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 The leading web portal for pharmacy resources, news, education and careers April 17, 2014
Pharmacy Choice - News - Pharmaceutical Industry Trends and Policy - April 17, 2014

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 Pharmaceutical Industry Trends and Policy
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4/17/14 - "Devices and Methods for Stimulation of Hair Growth" in Patent Application Approval Process
By a News Reporter-Staff News Editor at Politics& Government Week A patent application by the inventors Verner Rashkovsky, Ines; Vaynberg, Boris, filed on September 25, 2012, was made available online on April 3, 2014, according to news reporting originating from Washington, D.C., by VerticalNews correspondents. This patent application has not be
4/17/14 - "Process of Making and Using Pharmaceutical Formulations of Antineoplastic Agents" in Patent Application Approval Process
By a News Reporter-Staff News Editor at Women's Health Weekly A patent application by the inventors Ugwu, Sydney; Radhakrishnan, Vinay; Ihnat, Peter M.; Witchey-Lakshmanan, Lenore C., filed on December 2, 2013, was made available online on April 3, 2014, according to news reporting originating from Washington, D.C., by NewsRx correspondents. This
4/17/14 - Agios Initiates Phase 1 Study of AG-348, a First-in-class PKR Activator, for Pyruvate Kinase Deficiency
Agios Pharmaceuticals, Inc., a leader in the fields of cancer metabolism and inborn errors of metabolism, today announced dose administration of AG-348 in a Phase 1 study in healthy volunteers. Today s announcement marks the initiation of our first clinical program in IEMs and our third as a company, said David Schenkein, M.D., chief execu
4/17/14 - Akorn Completes Acquisition of Hi-Tech Pharmacal
Akorn, Inc., a niche pharmaceutical company, announced today that it has completed its previously announced acquisition of Hi-Tech Pharmacal Co., Inc. for $640 million in cash. The combination of Akorn and Hi-Tech will transform the Company into a larger, more diversified generic player. We are excited to announce that we have completed the acqu
4/17/14 - ARCA biopharma Announces Screening of First Patient in Phase 2B/3 Clinical Trial Evaluating Gencaro in Atrial Fibrillation
ARCA biopharma, Inc., a biopharmaceutical company developing genetically targeted therapies for cardiovascular diseases, today announced that the first patient has been genetically screened in GENETIC-AF, its Phase 2 B/3 adaptive design clinical trial. Michael R. Bristow, President and CEO, ARCA biopharma, Inc. Dr. Michael R. Bristow, President and
4/17/14 - Astellas Pharma US Inc. to Pay $7.3 Million to Resolve False Claims Act Allegations Relating to Marketing of Drug Mycamine
Pharmaceutical company Astellas Pharma US Inc. will pay $7.3 million to resolve allegations that it violated the False Claims Act in connection with its marketing and promotion of the drug Mycamine for pediatric use, the Justice Department announced today. Astellas Pharma US Inc., located in Northbrook, Ill., manufactures and sells pharmaceutical d
4/17/14 - BB Biotech: Solid fundamental progress in the first quarter 2014
BB BIOTECH AG/ BB Biotech: Solid fundamental progress in the first quarter 2014. Interim Report of BB Biotech AG as of March 31, 2014 BB Biotech's portfolio reflects strong drug launches and key clinical events The Nasdaq Biotech Index advanced 4.3% in the first quarter. Consequently, BB Biotech AG's shares ended the first quarter up 15.0%, 15.5% a
4/17/14 - BioAlliance Pharma Reports a New Positive DSMB Recommendation to Continue Its Phase III Clinical Trial with Livatag in Primary Liver Cancer [Manufacturing Close - Up]
BioAlliance Pharma SA, a Company specializing in the development of drugs in orphan oncology diseases, announced that the European Independent Board of Experts, in charge of the safety profile of the ReLive Phase III trial, held its fourth meeting and once more unanimously recommended continuing the study without modification. As of today, about 40
4/17/14 - BioAlliance Pharma Reports DSMB Recommendation to Continue Phase III Clinical Trial [Professional Services Close - Up]
BioAlliance Pharma, a Company specialized in the development of drugs in orphan oncology diseases, announced that the European Independent Board of Experts, in charge of the safety profile of the ReLive Phase III trial, held its fourth meeting and once more unanimously recommended continuing the study without modification. The trial is still expand
4/17/14 - Biosimilars Market by Product & Application - Global Forecast to 2018
Dublin- Research and Markets has announced the addition of the "Biosimilars Market by Product& Application- Global Forecast to 2018" report to their offering. The global market is segmented on the basis of products, applications, and services. The global market will be worth $2.0 billion by 2018, growing at a CAGR of 20.1% during the forecast perio
4/17/14 - Boehringer Ingelheim receives 'Facility of the Year Award' for Equipment Innovation in biopharmaceutical manufacturing
ENP Newswire- 17 April 2014. Release date- 16042014- Biberach, Germany,- Boehringer Ingelheim has received the Facility of the Year Award for Equipment Innovation in the project' Aseptic Area 5 and Combi Line', one of its aseptic drug product manufacturing areas at the company's Biberach site. The Biberach site is the home of Europe's largest facil
4/17/14 - Breathe Technologies, Inc. Announces FDA Clearance For NIOV System For Use With Compressed Gas
The previous four FDA clearances cover the use of the Breathe NIOV System with compressed oxygen for home and institutional use, and include invasive and noninvasive patient circuits. The Breathe NIOV System is the first and only FDA- cleared, wearable, ventilation system for people with respiratory insufficiency. The new FDA clearance for use of t
4/17/14 - Bristol-Myers Squibb Reports Submission of New Drug Application to U.S. FDA for a Fixed-Dose Combination Tablet of Atazanavir Sulfate with Cobicistat... [Health & Beauty Close - Up]
