Delcath Confirms FDA Panel Voted 16-0 Against Melblez Kit; AVEO, Astellas Confirm Unfavorable Vote by FDA on Tivozanib Print E-mail
By Staff and Wire Reports   
Thursday, 02 May 2013 19:15
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 2, 2013.

Delcath Systems, Inc. (NASDAQ: DCTH) announced that the U.S. FDA Oncologic Drugs Advisory Committee (ODAC) voted 16 to 0 with no abstentions that benefits of treatment with Delcath's Melblez^TM Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System) for the treatment of patients with unresectable ocular melanoma metastatic to the liver do not outweigh the risks associated with the procedure.

The FDA is not bound by the recommendation of its advisory committee, but will consider the committee's guidance as it evaluates the Melblez Kit New Drug Application (NDA). The Prescription Drug User Fee Act (PDUFA) goal date for completion of the FDA's review and decision regarding approval of the Melblez Kit NDA is September 13, 2013.

"As we conveyed during the presentation to the ODAC, we believe our clinical trial data support Melblez Kit as an effective treatment option offering clinical benefits to patients with unresectable metastatic ocular melanoma in the liver" said Eamonn P. Hobbs, President and CEO of Delcath Systems. "While we were disappointed in today's outcome, we will continue to work closely with the FDA throughout its ongoing evaluation of Melblez Kit. We remain committed to providing access to this promising new treatment for patients who have few choices with regard to treatments."


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AVEO Oncology (NASDAQ: AVEO) and Astellas Pharma Inc. reported the U.S. FDA Oncologic Drugs Advisory Committee (ODAC) voted that the application for investigational agent tivozanib did not demonstrate a favorable benefit-to-risk evaluation for the treatment of advanced renal cell carcinoma (RCC) in an adequate and well-controlled trial (13 to 1, 0 abstentions).

“While we are disappointed with the outcome of the ODAC vote, we remain confident in the efficacy, safety and tolerability of tivozanib in RCC patients,” said Tuan Ha-Ngoc, president and chief executive officer of AVEO. “We are committed to the RCC patient community and will work closely with the FDA to address the issues discussed by the panel today as the Agency continues its ongoing review of the New Drug Application for tivozanib.”

The ODAC provides the FDA with independent expert advice and recommendations. The FDA is not bound by the Committee's guidance, but its input will be considered by the Agency in its review of the tivozanib New Drug Application (NDA), which was submitted by AVEO on September 28, 2012. According to the timelines established by the Prescription Drug User Fee Act (PDUFA), the review of the NDA is expected to be complete by July 28, 2013.

The ODAC reviewed findings from a total of 17 trials involving more than 1,000 patients, including the global Phase 3 TIVO-1 (TIvozanib Versus SOrafenib in 1st line Advanced RCC) trial, a randomized superiority-designed pivotal trial evaluating the efficacy and safety of tivozanib compared to sorafenib, an approved targeted agent, in 517 patients with advanced RCC. In TIVO-1, tivozanib demonstrated a statistically significant improvement in progression-free survival, the primary endpoint of the study, and a favorable tolerability profile when compared to sorafenib.



Also Thursday:



Acorda Therapeutics, Inc. (Nasdaq: ACOR)
today announced its financial results for the first quarter ended March 31, 2013.

A.P. Pharma, Inc. (OTCBB: APPA.OB)
, a specialty pharmaceutical company, today announced that its Board of Directors has appointed a new management team to lead the Company.

Arrowhead Research Corporation (NASDAQ:ARWR)
, a targeted therapeutics company, today announced that it will report its financial results for the fiscal 2013 second quarter ended March 31, 2013, on Thursday, May 9, 2013, at 4:30 p.m. Eastern time (1:30 p.m. Pacific time).

AtossaGenetics, Inc. (NASDAQ: ATOS)
, The Breast Health Company™, has signed an agreement with Millennium HealthCare Inc. (PINKSHEETS: MHCC) for the distribution by Millennium Medical Devices of Atossa's ForeCYTE Breast Health devices, which consist of the patented MASCT pump and ForeCYTE patient collection kits.

AVEO Oncology (NASDAQ: AVEO) today announced that NASDAQ halted trading of AVEO common stock this morning, May 2, 2013. The U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) meets today to discuss the New Drug Application (NDA) for tivozanib for the treatment of patients with advanced renal cell carcinoma (RCC).

AVEO Oncology (NASDAQ: AVEO)
and Astellas Pharma Inc. (TSE: 4503) today reported that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted that the application for investigational agent tivozanib did not demonstrate a favorable benefit-to-risk evaluation for the treatment of advanced renal cell carcinoma (RCC) in an adequate and well-controlled trial (13 to 1, 0 abstentions).

BASi (Bioanalytical Systems, Inc.) (NASDAQ: BASI)
announced today that it is collaborating with Pinnacle Technology Inc. in proof-of-concept studies combining BASi's Culex® NxT automated blood sampling system with Pinnacle's glucose sensor to create an innovative new option for high quality data collection for diabetes and other glucose research.

BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX)
, a biopharmaceutical development company, announced today that the Company was invited to deliver an oral presentation at the 2013 National Education Conference & Gluten-Free Expo, the Celiac Disease Foundation's annual conference, in Pasadena, California.

Cadence Pharmaceuticals, Inc. (NASDAQ: CADX)
, a biopharmaceutical company focused on acquiring, in-licensing, developing and commercializing proprietary products principally for use in the hospital setting, today reported financial results for the first quarter ended March 31, 2013.

