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Analyzing the FDA bill's course: Bipartisanship or something else?

The bipartisan treatment the FDA user fee bill has enjoyed did not fall like manna from heaven. It came at the insistence of the pharmaceutical and medical device industries, the FDA and legislators on both sides of the aisle who agreed early on they would get a deal done. And then actually did it.

27 Jun 2012

Top-line final data from Provectus’ PV-10 phase 2 trial on metastatic melanoma

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, announced that top-line final data from its phase 2 clinical trial of PV-10 for metastatic melanoma were presented at the 2nd European Post-Chicago Melanoma Meeting 2012, Interdisciplinary Global Conference on Developing New Treatments for Melanoma, on June 22, 2012, in Munich, Germany.

27 Jun 2012

Sunshine Biopharma completes Adva-27a cytotoxicity study on multidrug-resistant lung cancer

Sunshine Biopharma Inc., a pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer, today announced that it has completed a cytotoxicity study of its lead compound, Adva-27a, in H69AR, a Multidrug Resistant Small Cell Lung Cancer cell line. Cytotoxicity studies measure the ability of a drug to destroy cancer cells in vitro.

27 Jun 2012

RXi Pharmaceuticals initiates RXI-109 Phase 1 trial to reduce surgical scars

RXi Pharmaceuticals Corporation today announced that it successfully initiated its first ever clinical study with an RNAi compound, RXI-109, using their proprietary self-delivering RNAi technology.

27 Jun 2012

BioSpecifics commences XIAFLEX Phase II trial in human lipoma

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX in the U.S. and XIAPEX in Europe and Eurasia, today announced that it has initiated its Phase II trial of XIAFLEX (collagenase clostridium histolyticum) for the treatment of human lipoma.

27 Jun 2012

Report on the global market for breast cancer diagnostics and drug technologies

Breast Cancer Diagnostic and Drug market are recovering after significant slowdown during the global recession. Having accurate market data and analysis will be essential to companies seeking to compete on the global stage as the market reemerges into success.

26 Jun 2012

Biological filter to remove estrogens from waste water and drinking water

A biological filter to remove estrogens from waste water and drinking water. The 15 Bielefeld students submitting this project to the 'international Genetically Engineered Machine competition' (iGEM) at the Massachusetts Institute of Technology (MIT) in Boston, USA are setting their sights high.

26 Jun 2012

First Edition: June 26, 2012

Today's headlines include reports setting the scene for Thursday's Supreme Court decision that will determine the health law's future.

26 Jun 2012

Nanoparticles that can slip through mucus barriers shown to protect against herpes infections

Johns Hopkins researchers say they have demonstrated, for the first time in animals, that nanoparticles can slip through mucus to deliver drugs directly to tissue surfaces in need of protection. The researchers used these mucus-penetrating particles (MPPs) to protect against vaginal herpes infections in mice and the goal is to create similar MPPs to deliver drugs that protect humans against sexually transmitted diseases or even treat cancer.

26 Jun 2012

Vatican official calls on international community to provide 'free, efficient' HIV treatment in Africa

Cardinal Tarcisio Bertone, the Vatican's secretary of state and number two official, "called Friday on the international community to provide 'free and efficient treatment' for AIDS in Africa, starting with pregnant women, mothers and their babies," Agence France-Presse reports.

26 Jun 2012

CCI, NextBio partner to adopt genomics in the clinic

NextBio and Cancer Care Institute (CCI) announced today a strategic partnership aimed at furthering the adoption of genomics in the clinic. The collaboration will facilitate use of the NextBio platform to interpret genomic molecular data for oncology patients and streamline the complete workflow for use of molecular data in a clinical setting.

26 Jun 2012

KaloBios’ KB001 shows promise against Pa pneumonia

Phase 2a trial results with KB001 suggest the recombinant, human PEGylated monoclonal antibody fragment, under development by KaloBios Pharmaceuticals, Inc. and Sanofi Pasteur, offers potential as an alternative to antibiotics for preventing or reducing pneumonias in mechanically ventilated intensive care unit (ICU) patients heavily colonized with Pseudomonas aeruginosa (Pa).

26 Jun 2012

Pfizer, Wyeth and PF Prism file suit against Watson over generic Pristiq

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. - Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Desvenlafaxine Succinate Extended-release Tablets, 50 mg and 100 mg.

26 Jun 2012

CytRx achieves key milestone in advancing tamibarotene Phase 2b trial for NSCLC

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced the recommendation by the Data Safety Monitoring Board (DSMB) to continue with the global Phase 2b clinical trial with tamibarotene in combination with chemotherapeutical agents as a first-line treatment for patients with advanced non-small-cell lung cancer.

26 Jun 2012

CHRI signs new sales LOI with Pengxi Huitong Pharmaceutical

China Health Resource, Inc., announced today that it has signed a new sales letter of intent (LOI) for this year for its proprietary Yishen Capsule valued at 25 million RMB; approximately $4 million USD.

26 Jun 2012

Sinovac provides update on EV71 vaccine Phase III trial on HFMD

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, today provided an update on its Phase III clinical trial progress and commercialization preparation for its proprietary inactivated Enterovirus 71 (EV71) vaccine against hand, foot and mouth disease (HFMD).

26 Jun 2012

Enrollment commences in Stealth Peptides' Bendavia Phase II clinical study for acute STEMI

Stealth Peptides Incorporated, a privately held biopharmaceutical company developing innovative therapies for cardiovascular disease and its complications, announced today that the first patient was enrolled in its multinational Phase II clinical study with Bendavia focused on ischemia reperfusion and microvascular injuries for patients experiencing acute ST-segment elevation myocardial infarction.

25 Jun 2012

Thomson Reuters unveils new regulatory intelligence solution at DIA 2012

The Intellectual Property & Science division of Thomson Reuters unveiled Cortellis for Regulatory Intelligence™ at the DIA 2012 Annual Meeting in Philadelphia today. This new offering is the next generation of Thomson Reuters IDRAC™, the company's best-in-class regulatory intelligence tool that provides pharmaceutical professionals with reliable and accurate global regulatory information to gain competitive advantage and minimize regulatory risks.

25 Jun 2012

China SFDA approves China Biologic's Human Coagulation Factor VIII

China Biologic Products, Inc., a leading fully integrated plasma-based biopharmaceutical company in China, today announced that its indirectly owned subsidiary, Shandong Taibang Biological Products Co., Ltd. has received a manufacturing approval certificate from the China State Food and Drug Administration for Human Coagulation Factor VIII ("FVIII").

25 Jun 2012

NIH awards Sirnaomics SBIR grant for developing STP705 siRNA wound healing product

Sirnaomics, Inc. announced today that the company has been awarded another NIH SBIR grant for developing its small interfering RNA (siRNA) therapeutic product STP705 to improve skin wound healing with minimized scar formation.

25 Jun 2012