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Pharma Industry News (Page 16)
New Studies Support Use Of Intravenous Vimpat(R) (lacosamide) (C-V) In Hospital And Emergency Settings Results of two new studies support the use of the intravenous formulation of the antiepileptic drug (AED) Vimpat® for patients requiring add-on therapy in clinical settings where oral AED therapy is temporarily not feasible... ...more	08 Dec 2009
Oxygen Biotherapeutics, Inc. Enrolls First Patient In Traumatic Brain Injury Clinical Trial In Switzerland Oxygen Biotherapeutics, Inc. (OTC Bulletin Board: OXBT) announced that the first patient has been enrolled in the company's Phase II-b, dose escalation, clinical trial in Switzerland for use of Oxycyte(TM) emulsion in traumatic brain injury (TBI). Oxycyte is the Company's perfluorocarbon (PFC) therapeutic oxygen carrier... ...more	05 Dec 2009
Degarelix (FIRMAGON(R)) Vs Leuprolide (Lupron Depot(R)) In Patients With Advanced Prostate Cancer: Further Analysis From A Phase III Pivotal Trial Drs. Neal Shore and E. David Crawford presented results for prostate-specific antigen (PSA) recurrence from the additional analysis of secondary end points of biochemical recurrence rate in a Phase III pivotal study of FIRMAGON® (monthly degarelix for injection) or monthly leuprolide in prostate cancer patients during the first year of treatment... ...more	05 Dec 2009
US FDA Approves SEROQUEL XR(R) For Add-On Treatment Of Major Depressive Disorder AstraZeneca (NYSE: AZN) announced that the US Food and Drug Administration (FDA) has approved once-daily SEROQUEL XR® (quetiapine fumarate) Extended Release Tablets as adjunctive (add-on) treatment to antidepressants in adults with Major Depressive Disorder (MDD)... ...more	05 Dec 2009
CBO Report Shows Hundreds Of Millions Spent On Direct Marketing Of Drugs To Consumers The Congressional Budget Office released an "interesting report" on on how "pharmaceutical companies market prescription drugs, a subject that has received some scrutiny during the debate on ways to control health care spending," The New York Times reports... ...more	04 Dec 2009
Media Registration For BIO International Convention Now Available Online The Biotechnology Industry Organization (BIO) announces the opening of media registration for the 2010 BIO International Convention. Hosted by BIO, the global event for biotechnology will take place May 3-6, 2010, in Chicago, Ill at McCormick Place. "We're excited to head back to Chicago for the 2010 BIO International Convention," said BIO President and CEO Jim Greenwood... ...more	04 Dec 2009
Amira Pharmaceuticals Announces Initial Positive Phase 1 Clinical Data For AM461, A Back-Up To Amira's Lead DP2 Antagonist, AM211 Amira Pharmaceuticals, Inc. announced initial positive data from a Phase 1 clinical study of AM461, the Company's second oral selective antagonist of the DP2 (also known as CRTH2) receptor. The interim results demonstrate that a dose proportional pharmacodynamic (PD) effect can be achieved with AM461. Additionally, AM461 Phase 1 data to date demonstrates a good safety profile... ...more	04 Dec 2009
VIA Pharmaceuticals Completes Patient Visits In Phase 2 Trial Of VIA-2291 VIA Pharmaceuticals, Inc. (Nasdaq: VIAP), a biotechnology company focused on the development of compounds for the treatment of cardiovascular and metabolic disease, announced that it has completed the last patient visit in its Phase 2 FDG-PET clinical trial of VIA-2291... ...more	04 Dec 2009
Endo Pharmaceuticals Provides Regulatory Update On AVEED(TM) (Testosterone Undecanoate) Injection Endo Pharmaceuticals (Nasdaq: ENDP) announced that it received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for its extended-duration testosterone undecanoate injection, AVEED(TM), for men diagnosed with low testosterone. Low testosterone is also known as hypogonadism... ...more	04 Dec 2009
Pharmasurgics To Begin Phase II Clinical Trial For Prevention Of Post-Surgical Adhesions Pharmasurgics AB - part of the Karolinska Development dermatology and wound healing company "Pergamum" announced that Pharmasurgics has received approval from the Swedish Medical Products Agency to begin a Phase II clinical trial... ...more	04 Dec 2009
