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Roundup: N.Y., Texas, Calif. Medicaid plans spark protests; Conn. nursing homes; Fla. Medical Board

Gov. Andrew Cuomo's effort to strip lawmakers of power over the state's Medicaid program is facing a barrage of criticism in both houses and parties. Lawmakers on Wednesday described the governor's Medicaid proposal as an intrusion on their powers and said they would block it from becoming law.

4 Feb 2011

CVBT seeks FDA 'fast track' designation for CVBT-141B to treat ischemic diabetic wounds

CardioVascular BioTherapeutics, Inc. today announced it has submitted an application to the U.S. FDA to obtain "fast track" designation for CVBT-141B, its biological therapy to treat ischemic diabetic wounds based on the active ingredient fibroblast growth factor-1 (FGF-1).

4 Feb 2011

AMRI's Burlington facility granted AIFA approval to manufacture octreotide

AMRI announced today that it has received approval from the Italian Medicines Agency (AIFA) for its facility in Burlington, MA to manufacture the commercial drug product octreotide for a customer in the European Union (EU).

4 Feb 2011

MedAssurant, UNC to assess relationship between insulin and cancer development

MedAssurant, a leading provider of data-driven healthcare solutions, today announced the initiation of a joint study with the University of North Carolina to assess the relationship between the use of long-acting insulin to treat diabetes and the development of cancer.

4 Feb 2011

Congress moves to consider foreign aid spending cuts

On Thursday, House Republicans are expected to "announce fiscal 2011 spending caps," CQ reports. "Budget Chairman Paul D. Ryan, R-Wis., is slated to reveal the top-line discretionary spending limits ... for the remainder of the fiscal year under unprecedented power that the GOP majority gave him in January. House leaders have said they are aiming to make $55 billion to $60 billion in cuts, while a more conservative faction is pushing for $100 billion in cuts. It is unclear where Ryan's numbers will fall," the publication reports.

4 Feb 2011

Sodium Thiosulfate Injections recalled

American Regent is conducting a nationwide voluntary recall.

4 Feb 2011

U.S. Patent Office issues Notice of Allowance to Antigen Express AE37 cancer vaccine

Generex Biotechnology Corporation, together with its wholly-owned immunotherapeutic vaccines subsidiary, Antigen Express, announced today that Antigen Express has received a Notice of Allowance from the United States Patent Office relating to an application making augmentative pharmaceutical composition claims for the Antigen Express AE37 immunotherapeutic cancer vaccine.

4 Feb 2011

MicroCHIPS commences first hPTH clinical study in women with osteoporosis

MicroCHIPS, a developer of innovative drug delivery systems, is initiating the first clinical study to demonstrate precisely controlled delivery of a peptide from a multi-reservoir, programmable, implant system.

4 Feb 2011

More careful regulation of FDA's Humanitarian Device Exemption in psychiatric patients needed

Warning that patients could be at risk, an interdisciplinary group of multinational investigators is calling on the U.S. Congress and federal regulators to tighten a law that permits use of brain devices to treat rare neuropsychiatric disorders without supporting clinical trials or stringent patient oversight.

4 Feb 2011

Cardiac team implants pulmonary valve in children without open-heart surgery

The pediatric cardiac team at Oregon Health & Science University Doernbecher Children's Hospital is the first in the region and one of a handful in the nation to implant a pulmonary heart valve without open-heart surgery.

4 Feb 2011

The 'catastrophic' experience: Is the past prologue?

A president uses his pulpit to call for health reform, but initial agreement over the need for change eventually descends into partisan bickering.

4 Feb 2011

Physiotherapy Associates opens new clinic in Silver Spring

Physiotherapy Associates, the nation's foremost provider of outpatient rehabilitation services, announces the opening of a new physical therapy clinic in Silver Spring, MD.

4 Feb 2011

Women's risk of getting breast cancer increases from one in nine to one in eight

The lifetime risk of getting breast cancer has risen from one woman in nine to one in eight - according to Cancer Research UK.

4 Feb 2011

JDRF, Eli Lilly sign agreement to fund type 1 diabetes research for re-generative medicine

Eli Lilly and Company and the Juvenile Diabetes Research Foundation today announced that they have signed an agreement to fund early-stage research that could enable patients with type 1 diabetes to regenerate insulin-producing cells destroyed by the disease.

4 Feb 2011

Pacira prices initial public offering at $7.00 per share

Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, today announced the pricing of its initial public offering of 6,000,000 shares of its common stock at $7.00 per share, before underwriting discounts and commissions.

4 Feb 2011

Scientists unravel mystery about how new tumors in individuals with breast cancer take root

In a discovery that may lead to a new treatment for breast cancer that has spread to the bone, a Princeton University research team has unraveled a mystery about how these tumors take root.

4 Feb 2011

House Republicans consider new Medicare limits

House Republicans are debating whether to propose new limits on the growth of Medicare and other entitlement programs, weighing a gamble that voters are more concerned about trimming the federal deficit than holding on to promised benefits (Hook, 2/3).

4 Feb 2011

Alimera reports 36-month results from ILUVIEN Phase 3 FAME study for DME

Alimera Sciences, Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today reported results through month 36 of the completed FAME™ Study.

4 Feb 2011

Positive top-line results from ILUVIEN Phase 3 trial in patients with DME

pSivida Corp., a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, including the investigational drug ILUVIEN for the treatment of Diabetic Macular Edema, today announced month 36, top-line readout results for the FAME Study prepared by its licensee, Alimera Sciences.

4 Feb 2011

ConforMIS receives FDA 510(k) clearance for iTotal CR Knee Replacement System

ConforMIS has received 510(k) clearance from the U.S. Food and Drug Administration to commercially market its iTotal® CR Knee Replacement System. The iTotal CR is the only true patient-specific system available for patients who would traditionally receive a standard total knee replacement (TKR).

4 Feb 2011