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 The leading web portal for pharmacy resources, news, education and careers September 27, 2016
Pharmacy Choice - News - U.S. Pharmaceutical Industry - September 27, 2016

Pharmacy News

 U.S. Pharmaceutical Industry
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9/26/16 - 12 Biggest Mid-Day Gainers For Monday
Array Biopharma Inc shares jumped 57.9 percent to $5.76 after the company disclosed that its COLUMBUS Phase 3 study of encorafenib plus binimetinib for BRAF-mutant melanoma has met primary endpoint. Lipocine Inc shares climbed 23.4 percent to $4.80 after the company reported positive top-line Phase 2 b study results for LPCN 1111. Chemtura Corp sha
9/26/16 - 30,000 opioid deactivation pouches being distributed in Minn. [Star Tribune (Minneapolis)]
Sept. 25 Hennepin County is on pace to break a dubious record in 2016.. At the meeting, Mallinckrodt Pharmaceuticals, a St. Louis- based company, announced the donation of 30,000 drug deactivation pouches that will be handed out to people locally who want to easily dispose of opioids at home. "These are alarming trends, and frankly law enforceme
9/26/16 - A List of Biomarkers Used as Outcomes in Development of FDA-Approved New Molecular Entities and New Biological Therapeutics (October 2007 to December...
SUMMARY: The Food and Drug Administration is correcting a notice entitled "A List of Biomarkers Used as Outcomes in Development of FDA-Approved New Molecular Entities and New Biological Therapeutics; Establishment of a Public Docket" that appeared in the Federal Register of September 19, 2016. The document announced the establishment of a docket to
9/26/16 - AbbVie Announces Submission of a Supplemental New Drug Application for Ibrutinib (IMBRUVICA) for Treatment of Marginal Zone Lymphoma
AbbVie, a global biopharmaceutical company, today announced that it submitted a supplemental New Drug Application to the U.S. Food and Drug Administration for ibrutinib to treat patients with marginal zone lymphoma. IMBRUVICA is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company and Janssen Biotech, Inc.. "We continue t
9/26/16 - Actinium Pharmaceuticals to Sponsor and Participate in Be The Match Walk+Run to Raise Awareness for Bone Marrow Transplant
Actinium Pharmaceuticals, Inc., a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today that the Company has sponsored and will participate in the upcoming Be The Match Walk+ Run being held on Saturday, October 1, 2016, at Firefighter s Field on Roosevelt I
9/26/16 - Aerpio Therapeutics Initiates Phase 1a Study of AKB-4924, a First in Class Once-Daily, Orally Administered HIF-1 Stabilizer, in Development to Treat Inflammatory Bowel Disease (IBD)
Aerpio Therapeutics, Inc., today announced that it has dosed the first subject in a Phase 1 a clinical trial evaluating its product candidate AKB-4924 for the treatment of IBD. Initiating the clinical development program for AKB-4924 represents a major milestone, commented Kevin Peters, M.D., Aerpio s Chief Scientific Officer. AKB-4924
9/26/16 - Akari Therapeutics to Present at Upcoming Investor Conferences on September 27 and 28 in New York City [Jerusalem Post (Israel)]
-Akari Therapeutics, an emerging growth, clinical-stage biopharmaceutical company, announced that Dr. Ladenburg Thalmann 2016 Healthcare Conference in New York City on Tuesday, September 27, 2016 at 12:00 pm ET. LEERINK Partners Roundtable Series: Rare Disease Day 2016 in New York City on Wednesday, September 28, 2016 at 10:35 am ET.
9/26/16 - Aldeyra Therapeutics Provides Update on Late-Stage Clinical Trials at 2016 Research and Development Day
First-Ever Vehicle-Controlled Phase III Clinical Trial in Noninfectious Anterior Uveitis. Aldeyra Therapeutics, Inc., a biotechnology company focused on the development of products to treat diseases related to aldehydes, today provided updates on its plans for late-stage clinical trials at the Aldeyra 2016 Research and Development Day.
9/26/16 - Amgen And UCB Announce U.S. FDA Acceptance Of Biologics License Application For Romosozumab
THOUSAND OAKS, Calif. and BRUSSELS, Sept. 26, 2016/ PRNewswire/ Amgen and UCB today announced that the U.S. Food and Drug Administration has accepted for review the Biologics License Application for romosozumab, an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.
9/26/16 - ARMO BioSciences Announces Data Presentations at the CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference
ARMO BioSciences, Inc., a clinical-stage biotechnology company, today announced the presentation of new Phase 1 b clinical data on the Company's lead investigational immuno-oncology drug AM0010 in combination with an anti-PD-1 checkpoint inhibitor in patients with renal cell carcinoma or non-small cell lung cancer. "There is a growing body of cl
9/26/16 - Array BioPharma and Pierre Fabre Announce COLUMBUS Phase 3 Study of Encorafenib plus Binimetinib For BRAF-Mutant Melanoma Met Primary Endpoint
Array BioPharma and Pierre Fabre today jointly announced top-line results from Part 1 of the Phase 3 COLUMBUS study evaluating LGX818, a BRAF inhibitor, and MEK162, a MEK inhibitor, in patients with BRAF- mutant advanced, unresectable or metastatic melanoma. "The COLUMBUS Part 1 trial results demonstrate a robust PFS benefit associated with the
9/26/16 - Array BioPharma, Inc. (ARRY) Reports Top-Line Results from Phase 3 Study
Array BioPharma, Inc. jointly announced with Pierre Fabre the results from Part 1 of the Phase 3 COLUMBUS study evaluating LGX818, a BRAF inhibitor, and MEK162, a MEK inhibitor, in patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The study met its primary endpoint, meaningfully improving progression free survival compared wi
9/26/16 - Athenex Inc. and SunGen Pharma enter into U.S. joint venture agreement for a portfolio of 7 approved pharmaceutical products
BUFFALO, New York and HONG KONG, Sept. 27, 2016/ PRNewswire/ Athenex Pharmaceutical Division and SunGen Pharma LLC, DBA Peterson Pharmaceuticals, a specialty pharmaceutical company located in New Jersey, today announced a joint venture agreement to launch and market 7 pharmaceutical products, both injectable and solid oral dosage, in the United S
9/26/16 - Axovant Sciences Receives FDA Fast-Track Designation for Intepirdine as an Investigational Treatment for Dementia with Lewy Bodies
Axovant Sciences Ltd., a leading clinical-stage biopharmaceutical company focused on the treatment of dementia, today announced that the company has received Fast Track designation for its Investigational New Drug application for intepirdine in the treatment of dementia with Lewy bodies from the U.S. Food and Drug Administration.
