HUNTINGTON -- A Wyoming County man is suing St. Mary's Medical Center for failing to provide him with adequate anesthesia services and/or adequate post-operative care while he was a patient.

Cardiac Anesthesia Plus,Inc., was also named as a defendant in the suit.

James O'Neal was a patient of the defendants and while he was at the hospital, the defendants' negligence resulted in dehydration and/or acute renal failure and chronic renal dysfunction, according to a complaint filed March 16 in Cabell Circuit Court.

O'Neal claims at various times, both Stanislav Stritz and Dr. Mark Newfield provided treatment to him as a function of their association and agency with Cardiac Anesthesia Plus and deprived him of a meaningful understanding and opportunity to consider anesthesia and the consequences.

As a result of the defendants' breaches, O'Neal suffered from acute renal failure; was required to undergo dialysis; has permanent renal dysfunction; and has experienced increased medical expenses; pain and suffering; emotional distress; loss of wages and earning capacity; and was otherwise harmed and damaged, according to the suit.

O'Neal claims he will also incur future medical expenses for kidney management and treatment and now carries a significantly increased risk attendant with routine and future surgical procedures.

O'Neal is seeking compensatory damages. He is being represented by Timothy P. Lupardus.

The case has been assigned to Circuit Judge David M. Pancake.

Cabell Circuit Court case number: 12-C-172

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THOUSAND OAKS, Calif—Last week was a busy one for Amgen (AMGN -0.03%), with good news mixed in with bad.  The largest biotech in the world lost its anemia drug monopoly in the U.S., but also announced good results for experimental drugs that have the potential to tap huge markets.The question now is whether the good news outweighs the bad.

Anemia drugs
Amgen's anemia drug monopoly began 23 years ago when Epogen was approved. Free to set prices and raise them significantly, the company's sales of Epogen have amounted to $37 billion, just for the treatment of American dialysis patients. Amgen also has a licensing agreement with Johnson & Johnson (JNJ -0.59%), which sells the same drug under the name Procrit for other uses. Another form of the drug, Aranesp, sold for $26 billion.

Last week, that monopoly was broken when the Food and Drug Administration (FDA)  approved Affymax's (AFFY +0.25%) therapy Omontys for the treatment of anemia in adult dialysis patients with chronic kidney disease (CKD).

Similar to Epogen, the drug stimulates the bone marrow to produce more red blood cells, allowing patients to avoid blood transfusions. But Affymax's drug may be more attractive as it is to be injected once a month, whereas Amgen's drug is usually given three times a week. And while Amgen recently struck supply agreements with leading dialysis providers, Affymax claims Omontys will be sold at a 20 percent discount to Epogen.

But this was just the latest hit to Amgen's anemia drug franchise in recent years. Sales of Epogen have already been declining because of safety concerns about increased risk of heart attacks, strokes and other cardiovascular problems. Epogen sales dropped 19 percent to $2 billion in 2011 from $2.5 billion in 2010. Aranesp sales dropped 7 percent to $2.3 billion from $2.5 billion in 2010 worldwide, mainly because of a double-digit decline in the U.S. Changes in reimbursements from Medicare put added pressures on sales.

In the pipeline
For years, investors put their hopes in Amgen's osteoporosis drugs Prolia and Xgeva. But sales of the two treatment have yet to gain the expected momentum, and the FDA is unsure about expanding Xgeva's uses.

Meanwhile, Amgen released impressive results a week ago about a new class of cholesterol drug. The study showed the drug, given by monthly injections, dramatically lowered LDL, or the "bad" cholesterol.

Amgen is not the only one attempting to reach this potential $20 billion market first. Regeneron (REGN +2.37%), which in partnership with Sanofi Aventis (SNY -1.17%) is developing a similar drug, also announced results from its study. While Regeneron is a step ahead in its studies, the results of its drug fell short of Amgen's. Merck (MRK +0.09%), Bristol-Myers Squibb (BMY +0.30%) and others are also developing similar drugs.

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Below is a look at some of the headlines for companies that made news in the healthcare sector on April 2, 2012.

Novo Nordisk (NYSE:NVO), a world leader in diabetes care, announced the U.S. FDA has approved Levemir® (insulin detemir [rDNA origin] injection) for a pregnancy Category B classification, indicating that Levemir®, when used in pregnant women with diabetes, did not increase the risk of harm to the unborn baby.

The label update makes Levemir® the first and only basal insulin analog to have this classification. Until this decision, NPH (human insulin) was considered the standard of care for diabetes in pregnancy. Now, Novo Nordisk is the only company that offers a complete portfolio of insulin analogs with a pregnancy Category B classification.

