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FDA completes IIWA to curb illegal actions involving medical products

The U.S. Food and Drug Administration today completed a coordinated, weeklong, international effort, called the International Internet Week of Action (IIWA), intended to curb illegal actions involving medical products.

20 Nov 2009

ScinoPharm receives Potent Compound Safety Certification from SafeBridge Consultants

ScinoPharm, a leading global supplier of active pharmaceutical ingredients (APIs), announced that its Tainan facility has received the Potent Compound Safety Certification from SafeBridge(R) Consultants, Inc.

20 Nov 2009

Swissmedic grants marketing authorization for Amitiza

Sucampo Pharma Europe Ltd., a subsidiary of Sucampo Pharmaceuticals, Inc., today announced that Swissmedic, the Swiss Agency for Therapeutic Products, has granted a marketing authorization for Amitiza® (lubiprostone) 24 microgram (mcg) gel capsules for the long-term treatment of patients with chronic idiopathic constipation (CIC).

20 Nov 2009

Two million enroll in Medicaid during first half of 2009

HealthLeaders-InterStudy, the leading provider of managed care market intelligence, reports that nationwide, Medicaid enrollment grew by two million lives in the first half of 2009 to more than 52 million, reflecting the economic downturn and exacerbating many states' budget concerns.

20 Nov 2009

BioCryst Pharmaceuticals declares proposed public offering of common stock

BioCryst Pharmaceuticals, Inc. today announced the pricing of a public offering of 5,000,000 shares of its common stock at $9.75 per share, resulting in gross proceeds of $48.75 million.

19 Nov 2009

CDAS, Prestwick Chemical sign drug discovery research agreement

Caliper Life Sciences, Inc. (Nasdaq: CALP), a leading provider of tools and services for drug discovery and life sciences research, today announced a strategic partnership between the company's contract research organization, Caliper Discovery Alliances & Services (CDAS), and Prestwick Chemical (Strasbourg, France) to provide customized outsourced medicinal chemistry and in vitro and in vivo preclinical biology programs for drug discovery research.

19 Nov 2009

Ligand Pharmaceuticals receives $2 million in milestone payments from N. V. Organon

Ligand Pharmaceuticals Incorporated announced today that it has received $2 million in milestone payments from N. V. Organon, a subsidiary of Merck & Co., Inc., stemming from its research collaboration that is due to expire at the end of December.

19 Nov 2009

Senate health bill released, another step toward Democratic-backed reforms

"Senate Majority Leader Harry Reid set the stage for a climactic debate in the Senate over health care by unveiling a 10-year, $848 billion bill that would extend insurance to 31 million Americans without coverage," The Wall Street Journal reports.

19 Nov 2009

Daschle still making voice heard on health care

The Hill reports that former Senate Majority Leader Tom Daschle helped Obama Administration officials strategize to win health care reform votes from Senators on Capitol Hill Wednesday.

19 Nov 2009

Adamas Pharmaceuticals expands its Phase 2 TCAD therapy study for influenza A

Adamas Pharmaceuticals, Inc., a privately held company, announced today that it has expanded its Phase 2 clinical study of a proprietary investigational triple-combination antiviral drug therapy for influenza to include centers in the United States, Canada and Europe. The study, which was initiated in August 2009 in the Southern Hemisphere, is designed to investigate Adamas' triple combination antiviral drug (TCAD) therapy as a treatment for influenza A, including novel influenza A/H1N1, the cause of the current flu pandemic.

19 Nov 2009

WaferGen Biosystems launches new SmartChip Service for gene-expression profiling of thousands of genes

WaferGen Biosystems, Inc., a leading developer of state-of-the-art genetic analysis systems, today announced a new, innovative service for gene-expression profiling of thousands of genes using the SmartChip(TM) Real-Time PCR System. By taking advantage of the SmartChip Real-Time PCR system, WaferGen will offer universities, pharmaceutical and diagnostic companies a service that utilizes pathway-specific gene panels to discover and validate new biomarkers.

