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Hospira commences EPO Phase I U.S. clinical trial in renal dysfunction patients with anemia

Hospira, Inc., the world leader in generic injectable pharmaceuticals, today announced the start of a U.S. Phase I clinical trial of its biosimilar erythropoietin (EPO) in patients with renal (kidney) dysfunction who have anemia, an important step on the road toward introducing a biosimilar product in the United States. Erythropoietin is a treatment for anemia associated with chronic renal failure and chemotherapy.

26 Jul 2010

QPS acquires Xendo Drug Development

QPS Holdings, LLC, a leading full-service GLP/GCP-compliant contract research organization providing testing services to support preclinical and clinical research and development, announced the completion of its acquisition of Xendo Drug Development BV (XDD), headquartered in Groningen, The Netherlands. XDD, a European contract research organization (CRO), will be known as QPS Netherlands BV and become a wholly-owned subsidiary of QPS Holdings, LLC.

26 Jul 2010

Today's OpEds: Health reform and long-term care; Health care incentives; Reasons for optimism or repeal and replace?

Our system of long-term care does not provide adequate or coordinated human services and medical treatment for our growing aging population. … Thanks to a provision of the new health care law known as the Community Living Assistance Services and Supports program, tomorrow's continuum of care does not have to be so unforgiving. For the first time, a voluntary public insurance program will be available to help adults and families pay for long-term care services (Bruce Chernof, 7/23).

26 Jul 2010

Colorcon acquires business of Pharmaceutical Coatings

Colorcon, Inc. today announced the acquisition of the business of Pharmaceutical Coatings Pvt. Ltd. (India) which includes the company's full product portfolio, plus a new facility in Goa that is currently under construction.

26 Jul 2010

KIKA Clinical Solutions reports 47% increase in service bookings during first-half of 2010

KIKA™ Clinical Solutions is on track for unprecedented 2010 growth. KIKA is the leading provider of advanced EDC solutions for Clinical Asset Management™ for the pharmaceutical, biotechnology and medical device markets.

26 Jul 2010

Tibotec submits NDA for TMC278 anti-HIV compound to FDA

Tibotec Pharmaceuticals today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TMC278 (rilpivirine), an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), being studied for once-daily use with other antiretroviral agents in treatment-naive HIV-1-infected adults. If approved, TMC278 will be the third anti-HIV compound to be introduced by Tibotec Pharmaceuticals.

26 Jul 2010

AVEO's initiation of AV-299 Phase 2 trial for lung cancer triggers $750,000 milestone payment to XOMA

XOMA Ltd., a leader in the discovery and development of therapeutic antibodies, announced receipt of a $750,000 milestone payment under its collaboration with AVEO Pharmaceuticals, Inc.. The milestone payment resulted from AVEO's recent initiation of a Phase 2 clinical trial to evaluate its AV-299 antibody for the treatment of non-small cell lung cancer. AV-299 is a humanized antibody to hepatocyte growth factor (HGF).

26 Jul 2010

Onyx reports positive results from carfilzomib Phase 2b 003-A1 study in multiple myeloma

Onyx Pharmaceuticals, Inc. today announced positive top-line results from the Phase 2b 003-A1 study of single-agent carfilzomib, a selective, next generation proteasome inhibitor, in patients with relapsed and refractory multiple myeloma.

26 Jul 2010

First Edition: July 26, 2010

Today's headlines include news about the politics of implementing the new health reform law as well as the ADA's 20th anniversary.

26 Jul 2010

Report on shaping marketplace to support successful oncology product launches

The bio-pharmaceutical marketplace – and the oncology therapeutic area in particular – continues to evolve as new medicines and technologies create valuable market opportunities. It's in this competitive and challenging environment that organizations with new oncology products are scrutinizing their strategies and tactics to support market education.

26 Jul 2010

Cerenis, Novasep awarded French Government funding for development of CER-001 HDL mimetic

Cerenis Therapeutics SA (Cerenis), a biopharmaceutical company developing novel high-density lipoprotein (HDL) therapies to treat cardiovascular and other metabolic diseases, and Groupe Novasep (Novasep), a leading supplier of manufacturing solutions to the life sciences industries, announce today that they have received French Government funding through OSEO to finance the development of CER-001, a Cerenis HDL mimetic.

