FDA staff oppose Northera hypotension drug
WASHINGTON (Reuters) – Health regulators recommended that Chelsea Therapeutics International Ltd’s hypotension drug Northera not be approved for use in the United States, sending the company’s shares down over 14 percent.
A review by Food and Drug Administration staff said the treatment, known generically as droxidopa, had not demonstrated durable effectiveness in clinical trials and showed “worrisome” safety signals in test results and post-marketing cases in Japan.
FDA staff oppose Chelsea’s Northera, shares fall
WASHINGTON (Reuters) – U.S. health regulators recommended that Chelsea Therapeutics International Ltd’s (CHTP.O: Quote, Profile, Research, Stock Buzz) hypotension drug Northera not be approved for use in the United States, sending the company’s shares down over 14 percent.
A review by Food and Drug Administration staff said the treatment, known generically as droxidopa, had not demonstrated durable effectiveness in clinical trials and showed “worrisome” safety signals in test results and post-marketing cases in Japan.
US Republican senator sees short-term Medicare ‘doc fix’
WASHINGTON, Feb 14 (Reuters) – U.S. lawmakers are
close to a deal that would stave off steep cuts in Medicare
reimbursements for physicians for the next 10 to 24 months, a
top Republican senator said on Tuesday.
“We’ve got the next two or three days and perhaps these
issues will be largely resolved today,” Senator Jon Kyl, a
member of a bipartisan committee seeking agreement on a
so-called “doc fix,” told about 500 physicians who have flocked
to Washington this week to lobby lawmakers on the issue.
Obama’s ’13 budget to increase healthcare savings
WASHINGTON, Feb 13 (Reuters) – President Barack Obama
on Monday proposed more aggressive deficit reductions through
savings from Medicare, Medicaid and other federal healthcare
programs than the White House put forward just five months ago.
At the same time, the president proposed giving an extra $1
billion to the federal agency that will implement his landmark
reform law.
Obama’s ’13 budget plan would ramp up healthcare savings
WASHINGTON (Reuters) – President Barack Obama on Monday proposed more aggressive deficit reductions through savings from Medicare, Medicaid and other federal healthcare programs than the White House put forward just five months ago.
The president’s budget proposal for fiscal year 2013 seeks a total of $364 billion in healthcare savings over 10 years, which the White House hopes to achieve by cutting Medicare and Medicaid payments to healthcare providers, raising costs on future Medicare beneficiaries and cracking down on waste and fraud. Medicare is for the elderly and Medicaid is for the poor.
Komen VP steps down after Planned Parenthood flap
WASHINGTON (Reuters) – A senior executive of the breast cancer charity Susan G. Komen for the Cure has resigned after a public outcry over the group’s decision to cut funding to women’s health organization Planned Parenthood.
Karen Handel, a Republican who once ran for governor of Georgia on a platform calling for defunding of Planned Parenthood, stepped down from her role as the top U.S. breast cancer charity’s senior vice president for public policy and chief lobbyist, the organization said on Tuesday.
Komen struggles to defuse Planned Parenthood crisis
WASHINGTON (Reuters) – The world’s leading breast cancer charity, Susan G. Komen for the Cure, struggled on Thursday to defuse a growing crisis over its decision to cut funding for Planned Parenthood, which provides abortion and birth control services.
The sudden rift between the two top U.S. women’s health advocacy groups triggered a furious debate on social media sites between supporters and opponents of abortion rights.
Komen charity denies abortion pressure in funding shift
WASHINGTON (Reuters) – Breast cancer charity Susan G. Komen for the Cure on Thursday denied political pressure from anti-abortion groups had anything to do with its decision to cut off funding for the Planned Parenthood Federation of America, trying to contain a crisis between the two leading women’s health groups.
In a 3-1/2 minute video statement posted on its website and the video site YouTube, the Komen foundation said critics have mischaracterized its decision to deny new money to Planned Parenthood and warned the controversy could distract attention from the struggle against breast cancer.
Judge: health labels may stem tobacco co rights
WASHINGTON (Reuters) – A federal rule requiring large graphic health warnings on cigarette packaging and advertising may violate the free speech rights of tobacco companies, a U.S. district court judge said at a hearing on Wednesday.
In a case that could wind up before the Supreme Court, five cigarette makers are suing to overturn a Food and Drug Administration rule requiring companies to label tobacco products with images of rotting teeth, diseased lungs and other images intended to illustrate the dangers of smoking.
White House defends birth control rule against religious protest
WASHINGTON (Reuters) – The White House on Tuesday defended a new federal rule requiring religiously affiliated nonprofit groups to provide free birth control coverage to women, as opponents ratcheted up pressure to alter the provision.
The decision, announced on January 20 by Health and Human Services Secretary Kathleen Sebelius, has spurred angry opposition from social conservatives. Roman Catholic officials are mulling a possible legal or legislative challenge.
