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 The leading web portal for pharmacy resources, news, education and careers June 29, 2016
Pharmacy Choice - News - Pharmaceutical Development - June 29, 2016

Pharmacy News

 Pharmaceutical Development
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6/29/16 - ANTH Dims On BRIGHT-SC Data, CYAD Fails To Chart, LLY Gets FDA Panel Nod
FOSTER CITY- An interim analysis of proteinuria data from Anthera Pharmaceuticals Inc.' s phase II proof-of-concept study of Blisibimod in IgA nephropathy, dubbed BRIGHT-SC, has revealed that the trial did not meet the predefined statistical primary endpoint of complete or partial response. Aurinia Pharmaceuticals Inc. has completed an analysis of
6/29/16 - BioTime, Inc. Announces Proposed Public Offering of Common Stock
By a News Reporter-Staff News Editor at Biotech Week BioTime, Inc., a clinical-stage biotechnology company focused on developing and commercializing novel therapies in the field of regenerative medicine, announced its intent to offer to sell shares of its common stock in an underwritten public offering. Copies of the prospectus supplement and...
6/29/16 - FDA accepts IND for Phase II Study of Mazindol in Adults with ADHD
By a News Reporter-Staff News Editor at Biotech Week FDA has accepted an investigational new drug submitted by NLS Pharma, a Swiss biotech group developing next-generation ADHD therapies for a phase II proof-of-concept clinical trial evaluating the use of Mazindol in adults with Attention Deficit Hyperactivity Disorder. Dr. Wigal has been author
6/29/16 - Findings on Tissue Engineering Described by Researchers at University of Pittsburgh Medical Center (A prospective, multi-center clinical and...
Findings on Tissue Engineering Described by Researchers at University of Pittsburgh Medical Center. Our news journalists obtained a quote from the research from the University of Pittsburgh Medical Center, "At 24 months, 55/ 76 patients were evaluated, with 49/ 76 having sufficient data to determine the primary endpoint. Our news journalists report
6/29/16 - Lilly : FDA Panel Recommends Approval Of Jardiance For Cardiovascular Indication
INDIANAPOLIS- A U.S. Food and Drug Administration Advisory Committee voted 12-11 that substantial evidence exists to establish that Jardiance reduces cardiovascular or CV death in adults with type 2 diabetes and established CV disease. JARDIANCE, which is marketed by Boehringer Ingelheim and Eli Lilly and Company, is the only oral T2D medicine show
6/29/16 - Multi-center trial to test new treatment for chronic cough
By a News Reporter-Staff News Editor at Biotech Week The National Institute for Health Research has announced its participation in a clinical trial to test a promising new treatment for chronic cough. The trial involves 200 patients at 47 sites in the UK and US. Working with the NIHR, Illingworth Research is managing the UK study sites for this t
6/29/16 - Taiga Biotechnologies Awarded Orphan Drug Designation for Stem Cell Therapy
By a News Reporter-Staff News Editor at Biotech Week The Food and Drug Administration has given Taiga Biotechnologies Inc. Orphan Drug Designation for an experimental product designed to treat children with a rare immune deficiency that forces them to live in a sterile environment. "The ultimate goal of our approach is to see an improvement of s
6/29/16 - Veloxis Receives Envarsus XR Package Insert Label Enhancements Based on Study of African-American Transplant Recipients
Veloxis Pharmaceuticals A/S today announced that once-daily Envarsus XR , indicated for the prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus immediate-release formulations, in combination with other immunosuppressants, received FDA approval for label enhancements. These enhancements are related to the...
6/28/16 - AcelRx Pharmaceuticals Completes Patient Enrollment in Remaining Phase 3 Studies of ARX-04 as a Potential Treatment of Moderate-to-Severe Acute Pain
AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain, announced that it has completed patient enrollment in the two remaining Phase 3 studies of ARX-04:. Pamela Palmer, AcelRx's chief medical officer and co-found
6/28/16 - Anthera Provides Clinical Program Updates for Blisibimod and Sollpura
Anthera Pharmaceuticals, Inc. today announced results from interim analysis of the Phase 2 BRIGHT-SC proof-of-concept study in 57 patients with biopsy-proven IgA Nephropathy. Additionally, Anthera announced that its Phase 3 SOLUTION clinical study with Sollpura has closed screening and that the first patients in the Phase 3 CHABLIS 7.5 clinica
6/28/16 - Auris Medical Completes Enrollment of Phase 3 TACTT3 Trial with Keyzilen in Acute and Post-Acute Inner Ear Tinnitus
Auris Medical Holding AG, a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology, today announced that it has completed patient enrollment in the Phase 3 TACTT3 clinical trial with Keyzilen TM in acute and post-acute inner ear tinnitus. "Our Phase 3 clinical trial program for Ke
6/28/16 - Axial spondyloarthritis: Patients see sustained benefit with certolizumab pegol [Yerepouni Daily News (Lebanon)]
Researchers are reporting that early rapid improvements in the signs and symptoms of axial spondyloarthritis in patients treated with certolizumab pegol are maintained at 4 years. Desiree van der Heijde, with Leiden University Medical Centre in the Netherlands, and colleagues elsewhere examined outcomes at week 204 in patients who were randomized t
6/28/16 - Axsome Therapeutics Added to Russell 3000 and Russell 2000 Indexes [Cyprus Mail]
-Axsome Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system disorders, has been added to the broad-market Russell 3000 and small-cap Russell 2000 Indexes, as part of the Russell US Indexes annual reconstitution, effective after the US market opens on June 27.
