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Proving value a challenge for comparative effectiveness and pharmaceutical technologies

The Wall Street Journal reports that "an examination of one of the best-known examples of a comparative-effectiveness analysis shows how complicated such a seemingly straightforward idea can get" as officials look for savings in the health care system." One study, called Courage, "found that the most common heart surgery -- a $15,000 procedure that unclogs arteries using a small scaffold or stent -- usually yields no additional benefit when used with a cocktail of generic drugs in patients suffering from chronic chest pain."

12 Feb 2010

Ulcerative colitis drug market to grow up to $2.1 billion in 2018

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the ulcerative colitis drug market will nearly double from $1.2 billion in 2008 to $2.1 billion in 2018 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.

12 Feb 2010

3SBio, Ascentage Pharma announce cancer therapeutics collaboration

3SBio Inc., a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, and Ascentage Pharma Group Corporation, Ltd. ("Ascentage Pharma") announced today that they have formed a strategic alliance to research, develop and commercialize best-in-class targeted cancer therapeutics focusing on programmed cell death, or apoptosis. The alliance will leverage Ascentage Pharma's expertise in structure-based small molecule design, lead optimization and preclinical development with 3SBio's proven drug development and commercialization capabilities in China.

12 Feb 2010

Medicaid and other state programs face questions about fraud, other difficulties

The state's Medicaid Fraud Division said two state agencies, the Health Department and Human Services Department that administer the Medicaid program, "'filtered' and 'sanitized' information and documents requested by investigators, hindering numerous investigations." The federal Centers for Medicare and Medicaid Services wil investigate the allegations (Furlow, 2/10).

12 Feb 2010

Coalition group calls for bigger FDA budget

The Los Angeles Times reports that when the president's budget was announced, calling for an increase in the FDA's budget, "a coalition of public interest advocates, patient groups and healthcare industry interests regulated by the FDA had a swift response: It's not enough. 'We are disappointed in the president's budget request and ... will seek to increase' the budget, said Steven Grossman, deputy executive director of Alliance for a Stronger FDA.

11 Feb 2010

FDA grants approval for Abbott's antiretroviral medication Norvir

Abbott announced today that the U.S. Food and Drug Administration (FDA) has granted approval of a new tablet formulation of the company's antiretroviral medication Norvir ® (ritonavir). The new Norvir tablets can be stored at room temperature and do not require refrigeration, making it more convenient for patients.

11 Feb 2010

Alcon reports 2009 fourth quarter results

Alcon, Inc. reported that global sales rose 14.5 percent to $1.72 billion for the fourth quarter of 2009, or an 8.5 percent increase excluding the impact of foreign exchange fluctuations. Reported net earnings for the fourth quarter of 2009 grew 8.0 percent to $458 million, or $1.51 per diluted share.

11 Feb 2010

3SBio submits application for Phase I clinical trial of NuPIAO to the Chinese SFDA

3SBio Inc., a leading biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products primarily in China, today announced that it has submitted its application for a Phase I clinical trial for NuPIAO to the Chinese State Food and Drug Administration (SFDA).

11 Feb 2010

RadPharm and Medifacts International announce merger

RadPharm Inc., a leading Imaging Core Laboratory, and Medifacts International, Inc., a leading Cardiovascular Core Laboratory, today announced the merger of their business operations. The combined company will be named CoreLab Partners ("CoreLabs") and will have its corporate headquarters in Princeton, New Jersey.

11 Feb 2010

Cadence Pharmaceuticals' IV acetaminophen NDA receives FDA Complete Response letter

Cadence Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response letter to its New Drug Application (NDA) for intravenous (IV) acetaminophen.

11 Feb 2010

China Pediatric Pharmaceuticals issues 375,000 common stock shares in private placement transaction

China Pediatric Pharmaceuticals, Inc., today announced it has recently closed a private placement financing. In the transaction the Company issued 375,000 shares of the Company's common stock at a price of $4.00 per share for an aggregate purchase price of $1.5 million.

11 Feb 2010

Alexion Pharmaceuticals announces financial results for quarter and year ended December 31, 2009

Alexion Pharmaceuticals, Inc. today announced financial results for the quarter and year ended December 31, 2009. For the three months ended December 31, 2009, Alexion Pharmaceuticals, Inc. ("Alexion" or, the "Company") reported net product sales of Soliris® (eculizumab) of $110.6 million, reflecting strong additions of new patients, compared to $77.4 million for the same period in 2008.

11 Feb 2010

PAREXEL International, Proteome Sciences form biomarker alliance

PAREXEL International Corporation, a leading global biopharmaceutical services provider, and Proteome Sciences plc, a leading provider of protein biomarker discovery, validation, and assay development services, today announced the formation of an alliance focused on enhancing PAREXEL's biomarker capabilities for early phase clinical development. PAREXEL is using Proteome Sciences' PS Biomarker Services™ protein and peptide biomarker capabilities to support biopharmaceutical companies in making earlier assessments of new compounds in development.