The FDA category change was based on a review of a large, randomized controlled trial examining Levemir® in pregnant women with type 1 diabetes. The study compared the safety and efficacy of Levemir® against NPH insulin in the treatment of 310 women. The study found that patients taking Levemir® had similar A1C reduction at gestational week 36 and lower fasting plasma glucose levels at gestational weeks 24 and 36 compared with NPH. Additionally, the study found no differences in the overall safety profile during pregnancy, on pregnancy outcomes or the health of the fetus and newborn.

"We are excited that the FDA has granted approval for this new category rating for Levemir®," said Lois Jovanovi?, MD, MACE, Chief Scientific Officer, Sansum Diabetes Research Institute in Santa Barbara, California. "For women who are pregnant, diabetes can be extremely challenging; they must be even more diligent and careful when monitoring blood sugar levels than before they were pregnant. This approval provides patients with a long-acting insulin analog option that can help them manage their blood sugar.”

In the U.S., there are approximately 1.85 million women of child-bearing age with diabetes. For those who want to get pregnant, this development gives them another option to manage their diabetes.

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Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) reported the Phase 3 "X-PECT" (Xeloda® + Perifosine Evaluation in Colorectal cancer Treatment) clinical trial evaluating perifosine (KRX-0401) + capecitabine (Xeloda) in patients with refractory advanced colorectal cancer did not meet the primary endpoint of improving overall survival versus capecitabine + placebo.

This Phase 3 trial was conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA.  468 patients at sixty-five U.S. sites participated in this study.

Ron Bentsur, Chief Executive Officer of Keryx, stated, "We are all extremely disappointed with the results of the study.  We thank the investigators who participated in what we believe was a well-run study, despite the outcome.  We will evaluate whether our Phase 3 study of Perifosine in relapsed/refractory multiple myeloma will continue as planned."

Mr. Bentsur commented further, "With approximately $31 million in cash as of March 31, 2012, and a well-controlled burn rate, we plan to focus our resources on the pending completion of the Zerenex (ferric citrate) long-term Phase 3 study for end stage renal disease (ESRD) patients with hyperphosphatemia, expected in the fourth quarter of 2012, and the New Drug Application (NDA) filing for Zerenex which will hopefully follow shortly thereafter."

Also Monday:

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced the launch of a new interactive patient website called Ampyra Journeys (www.AmpyraJourneys.com).

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced the presentation of new preclinical data on its investigational pan-BCR-ABL inhibitor, ponatinib, and its investigational dual EGFR-ALK inhibitor, AP26113, at the American Association for Cancer Research Annual Meeting in Chicago.

Astro-Med, Inc. (NASDAQ: ALOT), a world leader in the data acquisition and recording market, today introduced its new TMX®-18 High-Speed Data Acquisition System, offering best in class efficiency for general purpose data capture, review, archive, and analysis.

Bristol-Myers Squibb Company (NYSE:BMY) will announce results for the first quarter of 2012 on Thursday, April 26, 2012.

Cannabis Science, Inc. (OTCBB: CBIS) a pioneering U.S. biotech company developing cannabis pharmaceutical and over the counter nutraceutical products, is pleased to report it is moving forward with its FDA IND process.

Citadel EFT, Inc. (OTCQB: CDFT) (PINKSHEETS: CDFT), which offers U.S. merchants credit card terminals, online services, mail order and retail credit card processing services, announces today that it has signed on merchant credit card services for Buypureomega.com.

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) will issue its first quarter 2012 financial results at 4:00 p.m. ET on Wednesday, April 18th, 2012.

Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care announced today that Edward J. Quilty, the Company’s chief executive officer will present a corporate overview and update at the 11th Annual Needham Healthcare Conference taking place from April 3-4, 2012 at The New York Palace Hotel, New York City.

Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care, today announced the pricing of an underwritten registered direct offering of 2,125,000 shares of common stock at a price of $9.25 per share.

EasyMed Services Inc. (CNSX:EZM) (OTCBB:EMYSF) (MUN:EY6) ("ESI") is pleased to announce today that it has entered into a letter of intent dated April 1, 2012 (the "Letter of Intent") with Biosign Technologies Inc. (TSX VENTURE:BIO) ("Biosign") to complete a business combination (the "Transaction").

Exelixis, Inc. (NASDAQ:EXEL) announced today that its lead compound, cabozantinib, will be the subject of nine separate data presentations at the upcoming Annual Meeting of the American Society of Clinical Oncology (ASCO).

Fibrocell Science, Inc. (OTCBB: FCSC), an autologous cellular therapeutic company focused on the development of innovative products for aesthetic, medical and scientific applications, announced today that it has rescheduled its fourth quarter 2011 business update investor conference call to Tuesday, April 3, 2012 at 8:00 AM Eastern Time.

