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 The leading web portal for pharmacy resources, news, education and careers April 24, 2014
Pharmacy Choice - News - Pharmaceutical Industry Trends and Policy - April 24, 2014

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 Pharmaceutical Industry Trends and Policy
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4/24/14 - Alexion CEO Received $30M in Compensation in 2013 [The Hartford Courant :: ]
April 24 The CEO of Alexion, the Cheshire- based pharmaceutical company that makes the most expensive drug in the world, received $30.15 million in compensation last year, according to a federal filing Wednesday. Leonard Bell's Yale research, only has one product so far: Soliris. The drug treats ultra-rare diseases and generally insurers pay more
4/24/14 - Alkermes Reports Positive Phase 3 Study Results [Professional Services Close - Up]
Alkermes announced positive topline results from a randomized, double-blind, placebo-controlled phase 3 clinical trial of aripiprazole lauroxil in patients with schizophrenia. "These statistically significant efficacy data demonstrate aripiprazole lauroxil's ability to provide clinically meaningful symptom control in patients struggling with...
4/24/14 - Array Biopharma Announces Binimetinib Continues to Advance in Clinical Development; Protalix Announces Data on Oral antiTNF
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 23, 2014.{ nfg} Following the recent announcement by Novartis and GlaxoSmithKline that they have entered into a definitive agreement to exchange certain assets, Array BioPharma Inc. reports that Novartis has indicated that it will continue to hon
4/24/14 - Arxspan Introduces SAFE-BioPharma Signature Web Service
By a News Reporter-Staff News Editor at Computer Weekly News Arxspan, which develops applications for the life sciences, has created a web service that facilitates integration of SAFE-BioPharma digital signatures directly into numerous software applications. "Arxspan's new capability provides the SAFE-BioPharma community with an uncomplicated an
4/24/14 - Axiom Food's Oryzatein Becomes First Rice Protein Ever To Earn GRAS Approval
By a News Reporter-Staff News Editor at Politics& Government Week On the heels of a 2013 double-blind clinical trial which proved Axiom Food's Oryzatein plant-based brown rice protein equals animal-based whey in building and repairing muscles, Oryzatein has now become the very first brown rice protein to be granted GRAS approval. The GRAS appr
4/24/14 - Bill Ackmans Got A Fever And The Only Prescription Is More Takeovers [Dealbreaker]
Ackman, who has teamed up with Canadian pharmaceutical company Valeant to launch a $45.6 billion takeover of Botox maker Allergan, warned drugmakers Tuesday that he plans to go on a little buying spree. "This is not the last deal we're going to do," he said. "There are $10 trillion worth of targets," said Ackman, referring to the combined market
4/24/14 - Breast cancer Blow for sufferers as expensive drug is blocked [Bristol Evening Post (England)]
Scores of people living in the Bristol area benefited from the treatment when it was trialled at Bristol Royal Infirmary. Dr Mark Beresford, consultant clinical oncologist, who was leading a trial at Bristol, said: "The news that Nice plans to refuse routine access to Kadcyla on the NHS is hugely disappointing. "The good news is that women can sti
4/24/14 - BRIEF: Coral Gables drug company to make new medicine available at no cost [The Miami Herald :: ]
April 23 Coral Gables- based Catalyst Pharmaceutical Partners soon will make its investigational drug Firdapse available at no cost to patients with a certain autoimmune disorder. Catalyst said it expects to submit an application for Firdapse's approval with the U.S. Food and Drug Administration next year. Catalyst has been leading the developmen
4/24/14 - Canada : Proskauer Expands Life Sciences Practice with Noted Patent Litigator Siegmund Gutman in Los Angeles [TendersInfo (India)]
Mr. Gutman is an accomplished patent litigator, having frequently represented clients before trial and appellate courts, as well as arbitration panels. In the life sciences area, Mr. Gutman concentrates his practice on developing and executing market exclusivity and freedom-to-operate strategies, including patent office and FDA regulatory strategie
4/24/14 - Cubist Submits New Drug Application for Investigational Antibiotic Ceftolozane/tazobactam [Health & Beauty Close - Up]
Cubist Pharmaceuticals, Inc. announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration for approval of its investigational antibiotic ceftolozane/ tazobactam for the treatment of Complicated Urinary Tract Infections and Complicated Intra-Abdominal Infections. The NDA submission is based on positive data from...
