AstraZeneca And Pharmacyclics Enter Clinical Trial Collaboration To Evaluate IMBRUVICA®; Covidien's HawkOne Directional Atherectomy System Receives FDA 510(K) Clearance Print E-mail
By Josh Gee   
Tuesday, 04 November 2014 20:32
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 4, 2014.
Pharmacyclics (NASDAQ: PCYC) announced they have entered into a clinical trial collaboration to evaluate novel combination therapies targeting a number of hematologic cancers.  The collaboration will explore separate combinations of two different AstraZeneca investigational PI3 kinase pathway inhibitors in combination with IMBRUVICA® (ibrutinib), Pharmacyclics' oral Bruton's tyrosine kinase inhibitor, for the treatment of patients with relapsed or refractory Diffuse Large B-cell Lymphomas. Preclinical evidence suggests that the combination of IMBRUVICA with these investigational medicines may enhance their effects.

Under the terms of the agreement, AstraZeneca and Pharmacyclics will collaborate on a non-exclusive basis and multiple studies may be considered and conducted. The studies will be led by AstraZeneca.

The Phase I element of each study is expected to establish a recommended safe and tolerable dose and schedule for the combination, and the Phase IIa element will assess its safety and efficacy in an expanded patient population. The financial terms of the agreement have not been disclosed. The results of the clinical studies will be used to determine whether further clinical development of the different combinations is warranted.

Susan Galbraith, Head of AstraZeneca's Oncology Innovative Medicines Unit said, "There is a clear and significant unmet need in the treatment of hematologic malignancies, an area of increasing focus for AstraZeneca. Our partnership with Pharmacyclics will allow us to explore new and potentially potent treatment combinations, which could have a positive impact on patient outcomes."

"We are optimistic that combining our oral once-per-day IMBRUVICA with other agents has the potential to enhance efficacy and duration across the landscape of hematologic cancers," said Bob Duggan, Chairman & CEO, Pharmacyclics.

IMBRUVICA is being developed and commercialized jointly by Pharmacyclics and Janssen Biotech, Inc.


 

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Covidien plc (NYSE: COV)
announced U.S. FDA 510(k) clearance for the HawkOne™ directional atherectomy system. The latest addition to Covidien's directional atherectomy portfolio, the HawkOne™ system provides physicians with an enhanced cutting mechanism to more effectively treat the widest variety of plaque in patients with peripheral arterial disease (PAD).

PAD affects more than 202 million people worldwide1 and more than 10 million people in the U.S.2 It occurs when arteries in the legs become narrowed or blocked by plaque, and it can cause severe pain, limited physical mobility and non-healing leg ulcers. PAD can also lead to serious health consequences such as amputation, cardiovascular disease and death.

“Covidien is committed to being the clear first choice for our physician and hospital partners by delivering new innovative technologies that help save and improve patient lives,” said Brian Verrier, president, Peripheral Vascular, Covidien. “The FDA clearance of the HawkOne™ system enhances our leading peripheral vascular portfolio and further demonstrates Covidien's leadership in the atherectomy space.”

Covidien's directional atherectomy portfolio includes the TurboHawk™ and SilverHawk™ systems and is backed by more than 15 peer-reviewed studies. Recent published data from the DEFINITIVE LE study in the Journal of American College of Cardiology, Cardiovascular Interventions demonstrated 95 percent limb salvage in patients with critical limb ischemia (CLI) and 78 percent overall patency (the ability for the treated artery to remain open) in claudicant patients at 12 months following treatment with directional atherectomy.



Also Tuesday:

 

CAS Medical Systems, Inc. (Nasdaq:CASM)
, a leader in medical devices for non-invasive patient monitoring, today reported financial results for the three and nine months ended September 30, 2014.

Celldex Therapeutics, Inc. (Nasdaq:CLDX)
today reported business and financial highlights for the third quarter ended September 30, 2014.

Codexis, Inc. (Nasdaq:CDXS)
, a leading developer of biocatalysts for the pharmaceutical and fine chemical industries, today announced financial results for the third quarter and nine months ended September 30, 2014.

CombiMatrix Corporation (Nasdaq:CBMX)
, a molecular diagnostics company specializing in DNA-based testing services for pre- and postnatal developmental disorders, today reported financial results for the third quarter and nine months ended September 30, 2014.

The Cooper Companies, Inc. (NYSE:COO)
today announced it will release fourth quarter and full year 2014 financial results on Thursday, December 4, 2014, at 4:00 PM ET.