6/28/16 - BeyondSpring's Global Phase III Non-Small Cell Lung Cancer Clinical Trial for Plinabulin Launches in China
BeyondSpring Pharmaceuticals, a clinical stage biopharmaceutical company focused on the development of innovative cancer therapies, including a Phase III immuno-oncology compound and strong pipeline in collaboration with the Fred Hutchinson Cancer Research Center, announced today that its global Phase III non-small cell lung cancer clinical trial
6/28/16 - BioLineRx Announces Regulatory Submissions for Phase 2a Trial of BL-8040 in Combination with KEYTRUDA (pembrolizumab) for Treatment of Pancreatic Cancer
TEL AVIV, Israel, June 28, 2016/ PRNewswire/ BioLineRx Ltd., a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today the filing of regulatory submissions required to commence a Phase 2 a trial for BL-8040 in combination with KEYTRUDA for the treatment of
6/28/16 - Celgene joins DNDi's 'Drug Discovery Booster'
By a News Reporter-Staff News Editor at World Disease Weekly The biopharmaceutical company Celgene has become the fifth company to join the "Neglected Tropical Diseases Drug Discovery Booster" consortium, a new initiative to accelerate and cut the cost of early stage drug discovery for two of the world's most neglected diseases, leishmaniasis and
6/28/16 - Cempra Submits Marketing Authorization Application to EMA for Solithromycin in the Treatment of Community-Acquired Bacterial Pneumonia
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 completion of its submission of the MAA for solithromycin to the European Medicines Agency for the treatment of community-acquired bacterial pneumonia.
6/28/16 - Coherus Announces Positive Phase 2b Efficacy Data on Novel Oral Therapy in Relapsing Remitting Multiple Sclerosis
REDWOOD CITY, Calif., June 28, 2016 Coherus BioSciences, Inc., a leading global biosimilars company with late-stage clinical products, today announced that a study with CHS-131 in treatment-nave, relapsing remitting multiple sclerosis subjects demonstrated approximately a 50% decrease in the incidence of new contrast-enhancing lesions over six
6/28/16 - Corcept Therapeutics Appoints Renee D. Gala to Board of Directors
Corcept Therapeutics Incorporated, a pharmaceutical company engaged in the discovery, development and commercialization of drugs that treat severe metabolic, psychiatric and oncologic disorders by modulating the effects of the stress hormone cortisol, announced today that Rene D. Gal has joined the company's Board of Directors.
6/28/16 - Cure Forward Announces First Trial Recruitment Collaboration That Will Expand Patient Access to Innovative Treatments
Cure Forward, an online precision medicine platform for cancer patients and their care teams, and Novartis Pharmaceuticals Corporation today announced that Cure Forward s unique Clinical Trial Exchange will support Novartis in identifying potential patients for all of its current oncology trials. The collaboration further validates Cure Forward
6/28/16 - Dr. Jonathan Kulbersh Discusses the Recent U.S. FDA Approval of Allergens Juvderm Volbella for the Lips and Perioral Rhytids [Cihan News Agency (Turkey)]
-The United States FDA recently approved the use of the dermal filler, Volbella, starting in October of 2016, according to Yahoo Finance. Volbella is a great addition to the dermal filler family, said Dr. Kulbersh. With the media exposure of reality stars like Kylie Jenner to musician Iggy Azalea undergoing lip injection procedures, the popularity
6/28/16 - DrugDev Launches CRO Preferred Partner Program with Charter Member INC Research
For years, DrugDev technology has been used directly by leading pharmaceutical companies to improve how their clinical trials are run. When sponsors work with a Preferred Partner such as INC, they have the confidence that their selected CRO is a trustworthy expert with real-world experience using DrugDev's SaaS tools to supplement or enhance the va
6/28/16 - Emergent BioSolutions Receives BARDA Task Order Valued at Up to $21.9 Million to Develop and Manufacture a Zika Vaccine [Cyprus Mail]
-Emergent BioSolutions Inc. today announced that its Center for Innovation in Advanced Development and Manufacturing has received a task order from the Biomedical Advanced Research and Development Authority valued at up to $21.9 million to develop and manufacture three cGMP lots of a Zika vaccine for use in a Phase 1 clinical trial. The task order
6/28/16 - Endo Announces Issuance of Vasostrict Patent
DUBLIN, June 28, 2016/ PRNewswire/ Endo International plc today announced that one of its operating companies, Par Pharmaceutical, has been issued a new patent by the U.S. Patent and Trademark Office relating to Vasostrict 20 units/mL. This Orange Book listing requires any Abbreviated New Drug Application applicant seeking FDA approval for a g
6/28/16 - FDA Advisory Committee recommends approval of Jardiance (empagliflozin) for cardiovascular indication in 12-11 vote
RIDGEFIELD, Conn. and INDIANAPOLIS, June 28, 2016/ PRNewswire/ A U.S. Food and Drug Administration Advisory Committee today voted 12-11 that substantial evidence exists to establish that Jardiance reduces cardiovascular death in adults with type 2 diabetes and established CV disease. JARDIANCE, which is marketed by Boehringer Ingelheim and Eli
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