Showing posts with label Rejects. Show all posts
Showing posts with label Rejects. Show all posts

Sunday, July 21, 2013

New Hampshire Rejects All Private Prison Bids

New Hampshire officials rejected all four bids to privatize its prisons, citing prison operators’ insufficient understanding of court-mandated standards of inmate care, and proposed wages that are half what prison security staff now earn. The decision comes following a recent vote by the state House of Representatives to prohibit private prisons in the state. For-profit prison operators’ interest in profiting off inmates leads to perverse incentives, and many private facilities have been cited for human rights abuses and violations of state law. The Concord Monitor reports:

“The proposals exhibited a lack of understanding of the overarching legal requirements placed upon the (corrections department) relating to the court orders, consent decrees and settlements which, in large part, dictate the administration and operation of their correctional facilities and attendant services to the inmate populations,” read the report. It concluded that meeting those requirements for inmates’ medical and mental health care “appeared to be too great a burden for the vendors.”

The state’s decision to cancel the bid puts prison privatization off the table for now unless Gov. Maggie Hassan or the Legislature directs the state to reissue the bid, said Michael Connor of the state Department of Administrative Services. That seems unlikely. […]

State corrections and administrative service officials began investigating prison privatization in 2011 at the direction of former governor John Lynch and the last Legislature. Four companies submitted 17 proposals that were so voluminous and complex that state officials hired a private consultant, at a cost of $171,000, to help them evaluate the bids.

New Hampshire’s now-governor has been vocal in opposition to private prisons, and her spokesman said this week that “the track record of such arrangements in other states has not demonstrated success in terms of protecting taxpayer dollars while maintaining the highest level of public safety.” The state could, however, solicit new proposals in future years if the House bill to prohibit the facilities is not also approved by the Senate.

Earlier coverage of the bids reports that the three national private prison companies each have at least two lobbyists in the state, reflecting the nationwide efforts of prison firms to lobby for privatization of prison facilities, prison health care, and laws that incarcerate more people in a country that already has the world’s highest incarceration rate. Legislators who support private prisons, many enriched by campaign contributions from these very companies, have claimed that they are a way to save money. But New Hampshire’s report confirms the experiences of other states – that these prisons cost more. New Hampshire spent $171,000 for a consultant to pore through proposals that, in spite of being too unwieldy to be reviewed in-house, failed to address basic state criteria. What’s more, New Hampshire’s report is the latest evidence that private firms’ attempts to cut costs come at the expense of adequate inmate treatment and good wages.


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Monday, July 15, 2013

India's Top Court Rejects Novartis Patent Protection

India's top court has dismissed Swiss drugmaker Novartis's attempt to win patent protection for its cancer drug Glivec, a serious blow to Western pharmaceutical firms who are increasingly focusing on India to drive sales.

The decision also sets a benchmark for several intellectual property disputes in India, where many patented drugs are unaffordable for most of its 1.2 billion people, 40 percent of whom earn less than $1.25 a day.

India's domestic drugs market is the 14th largest globally, but with annual growth of 13-14 percent and the world's second biggest population, it has massive potential at a time when traditional developed markets have slowed down.

The Supreme Court's landmark ruling is likely to affect several other companies and their branded medicines.

Pfizer's cancer drug Sutent and Roche Holdings hepatitis C treatment Pegasys lost their patented status in India last year, and Monday's ruling will make it tougher for them to win back patent protection.

"Henceforth, multinational pharma companies are likely to want that their patents are first recognized in India before launch of a patented product," said Ameet Hariani, managing partner at Mumbai-based law firm Hariani & Co.

Novartis has previously that said it needs legal certainty if it is to plan further investment in drug research in India.

The ruling is a boost for healthcare activists who want the government to make medicines cheaper in a country where patented drugs constitute under 10 percent of total drug sales.

Novartis has been fighting since 2006 to win a patent for an amended form of Glivec. In 2009 it took its challenge against a law that bans patents on newer but not radically different forms of known drugs to the Supreme Court.

India has refused protection for Glivec on the grounds that it is not a new medicine but an amended version of a known compound. By contrast, the newer form of Glivec has been patented in nearly 40 countries including the United States, Russia and China.

