Pharmaceuticals News and Research

RSS

Manhattan Scientifics completes agreement to acquire all commercial rights to Senior Scientific

Manhattan Scientifics Inc., a nanomedicine technology transfer and commercialization pioneer, today announced completion of its agreement to acquire all commercial rights to the body of work of nuclear physicist Edward R. Flynn, PhD and his company, Senior Scientific LLC.

26 Feb 2010

Resverlogix commences enrollment in RVX-208 Phase 2 clinical trial for atherosclerosis in ACS patients

Resverlogix Corp. announced today that it has officially activated the first site for the ASSURE 1 trial and commenced enrollment of patients for dosing of RVX-208. ASSURE 1 is the second Resverlogix Phase 2 clinical trial, led by Cleveland Clinic. This trial will examine RVX-208, Resverlogix's oral small molecule therapy for the treatment of atherosclerosis, in patients with acute coronary syndrome (ACS). This preparatory acute coronary syndrome study will ensure that 50 percent of the enrolled patients receive the IVUS (intravascular ultrasound) assessment.

26 Feb 2010

Genta initiates new dose-ranging study of tesetaxel drug

Genta Incorporated announced that the Company has initiated a new dose-ranging study of tesetaxel, the Company’s novel oral tubulin inhibitor, using a weekly dosing regimen. Tesetaxel -- a late Phase 2 oncology product -- is the leading oral taxane currently in clinical development.

26 Feb 2010

USPTO issues notice of allowance for Vanda Pharmaceuticals' Fanapt long-acting injectable formulation

Vanda Pharmaceuticals Inc. announced today that the U.S. Patent and Trademark Office has issued a notice of allowance for its patent application of a microsphere, long-acting injectable formulation of its antipsychotic product, Fanapt™ (iloperidone). When issued, this U.S. patent will expire on October 30, 2022, and in addition, the U.S. Patent and Trademark Office has granted a patent term adjustment of 300 days, leading to an effective expiration date of August 26, 2023.

26 Feb 2010

Ferring Pharmaceuticals, GSN sign agreement to test Parental Support technology

Ferring Pharmaceuticals and Gene Security Network announced that they have signed an agreement to conduct a clinical trial of GSN's advanced preimplantation genetic diagnosis (PGD) technology, Parental Support™.

26 Feb 2010

Kinex Pharmaceuticals announces KX2-391 Phase 2 safety and efficacy clinical trial in men with CRPC

Kinex Pharmaceuticals opened a Phase 2 clinical trial to evaluate the safety and efficacy of KX2-391 in patients with bone-metastatic, castrate-resistant prostate cancer (CRPC) who have not had prior chemotherapy.

25 Feb 2010

E. Fougera receives first generic approval for Imiquimod Cream 5%

E. Fougera & Co., a leading specialty pharmaceutical manufacturer, today announced it has received first generic approval from the FDA for Imiquimod Cream 5% (Rx). Fougera's Imiquimod Cream 5% is rated AB, generically equivalent to Aldara® by Graceway Pharmaceuticals and substitutable for all indications. According to industry data, U.S. sales of the brand named product in 2009 exceed $360 million.

25 Feb 2010

FDA sets new PDUFA action date for exenatide once weekly NDA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today confirmed that the U.S. Food and Drug Administration (FDA) has set a new Prescription Drug User Fee Act (PDUFA) action date of March 12 for its review of the exenatide once weekly new drug application (NDA).

25 Feb 2010

Biovail reports 33% increase in total revenues for fourth-quarter 2009

Biovail Corporation today announced financial results for the three-month and 12-month periods ending December 31, 2009.

25 Feb 2010

Impax Laboratories announces record net income of $0.61 per diluted share for fourth-quarter 2009

Impax Laboratories, Inc. today reported its strongest financial results in its history due to record sales from its Global products sales channel.

25 Feb 2010

Regulus Therapeutics, GSK announce new collaboration on microRNA therapeutics targeting microRNA-122

Regulus Therapeutics Inc. today announced the establishment of a new collaboration with GlaxoSmithKline (GSK) to develop and commercialize microRNA therapeutics targeting microRNA-122 in all fields with Hepatitis C Viral infection (HCV) as the lead indication. Under the terms of the new collaboration, Regulus will receive additional upfront and early-stage milestone payments with the potential to earn more than $150 million in miR-122-related combined payments, and tiered royalties up to double digits on worldwide sales of products.

25 Feb 2010

Mylan reports total revenues of $1.35 billion for fourth-quarter 2009

Mylan Inc. today announced its financial results for the three and twelve months ended December 31, 2009.

25 Feb 2010

Cannabis Science completes selection of initial cannabis-based pharmaceutical for FDA clinical trials

Cannabis Science Inc., a pharmaceutical cannabis company, is pleased to report to their shareholders that the choice of our initial cannabis-based pharmaceutical for FDA clinical trials has been made. The Company has reported several possible drugs for FDA clinical trials. Based on extensive studies, the Company has decided to contract with a group based in Colorado to handle the Company’s FDA filings.

