovate UK are supporting research and clinical trials of a bio-active implant to treat post-operative infection after total knee replacement. Implant manufacturers MatOrtho and advanced metal coating developer the Wallwork Group are leading the programme. Significant support with clinical trials and evaluation is being provided by the Royal...
8/25/16 - Findings from Royal Surrey County Hospital NHS Trust Broaden Understanding of Obstetrics and Gynecology (Clinical utility of a novel ultrasonic...
By a News Reporter-Staff News Editor at Women's Health Weekly Current study results on Obstetrics and Gynecology have been published. According to news reporting originating in Guildford, United Kingdom, by NewsRx journalists, research stated, "Objective: The ultrasonic advanced energy study device is the first surgical device indicated to seal v
8/25/16 - FIT Biotech Oy: FIT Biotech's GMP facility audited and approved - the company resumes manufacturing of drug candidates
FIT BIOTECH OY Company announcement August 25, 2016 at 9.45 am EET FIT Biotech's GMP facility audited and approved- the company resumes manufacturing of drug candidates Finnish Medicines Agency Fimea has reapproved FIT Biotech Ltd's GMP- manufacturing license, which was withheld as previously announced. The project started in January 2016 and will.
8/25/16 - Galectin Therapeutics Announces Results From 12-Week Extension of Phase 2a Psoriasis Clinical Trial
Galectin Therapeutics Inc., the leading developer of therapeutics that target galectin proteins, announces interim results from an exploratory, open-label, Phase 2 a clinical trial with GR-MD-02 in patients with moderate-to-severe plaque psoriasis.. In May, the company announced significant improvement in PASI scores at the 12- week mark for all
8/25/16 - HEALTH URMC clinical trials lead way to vaccines
The Vaccine Research Unit at the University of Rochester Medical Center began conducting vaccine trials in the 1970 s and they haven t stopped. Here are a few of the infectious threats that the Vaccine Research Unit team, led by John J. Treanor, M.D., chief of infectious diseases at UR medicine s Strong Memorial Hospital, has tackled in the p
8/25/16 - HEB Gets Some Relief, ITEK Awaits Data In Dec., NYMX Abuzz, FDA Snubs AMGN
THOUSAND OAKS- The FDA has turned down Amgen Inc.' s Parsabiv, proposed for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis. Amgen is reviewing the Complete Response Letter, and anticipates a post-action meeting with the FDA later this year to discuss the Complete Response. Biomerica Inc.
8/25/16 - HEB Gets Some Respite, ITEK Awaits Data In Dec., NYMX Abuzz, FDA Snubs AMGN
THOUSAND OAKS- The FDA has turned down Amgen Inc.' s Parsabiv, proposed for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis. Amgen is reviewing the Complete Response Letter, and anticipates a post-action meeting with the FDA later this year to discuss the Complete Response. Biomerica Inc.
8/25/16 - Herantis Pharma Plc's Half year financial report January 1-June 30, 2016 (unaudited)
Herantis Pharma Plc Company release August 25, 2016 at 9:00am Development of Lymfactin and CDNF proceeds as planned Herantis Pharma Plc's Half year financial report January 1- June 30, 2016 Highlights in January- June 2016:* Patient recruitment was started in May in a clinical study with the company's drug candidate Lymfactin in breast cancer
Articles(s): 1 - 25 of 223     Next >>     Go To Page:


© 2016 Thomson Reuters. All rights reserved.

Pharmacy News Index
  Drug Delivery Systems
  Drugstores
  FDA Final Approvals
  Front Page Healthcare News
  Generic Drugs
  Hospital Industry
  Internet Pharmacy
  IT in Healthcare
  Medicare & Medicaid
  Over-the-Counter Drugs
  Pharm Industry Trends and Policy
  Pharmaceutical Development
  Pharmaceutical Industry

FEATURED CE LESSON

Men's Health in Older Adults: Benign Prostatic Hyperplasia and Erectile Dysfunction
This lesson is supported by:
RxSchool
Pharmacy Spanish
This lesson is supported by:
RxSchool
Drug Therapy Management Series Part III: Geriatric Disorders
This lesson is supported by:
RxSchool

Special Announcement

Free Membership
Enjoy Drug Search, industry newsletters and more...


Websites » RxCareerCenter.comRxSchool.comClubStaffing.comNursingJobSource.comRN.com
Copyright © 2009 Pharmacy Choice - All rights reserved.
Terms and Conditions | Privacy Statement
888-682-4415