The Supreme Court decided that Glivec does not satisfy the "novelty" aspect, Pravin Anand, lawyer for Novartis, told reporters.

Shares in Novartis India Ltd, the Indian unit of the drugmaker, fell over 5 percent after the verdict. They were down 4.63 percent at 571.10 rupees by 0528 GMT.


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Monday, July 8, 2013

Arkansas House Committee Rejects Tax Break For The Poor, Approves Two For The Rich

States across the country are pushing tax cuts as a way to stimulate economic growth, and an Arkansas House Committee joined them yesterday by approving an income tax cut and raising an exemption on investment taxes. While approving two tax proposals that will largely benefit the wealthy, however, the committee rejected a proposal that would give a tax break to low-income families.

The efforts are aimed at stimulating job and economic growth, according to Republican state legislators, the Associated Press reports:

The income tax proposal, which will cost the state about $57 million a year, is expected to be the largest piece of the tax cut package being negotiated. The proposal would lower the top income tax rate from 7 percent to 6.875 percent and increase the minimum income it applies to from $34,000 to $44,000. The reduction would take effect for the 2014 tax year. The lawmaker behind the idea said it would help Arkansas generate jobs by making its tax rate more competitive with surrounding states. [...]

The panel also endorsed Carter’s proposal to increase the income tax exemption on capital gains of at least $5 million from 30 percent to 70 percent. It would also create a 70 percent exemption for any net capital gains relating to the sale of Arkansas property acquired after Jan. 1, 2014.

Even as it raises the minimum amount needed to qualify for taxation, the income tax proposal would grant more than half of its benefits to Arkansans who make more than $155,000 a year, according to the Institute on Taxation and Economic Policy. The capital gains exemption, which ITEP calls one of the two “most regressive state income tax loopholes,” would only benefit wealthy families. But cutting taxes to stimulate growth isn’t the best strategy: a report from the Center on Budget and Policy Priorities released this week found that states that implemented tax cuts in the 1990s saw slower economic growth afterward than states that did not.

At the same time, the committee rejected a proposed Earned Income Tax Credit that would have given breaks to low-income residents, just as the EITC does on federal taxation. Arkansas’ tax code is already among the most regressive in the country, according to ITEP. It’s poorest residents pay 11.9 percent of their income in taxes, the 10th highest percentage among the 50 states and Washington DC. The richest one percent of its residents pay just 6 percent of their income in taxes. Gov. Mike Beebe (D) has warned the legislature that his budget does not include room for costly tax cuts, which should prevent Arkansas’ House Republicans from making the tax code even more regressive.


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Sunday, June 30, 2013

FDA rejects United Therapeutics' oral hypertension drug again

March 25 (Reuters) - Biotechnology company United Therapeutics Corp said its oral drug to treat hypertension was rejected for the second time by U.S. health regulators, sending its shares down 6 percent before the bell to $57.

The drugmaker did not say it would quit pursuing a marketing approval for the tablet.

"We remain confident that oral treprostinil will play an important role in treating pulmonary arterial hypertension," Chief Executive Martine Rothblatt said.

The drug, treprostinil diolamine, was first rejected by the U.S. Food and Drug Administration in October after it had failed to show statistically significant results in patients taking a six-minute walk test during clinical studies.

United Therapeutics already has a treprostinil injection named Remodulin and an orally inhaled version Tyvaso on the market to treat pulmonary arterial hypertension, a disease characterized by abnormally high blood pressure in the pulmonary artery that carries blood from the heart to the lungs.

Remodulin, the company's lead product, accounted for half of United Therapeutics's revenue last year. The company also sells Adcirca, an oral tablet to treat PAH.

Oral versions are usually preferred over other forms due to their ease of administration.

(Reporting By Vrinda Manocha in Bangalore; Editing by Sreejiraj Eluvangal)

((Vrinda.Manocha@thomsonreuters.com)(within U.S. +1 646 223 8780, outside U.S. +91 80 4135 5800)(Reuters Messaging: vrinda.manocha.thomsonreuters.com@reuters.net))

Keywords: UNITEDTHERAPEUTICS FDA/HYPERTENSIONDRUG


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UPDATE 1-FDA rejects United Therapeutics' oral hypertension drug again

* Rejects resubmission filed in February

* Co likely to conduct fresh late-stage trial - analyst

* Shares down about 6 pct in early trade

(Adds analyst comment) By Vrinda Manocha

March 25 (Reuters) - Biotechnology company United Therapeutics Corp said its oral drug to treat hypertension was rejected for the second time by U.S. health regulators, sending its shares down about 6 percent in early trade on the Nasdaq.