25 Feb 2010

Healthcare industries pay millions to summit invitees, says CREW’s study

On the eve of President Obama’s health care reform summit, Citizens for Responsibility and Ethics in Washington (CREW) released data showing that since 2005, health care special interests have invested at least $28 million in the campaigns of House and Senate leaders, chairs and ranking members of committees with primary jurisdiction over health care legislation. Additionally, President Obama received over $18.6 million during his presidential campaign.

25 Feb 2010

Texas Plant-Expressed Vaccine Consortium announces biotherapeutic manufacturing initiative for infectious diseases

Leaders of the Texas Plant-Expressed Vaccine Consortium today announced a biotherapeutic manufacturing initiative designed to show proof of concept for a landmark new technology that could dramatically increase the nation's capability to produce vaccines for infectious diseases, including influenza.

25 Feb 2010

OncoGenex Pharmaceuticals receives CHMP advice on OGX-011 development plan in treatment of mCRPC

OncoGenex Pharmaceuticals announced today that it has received written, scientific advice from the European Medicines Agency (EMA) on the company's development plan for OGX-011 (also known as custirsen) for the treatment of men with metastatic castrate-resistant prostate cancer (mCRPC). The input received from the Committee for Medicinal Products for Human Use (CHMP) at the EMA was in overall agreement with OncoGenex's development plan regarding the proposed preclinical studies and both the study designs and analyses for the Phase III trials.

25 Feb 2010

ICON reports net revenues of $227.4M for fourth-quarter 2009

ICON, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today reported its financial results for the fourth quarter ended December 31, 2009.

25 Feb 2010

FEHBP's H.R. 4489 overhaul will undermine cost-saving tools and disrupt prescription drug benefits

“Regrettably, the FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act (H.R. 4489) would undermine many of the cost-saving tools used in FEHBP and disrupt prescription drug benefits for 8 million federal employees, retirees, and their families.”

25 Feb 2010

Translational Regenerative Medicine Forum in Winston-Salem

A spray-on skin product and an injectable cell therapy for heart attack patients are among 17 regenerative medicine technologies that will be showcased during the Translational Regenerative Medicine Forum, set for April 6-8 in Winston-Salem.

25 Feb 2010

Delays and variability in UK clinical research projects result in skill shortages

Significant new research from Warwick Business School and Queen Mary, University of London, warns that delays and variability in the approvals process for clinical research could be causing pharmaceutical companies to look outside the UK and risks the country losing some of its most experienced researchers.

25 Feb 2010

Pharmaceuticals News and Research

Manhattan Scientifics completes agreement to acquire all commercial rights to Senior Scientific

Resverlogix commences enrollment in RVX-208 Phase 2 clinical trial for atherosclerosis in ACS patients

Genta initiates new dose-ranging study of tesetaxel drug

USPTO issues notice of allowance for Vanda Pharmaceuticals' Fanapt long-acting injectable formulation

Ferring Pharmaceuticals, GSN sign agreement to test Parental Support technology

Kinex Pharmaceuticals announces KX2-391 Phase 2 safety and efficacy clinical trial in men with CRPC

E. Fougera receives first generic approval for Imiquimod Cream 5%

FDA sets new PDUFA action date for exenatide once weekly NDA

Biovail reports 33% increase in total revenues for fourth-quarter 2009

Impax Laboratories announces record net income of $0.61 per diluted share for fourth-quarter 2009

Regulus Therapeutics, GSK announce new collaboration on microRNA therapeutics targeting microRNA-122

Mylan reports total revenues of $1.35 billion for fourth-quarter 2009

Cannabis Science completes selection of initial cannabis-based pharmaceutical for FDA clinical trials

Healthcare industries pay millions to summit invitees, says CREW’s study

Texas Plant-Expressed Vaccine Consortium announces biotherapeutic manufacturing initiative for infectious diseases

OncoGenex Pharmaceuticals receives CHMP advice on OGX-011 development plan in treatment of mCRPC

ICON reports net revenues of $227.4M for fourth-quarter 2009

FEHBP's H.R. 4489 overhaul will undermine cost-saving tools and disrupt prescription drug benefits

Translational Regenerative Medicine Forum in Winston-Salem

Delays and variability in UK clinical research projects result in skill shortages

Oxygen Measurement eBook - Easily Understand Dissolved Oxygen Measurement eBook

Latest eBooks

A practical guide to lipid nanoparticle formulation and resizing

Editorial Focus eBook - Spatial and single-cell omics (1st edition)

Industry Focus eBook - Analytical Chemistry (3rd edition)

Industry Focus eBook - Microbiome (1st edition)

Managing vibration in IVF laboratories

Improving healthcare sustainability through carbon data

A New Approach to Preventing Bladder Cancer Recurrence