Onyx and Idis Form Partnership to Introduce Carfilzomib Managed Access Program; Teva Receives EU Authorization for Lonquex® Print E-mail
By Staff and Wire Reports   
Thursday, 08 August 2013 19:48

Below is a look at some of the headlines for companies that made news in the healthcare sector on August 8, 2013.
Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) announced that it is partnering with Idis Limited to initiate a Managed Access Program for carfilzomib in certain countries in Europe for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of completion of the last therapy.

Managed Access Programs provide biopharmaceutical companies with a way to allow eligible patients ethical access to medicines for unmet medical needs. Access is provided in response to physician requests in a fully compliant manner, where no alternative treatment options are available.

For more information about Idis' services and its Managed Access Programs, healthcare professionals may contact Idis via telephone on +44 (0)1932 824 123, fax +44 (0)1932 824 323, or via email at [email protected]

"Idis is the recognized leader in Managed Access Programs, making them an ideal partner to oversee this important initiative on behalf of Onyx," said Pablo J. Cagnoni, M.D., Executive Vice President, Global Research & Development and Technical Operations, Onyx Pharmaceuticals.

Idis, a UK-based global company, has over 25 years of experience partnering with pharmaceutical and biotechnology companies to create regulatory-compliant, ethical access to medicines for healthcare professionals and their patients with unmet medical needs.

"Patients with advanced cancer face unique challenges, among them, gaining timely access to innovative new therapies," said Tony Dutta, Managing Director of Idis. "Through our work with Onyx Pharmaceuticals, we will share our expertise in successfully addressing access challenges and help educate a broad range of stakeholders on navigating the options and obstacles that exist for these patients."


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Teva Pharmaceutical Industries Ltd (NYSE: TEVA)
announced the European Commission has granted marketing authorization for Lonquex® (lipegfilgrastim). This approval provides the regulatory framework for the commercialization of Lonquex® in all twenty eight countries of the European Union plus Norway, Iceland and Liechtenstein.

Lonquex® is a long-acting recombinant granulocyte colony-stimulating factor (G-CSF) with the active ingredient lipegfilgrastim – a novel glycoPEGylated (PEG; polyethylene glycol) filgrastim molecule. Lonquex® (lipegfilgrastim) is indicated for the reduction of the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes). Lonquex® is intended as a once-per-cycle fixed dose, subcutaneous injection for neutrophil support in cancer patients receiving myelosuppresive chemotherapy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes).1

“This is an important milestone for Teva Specialty Medicines in Europe and demonstrates our commitment to making a difference to the lives of those with cancer” said Dr. Rob Koremans, President and CEO of Teva Specialty Medicines. “Lonquex® is an alternative G-CSF treatment for helping manage neutropenia during myelosuppressive chemotherapy. The European approval comes earlier than expected, just 8 weeks after the positive CHMP opinion. We look forward to providing this oncology supportive care treatment option in all European Union member states.”

Lonquex® has undergone a full clinical development program, including pre-clinical to clinical in vivo studies, as part of the efficacy and tolerability assessment for use with chemotherapy patients.

Dr. Michael Hayden, Teva's President of Global R&D and Chief Scientific Officer, commented: “Effective prevention and treatment of febrile neutropenia is an important consideration for clinicians managing cancer patients who are undergoing cytotoxic chemotherapy. As well as targeting cancer cells, chemotherapy affects rapidly-dividing bone marrow cells, thereby dramatically reducing a patient's ability to fight off infection, with potentially serious consequences. This approval is testament to Teva's commitment to bringing new and alternative treatments to market to support clinicians in caring for patients."


Also Thursday:


Aeterna Zentaris Inc. (NASDAQ:  AEZS) (TSX: AEZ)
(the "Company"), a specialty biopharmaceutical company engaged in developing novel treatments in oncology and endocrinology, today reported financial and operating results as at and for the second quarter ended June 30, 2013.

The Alkaline Water Company Inc. (OTCBB: WTER)
, developers of an innovative, state of the art, proprietary electrolysis beverage process packaged and branded as Alkaline84, a premier alkaline drinking water for balanced lifestyles, today announced an agreement with three leading retail chains in Southern California.

Amyris, Inc. (Nasdaq:AMRS)
, a leading renewable chemicals and fuels company, today announced financial results for the second quarter ended June 30, 2013.

Atossa Genetics, Inc. (NASDAQ: ATOS)
, the Breast Health Company™, announced today that BUYINS.NET, http://www.buyins.net, a leading provider of Regulation SHO compliance monitoring, short sale trading statistics and market integrity surveillance, has initiated coverage on Atossa Genetics after releasing the latest short sale data through August 6, 2013.

Baxano Surgical, Inc. (Nasdaq:BAXS)
, a medical device company focused on designing, developing and marketing minimally invasive products to treat degenerative conditions of the spine affecting the lumbar region, today announced its financial results for the second quarter ended June 30, 2013.

diaDexus, Inc. (OTCQB:DDXS)
, a company developing and commercializing proprietary cardiovascular diagnostic products, today announced financial results for the second quarter ended June 30, 2013.

Diversicare Healthcare Services, Inc. (Nasdaq:DVCR)
, a premier provider of long-term care services primarily in the Southeast and Southwest, today announced its results for the second quarter ended June 30, 2013.

Dyadic International, Inc. (OTC Pink: DYAI)
, a global leader in the commercial application of biotechnology for the discovery, development and production of enzymes and other proteins, today announced financial results for the quarter ended June 30, 2013.