Bristol-Myers Squibb Company announced the submission of a new drug application on April 4, to the U.S. Food and Drug Administration for a fixed-dose combination of atazanavir sulfate, a protease inhibitor marketed as Reyataz, and cobicistat, an investigational pharmacokinetic enhancer, or boosting agent, that can increase the level of certain HIV-
4/17/14 - Cancer Monthly Advises Actos Users to Know the Symptoms of Bladder Cancer
According to court testimony, the subject of last week's trial, New Yorker Terrence Allen, took Actos for five years before he was diagnosed with bladder cancer in 2011. But an FDA warning about Actos issued that same year says even people who were on the drug for a year could face a 40% higher chance of developing bladder cancer. In its warning st
4/17/14 - DIA 2014 50th Annual Meeting to Examine the Changing Landscape for Bioinnovation
DIA, in partnership with the Tufts Center for the Study of Drug Development, will convene health care experts for a forum called The Changing Landscape for Bioinnovation: The Emergence of Small Pharma, Strategic Alliances and Precision Medicine during DIA s 50th Annual Meeting at the San Diego Convention Center June 15 to 19. Smaller and s
4/17/14 - Dimension Therapeutics Makes Appointments to Leadership Team and Scientific Advisory Board [Health & Beauty Close - Up]
Dimension Therapeutics, a gene therapy company focused on developing novel treatments for rare diseases, announced the appointments of K. Reed Clark, Ph.D. to the newly created position of vice president, manufacturing and Terrence R. Flotte, M.D., Celia and Isaac Haidak Professor in Medical Education, dean of the School of Medicine and provost and
4/17/14 - Drug Developers Are Using New Models and Methods to Boost Clinical Success Rates, According to Tufts Center for the Study of Drug Development [Global Data Point]
"The research-based drug industry is racing to boost its research pipelines, as existing patents expire and development times continue to lengthen," said Tufts CSDD Director Kenneth I Kaitin. "Drug companies are exploring new approaches to product development that focus on increasing the probability of clinical success and speeding time to market.
4/17/14 - ePharmaSolutions' ReferralPlus Increases Match Rate For Clinical Trial Volunteers By More than 66% During Pilot Studies With Major Pharmaceutical... [Global Data Point]
ePharmaSolutions' ReferralPlus Increases Match Rate For Clinical Trial Volunteers By More than 66% During Pilot Studies With Major Pharmaceutical Consortium Members. "We are absolutely thrilled with the results of these pilots and want to thank all of the pharmaceutical companies who helped us reach this important milestone," stated Lisa La Luna,.
4/17/14 - FDA Grants Approval to Merck's Grastek (Timothy Grass Pollen Allergen Extract) Sublingual Tablet as Immunotherapy to Treat Grass Pollen-Induced... [Health & Beauty Close - Up]
FDA Grants Approval to Merck's Grastek Sublingual Tablet as Immunotherapy to Treat Grass Pollen-Induced Allergic Rhinitis with or without Conjunctivitis in Children and Adults. Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration has approved Grastek Tablet for Sublingual Use.
4/17/14 - First Round of Speak Exposure of Global Pharma Congress 2014
Topic: Action and prospects from regulator: Updates of Three-years Test Plan of QbD from FDA and EMA. FDAer responsible for premarket clearance of submissions by regulated industries as well as a member of FDA inspection team and participated in numerous on-site inspections. He also helps API and dosage form pharmaceutical companies in handling of
4/17/14 - FRANCE - Scandal-hit French doctor Jacques Servier dies [FRANCE 24]
French doctor and businessman Jacques Servier passed away on Wednesday. The 92 year old founder of the controversial French pharmaceutical giant, Servier Laboratories, died at his home in Neuilly, a western suburb of Paris, on April 16th. Servier Laboratories, France's second biggest pharmaceutical company, was at the centre of the Mediator diabete
4/17/14 - Galectin Therapeutics Announces First Patient Dosed in Second Cohort of Phase 1 Trial of GR-MD-02 for NASH With Advanced Fibrosis
Galectin Therapeutics, the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announced today that the first patient in cohort 2 of its Phase 1 clinical trial of GR-MD-02 in patients with NASH with advanced fibrosis has been successfully dosed with 4 mg/kg, which is double the dose given in cohort 1. Coh
4/17/14 - Galectin Therapeutics Announces First Patient Dosed in Second Cohort of Phase 1 Trial of GR-MD-02 for NASH With Advanced Fibrosis; Exoects GR-MD-02 Phase 1 Cohort 2 Result at End of July
Galectin Therapeutics, the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announced today that the first patient in cohort 2 of its Phase 1 clinical trial of GR-MD-02 in patients with NASH with advanced fibrosis has been successfully dosed with 4 mg/kg, which is double the dose given in cohort 1. Cohor
4/17/14 - GlycoMimetics Reports Presentation of Data on Rivipansel (GMI-1070) in Combination with Current FDA-Approved Treatment for Sickle Cell Disease [Health & Beauty Close - Up]
GlycoMimetics, Inc. announced that data for its lead clinical drug candidate, rivipansel, was highlighted via one oral presentation and one poster at the 8th Annual Sickle Cell Disease Research and Educational Symposium and 37th National Sickle Cell Disease Scientific Meeting, held April 11-14, at the InterContinental Miami. GlycoMimetics is develo
4/17/14 - Horizon Pharma Announces the Appointment of H. Thomas Watkins to Its Board of Directors
Horizon Pharma, Inc. today announced the appointment of H. Thomas Watkins, former director, president and chief executive officer of Human Genome Sciences, to its board of directors. "Tom brings valuable industry experience to our board as a highly regarded biotechnology leader," said Timothy P. Walbert, chairman, president and chief executive off
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