China Biologic Products, Inc. (NASDAQ: CBPO)
, a leading fully integrated plasma-based biopharmaceutical company in China, today announced that the Company plans to release first quarter 2013 financial results on Wednesday, May 8, 2013 after the market closes.

Cytori Therapeutics (NASDAQ: CYTX)
will provide a live webcast of its first quarter financial results and business update on Thursday, May 9, 2013 at 5:00 PM Eastern Time.

Cytomedix, Inc. (OTCQX: CMXI)
, a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today that AutoloGel™ will be featured in oral and poster presentations at the Symposium on Advanced Wound Care (SAWC), that is being held in Denver, Colorado on May 1- 5, 2013.

GeoVax Labs, Inc. (OTCQB: GOVX)
, a biotechnology company developing HIV/AIDS vaccines, announced its financial results for the three months ended March 31, 2013 and provided a clinical development update.

Gilead Sciences (Nasdaq: GILD) today announced plans to initiate a third Phase 3 clinical trial of the company’s investigational fixed-dose combination tablet of sofosbuvir and ledipasvir for the treatment of chronic hepatitis C virus (HCV) infection.

Harbor Island Development Corp. (OTCQB: HIDC)
, (the “Company”), through its wholly owned subsidiary BrandSeed Media Services LLC. (“BrandSeed”), a multi-channel direct marketing service provider, today announced that the Company has signed an exclusive marketing agreement with House Brands, LLC (“HouseBrands”).

Incyte Corporation (Nasdaq: INCY)
today reported first-quarter 2013 financial results, including revenue from Jakafi® (ruxolitinib), which is approved by the U.S. Food & Drug Administration (FDA) for the treatment of patients with intermediate or high-risk myelofibrosis (MF). The Company also updated information about key clinical programs.

Insulet Corporation (NASDAQ: PODD)
, the leader in tubeless insulin pump technology with its OmniPod® Insulin Management System, today announced it has entered into an agreement with Eli Lilly and Company in which Insulet will develop a new version of the OmniPod insulin pump specifically designed to deliver Humulin® R U-500 insulin, (regular U-500 [Concentrated] insulin human injection, USP [rDNA origin]), a concentrated form of insulin used by people with highly insulin resistant type 2 diabetes.

Life Technologies Corporation (NASDAQ: LIFE)
today announced results for its first quarter ended March 31, 2013.  Revenue for the first quarter was $963 million, an increase of 2.5 percent over the $939 million reported for the first quarter of 2012.  

Janssen R&D Ireland (Janssen) and Johnson & Johnson (NYSE: JNJ) will provide a pre-recorded webcast for investors and other interested parties on Friday, May 3, at approximately 8:30 a.m., Eastern Time, to discuss simeprevir phase 3 clinical data presented at The International Liver Congress of the European Association for the Study of the Liver (EASL).

Millennium HealthCare Inc. (OTC Pink: MHCC)
today announced that its Medical Device subsidiary signed an agreement with Atossa Genetics Inc. (NASDAQ: ATOS) for the distribution of Atossa's ForeCYTE Breast Health devices, which consist of the patented MASCT pump and ForeCYTE patient collection kits.

mPhase Technologies, Inc. (OTCBB: XDSL)
reported today that it has received an Issue Notification from the U.S. Patent & Trademark Office for a key patent relating to a device for fluid spreading and transport.

Nektar Therapeutics (Nasdaq: NKTR)
will announce its financial results for the first quarter ended March 31, 2013 on Thursday, May 9, 2013, after the close of U.S.-based financial markets.

Neurocrine Biosciences, Inc. (NASDAQ: NBIX)
today announced its financial results for the quarter ended March 31, 2013.  For the first quarter of 2013, the Company reported net loss of $12.1 million, or $0.18 loss per share, compared to a net loss of $0.9 million, or $0.01 loss per share, for the same period in 2012.

Nuvilex, Inc. (OTCQB: NVLX)
has already produced impressive results from its two independent Phase II clinical trials in patients with advanced, inoperable pancreatic cancer.

OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI)
today provided an overview of clinical development activities for its two product candidates, custirsen and OGX-427, and announced first quarter 2013 financial results.

Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, will announce financial results for the first quarter ended March 31, 2013, on Wednesday, May 8, 2013 after the markets close.

Parametric Sound Corporation (NASDAQ: PAMT), a leading innovator of audio technology and solutions, today announced financial results for its second fiscal quarter ended March 31, 2013.

Plandai Biotechnology, Inc. (OTCQB: PLPL)
, a producer of highly bioavailable plant extracts for industries including health, wellness, nutraceutical, and pharmaceutical, today announced an agreement under which Willows Ingredients, Ltd. of Ireland  will distribute Plandai's Phytofare™ extracts into European markets.

PLC Systems Inc. (OTCQB: PLCSF)
, a company focused on innovative medical device technologies, today announced that it will participate in the Taglich Brothers 10th Annual Small Cap Equity Conference.

Rite Aid Corporation (NYSE: RAD) today announced sales results for April.

Santarus, Inc. (NASDAQ: SNTS)
and VeroScience, LLC today announced the inclusion of CYCLOSET® (bromocriptine mesylate) as a therapy for patients with type 2 diabetes in a new comprehensive diabetes management algorithm published by the American Association of Clinical Endocrinologists (AACE).

Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced it will host a teleconference and webcast with management to discuss the first quarter 2013 financial results, provide an update on the Company's business, and discuss expectations for the future.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA)
today reported results for the quarter ended March 31, 2013.

Verenium Corporation (Nasdaq: VRNM), a leading industrial biotechnology company focused on the development and commercialization of high-performance enzymes,today announced that it will release first quarter 2013 financial results on Thursday, May 9, 2013 after market close.



"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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