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Sucampo, Takeda initiate dosing in third lubiprostone phase 3 trial for opioid-induced bowel dysfunction

Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals North America, Inc. today announced the dosing of the first patient in the third phase 3 clinical trial of lubiprostone for the treatment of opioid-induced bowel dysfunction (OBD) in subjects with chronic, non-cancer pain, excluding those taking methadone. The primary endpoint is an overall responder rate based on the change from baseline in the reported frequency of spontaneous bowel movements (SBMs).

7 Jan 2011

New poll finds Americans split on repeal; Divide on Capitol Hill deepens

A new Gallup Poll found that public opinion is "closely divided" over whether Congress should vote to undo the health law. And on Capitol Hill, the divide is deep and entrenched, closely tracking with political loyalties. Even as GOP leaders point to the push to stop the health law as a way to "send a signal" to the American people, Senate Dems are plotting actions of their own.

7 Jan 2011

StemCells $10 million common stock offering to close today

StemCells, Inc. announced today that it has entered into an agreement to sell ten million shares of its common stock to selected institutional investors at a price of $1.00 per share, which represents a 10% discount to the closing price per share of January 6. The offering is expected to close today, subject to customary closing conditions, and StemCells expects to receive net proceeds, after deducting offering expenses and fees, of approximately $9.4 million.

7 Jan 2011

CBO analysis estimates health overhaul repeal price tag to be $230 billion

With the CBO findings, GOP efforts to undo the health law and claim the mantle of fiscal responsibility took a hit. Democrats immediately pounced on the cost estimate as new ammunition in an ongoing battle. But Republican leaders dismissed the document, saying it is a "job-killing" measure that would add to the nation's debt and instead pointed to a report of their own.

7 Jan 2011

Dendreon provides U.S. commercialization and European strategy updates for PROVENGE

Dendreon Corporation today announced several updates regarding the U.S. commercialization of PROVENGE® (sipuleucel-T), the European strategy for PROVENGE, and progress on its pipeline.

7 Jan 2011

California insurance watchdog asks insurer to delay rate hike

California's top insurance watchdog is asking one of his state's biggest health insurers to delay a planned rate increase for nearly 200,000 policyholders. For some, the rate hike by Blue Shield of California would be as high as 59%. It would be the third hike since last fall. Blue Shield says the increases are not related to health care overhaul (1/7).

7 Jan 2011

BIND Biosciences commences BIND-014 Phase 1 clinical trial in cancer

BIND Biosciences announced today that it has initiated a Phase 1 clinical trial to assess the safety, tolerability and pharmacokinetic profile of BIND-014 in cancer patients. BIND-014, the first product candidate to enter clinical evaluation from BIND's broad proprietary Medicinal Nanoengineering platform, is a targeted polymeric nanoparticle containing the cytotoxic agent, docetaxel.

7 Jan 2011

Fact-checking claims, questions in the continuing overhaul debate

News outlets review some of the health law's policy specifics and ask questions about specific components, such as how the law's prevention fund is faring.

7 Jan 2011

Targeted Genetics acquires Biocontrol

Targeted Genetics Corporation, today announced the completion of the acquisition of Biocontrol Limited.

7 Jan 2011

Today's Opinions: Brooks, Reich, Fund, Cook on repeal; End-of-life care controversy continues

The health care reform law was signed 10 months ago, and what's striking now is how vulnerable it looks. Several threats have emerged — some of them scarcely discussed before passage — that together or alone could seriously endanger the new system. ... After the trauma of the last two years, many people wish the issue would go away. But it's not going away, especially since costs will continue to rise. (David Brooks, 1/6).

7 Jan 2011

Substantial equivalence review requirement for new tobacco products announced

The U.S. Food and Drug Administration announced today that certain tobacco products introduced or changed after Feb. 15, 2007 must be reviewed by the agency. In FDA guidance published today, the agency outlines a pathway for marketing a product whereby the company marketing the product must prove that it is "substantially equivalent" to products commercially available on Feb. 15, 2007.

7 Jan 2011

Study finds combined treatments safe and effective for severe acute pancreatitis

The use of combined treatments for severe acute pancreatitis is safe and effective in managing the disease, resulting in shorter hospitalizations and fewer radiological procedures than standard therapy, according to a study in Clinical Gastroenterology and Hepatology, the official journal of the American Gastroenterological Association (AGA) Institute. In a related study, doctors found that patients with infected pancreatic necrosis were able to avoid surgery through primary conservative treatment, which is in-patient medical treatment.