EnteroMedics Inc. (NASDAQ: ETRM)
, the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that Mark B. Knudson, Ph.D., EnteroMedics' President and Chief Executive Officer, is scheduled to present at the Canaccord Genuity 33rd Annual Growth Conference on Thursday, August 15, 2013 at 4:00 pm Eastern Time at the Intercontinental in Boston, MA.

Galena Biopharma (Nasdaq:GALE)
, a biopharmaceutical company commercializing and developing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today reported its financial results for the three months and six months ended June 30, 2013 and provided a business update.

Graymark Healthcare, Inc. (OTCQB: GRMH)
, a leading provider of care management solutions to the sleep disorder market, will hold a conference call on Tuesday, August 13, 2013 at 4:30 p.m. Eastern time to discuss its financial results for the second quarter ended June 30, 2013, and the recent acquisition of Foundation Surgical Hospital Affiliates LLC and Foundation Surgery Affiliates LLC (collectively "Foundation".)

Hansen Medical, Inc. (NASDAQ: HNSN)
, a global leader in intravascular robotics, today announced that it has closed the private placement announced on July 31, 2013, through which approximately 28.5 million shares of the Company's common stock were purchased by Oracle Investment Management, leading medical device executive Jack W. Schuler, certain members of the Company's Board of Directors, and other existing and new shareholders, including several former healthcare executives.

Health Revenue Assurance Holdings Inc. (OTCQB: HRAA)
, a provider of technology and revenue integrity solutions for healthcare organizations, has announced the addition of two new independent members to its Board of Directors. Peter Russo, former CFO of magicJack and Corporate Strategist Michael Brainard will join HRAA's board, effective today.

Hyperion Therapeutics, Inc. (Nasdaq:HPTX)
today announced that it will host a teleconference and webcast with management to provide a general business overview, as well as to discuss its second quarter 2013 financial results on Wednesday, August 14, 2013 at 4:30 p.m. EDT (1:30 p.m. PDT.)

Intuitive Surgical, Inc. (Nasdaq:ISRG)
today reported that equity awards approved by the Compensation Committee of the Board of Directors, which consists entirely of Independent Directors, were made to 99 new employees.

LipoScience, Inc. (Nasdaq:LPDX)
today announced that two new members have recently joined the Board of Directors, Jeffrey T. Barber and James R. ("Bob") Hurley.

Milestone Scientific Inc. (OTCQB: MLSS)
, the recognized leader in advanced, computer-controlled injection technologies, today announced financial results and provided a business update for the three and six months ended June 30, 2013.

NeoStem, Inc. (Nasdaq:NBS)
, a leader in the emerging cellular therapy market, today announced its second quarter results and provided highlights of its recent activities.

Oculus Innovative Sciences, Inc. (Nasdaq:OCLS)
today announced financial results for the first quarter of fiscal year 2014, ended June 30, 2013.

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

Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX)
today announced that it is partnering with Idis Limited to initiate a Managed Access Program for carfilzomib in certain countries in Europe for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of completion of the last therapy.

Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX)
today reported its financial results for the second quarter 2013 and provided a business update on Kyprolis® (carfilzomib) for Injection, Nexavar® (sorafenib) tablets and Stivarga® (regorafenib) tablets.

Parametric Sound Corporation (NASDAQ: PAMT)
, a leading innovator of audio technology and solutions, today announced financial results for its third fiscal quarter ended June 30, 2013.

PDL BioPharma, Inc. (NASDAQ: PDLI)
today reported financial results for the second quarter and six months ended June 30, 2013.

Rosetta Genomics Ltd. (NASDAQ: ROSG)
, a leading developer and provider of microRNA-based molecular diagnostics, and Ramot, the technology transfer company of Tel Aviv University, announces that the Israeli Office of the Chief Scientist (OCS) has awarded both companies a grant in the amount of 650,000 NIS (~200,000 USD) to support the first year development of oncology therapeutics utilizing Rosetta Genomics' novel microRNA technology combined with Tel Aviv University's novel delivery system.

SOHM, Inc. (PINKSHEETS: SHMN)
, a Generic Pharmaceutical, Neutraceutical and Cosmeceutical manufacturer launched a unique protein supplement I-Prolec™ in India.

Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP)
today announced that it has begun the search for a new Chief Executive Officer (CEO). Sucampo also announced that once a new CEO is named by the Board of Directors (Board), Dr. Ryuji Ueno, M.D., Ph.D., Ph.D., co-founder of Sucampo, CEO, Chairman of the Board, and Chief Scientific Officer (CSO), will focus exclusively on his role as CSO of Sucampo.

Venaxis, Inc. (Nasdaq: APPY)
, an in vitro diagnostic company focused on obtaining FDA clearance and commercializing its CE Marked APPY1™ Test, a rapid, multiple biomarker-based assay for identifying patients that are at low risk for appendicitis, today announced it will present at the Canaccord Genuity 33rd Annual Growth Conference, to be held August 14-15, 2013, at the Intercontinental Boston in Boston, MA.

XOMA Corporation (Nasdaq:XOMA)
, a leader in the discovery and development of therapeutic antibodies, announced today members of its executive team will present at two upcoming investor conferences.

ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP)
today announced financial results for the second quarter ended June 30, 2013, and provided an update on the Company's key development activities, including advances in its synthetic biology platform with Channel Collaborator Intrexon Corporation.




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