Need For A Global Strategy To Develop New Antibiotics In this weekÂ´s The Lancet, an editorial supports the recent calls for a universal effort in developing new antibiotics. It reports that prospects for replacing current antimicrobial drugs are reduced... ...more	04 Dec 2009
Peregrine Completes Patient Enrollment In Cotara(R) Dose Confirmation And Dosimetry Brain Cancer Trial Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) reported completion of patient enrollment in a dose confirmation and dosimetry trial of Cotara® in patients with relapsed glioblastoma multiforme (GBM), the deadliest form of brain cancer. Cotara is a targeted monoclonal antibody linked to a radioisotope being developed as a potential new treatment for GBM... ...more	03 Dec 2009
NOVAVAX Reports Positive Clinical Results From Pivotal Study Of H1N1 Influenza Vaccine In Mexico Novavax, Inc. (Nasdaq: NVAX) reported favorable initial results from the first stage of a two-stage pivotal Phase II study evaluating the safety and immunogenicity of the company's 2009 H1N1 virus-like particle (VLP) pandemic influenza vaccine... ...more	03 Dec 2009
Dermagen Reports Successful Phase I/IIa Clinical Trial For Atopic Dermatitis DermaGen AB - part of the Karolinska Development dermatology and wound healing company "Pergamum" announced that Dermagen AB has received promising results from a clinical Phase I/IIa study. DermaGen AB is developing a novel antimicrobial peptide (AMP) treatment for atopic dermatitis... ...more	03 Dec 2009
European Commission And Biopharmaceutical Industry Lay Out Steps To Improve Business Environment For Sector SMEs EBE, the European Biopharmaceutical Enterprises and the European Commission's Enterprise and Industry Directorate General today jointly presented a workshop on access to finance for small and medium-sized biopharmaceutical companies in Europe... ...more	02 Dec 2009
Pacira Announces Results Of Another Positive Phase III Trial In Post Operative Pain Pacira Pharmaceuticals, Inc., announced that its second Phase III placebo controlled study of EXPAREL(TM) (DepoBupivacaine) met its primary endpoint... ...more	02 Dec 2009
Sinovac Obtains Fourth H1N1 Vaccine Order From Chinese Central Government Sinovac Biotech Ltd. (NYSE: SVA), a leading provider of biopharmaceutical products in China, announced that it has received its fourth purchase order for its H1N1 vaccine, PANFLU.1(TM), from China's Ministry of Industry and Information Technology for the national purchase plan. Under this purchase order, Sinovac is required to produce an additional one million doses of PANFLU.1 (TM) (15ug/0... ...more	02 Dec 2009
FDA Approves ZEGERID OTC(TM) For Over-the-Counter Treatment Of Frequent Heartburn Merck & Co., Inc. announced that the U.S. Food and Drug Administration (FDA) has approved ZEGERID OTC(TM) (omeprazole 20 mg/sodium bicarbonate 1100 mg capsules), for over-the-counter treatment of frequent heartburn. ZEGERID OTC will be marketed over-the-counter by Schering-Plough HealthCare Products, Inc., the consumer healthcare division of Merck & Co., Inc... ...more	02 Dec 2009
New Drug Application Submitted To FDA For Tapentadol Extended Release Tablets For Management Of Chronic Pain Johnson & Johnson Pharmaceutical Research & Development, L.L.C. announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tapentadol extended release (ER) tablets, an investigational oral analgesic for the management of moderate to severe chronic pain in patients 18 years of age or older... ...more	02 Dec 2009
Elsevier Is Re-launching 'Embase' To Be A Powerful Resource Elsevier, the world's leading publisher of scientific, medical and technical products and services, has announced a major re-launch of Embase, its comprehensive biomedical database which holds over 20 million indexed records from more than 7,000 active, peer reviewed journals. Embase has long played a key role in the advancement of new biomedical and pharmaceutical insights... ...more	02 Dec 2009
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