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 The leading web portal for pharmacy resources, news, education and careers April 23, 2017
Pharmacy Choice - News - Pharmaceutical Development - April 23, 2017

Pharmacy News

 Pharmaceutical Development
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4/16/17 - 5 Top NASDAQ Biotech Stocks: Neurocrine Biosciences Gained 32.68 Percent
Neurocrine Biosciences Novelion Therapeutics Akorn, Inc. Galectin Therapeutics Inc. ZIOPHARM Oncology Neurocrine Biosciences. Neurocrine received a boost thanks to the news that the FDA approved Ingrezza, the company s drug for tardive dyskinesia which causes involuntary movements in the face. Neurocrine earned FDA approval without getting a bla
4/15/17 - Basaglar challenges Sanofis insulin drug Lantus [Tehran Times (Iran)]
Eli Lilly and Boehringer Ingelheim launched Basaglar, a biosimilar referencing Sanofis blockbuster insulin drug Lantus, in South Korea on Thursday, intent on challenging the original drugs dominance in the domestic market for diabetes treatments. It was approved by the European Medicines Agency in 2014 and by the US Food and Drug Administration in
4/15/17 - Can California's 'right to try' law help save terminal patients? [The Sacramento Bee]
April 15 Brynnlee and Archer Thomas, ages 4 and 2, didn't hesitate on a recent morning when their grandmother, Shelly Hoover, called for help removing her socks. Since being diagnosed with Lou Gehrig's disease in 2013, the Lincoln resident has made every effort to keep life vibrant even as she slowly loses control of her own muscles. Hoover, an e
4/15/17 - Company Spotlight: Incyte
WASHINGTON- Shares of Incyte Corp. have gained nearly 38% year-to-date compared to a modest 8.77% rise in the iShares NASDAQ Biotech Index ETF during the same period. The Company received its first FDA approval in November 2011 and it was for Jakafi, a JAK1 and JAK2 inhibitor, indicated for the treatment of patients with myelofibrosis and polycythe
4/15/17 - Destiny hires CEO with IPO experience as antibiotic 2b nears [Arab News (Saudi Arabia)]
Clark joins the biotech from Ergomed, a CRO that made its name through risk-sharing agreements with drug developers. Clarks stint in charge of the finances covered the period in which Ergomed prepared for and executed its IPO. Ergomed completed its acquisition of PrimeVigilance as part of the IPO.
4/15/17 - Eli Lilly And Incyte Say FDA Issues CRL For Baricitinib [T-break Tech (Middle East)]
The letter indicated that the FDA is unable to approve the application in its current form. Specifically, the FDA indicated that additional clinical data are needed to determine the most appropriate doses. Lilly and Incyte submitted the NDA for baricitinib to the FDA in January 2016, and in January 2017 announced the FDA`s three-month extension to
4/15/17 - FDA calls for more tests for Lily-Incyte arthritis drug
Eli Lilly and Company and Incyte Corp., Wilmington, announced that the U.S. Food and Drug Administration denied approval of an arthritis drug, citing the need for additional trials. has issued a complete response letter for the New Drug Application of the investigational medicine. The FDA indicated that additional clinical data are needed to determ
4/15/17 - Implementing Risk-Based Approaches During Longer Clinical Trials Maximizes Financial Impact
By a News Reporter-Staff News Editor at Investment Weekly News Life science firms look to risk-based monitoring to reduce costs associated with clinical studies, according to a study by business intelligence firm Cutting Edge Information. According to the study, "Risk-Based Monitoring: Inject Remote Risk Assessment to Optimize Clinical Trial Outc
4/15/17 - Lilly`s Rheumatoid Arthritis Pill Rejected by Regulators [Sudan Tribune]
Eli Lilly said U.S. regulators have rejected its much-anticipated pill for the immune disorder rheumatoid arthritis, the drugmaker`s second drug development setback since November. Lilly said it disagrees with FDA`s conclusions but will work with the agency on a plan to eventually get the drug, baracitinib, approved for U.S. patients. Eli Lilly& Co
4/15/17 - Reps. Paulsen, Kind Introduce Bill to Reduce Obesity Among Seniors
Congressman Erik Paulsen and Congressman Ron Kind introduced the Treat and Reduce Obesity Act to expand access to treatment options for Medicare beneficiaries afflicted with obesity. When Medicare Part D was created in 2006, there were no widely-accepted FDA- approved obesity drugs on the market. The Treat and Reduce Obesity Act would remove the ex
4/14/17 - "Paramyxovirus Immunogens and Related Materials and Methods" in Patent Application Approval Process (USPTO 20170080081)
By a News Reporter-Staff News Editor at Drug Week A patent application by the inventors Li, Jianrong; Zhang, Yu; Wang, Rongzhang, filed on December 1, 2016, was made available online on March 30, 2017, according to news reporting originating from Washington, D.C., by NewsRx correspondents. This patent application is assigned to Ohio State Innovat
4/14/17 - 2-Day In-Person Seminar by Ex-FDA Official: FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials (Tampa, FL, United States - May 18-19, 2017) - Research and Markets
Research and Markets has announced the addition of the " FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials: 2- Day In-Person Seminar by Ex-FDA Official" conference to their offering. Review the FDA recommendations and requirements for implementing a compliant program for the phase 1 clinical program. The following topics will be d
4/14/17 - argenx receives first preclinical milestone payment in AbbVie collaboration [Syrian Arab News Agency]
Breda, the Netherlands/ Ghent, Belgium argenx, a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, today announced the achievement of the first of two preclinical milestones on its way to the investigational new drug filing of ARGX-1
4/14/17 - BioDelivery Sciences Announces the Granting of Two New Patents to be Listed in FDA's Orange Book Further Extending and Strengthening Patent...