From Parexel 11 Feb 2010

Nontraditional companies to help reshape healthcare marketplace

Information technology (IT) companies, large retailers, and telecommunication firms are strategically poised to capitalize on rapid changes taking place in health care, and pharmaceutical companies are increasingly looking for innovative ways to collaborate with these new players to reach and improve outcomes for patients.

11 Feb 2010

SafeBridge Consultants validates improved hygiene air sampling and analytical method for naproxen sodium

SafeBridge® Consultants, Inc. headquartered in Mountain View, California announced today that its industrial hygiene analytical laboratory has recently validated an industrial hygiene air sampling and analytical method with improved analytical sensitivity for measurement of naproxen sodium on filters. SafeBridge now has a validated method that will detect as low as 20 picograms per filter in an air sample collected on appropriate media. This limit of detection is four (4) to five (5) times lower than methods available from other commercial laboratories.

11 Feb 2010

Intellect Neurosciences: Several significant stakeholders commit funds

Intellect Neurosciences, Inc., a biopharmaceutical company focused on development of disease-modifying therapeutic agents for Alzheimer's disease ("AD"), announced today that several of its significant shareholders (the "Interested Shareholders") have agreed in principle to provide interim funding to the Company and assist the Company in its efforts to restructure its balance sheet.

11 Feb 2010

Simcere Pharmaceutical Group subsidiary receives Chinese SFDA approval for Zanamivir

Simcere Pharmaceutical Group, a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded generic and proprietary pharmaceuticals in China, today announced that one of its subsidiaries, Nanjing Simcere Dongyuan Pharmaceutical Co. Ltd., has received new drug registration approval from the State Food and Drug Administration ("SFDA") to manufacture and sell Zanamivir, a neuraminidase inhibitor inhalant used in the prevention and treatment of Influenza A and Influenza B. Zanamivir is marketed globally by GlaxoSmithKline under the trade name Relenza.

11 Feb 2010

'CARES by GSK' introduces oncology co-pay assistance program

GlaxoSmithKline today announced the launch of CARES by GSK, a comprehensive program that provides a single point of contact to GSK services and programs designed to improve access to GSK oncology and specialty medications. In addition to the comprehensive offerings that include specialty reimbursement services and free medicine, CARES by GSK now offers its first oncology co-pay assistance program to further help eligible patients with limited insurance coverage to have better access to GSK oral oncology and specialty medicines.

11 Feb 2010

PwC: Companies in Life Sciences sector captured largest share of overall venture capital during 2009

Companies in the Life Sciences sector, which includes the biotechnology and medical device industries, captured the largest share of overall venture capital during 2009, reflecting the relative strength of the sector during the economic downturn, according to PricewaterhouseCoopers LLP (PwC).

11 Feb 2010

Indiana's pharmaceutical research and manufacturing companies maintained steady growth in 2009

Indiana's contract pharmaceutical research and manufacturing companies continued to expand in 2009, despite challenges in the biopharmaceutical contract service sector due to the downturn in the economy, the prospect of healthcare reform and other market developments.

11 Feb 2010

Pharmaceuticals News and Research

Proving value a challenge for comparative effectiveness and pharmaceutical technologies

Ulcerative colitis drug market to grow up to $2.1 billion in 2018

3SBio, Ascentage Pharma announce cancer therapeutics collaboration

Medicaid and other state programs face questions about fraud, other difficulties

Coalition group calls for bigger FDA budget

FDA grants approval for Abbott's antiretroviral medication Norvir

Alcon reports 2009 fourth quarter results

3SBio submits application for Phase I clinical trial of NuPIAO to the Chinese SFDA

RadPharm and Medifacts International announce merger

Cadence Pharmaceuticals' IV acetaminophen NDA receives FDA Complete Response letter

China Pediatric Pharmaceuticals issues 375,000 common stock shares in private placement transaction

Alexion Pharmaceuticals announces financial results for quarter and year ended December 31, 2009

PAREXEL International, Proteome Sciences form biomarker alliance

Nontraditional companies to help reshape healthcare marketplace

SafeBridge Consultants validates improved hygiene air sampling and analytical method for naproxen sodium

Intellect Neurosciences: Several significant stakeholders commit funds

Simcere Pharmaceutical Group subsidiary receives Chinese SFDA approval for Zanamivir

'CARES by GSK' introduces oncology co-pay assistance program

PwC: Companies in Life Sciences sector captured largest share of overall venture capital during 2009

Indiana's pharmaceutical research and manufacturing companies maintained steady growth in 2009

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