7 Jan 2011

Some Democrats wrestle with reform positions, others file amendments on repeal to force GOP votes against popular consumer protections

As the House vote on repealing the health law looms in the near future, some Democrats are contemplating their votes in the context of stiff election pressure or expressing their doubts about the measure's individual mandate. Meanwhile, in a strategic measure, other Democrats are pursuing amendments to the GOP repeal bill that would force up-or-down votes on the health care law's popular consumer provisions.

7 Jan 2011

Single cellular crisis shatters chromosomes in cancer causation

Remarkable new research overthrows the conventional view that cancer always develops in a steady, stepwise progression. It shows that in some cancers, the genome can be shattered into hundreds of fragments in a single cellular catastrophe, wreaking mutation on a massive scale.

7 Jan 2011

World's largest medical robotic conference

The International Robotic Urology Symposium 2011 is hosted by the Henry Ford Vattikuti Urology Institute and the Vattikuti Foundation.

7 Jan 2011

ASBP raises concern over FDA recommendations to lower BMI requirements for lap-band surgery

The American Society of Bariatric Physicians (ASBP) is concerned that the FDA advisory panel recommended lowering the BMI requirement for lap-band surgery, while the FDA recently denied two new obesity medications. Bariatric surgery is drastic and expensive and carries higher morbidity and mortality risks than lifestyle interventions or medication. Patients who could have otherwise lost weight in a non-surgical medical bariatric program may now be encouraged to skip medical therapy and jump directly to surgery.

7 Jan 2011

Study supports two-dose vaccine regimen for protecting children from chickenpox

Two doses of the varicella, or chickenpox, vaccine provide excellent protection in children against this highly contagious and, in some cases, severe disease. To be published in the February 1 issue of The Journal of Infectious Diseases, the findings support the two-dose vaccine regimen recommended in the United States since 2006.

7 Jan 2011

Hologic announces acquisition of Interlace Medical

Hologic, Inc., a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, announced today it has acquired Interlace Medical, Inc. (Interlace), the developer and manufacturer of the MyoSure hysteroscopic tissue removal system (MyoSure). Interlace's operations will be integrated within Hologic's GYN Surgical Products division.

From Hologic, Inc. 7 Jan 2011

ADVENTRX Pharmaceuticals to raise $22.5 million

ADVENTRX Pharmaceuticals, Inc. announced today that it has entered into definitive agreements to sell 8,184,556 units in a registered direct offering to RA Capital Management, certain healthcare-focused investors, and other institutional investors for a per unit purchase price of $2.75, representing gross proceeds to ADVENTRX of approximately $22.5 million.

7 Jan 2011

First Edition: January 16, 2011

Today's headlines include news about public opinion regarding the GOP health law repeal effort.

7 Jan 2011

Medical News

Sucampo, Takeda initiate dosing in third lubiprostone phase 3 trial for opioid-induced bowel dysfunction

New poll finds Americans split on repeal; Divide on Capitol Hill deepens

StemCells $10 million common stock offering to close today

CBO analysis estimates health overhaul repeal price tag to be $230 billion

Dendreon provides U.S. commercialization and European strategy updates for PROVENGE

California insurance watchdog asks insurer to delay rate hike

BIND Biosciences commences BIND-014 Phase 1 clinical trial in cancer

Fact-checking claims, questions in the continuing overhaul debate

Targeted Genetics acquires Biocontrol

Today's Opinions: Brooks, Reich, Fund, Cook on repeal; End-of-life care controversy continues

Substantial equivalence review requirement for new tobacco products announced

Study finds combined treatments safe and effective for severe acute pancreatitis

Some Democrats wrestle with reform positions, others file amendments on repeal to force GOP votes against popular consumer protections

Single cellular crisis shatters chromosomes in cancer causation

World's largest medical robotic conference

ASBP raises concern over FDA recommendations to lower BMI requirements for lap-band surgery

Study supports two-dose vaccine regimen for protecting children from chickenpox

Hologic announces acquisition of Interlace Medical

ADVENTRX Pharmaceuticals to raise $22.5 million

First Edition: January 16, 2011

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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