By a News Reporter-Staff News Editor at Drug Week- BioDelivery Sciences International, Inc. announced that two important new patents were granted extending patent protection around all three of its FDA approved products, BELBUCA buccal film, BUNAVAIL buccal film, and ONSOLIS , further strengthening BDSI's overall intellectual property pos
4/14/17 - CASI Pharmaceuticals Reports On Enrollment Status Of ENMD-2076 Phase 2 Study In Triple-Negative Breast Cancer
CASI Pharmaceuticals, Inc., a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, reported today that along with the investigators a decision has been reached to stop further patient enrollment in its Phase 2, open-label study of ENMD-2076 in previously treated locally advanced or...
4/14/17 - Credence Research: Contract Research Organization Services Market Growth, Trends, Key Players, Competitive Strategies and Forecasts 2016 - 2023 - Credence Research
The latest market report published by Credence Research, Inc. "Contract Research Organization Services Market, By Service Type, Research Type and Client Type- Growth, Future Prospects and Competitive Analysis, 2016- 2023," the global contract research organization services market was valued at US$ 25.9 Mn in 2015, and is expected to reach US$ 44.8
4/14/17 - DaVita Clinical Research Wins 2017 CRO Leadership Awards
By a News Reporter-Staff News Editor at Health& Medicine Week- HYPERLINK ""\ nDaVita Clinical Research, a specialty contract research organization with services spanning the full spectrum of drug and device development, has been recognized by Life Science Leader in multiple award categories of its 2017 CRO..
4/14/17 - Eli Lilly And Incyte Say FDA Issues CRL For Baricitinib
INDIANAPOLIS- Eli Lilly and Co. and Incyte Corp. announced that the U.S. Food and Drug Administration has issued a complete response letter for the New Drug Application or NDA of the investigational medicine baricitinib, a once-daily oral medication for the treatment of moderate-to-severe rheumatoid arthritis or RA. The letter indicated that the FD
4/14/17 - iCAD Receives FDA Approval For PowerLook Tomo Detection
By a News Reporter-Staff News Editor at Drug Week- iCAD, an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, announced that PowerLook Tomo Detection received Premarket Approval from the U.S. Food and Drug Administration. "As the use of 3 D mamm
4/14/17 - Merck KGaA, Darmstadt, Germany Advances R&D Strategy through Unique Development Model with Avillion for Anti IL-17 A/F Nanobody
By a News Reporter-Staff News Editor at Drug Week Merck KGaA, Darmstadt, Germany, a leading science and technology company, announced a development agreement with Avillion, a UK- based company focused on increasing R&D output through innovative models, for anti IL-17 A/F Nanobody . Merck KGaA, Darmstadt, Germany's Anti IL-17 A/F Nanobody is
4/14/17 - Nabriva Therapeutics to present data at ECCMID supporting ongoing Phase 3 clinical development program for lefamulin [T-break Tech (Middle East)]
-Nabriva Therapeutics AG, a clinical-stage biopharmaceutical company engaged in the research and development of novel anti-infective agents to treat serious infections, with a focus on the pleuromutilin class of antibiotics, today announced that it will present data at the 27th European Congress of Clinical Microbiology and Infectious Diseases taki
4/14/17 - New Findings from T.C. Knepper et al Broadens Understanding of Oncology (Novel and Expanded Oncology Drug Approvals of 2016 PART 2: New Options in...
For more information on this research see: Novel and Expanded Oncology Drug Approvals of 2016 PART 2: New Options in the Management of Hematologic Malignancies. Oncology- New York, 2017; 31: 138-146. Oncology- New York can be contacted at: Ubm Medica, 535 Connecticut Ave, Ste 300, Norwalk, CT 06854, USA. The news correspondents report that addition
4/14/17 - North America Clinical Laboratory Test Market Is Expected to Grow at a CAGR of 5.9% by Forecast to 2022
North America Clinical Laboratory Test Market Research Report to by Forecast to 2022 Pune, Maharashtra 04/14/2017 The North America clinical laboratory test market has been evaluated as rapidly growing market and expected that the market will reach high growth figures. The benefits such as easy detection of diseases and treatment suggestions
4/14/17 - Precision Medicine Market - Global Industry Analysis, Size, Share, Growth Trends and Forecast, 2016 - 2024
Extensive R&D activities initiated by various major players has led to development of various advancements in precision medicine that have received FDA approval. For instance, in 2015, the U.S. government launched the Precision Medicine Initiative, under which a grant of approximately US$ 215 million was sanctioned for the Precision Medical Initiat
4/14/17 - Protalix plunges after cystic fibrosis trial [Sudan Tribune]
Protalix said that 16 patients were enrolled in the study, all of whom completed the study, and deemed the trial "positive." Protalix reported that the 16 cystic fibrosis patients treated for four weeks with alidornase alfa improved lung function by 3.4 points from baseline. Feuerstein wrote, "So, Protalix analyzed data on three additional patients
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