9/26/16 - Banks tumble with interest rates and US stocks slide
U.S. stocks are slumping Monday following losses in overseas markets. Banks are falling as Deutsche Bank hits an all-time low and interest rates move lower. Pfizer is pulling drug companies down after it announced it won't break up into two companies.
9/26/16 - BerGenBio AS: New BGB324 Study Points to Novel Mechanism to Enhance Immunotherapy Efficacy
Leading oncology biopharmaceutical company BerGenBio AS, today released important new preclinical study data on its first-in-class AXL inhibitor, BGB324. The study showed AXL to be a key factor in tumour resistance to the emerging class of new immune checkpoint inhibitors that can be targeted through combination therapy with BGB324.
9/26/16 - Bharat Book Bureau: Type 2 Diabetes (T2D) - Pipeline Analysis
Type 2 Diabetes Pipeline Analysis "gives comprehensive insight on the various drugs being developed for the treatment of T2D. The report covers all the drugs being developed in various phases. The pipeline focuses on novel pharmacologic drugs& regenerative medicines covering small molecules, monoclonal antibodies, stem cell therapies, Gene therapie
9/26/16 - Big Pharma, Little Understanding
After his time at Scios Inc., the company that developed Nesiritide and after retiring from Janssen Research& Development, LLC as a senior director in clinical research, Mills has adopted the mission of better informing the medical community and the general public about the workings of the often-mysterious pharmaceutical industry. Nesiritide: The R
9/26/16 - Bioblast's Special Medical Advisor to Make a Presentation Today On Trehalose as a Potential Therapeutic Agent for OPMD
Bioblast Pharma Ltd., a clinical-stage, orphan disease-focused biotechnology company, today announced that Zohar Argov, MD, Special Medical Advisor to the Executive Chairman of Bioblast Pharma, will present an invited lecture on Trehalose in Oculopharyngeal Muscular Dystrophy at the annual scientific meeting of the Muscle Study Group Societ
9/26/16 - BioCryst Closes $23 Million Senior Credit Facility
BioCryst Pharmaceuticals, Inc. today announced that the Company has closed a $23 million Senior Credit Facility with Midcap Financial. BioCryst Pharmaceuticals designs, optimizes and develops novel small molecule drugs that block key enzymes involved in rare diseases. MidCap Financial is a middle market-focused, specialty finance firm that provid
9/26/16 - Biogen Completes Rolling Submission of New Drug Application to FDA for Nusinersen as a Treatment for Spinal Muscular Atrophy
CAMBRIDGE, Mass.& CARLSBAD, Calif. Biogen and Ionis today announced that Biogen has completed the rolling submission of a New Drug Application to the U.S. Food and Drug Administration for the approval of nusinersen, an investigational treatment for spinal muscular atrophy. Their stories continue to inspire us and they are in the forefront of ou
9/26/16 - BioPharmX Announces Registered Direct Offering
BioPharmX Corporation, a specialty pharmaceutical company focusing on dermatology and women's health, today announced that it has entered into a definitive agreement with institutional investors to purchase shares of common stock for aggregate gross proceeds of approximately $930,000 in a registered direct offering. BioPharmX intends to use the n
9/26/16 - BrainScope Announces FDA Clearance of the First Handheld Medical Device for Assessment of the Full Spectrum of Traumatic Brain Injury [Saudi Press Agency (Saudi Arabia)]
Developed in partnership with the U.S. Department of Defense, the Ahead 300 provides a multi-modal device of clinically relevant measures, offering clinicians a comprehensive panel of data to assist in their diagnosis of the full spectrum of TBI, including concussion. The Ahead 300 represents an evolution from the three BrainScope products that hav
9/26/16 - Cavion to Present Clinical Trial Preliminary Results at ASTRO
Cavion LLC, a pharmaceutical company developing T-type calcium channel inhibitors for the treatment of oncologic and neurologic diseases, announced today that Ranjit Bindra, MD, PhD and Nataniel Lester-Coll, MD will present preliminary results from an ongoing Yale University Cancer Center and Cavion- sponsored Phase 1 clinical trial at the Annual M
9/26/16 - Complete Response Letter for REMOXY
Pain Therapeutics, Inc. announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration on the resubmission of its new drug application for REMOXY ER. Pain Therapeutics is evaluating the CRL and plan further discussions with the FDA. Conference Call Pain Therapeutics will host a conference call on Monday
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