19 Nov 2009

Lawmakers call for inquiry into pharmaceutical company price hikes

Congressional Democrats are seeking government investigations into recent price increases of brand-name prescription drugs, as Congress finalizes an overhaul of the healthcare system. Lawmakers are concerned the companies are trying to reap gains ahead of reforms aimed at lowering drug prices and forcing drugmakers to partly fund changes that aim to boost the number of Americans covered by health insurance.

19 Nov 2009

Altair Therapeutics initiates its IL-4 receptor alpha inhibitor bronchoprovocation phase 2 trial

Altair Therapeutics, Inc., a privately-held, biopharmaceutical company developing novel therapeutics for respiratory diseases, today announced the commencement of its IL-4 receptor alpha inhibitor bronchoprovocation trial. Study AIR645-CS2 is a phase 2, multi-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and efficacy of inhaled AIR645 in suppressing the asthmatic response in subjects with mild asthma. Results are expected in the third quarter of 2010.

19 Nov 2009

ScinoPharm Taiwan receives the SafeBridge Potent Compound Safety Certification

SAFEBRIDGE® CONSULTANTS, INC., headquartered in Mountain View, California, has announced that ScinoPharm Taiwan Limited in Tainan, Taiwan has met the criteria established under the SafeBridge program for “Potent Compound Safety Certification” and has been deemed competent and proficient in the safe handling of potent active pharmaceutical ingredients (“APIs”).

19 Nov 2009

Astellas Pharma and XenoPort submit NDA in Japan for PMDA approval

Astellas Pharma Inc. and XenoPort, Inc. today announced that a new drug application (NDA) has been filed with the Pharmaceuticals and Medical Device Agency (PMDA) in Japan for ASP8825 (gabapentin enacarbil), also known as XP13512, as a potential treatment for restless legs syndrome (RLS).

19 Nov 2009

OA panel develops a consensus of the optimal exogenous HA treatment using BioRestorative Profiling

A panel of osteoarthritis (OA) key opinion leaders has developed a consensus of the optimal exogenous hyaluronic acid (HA) treatment. This consensus was achieved by utilizing what the experts referred to as BioRestorative(TM) Profiling. This profiling examines HAs on the basis of their mimicking the body's natural HA.

19 Nov 2009

Findings suggest athletes abuse non-approved therapeutic compounds for performance enhancing effects

Researchers from the German Sport University Cologne in Germany found that non-steroidal and tissue-selective anabolic agents such as Selective Androgen Receptor Modulators (SARMs) are being sold on the black market for their performance enhancing qualities.

19 Nov 2009

RBM and Covance sign biomarker alliance and services agreement

Rules-Based Medicine, Inc. (RBM) today announced it has entered into a biomarker alliance and services agreement with Covance Inc. that will provide biotechnology and pharmaceutical companies with a powerful combination of biomarker technologies and services for use in drug development. Under terms of the agreement, Covance will use RBM as its exclusive third-party provider of multiplexed protein biomarker testing services, and RBM shall use Covance as its exclusive referral source for laboratory testing services.

19 Nov 2009

USP releases new CRMs for carbamazepine, phenytoin, and theophylline

To help bring greater certainty to the measurement of medication levels in a patient's bloodstream for three drugs with narrow therapeutic ranges, the U.S. Pharmacopeial Convention (USP) is releasing new certified reference materials (CRMs).

19 Nov 2009

New biomarkers can predict patients' response to certain drugs

Recent advances in cancer therapeutics have led to the discovery of biomarkers that can predict patient response to certain drugs. Screening for mutations in the epidermal growth factor receptor (EGRF) prior to non-small cell lung cancer treatment, for example, has been shown to indentify patients who are likely to respond to treatment with erlontinib. This maximizes the drug's impact, and spares patients who are not likely to benefit from being subjected to potentially debilitating side effects.

19 Nov 2009