4/24/14 - Data from Upsher-Smith's Epilepsy Portfolio to be Presented at Meeting of the American Academy Of Neurology [Health & Beauty Close - Up]
Upsher-Smith Laboratories, Inc.. a fully integrated pharmaceutical company committed to the development of new treatments for diseases of the central nervous system, will highlight new pooled phase 1 data from studies in healthy adults comparing the adverse event profile of USL255 with immediate-release topiramate in a poster presentation at the 66
4/24/14 - Eisai Launches New Comprehensive Information Website about Neglected Tropical Diseases and Elimination Initiatives
Tokyo, Apr 24, 2014 Eisai Co., Ltd. announced today that it has launched a new comprehensive information website called the "Eisai Access to Medicines Navigator" which provides information on Neglected Tropical Diseases and the various initiatives to eliminate these diseases in an easy to understand way. Many developing countries throughout the w
4/24/14 - Emergent BioSolutions Reports Orphan Drug Designation for BioThrax for Post-Exposure Prophylaxis of Anthrax Disease [Health & Beauty Close - Up]
Emergent BioSolutions Inc. announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to BioThrax for post-exposure prophylaxis of anthrax disease resulting from suspected or confirmed exposure to Bacillus anthracis. "Emergent is pleased with FDA's Orphan Drug Designation of BioThrax for post-exposure prophylaxis," sa
4/24/14 - European Urology Publishes Positive Clinical Trial Results of Topical Botulinum Toxin [Professional Services Close - Up]
The clinical trial was conducted at Tzu Chi University, Hualien, Taiwan. "The possibility of urinary retention and urinary tract infection are the primary drawbacks of the currently available botulinum toxins when treating OAB," according to Michael Chancellor MD, Chief Medical Officer of Lipella Pharmaceuticals. In an accompanying editorial, Prof
4/24/14 - FDA Accepts Gilead Sciences' Drug Applications for Cobicistat and Elvitegravir for HIV Therapy [Health & Beauty Close - Up]
Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration has accepted the company's refiling of two New Drug Applications for cobicistat, a pharmacoenhancing or "boosting" agent that increases blood levels of the protease inhibitors atazanavir and darunavir to enable once-daily dosing of these medicines in HIV therapy, and elviteg
4/24/14 - FDA Approves Cochlear Limited Aqua+ Accessory [Travel & Leisure Close - Up]
Cochlear Limited, a provider of implantable hearing solutions, announced that the US Food and Drug Administration has approved the Aqua+ accessory, a waterproof behind-the-ear solution for cochlear implant recipients. The Aqua+ is a form-fitting accessory that allows Cochlear Nucleus 5 and Nucleus 6 Implant recipients2 to swim underwater for up to
4/24/14 - FDA approves Sylvant for rare Castleman's disease
Release date- 23042014- The U.S. Food and Drug Administration today approved Sylvant to treat patients with multicentric Castleman's disease, a rare disorder similar to lymphoma. 'Sylvant is the first FDA- approved drug to treat patients with MCD,' said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Ce
4/24/14 - Germany : FDA Grants Orphan Drug Designation for Bayer s Investigational Ciprofloxacin Dry Powder for Inhalation for Treatment of NCFB [TendersInfo (India)]
Bayer HealthCare today announced that the U.S. Food and Drug Administration s Office of Orphan Products Development has granted an orphan drug designation for its investigational Ciprofloxacin Dry Powder for Inhalation for the treatment of non-cystic fibrosis bronchiectasis. Jrg Mller, Member of the Bayer HealthCare Executive Committee and Head
4/24/14 - Horizon Pharma Announces the U.S. Patent and Trademark Office Issued an Additional Notice of Allowance With Claims Covering RAYOS Prednisone...
By a News Reporter-Staff News Editor at Politics& Government Week Horizon Pharma, Inc. announced that Skyepharma has received a Notice of Allowance from the United States Patent and Trademark Office for U.S. "This patent allowance by the USPTO is another important milestone in achieving our goal of protecting the innovation and commercial potent
4/24/14 - HPV: Do Vaccinated Women Still Need a Pap Smear? polyDNA Answers Survey Question and Recommends Novirin Against the Latent HPV
polyDNA's latest survey discovered that 72% of female respondents who had been vaccinated against the human papillomavirus, wanted to know if they still need to have a regular pap smear. "Already got immunized with the HPV vaccine? The formula of this natural antiviral product was shown to reduce HPV symptoms in a post-marketing clinical study tha
4/24/14 - New breast cancer results illustrate promise and potential of I-SPY 2 trial
By a News Reporter-Staff News Editor at Women's Health Weekly In an innovative clinical trial led by UC San Francisco, the experimental drug neratinib along with standard chemotherapy was found to be a beneficial treatment for some women with newly diagnosed, high-risk breast cancer. The phase 2 data was presented in San Diego at the annual meeti
4/24/14 - Novartis announces portfolio transformation, focusing company on leading businesses with innovation power and global scale, Pharmaceuticals, Eye Care and Generics
Release date- 23042014- Basel- Novartis announced today that it has reached a definitive agreement with GlaxoSmithKline plc to exchange certain assets, building global leadership in key segments and focusing the company's portfolio. Under the agreement, Novartis would strengthen the company's innovative pharmaceuticals business by acquiring GSK...
4/24/14 - Patent Application Titled "Pharmaceutical Formulation Comprising an Antibody against P-Selectin and a Sugar Selected from Sucrose and Trehalose"...
Patent Application Titled "Pharmaceutical Formulation Comprising an Antibody against P-Selectin and a Sugar Selected from Sucrose and Trehalose" Published Online. By a News Reporter-Staff News Editor at Politics& Government Week According to news reporting originating from Washington, D.C., by VerticalNews journalists, a patent application by the
4/24/14 - Pharma firms turn attention to hearing loss
By a News Reporter-Staff News Editor at Gene Therapy Weekly Hearing loss affects 36 million Americans to some degree, often leaving them feeling isolated, but it has received little attention from the pharmaceutical industry- until now. Small firms have brought a handful of potential therapies to the development pipeline, and pharmaceutical heavy
4/24/14 - Pharmacyclics to Present Phase III and Long Term Follow Up Data on Imbruvica in Chronic Lymphocytic Leukemia (CLL) at ASCO [Health & Beauty Close - Up]
Pharmacyclics, Inc. announced that data from the Phase III PCYC- 1112 study of single agent Imbruvica vs. ofatumumab, an established therapy in relapsed refractory CLL, as well as data from an Independent Efficacy Evaluation of Imbruvica after three years of follow-up, will be presented at the American Society of Clinical Oncology 50th Annual Meeti
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