The drugmaker did not say it would quit pursuing a marketing approval for the tablet.

"We remain confident that oral treprostinil will play an important role in treating pulmonary arterial hypertension," Chief Executive Martine Rothblatt said.

The drug, treprostinil diolamine, was first rejected by the U.S. Food and Drug Administration (FDA) in October after it had failed to show statistically significant results in patients taking a six-minute walk test during clinical studies.

The company would probably conduct another late-stage trial for the drug as it had originally planned, Wedbush analyst Liana Moussatos told Reuters.

"After the first rejection,the company thought they'd have to do another late-stage trial and it would take four years before they could resubmit the marketing approval application," she said.

"They did some additional analysis and brought in some historical data and thought they would give it another shot."

The drug will not be approved before 2017 if the trial and the review takes four years.

United Therapeutics already has a treprostinil injection named Remodulin and an orally inhaled version Tyvaso on the market to treat pulmonary arterial hypertension, a disease characterized by abnormally high blood pressure in the pulmonary artery that carries blood from the heart to the lungs.

Moussatos said United Therapeutics did not need oral treprostinil to maintain its growth. She had earlier projected $399 million in peak annual sales for the drug, but had not included the oral variant in her model.

Remodulin, the company's lead product, accounted for $458 million in revenue last year, about half of United Therapeutics's net revenue. The company also sells Adcirca, an oral tablet to treat PAH.

Oral versions of drugs are usually preferred over other forms due to their ease of administration.

(Reporting By Vrinda Manocha in Bangalore; Editing by Sreejiraj Eluvangal)

((Vrinda.Manocha@thomsonreuters.com)(within U.S. +1 646 223 8780, outside U.S. +91 80 4135 5800)(Reuters Messaging: vrinda.manocha.thomsonreuters.com@reuters.net))

Keywords: UNITEDTHERAPEUTICS FDA/HYPERTENSIONDRUG


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Saturday, June 29, 2013

UPDATE 2-FDA rejects United Therapeutics' oral hypertension drug again

* Rejects resubmission filed in February

* Co likely to conduct fresh late-stage trial - analyst

* Shares down 2 pct

(Adds company comment, details)

By Vrinda Manocha

March 25 (Reuters) - Biotechnology company United Therapeutics Corp said the oral version of its drug to treat hypertension was rejected for the second time by U.S. health regulators, sending its shares down as much as 7 percent in morning trade on the Nasdaq.

The drugmaker had resubmitted its marketing approval application last month, and an analyst said the fresh rejection was likely to necessitate new trials and a delay of about four years before the company tried again.

The drug, treprostinil diolamine, was first rejected by the U.S. Food and Drug Administration (FDA) in October after it had failed to show statistically significant results in patients taking a six-minute walk test during clinical studies.

The company would now probably conduct another late-stage trial for the drug as it had originally planned, Wedbush analyst Liana Moussatos told Reuters. After the first rejection, the company had said that it could take four years to conduct a new trial and make a new application, she said.

However, "they did some additional analysis and brought in some historical data and thought they would give it another shot," she added.

United Therapeutics already has a treprostinil injection named Remodulin and an orally inhaled version Tyvaso on the market to treat pulmonary arterial hypertension (PAH), a disease characterized by abnormally high blood pressure in the pulmonary artery that carries blood from the heart to the lungs.

The FDA's latest rejection letter did not contain any new issues, the company's vice president for business development, Martin Auster, told Reuters.

"Our infused and inhaled versions have only penetrated a fraction of the market," Auster said. "We believe an orally delivered offering would be preferred by patients and physicians."

Wedbush's Moussatos said United Therapeutics did not need oral treprostinil to maintain its growth. She had earlier projected $399 million in peak annual sales for the drug, but had not included the oral variant in her model.

