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Genentech confirms EMA, FDA updates on Avastin for metastatic breast cancer

Genentech, a member of the Roche Group, confirmed that following the reviews of Avastin® (bevacizumab) in metastatic breast cancer by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), the following regulatory announcements were made by the individual health authorities:

17 Dec 2010

Iowa moves forward on health exchange; Texas medical school highlights geriatrics; Concerns grow about prisoners' mental health needs

Republican lawmakers on the state level are largely against the new health reform law—but they aren't against all of the behemoth legislation. Virginia dominated headlines this week when a federal judge ruled the individual mandate to buy insurance unconstitutional on Monday. Much less noticed: the very next day, a task force appointed by Republican Gov. Bob McDonnell recommended that the state implement a health insurance exchange earlier than federal guidelines require (Kliff, 12/16).

17 Dec 2010

Florida Judge hears arguments in 20-state health law challenge; says ruling will take time

The Associated Press: Attorneys for 20 states involved in a challenge to the new health law argued Thursday morning before U.S. District Judge Roger Vinson that it will "expand the government's powers in dangerous and unintended ways." The states were seeking "a summary judgment throwing out the health care law without a full trial. They argue it violates people's rights by forcing them to buy health insurance by 2014 or face penalties."

17 Dec 2010

FDA recommends removal of breast cancer indication from Avastin label

The U.S. Food and Drug Administration announced today that the agency is recommending removing the breast cancer indication from the label for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use.

17 Dec 2010

Health law challenges shift to Florida courtroom

Today marks a "new day in court" as oral arguments will be heard in a Florida courtroom regarding the 20-state legal challenge. This lawsuit includes issues surrounding the health law's individual mandate and Medicaid expansions. Meanwhile, analysis continues regarding Monday's decision by a federal court judge in Virginia and a new round of debate regarding whether the health overhaul lawsuits bring to light issues of judicial bias.

16 Dec 2010

Today's Opinions: Health law spending; Funding threats undercut U.S. legal tradition; Medicaid falls short

Rising entitlement spending is already driving the federal budget off a cliff. But Obamacare would add fuel to the fire with the largest entitlement expansion since the 1960s. So it takes a special kind of audacity for Obamacare's apologists to continue to insist that the new law will cut the projected budget deficits.

16 Dec 2010

Personalities, politics emerge from decision's aftermath

Personalities and politics swirl around news about Monday's ruling in the Virginia health law challenge, with news outlets detailing how judges in different cases reached their conclusions and examining Judge Henry Hudson's ties to a GOP consulting firm. More reports also surround the related political dust-ups and posturing.

16 Dec 2010

First Edition: December 15, 2010

Today's major health policy news is full of second-day stories and analysis regarding Monday's health law decision by a federal court judge in Virginia.

15 Dec 2010

OpEds: Assessing Judge Hudson's decision on individual mandate

In March, New Hampshire preschool teacher Gail O'Brien, who was unable to obtain health insurance through her employer, was diagnosed with an aggressive form of lymphoma. Her subsequent applications for health insurance were rejected because of her condition. With each round of chemotherapy costing $16,000, she delayed treatment because she knew her savings wouldn't last (Eric H. Holder and Kathleen Sebelius, 12/14).

14 Dec 2010

FDA issues final guidance for public's comments at advisory committee meetings

The U.S. Food and Drug Administration today issued final guidance for people who wish to comment during the agency's advisory committee meetings. The guidance provides instructions on how to request a time to speak and how FDA staff should respond to requests to speak at the meetings.

13 Dec 2010

New study says boxers are at substantial risk for acute injuries to head, heart, and skeleton

Boxers are at substantial risk for acute injuries to the head, heart, and skeleton. Subacute consequences after being knocked out include persistent symptoms such as headaches, impaired hearing, nausea, unstable gait, and forgetfulness.

13 Dec 2010

Ramius to acquire Cypress Bioscience

Ramius V&O Acquisition LLC, a subsidiary of Ramius LLC (collectively, "Ramius"), today announced that it has sent a letter to the Board of Directors of Cypress Bioscience, Inc. outlining its willingness to acquire all of Cypress' outstanding Common Stock in a negotiated transaction for $5.50 per share. The offer is conditioned upon Cypress commencing exclusive negotiations with Ramius no later than Friday, December 10, 2010 and entering into a definitive merger agreement by no later than Sunday, December 12, 2010.

10 Dec 2010

New challenges to FDA's 'no risk' classification of mercury fillings

FDA Device Division, still concerned about mercury toxicity in American dentistry, is convening yet another professional panel review regarding safety issues. A nationwide convergence of scientists, dental and medical professionals, lead by the International Academy of Oral Medicine and Toxicology (IAOMT) are provoking new challenges to the Food and Drug Administration's (FDA) July'09 "no risk" classification of mercury fillings .

10 Dec 2010

Sound masking therapy is of uncertain benefit when used alone to treat tinnitus

Tinnitus — what many think of as "ringing in the ears" — is the perception of sound without any real acoustic stimulation. Sound masking therapy, a common component of tinnitus treatment, is of uncertain benefit when used on its own, a new evidence review finds.

10 Dec 2010

Repeated cerebral trauma in boxing career may result in boxer's dementia

Up to 20% of professional boxers develop neuropsychiatric sequelae. But which acute complications and which late sequelae can boxers expect throughout the course of their career? These are the questions studied by Hans Förstl from the Technical University Munich and his co-authors in the current issue of Deutsches Ärzteblatt International (Dtsch Arztebl Int 2010; 107[47]: 835-9).

10 Dec 2010

Powerful GOP lawmakers clarifying plans for cutting health costs, repealing reform law

The Republican lawmaker who will take the chair of the House's main investigative committee has made clear his interest in examining the overuse of expensive medical procedures while a newly tapped GOP subcommittee chief pledges to "dismantle Obamacare." Meanwhile, the food safety bill has been folded into must-pass legislation to fund the U.S. government.

10 Dec 2010

European researchers develop new form of therapy for Alpha-mannosidosis

Alpha-mannosidosis is a rare childhood disease which causes symptoms such as mental retardation or hearing loss and is linked to a lower life expectancy. A European research team headed by Professor Paul Saftig from Christian-Albrechts-Universit-t zu Kiel has developed a form of therapy as part of the Alpha-Man project, which will receive around six million euros from the European Union for its next stage of trials.

9 Dec 2010

FDA advisory committee's approval of Contrave for obesity encourages OAC, TOS, ASMBS

The Obesity Action Coalition, The Obesity Society and the American Society for Metabolic and Bariatric Surgery found encouragement in the outcome of today's advisory committee hearing, favoring approval for the first new obesity treatment in more than 10 years.

8 Dec 2010

Microsurgical technique effective in removing acoustic tumors

Surgery to remove tumors under the brain known as acoustic neuromas produces favorable outcomes in the "vast majority" of patients, according to one of the largest studies of its kind.

8 Dec 2010

Conn. addresses insurance rates, Mass. physician groups evaluate controversial payment plan

"House and Senate leaders are eyeing passage of a second midyear spending bill before the start of the next legislative session to address more caseload-driven accounts that are running short on funds five months after Gov. Deval Patrick signed the fiscal 2011 budget. The deficiencies, which follow inaccurate enrollment estimates for MassHealth and other social service programs, threaten to eat into some the revenue surpluses the state has amassed over the first half of fiscal 2011, when tax receipts have exceeded projections" (Murphy, 12/7).

8 Dec 2010