Forest Laboratories, Inc. (NYSE: FRX), an international manufacturer and marketer of pharmaceutical products, will release its Fiscal 2012 Fourth Quarter financial results before the U.S. stock market opens on Tuesday, April 17, 2012.

Health Net, Inc. (NYSE:HNT) today announced that its subsidiary, Health Net Life Insurance Company, completed the sale of its Medicare stand-alone Prescription Drug Plan (Medicare PDP) business to a subsidiary of CVS Caremark (NYSE:CVS).

Illumina, Inc. (NASDAQ:ILMN) today announced estimated first quarter revenue of approximately $270 million.

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today presented new preclinical data for saridegib (IPI-926), its novel oral molecule that inhibits Smoothened, a key component of the Hedgehog pathway.

Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that data from the pivotal Phase III study with ZOSTAVAX® (Zoster Vaccine Live) in adults ages 50 to 59 were published in the April 1 issue of Clinical Infectious Diseases.

NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that its previously announced pre-IND Meeting was held with the USFDA on March 29th, 2012, as scheduled.

Stellar Pharmaceuticals Inc. (OTCQB:SLXCF) (OTCBB:SLXCF) (PINKSHEETS:SLXCF) ("Stellar" or "the Company"), an emerging specialty pharmaceutical company with a primary focus on the acquisition, licensing, development and promotion of healthcare products in Canada, today announced financial results for the year ended December 31, 2011.

Synageva BioPharma Corp. (NASDAQ:GEVA), a clinical stage biopharmaceutical company developing therapeutic products for rare disorders, announced today an expansion of its previous collaboration with Mitsubishi Tanabe Pharma Corporation (Head Office; Osaka, Japan, “MTPC”) to develop a second protein therapeutic for an undisclosed orphan disease using Synageva’s product development capabilities and proprietary protein expression platform.

Teva Pharmaceutical Industries Limited (NASDAQ: TEVA) ("Teva") announced today that it successfully priced its debut EUR 1 billion and CHF 450 million debt offerings, and that it entered into a JPY 100 billion (approximately USD 1.2 billion) senior unsecured fixed-rate syndicated term loan facility.

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that it has commenced commercial launch of both Irbesartan and Irbesartan-Hydrochlorothiazide Tablets, the Company’s generic versions of Sanofi Aventis’ high blood pressure treatments, Avapro® and Avalide® Tablets.

Walgreens (NYSE: WAG) (NASDAQ: WAG) and the Magic Johnson Foundation today announced a national campaign to address the health, educational and social needs of ethnically diverse, urban communities.

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Acceleron Pharma Inc. in Cambridge said collaborators at Beth Israel Deaconess Medical Center have presented preclinical data showing that its ACE-041 drug candidate, combined with sunitinib, inhibited tumor growth in a renal cell carcinoma model.

The data were presented today at the American Association for Cancer Research annual meeting in Chicago. The ACE-041, activin-receptor like kinase 1 receptor ligand trap, when used in combination with sunitinib, inhibited tumor growth in a model of vascular endothelial growth factor (VEGF)-inhibitor-resistant renal cell carcinoma.

“There is increasing evidence that combining anti-angiogenesis inhibitors with distinct mechanisms of action, such as a VEGF inhibitor with an ALK1 ligand trap, like ACE-041, can more effectively inhibit tumor angiogenesis,” Dr. Matthew Sherman, Acceleron’s chief medical officer, said in a statement. He added that the approach holds great promise, and that the company will pursue Phase 2 studies of ACE-041 in combination with VEGF inhibitors later this year.

Anti-angiogenesis therapies, including the VEGF-inhibitor sunitinib, are currently the standard of care in metastatic renal cell carcinoma. The treatments cause tumor shrinkage and extend progression-free survival in many patients, but the responses are typically short-lived due to the development of drug resistance, according to Acceleron. The preclinical data presented by Dr. Rupal Bhatt, assistant professor of hematology-oncology at Beth Israel, show that combining two distinct anti-angiogenic drugs, a VEGF inhibitor and ACE-041, may produce an enhanced therapeutic effect in treating metastatic renal cell carcinoma, the company said.

Acceleron is a privately-held biopharmaceutical company focused on developing protein therapeutics for orphan diseases and cancer. Last December it took in a $30 million investment from Celgene Corp. of New Jersey and its cadre of existing backers, including Advanced Technology Ventures, Alkermes, Avalon Ventures, Bessemer Ventures, Flagship Ventures, MPM BioEquities, OrbiMed Advisors, Polaris Ventures, QVT Financial, Sutter Hill Ventures, and Venrock.
 

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