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 The leading web portal for pharmacy resources, news, education and careers July 22, 2017
Pharmacy Choice - News - Pharmaceutical Development - July 22, 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:

7/22/17 - Amgen and Novartis ID the finish line in a wicked scramble for first CGRP migraine drug OK [Arab Times (Kuwait)]
The pharma giants said Thursday afternoon that the FDA has accepted their application for erenumab, the furthest advanced CGRP therapy which is now navigating toward a May 17 PDUFA date. But payers will also be expected to consider Eli Lillys 2- day advantage, or a Phase III outcome for Amgen and Novartis that was quite similar to Alders for 70 mg
7/22/17 - BrainStorm Wins $15.9M CIRM Grant for Phase III Trial of ALS Cell Therapy [Sport360]
BrainStorm Cell Therapeutics has won a $15.9 million grant from Californias regenerative medicine agency toward a Phase III trial of its amyotrophic lateral sclerosis cell therapy candidate NurOwn. NurOwn technology was developed in the laboratories of Dani Offen, Ph.D., and the late Eldad Melamed, M.D., at Tel Aviv University. BrainStorm said it i
7/22/17 - CHMP Recommends EU Approval for Roche's TECENTRIQ (Atezolizumab) in a Specific Type of Metastatic Lung and Two Types of Metastatic Bladder Cancer
Roche, a biotech company, issued the following news release:. Roche today announced that the EU Committee for Medicinal Products for Human Use has adopted a positive opinion for TECENTRIQ (R) as a monotherapy for the treatment of adults with locally advanced or metastatic non-small cell lung cancer after they have been previously treated with chemo
7/22/17 - Ema's Chmp Issues Positive Opinion for Avelumab for Treatment of Metastatic Merkel Cell Carcinoma
Pfizer, a pharmaceutical company, issued the following news release:. Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business as EMD Serono in the US and Canada, and Pfizer Inc. today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended the approval of avelumab* as
7/22/17 - FDA approves drug to reduce risk of HER2-positive breast cancer returning [Arab Finance (Egypt)]
The US Food and Drug Administration has approved neratinib as the first extended adjuvant therapy for early-stage, HER2-positive breast cancer. Neratinib is a kinase inhibitor that works by blocking several enzymes that promote cell growth. Richard Pazdur, director of FDAs Oncology Center of Excellence and acting director of the Office of Hematolog
7/22/17 - GSK Receives FDA Approval for a New Self-Injectable Formulation of Benlysta (Belimumab) for Systemic Lupus Erythematosus
GlaxoSmithKline issued the following news release:. GSK announced today that the US Food and Drug Administration has approved a new subcutaneous formulation of Benlysta for the treatment of adult patients with active, autoantibody positive SLE who are receiving standard therapy. Systemic Lupus Erythematosus is the most common form of lupus, a ch
7/22/17 - Ironwood slips as heartburn data underwhelm investors [Arab News (Saudi Arabia)]
A phase 2 b trial of Ironwood Pharmaceuticals IW-3718 has met its primary endpoint, teeing the heartburn candidate up to move into a pivotal trial and on to blockbuster sales. The divergence in interpretations of the data centers on whether the statistically-significant result against the primary endpoint is big enough to justify predictions of $2
7/22/17 - Janssen Receives Positive CHMP Opinion for SYMTUZA First Darunavir-Based Single-Tablet Regimen for Treatment of HIV
BEERSE, Belgium, July 21 Johnson and Johnson issued the following news release:. Janssen-Cilag International NV today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a Positive Opinion recommending marketing authorisation for SYMTUZA, a once-daily darunavir-based single tablet regimen.
7/22/17 - Kitov Pharma reports positive results from pre-clinical study of NT-219 in combo with Keytruda [Sport360]
Kitov Pharmaceuticals Holdings Ltd., an innovative biopharmaceutical company, announced results of a pre-clinical study demonstrating that NT-219, the lead drug candidate of its subsidiary TyrNovo Ltd., in combination with Keytruda, converted non-responding tumors to responders and blocked tumor progression in an immune-oncology preclinical model.
7/22/17 - MSDs Lantus biosimilar given conditional FDA approval [Sudan Tribune]
However, there is a hitch to the good news for MSD, it is dependent upon a patent infringement lawsuit brought against them by Sanofi. The tentative approval of Lusduna Nexvue is an important milestone, bringing us closer to offering this medicine to patients, said Sam Engel, Associate Vice President of Merck Clinical Research. For Sanofi, the appr
7/22/17 - NERLYNX (neratinib) Tablets Approved for HER2+ Breast Cancer in Extended Adjuvant Setting
McKesson issued the following news release:. Biologics, Inc., a McKesson Specialty Health oncology pharmacy services company, announced today it has been selected to be in the limited distribution network for Puma Biotechnology, Inc.' s new product, NERLYNX, a kinase inhibitor approved by the U.S. Food and Drug Administration. "We are pleased to b
7/22/17 - Race to CGRP migraine drug finish line enters the final straight [Arab Times (Kuwait)]
The US regulator has accepted the marketing application for Aimovig and started its review, keeping the drug in the front of the pack ahead of Lilly`s galcanezumab, Teva`s fremanezumab and Alder`s eptinezumab- all of which have phase III data in hand or coming soon. The start of the FDA review keeps Amgen and Novartis just ahead of fast-follower Li
7/22/17 - Sanofi, Regeneron Receive Positive CHMP Opinion for Dupixent (dupilumab) to Treat Adult Patients With Moderate-to-Severe Atopic Dermatitis
Sanofi, a life sciences company, issued the following news release:. Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the European Medicine Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for the marketing authorization of Dupixent (R), recommending its approval in Europe for use in adults with.