Remodulin, the company's lead product, accounted for $458 million in revenue last year, about half of United Therapeutics's net revenue. The company also sells Adcirca, an oral tablet to treat PAH.

United Therapeutics' PAH drugs compete with Gilead Sciences Inc's Letairis, Pfizer's Revatio and Swiss biotechnology company Actelion Ltd's Tracleer and Veletri.

United Therapeutics shares, which have risen about 14 percent since the drug was first rejected last year, were down about 2 percent at $59.73 on the Nasdaq.

(Reporting By Vrinda Manocha in Bangalore; Editing by Sreejiraj Eluvangal)

((Vrinda.Manocha@thomsonreuters.com)(within U.S. +1 646 223 8780, outside U.S. +91 80 4135 5800)(Reuters Messaging: vrinda.manocha.thomsonreuters.com@reuters.net))

Keywords: UNITEDTHERAPEUTICS FDA/HYPERTENSIONDRUG


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Saturday, February 9, 2013

Lesbian Military Spouse Rejects ‘Offensive’ Guest Membership To Spouses Group

This morning came news that the Association of Bragg Officers Spouses (ABOS) at Ft. Bragg had extended a “guest membership” to Ashley Broadway, the lesbian spouse of Lt. Col. Heather Mack. This concession was to serve as a temporary solution until the group reconsidered its membership policies, which it arbitrarily changed to exclude her. This afternoon, the L.A. Times is reporting that Broadway has rejected the offer, calling it ”not only offensive, but just plain hurtful”:

BROADWAY: My wife wears the same uniform as the spouses of [the club] and she’s just as prepared to give her life for our country. I wake up each and every day to the reality that I’m not equal, that my 15 years of love and faithfulness to my wife and country does not mean I’ll receive support as a military spouse.

Broadway and Mack married in November, but have been together for 15 years. The Pentagon has been supposedly reviewing military benefits for same-sex couples since the repeal of “Don’t Ask, Don’t Tell” took effect in September 2011, but has yet to take action.


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Friday, December 28, 2012

Supreme Court Rejects Hobby Lobby Attempt To Block Obamacare Contraception Mandate

NEWS FLASH

Supreme Court Rejects Hobby Lobby Attempt To Block Obamacare Contraception Mandate | The Supreme Court said Wednesday it will not block an Obamacare mandate that employers must provide insurance coverage for contraception. Hobby Lobby, a craft chain, was seeking an emergency injunction against the mandate after both a federal and district judge ruled against it. While Hobby Lobby can still pursue its lawsuit that claims the mandate violates religious freedom, Justice Sonia Sotomayor ruled that it could not show that an injunction blocking the mandate from taking effect was “necessary or appropriate.”

By Travis Waldron on Dec 27, 2012 at 12:45 pm


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Wednesday, December 26, 2012

Christie Rejects State-Based Health Exchange

New Jersey Gov. Chris Christie (R) declined to set up a state-based insurance exchange under the healthcare law Thursday — the same day he met with President Obama on Hurricane Sandy aid.

The move will be welcomed by conservatives who blamed Christie for praising Obama's response to the storm. Sandy hit just before the election and distracted national media coverage from Obama's campaign against Mitt Romney, who lost.

In a statement, Christie said New Jersey would default to a federally run exchange because the Obama administration did not provide enough information on alternatives. He also said an exchange would be "extraordinarily costly" for the state in spite of massive federal grants to build it.

"We will comply with the Affordable Care Act, but only in the most efficient and cost effective way for New Jersey taxpayers," Christie said in a statement.

"I will not ask New Jerseyans to commit today to a state-based exchange when the federal government cannot tell us what it will cost, how that cost compares to other options, and how much control they will give the states over this option that comes at the cost of our state’s taxpayers." 

In a technical sense, Christie vetoed a bill that would have begun to establish the exchange.

At least 17 states are declining to create their own marketplaces, and most are governed by Republicans who continue to oppose the healthcare law.

The decisions pose a huge challenge to the Department of Health and Human Services, which must step in and do the work itself. All exchanges must be up and running by Jan. 1, 2014.

Christie was in Washington Thursday to discuss recovery aid with Obama. He also met with White House chief of staff Jack Lew, budget director Jeffrey Zients and other senior officials, according to reports.

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