Endocyte, Inc. (Nasdaq:ECYT)
, a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, today announced that Mike Sherman, chief financial and operating officer of Endocyte, will present at the 2014 Credit Suisse Healthcare Conference on Tuesday, Nov.11, at 8:00 a.m. MT (10:00 a.m. ET).

Fate Therapeutics, Inc. (Nasdaq:FATE)
, a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators to treat orphan diseases, today announced that the Company will host a conference call and live audio webcast on Tuesday, November 11, 2014, at 5:00 p.m. EST to report its third quarter 2014 financial results and to provide a corporate update.

Galena Biopharma, Inc. (Nasdaq:GALE)
, a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major medical needs across the full spectrum of cancer care, today announced that data from the Company's Phase 1/2 trial of GALE-301, or Folate Binding Protein, will be presented at the upcoming Society for the Immunotherapy of Cancer (SITC) 29th Annual Meeting.

Health Insurance Innovations, Inc., (Nasdaq:HIIQ)
, a leading developer and cloud-based administrator of affordable health insurance plans, ancillary products, and research-driven consumer health insurance plan shopping tools, today announced the launch of the HII Velocity Partner Program for small group insurance brokers and employers.

Karyopharm Therapeutics Inc. (Nasdaq:KPTI)
, a clinical-stage pharmaceutical company, today announced the appointment of J. Scott Garland, Senior Vice President and Chief Commercial Officer of Relypsa Inc., to the company's board of directors.

Minerco Resources, Inc. (OTC:MINE)
, parent company of Level 5 Beverage Company, Inc., the makers of VitaminFIZZ® and Coffee Boost™, announced that development is moving forward on Vitamin Creamer®, the world's first nutritionally enhanced and functional coffee creamer.

Myriad Genetics, Inc. (Nasdaq:MYGN)
today announced financial results for its fiscal first quarter 2015, provided an update on recent business highlights, provided fiscal 2Q15 financial guidance and reiterated financial guidance for its fiscal year ending June 30, 2015.

NanoString Technologies, Inc. (Nasdaq:NSTG),
a provider of life science tools for translational research and molecular diagnostic products, today reported financial results for the third quarter ended September 30, 2014.

National Research Corporation (Nasdaq:NRCIA) (Nasdaq:NRCIB)
today announced results for the third quarter of 2014.

Oxford Immunotec Global PLC (Nasdaq:OXFD)
, a global, commercial-stage diagnostics company committed to improving patient care by providing advanced, innovative tests in the field of immunology, today announced third quarter 2014 financial results.

Receptos, Inc. (Nasdaq:RCPT),
a biopharmaceutical company developing therapeutic candidates for the treatment of immune and metabolic diseases, today provided development program updates and announced financial results for the third quarter ended September 30, 2014.

Revance Therapeutics, Inc. (Nasdaq:RVNC)
, a biopharmaceutical company developing botulinum toxin products for use in aesthetic and therapeutic indications, today announced that its management is scheduled to participate in the Credit Suisse 2014 Healthcare Conference in Phoenix, Arizona.

Sientra, Inc. (Nasdaq:SIEN)
, a medical aesthetics company, announced yesterday the closing of its initial public offering of 5,750,000 shares of common stock at a price to the public of $15.00 per share, which includes 750,000 shares purchased pursuant to the exercise in full of the underwriters' option to purchase additional shares.

Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN)
a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, today announced that the Company's management will present a Company overview and host investor meetings at the following investor conferences:

T2 Biosystems (Nasdaq:TTOO)
today reported operating highlights and financial results for the third quarter ended September 30, 2014.

Tauriga Sciences, Inc. (OTCQB:TAUG)
, a diversified life sciences company with interests in the natural wellness sector and in developing a proprietary synthetic biology platform technology, announced that it has signed a non-binding MOU with Japan-based iFlow, Ltd. ("iFlow") to distribute and sell three new Tauriga-branded natural wellness products to the Japan, Taiwan and Hong Kong regions (the "Territory").

Urologix®, Inc. (OTCQB:ULGX)
, the leading provider of in-office procedures for the safe, durable and effective treatment of BPH, today reported financial results for its fiscal year 2015 first quarter ended September 30, 2014.

Vascular Solutions, Inc. (Nasdaq:VASC)
today announced that the Company is scheduled to present at the 2014 Stifel Nicolaus Healthcare Conference in New York City on Tuesday, November 18th at 4:45pm (EST).



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