7/22/17 - Sens. Klobuchar, Lee Urge FDA to Consider Temporary Importation to Lower Prices on Prescription Drugs That Face Little or No Competition
Under the Short on Competition Act, the FDA could allow a company to sell a drug that faces little or no competition in the U.S. if the company already had approval to sell it in another country with similar safety requirements to the U.S and if the product has been on the market in that country for at least ten years. As a result, a company could
7/22/17 - Supply Of Item/services 1) Books & Journal (discount To Be Quoted Clearly) (details Can Be Had From Library Deptt:) 2)diagnostic Test Kits And Test Relating Material For Vrdl, 3 Kva Online Ups 24 Hours Power Backup, Led Light Source Us Fda Approved,
Quotations are invited for Supply of item/services 1) Books& Journal (Discount to be quoted clearly) (Details can be had from Library Deptt:) 2) Diagnostic Test Kits and Test relating material for VRDL, 3 KVA Online UPS 24 hours power backup, LED Light Source US FDA Approved, Automatic Tissue Processor& Microtome, Autopsy Table, Walk in cold room f
7/22/17 - Takeda explores computational chemistry leads from Schrdinger in $170M-plus pact; Aeterna Zentaris boots CEO, considers options [Arab Times (Kuwait)]
Three months after Aeterna Zentaris$ AEZS saw its shares crater on the news that its big Phase III study for Zoptrex had failed, the company has booted CEO David Dodd and replaced him with Michael Ward, a former exec for Sagent. Earlier in the week the biotech noted that the FDA had accepted its new NDA for Macrilen, overcoming its initial rejectio
7/22/17 - Vifors hyperkalaemia drug Veltassa approved in Europe [Sudan Tribune]
The approval is a major milestone for the Switzerland- headquartered speciality pharma company, which focuses on three main areas: iron deficiency with and without anaemia, and nephrology, in partnership with Vifor Fresenius Medical Care Renal Pharma. Its added is third area of cardio-renal therapies including hyperkalaemia when it licensed Veltass
7/21/17 - AbbVie Receives CHMP Positive Opinion for HUMIRA (adalimumab) for the Treatment of Pediatric Patients with Chronic Non-infectious Anterior Uveitis
AbbVie, a global biopharmaceutical company, announced today that the European Committee for Medicinal Products for Human Use of the European Medicines Agency has granted a positive opinion for HUMIRA for the treatment of chronic non-infectious anterior uveitis in pediatric patients from two years of age who have had an inadequate response to o
7/21/17 - Advanced Accelerator Applications Announces Positive CHMP Opinion Recommending Approval of Lutetium 177Lu Oxodotreotide (Lutathera) for Gastroenteropancreatic Neuroendocrine (GEP-NET) Tumors
Advanced Accelerator Applications S.A., an international specialist in Molecular Nuclear Medicine, today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending the marketing authorization of lutetium oxodotreotide* for the treatment of unresectable or metastati
7/21/17 - Aeterna Zentaris Inc. - NDA for Macrilen for the Evaluation of Growth Hormone Deficiency in Adults Granted December 30, 2017 PDUFA Date
Release date- 20072017- CHARLESTON, S.C.- Aeterna Zentaris Inc. today announced that it has been notified by the U.S. Food and Drug Administration, that the Company's New Drug Application seeking approval of Macrilen for the evaluation of growth hormone deficiency in adults has been accepted as a complete response to the FDA's November 5, 2014 Comp
7/21/17 - Aeterna Zentaris Resubmits NDA for Macrilen? for the Evaluation of Growth Hormone Deficiency in Adults
By a News Reporter-Staff News Editor at Health& Medicine Week Aeterna Zentaris Inc. announced that it has resubmitted a new drug application to the U.S. Food and Drug Administration, seeking approval of Macrilen? for the evaluation of growth hormone deficiency in adults. We believe that the FDA review period of our NDA will be up to six months,
7/21/17 - AgeneBio Receives Grant from Alzheimer's Drug Discovery Foundation for Drug-Discovery Program to Delay the Onset of Alzheimer's Dementia
By a News Reporter-Staff News Editor at Health& Medicine Week AgeneBio, a pharmaceutical company developing innovative therapeutics for unserved patients battling neurodegeneration, announced that the Company has received an additional $750,000 grant from the Alzheimer's Drug Discovery Foundation. The grant will support drug development of...
7/21/17 - Avantor opens new state-of-the-art Innovation Center in Bridgewater, New Jersey [All Iraq News Agency (AIN)]
Avantor, a global supplier of ultra-high-purity materials for customers across the life sciences and advanced technologies sectors, has opened a new research center in Bridgewater, New Jersey to help biopharmaceutical and pharmaceutical customers with a full range of upstream and downstream processes, from gene to protein expression through final..
7/21/17 - Brainstorm Awarded $16 Million Non-Dilutive Grant from CIRM in Support of Phase 3 Clinical Trial of NurOwn in ALS
HACKENSACK, N.J. and PETACH TIKVA, Israel, July 21, 2017/ PRNewswire/ Brainstorm Cell Therapeutics Inc., a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced that the California Institute for Regenerative Medicine has awarded Brainstorm a grant of $16 million to support the pivotal Phase 3 study of N
7/21/17 - Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI) Files An 8-K Financial Statements and Exhibits
Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI) Files An 8-K Financial Statements and ExhibitsItem 9.01 Financial Statements and Exhibits. Exhibit No. Description 99.1 Press Release dated July 21, 2017 BRAINSTORM CELL THERAPEUTICS INC. ExhibitEX-99.1 2 v471186-ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Brainstorm Awarded $16 Million Non-Dilutive Gr
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