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Tuesday, 18 June 2013

Ritz-Carlton to cease managing Ritz-Carlton Hotel, Palm Beach

The Ritz-Carlton Hotel Company, L.L.C. said today it would cease managing The Ritz-Carlton Hotel, Palm Beach as of July 1.

The owner of the property will be renaming and managing the hotel. Effective July 1, no Ritz-Carlton Rewards or Marriott Rewards points can be earned or redeemed at the property. In connection with its departure, Ritz-Carlton also said that it has filed a multi-million dollar counterclaim against the owner, RC/PB Inc., for breach of contract.

Ritz-Carlton noted that the court in the pending litigation filed by RC/PB permitted the owner to take over the hotel even as it dismissed the vast majority of the owner’s claims, but that the court also stated that such action would subject the owner to breach of contract damages claims. Ritz-Carlton categorically refuted the owner’s claims relative to the management of the hotel, saying that for the 22 years Ritz-Carlton has managed the hotel it has always passed the contractual performance test. In fact, under Ritz-Carlton’s management, the hotel was forecasted to earn millions of dollars in net profit in 2013.

Ritz-Carlton has been an active and contributing member of the Palm Beach community, and has managed the Palm Beach hotel with distinction, in the process earning accolades from a range of trusted luxury travel experts, including AAA, Forbes, Travel + Leisure, Conde Nast Traveler, Spa Finder and US News and World Report. The exemplary service and hospitality provided by the ladies and gentlemen of the The Ritz-Carlton have kept the company atop the J.D. Power and Associates Hotel Guest Satisfaction Study for Luxury Hotel Brands for three consecutive years.

The Ritz-Carlton continues to operate 9 hotels in Florida and is committed to Florida as a prime global destination.

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Lung Cancer: Expanded Alimta Label

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By Cole Petrochko, Staff Writer, MedPage Today

WASHINGTON -- The FDA has expanded the indication for pemetrexed injection (Alimta) to include maintenance therapy in combination with cisplatin for nonsquamous non-small cell lung cancer (NSCLC).

The FDA decision was based on data from a phase III trial of 939 patients with advanced nonsquamous NSCLC reported at the American Society of Clinical Oncology meeting in early June, 2012, which established its efficacy in maintenance therapy.

In that study patients were given 500 mg/m2 of pemetrexed injection on 21-day cycles with 75 mg/m2 of cisplatin, as well as B12 vitamins, folic acid, and dexamethasone. The 539 patients whose disease did not progress during the dual-treatment segment were randomized two-to-one to pemetrexed maintenance or placebo. Both study arms received best supportive care in addition to drug or placebo treatment.

Compared with placebo, pemetrexed treatment benefit was modest -- 44% of pemetrexed-treated patients achieved a complete or partial response to induction therapy versus 42% of patients, while 53% of patients receiving drug therapy and placebo had stable disease after sham or drug treatment.

However, patients receiving drug treatment had a significantly reduced risk of death (HR 0.78, 95% CI 0.64 to 0.96, P=0.02), and median progression-free survival for patients receiving pemetrexed was 4.1 months versus 2.8 months with placebo.

Adverse reactions for pemetrexed as a maintenance therapy during the trials included anemia, neutropenia, fatigue, nausea, vomiting, mucositis, stomatitis, and edema.

The drug was initially approved in 2004 as a combination therapy with cisplatin for malignant pleural mesothelioma where disease was unresectable or curative surgery was not possible and as a second-line treatment for locally advanced metastatic NSCLC after prior chemotherapy treatment.

Pemetrexed was approved as a first-line treatment for locally advanced or metastatic NSCLC in patients with nonsquamous histology in 2008. In 2009, the drug was given approval as a maintenance therapy for locally advanced or metastatic NSCLC in patients with nonsquamous histology following four cycles of platinum-based first-line chemotherapy without disease progression.

Cole Petrochko

Staff Writer

Cole Petrochko started his journalism career at MedPage Today in 2009, after graduating from New York University with B.A.s in Journalism and Psychology. When not writing for MedPage Today, he blogs about nerd culture, designs websites, and buys and sells collectible card game cards. He is based out of MedPage Today's Little Falls, N.J. Headquarters.

FDA OKs Opioid for Diabetic Pain

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By Cole Petrochko, Associate Staff Writer, MedPage Today

WASHINGTON -- The FDA has approved the first opioid painkiller for neuropathic pain associated with diabetic peripheral neuropathy, according to the drug maker.

Tapentadol (Nucynta ER) is an extended-release formulation of the oral analgesic. The twice-daily drug is targeted to adult diabetic patients with neuropathic pain who require continuous, around-the-clock opioid analgesic treatment, said Janssen Pharmaceuticals in a statement.

The drug was initially approved in 2008 as a treatment for moderate to severe acute pain management in adult patients with severe acute pain.

The extended-release formulation of tapentadol was indicated to include twice-daily treatment for patients with severe chronic pain who needed continuous treatment.

Safety and efficacy for the new indication were established in two randomized-withdrawal phase III trials. Among patients who had experienced at least one point reduction in pain after 3 weeks of drug treatment, those treated with tapentadol over 12 weeks experienced significantly better pain control than those switched to placebo.

Adverse events during trials included nausea, constipation, dizziness, headache, somnolence, vomiting, and headache.

Tapentadol is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma or hypercarbia in an unmonitored setting, hypersensitivity, gastrointestinal obstruction, and in patients taking monoamine oxidase inhibitors.

Patients taking tapentadol may be at risk for life-threatening respiratory depression, even if taken as indicated.

Patients taking serotonergic drugs with tapentadol are at risk for life-threatening serotonin syndrome.

The drug should not be taken accidentally or in excess of prescribed amounts due to risk of potentially fatal overdose, particularly if the drug is taken with alcohol.

As an opioid agonist, the drug has the potential for abuse or addiction.

Those discontinuing use of the drug should taper use, according to the company.

Janssen Pharmaceuticals is based in Raritan, N.J.

Cole Petrochko

Staff Writer

Jetrea Gets FDA Nod for Macular Adhesion

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By Cole Petrochko, Staff Writer, MedPage Today

WASHINGTON -- The FDA has approved ocriplasmin (Jetrea) as the first nonsurgical treatment for symptomatic vitreomacular adhesion.

Symptomatic vitreomacular adhesion is a condition where the jelly around the macula -- called vitreous -- moves away from it, which can damage the macula by tugging or pulling on it, the agency wrote in a statement.

The drug is delivered through an injection into the eye, where the enzyme in the treatment breaks down the ocular proteins responsible for the adhesion. The drug permits "a better separation between the vitreous and macula, and can reduce the chances that tugging will occur," the agency said.

Safety and efficacy were established in two clinical trials of a combined 652 patients with symptomatic vitreomacular adhesion. Patients were randomized to receive an injection of ocriplasmin or placebo, then followed for 28 days and checked for adverse events over 6 months.

In the combined trials, 26% of patients treated with ocriplasmin were free of the adhesion versus 10% of those treated with placebo.

Adverse events related to treatment included eye floaters, bleeding of eyelid and eye tissue, eye pain, photopsia, blurred vision, unclear vision, vision loss, retinal swelling, and macular edema.

The agency noted that the drug allows patients to "have a nonsurgical treatment option," Edward Cox, MD, director of the Office of Antimicrobial Products at the FDA's Center for Drug Evaluation and Research, said in the statement. The surgical treatment for symptomatic vitreomacular adhesion is known as vitrectomy and involves cutting the vitreous gel and sucking it out.

The drug is manufactured by ThromboGenics.

Cole Petrochko

Staff Writer