26 Jul 2010

Cerenis Therapeutics closes first round of series C, raises €40 million

Cerenis Therapeutics SA (Cerenis), a biopharmaceutical company specializing in the research and development of novel therapies based on the metabolism of HDL (the "good" cholesterol) to treat cardiovascular and other metabolic diseases, announced today it has raised €40 million in the first close of its series C financing. In this round €20 million came from the Fund for Strategic Investment (FSI) with an additional €20 million coming from the existing investors: Sofinnova Partners, HealthCap, Alta Partners and TVM Capital, EDF Ventures, OrbiMed and DAIWA Corporate Investment.

26 Jul 2010

Sartorius reports substantial gain in first half for 2010

Today Sartorius, a leading international process and laboratory technology provider, published its first-half results for 2010. Both the Biotechnology Division and the Mechatronics Division reported substantial gains in order intake and sales revenue. The two divisions expanded their business in all regions. Besides the continued strong development in the Biotechnology Division, the positive earnings contributed by the Mechatronics Division are especially encouraging, given that this division faced an exceptionally adverse business climate last year as a result of the global economic crisis.

From Sartorius 26 Jul 2010

L2FU reports 100% recovery of recent study's lost clinical trial patients

Recovering unnecessarily lost patient information is now a viable reality. Lost to follow up rates in clinical research trials can range from 20- 60%. As a result, patients who drop from a clinical trial and 'go missing' can impart a major set-back in pharmaceutical research. Failure to contact patients and obtain final closure data, or bring them back into the clinical trial (if the protocol allows) results in study delays, increased patient recruitment costs, compromised study data, and in some cases an insufficient amount of information to prove the safety and efficacy of a drug.

26 Jul 2010

Teva comments on FDA's approval of generic Lovenox injection

Teva Pharmaceutical Industries Ltd. commented today on the U.S. Food and Drug Administration's response to a citizen petition questioning the approval criteria for a generic Lovenox (enoxaparin sodium) injection and its subsequent approval of another generic filer's Abbreviated New Drug Application.

26 Jul 2010

Outcomes selected to administer MTM program for employees in the State of Iowa

Outcomes Pharmaceutical Health Care has been selected by the State of Iowa Department of Administrative Services to administer a Medication Therapy Management program for the state employee health plan.

26 Jul 2010

MedNet announces significant improvements to EMPOWER system

MedNet Solutions, a global life sciences technology solutions company specializing in clinical study management systems, is pleased to announce significant enhancements to EMPOWER, the company's comprehensive investigator initiated - sponsored research management solution. The EMPOWER system is currently being utilized on a world-wide basis by numerous pharmaceutical and medical device companies to automate and streamline investigator research submissions, management and reporting.

26 Jul 2010

Ohio sets up high risk pool; Four drug companies come under scrutiny for payments to Pittsburgh doctors, nurses

"Ohioans with pre-existing health conditions, such as cancer or diabetes, can apply for coverage under a new high-risk insurance pool beginning Aug. 1." Qualifications include evidence of a pre-existing condition, proof of Ohio residency and U.S. citizenship, state of being uninsured for six months prior to the date of applying for coverage and being "ineligible for coverage under the Medicare program, the Ohio Medical Assistance Program, the Ohio Children's Health Insurance Program, or an employer-sponsored group health plan, unless subject to a mandatory initial waiting period" (7/22).

26 Jul 2010

FDA grants marketing approval of ANDA for enoxaparin sodium for injection

Momenta Pharmaceuticals, Inc., a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that the U.S. Food and Drug Administration has granted marketing approval of the Abbreviated New Drug Application for enoxaparin sodium for injection filed by Sandoz. Developed under a collaboration agreement between Momenta and Sandoz, this product has been designated therapeutically equivalent to the reference-listed drug, Lovenox, which is marketed by Sanofi-Aventis.

26 Jul 2010

First generic version of Lovenox receives FDA approval for DVT

The U.S. Food and Drug Administration today approved the first generic version of Lovenox (enoxaparin sodium injection), an anti-coagulant drug used to prevent deep vein thrombosis, a potentially deadly blood clotting condition.

23 Jul 2010