Medidata Appoints Mike Capone COO; PV-10 Data at Esmo 2014 Show Print E-mail
By William Kent   
Monday, 29 September 2014 19:22
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 29, 2014.
Medidata (NASDAQ:MDSO)
, the leading global provider of cloud-based solutions for clinical research in life sciences, announced Michael L. Capone is joining the company as chief operating officer (COO). In the newly created COO role, he will report directly to Medidata's CEO Tarek Sherif and president Glen de Vries. Capone joins Medidata from ADP, one of the world's largest business-to-business software providers, where he served as corporate vice president of product development and chief information officer.

Capone will play a central role in Medidata's product development, professional services, go-to-market and day-to-day operations—continuing and accelerating Medidata's strategy to provide a comprehensive cloud platform that lowers the cost and risk of clinical trials and speeds new treatments to market.

"This is an exciting time for Medidata, with increasing acknowledgement of the Medidata Clinical Cloud™ as the life sciences' strongest cloud platform," said Sherif. "Mike's leadership in large-scale SaaS software development and his deep operational experience make him the right person to help us seize this moment and scale Medidata to capture the enormous opportunity ahead of us."

"Tarek and I are looking forward to working together with Mike as we continue to grow the business and help our customers bring life-saving and life-enhancing treatments to patients," added de Vries.

As corporate VP and CIO of ADP, a leading provider of human capital management services, Capone led product development and information technology. Under his technology leadership, ADP earned accolades for its innovations, and now serves more than 430,000 clients and 35 million users on its SaaS platforms. Capone is a 25-year veteran of ADP and has held positions in product development, information technology and operations. He earned a BS in computer science from Dickinson College and an MBA in finance from Pace University, and he serves on the board of several non-profit organizations, including the Leukemia and Lymphoma Society.

"Joining Medidata channels my personal passion for medical research into an innovative tech company early in its growth curve," said Capone. "All of the right ingredients are here: a solid business model, leading vertical SaaS platform and loyal customers. I'm eager to jump in and join the team in taking Medidata to the next level.


 
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Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT)
announced that data on its investigational agent PV-10 for intralesional (IL) treatment of locally advanced cutaneous melanoma was featured in a poster presentation on Sunday, September 28, 2014 during the European Society For Medical Oncology (ESM0) 2014 Congress in Madrid, Spain. The presentation showed that PV-10 elicits a high rate of response in injected tumors through its ablative effect, and additionally, that the durability of response as well as the bystander response in uninjected tumors implicate an additional immunologic mechanism secondary to ablation.  Link to full release:  http://www.pvct.com/pressrelease.html?article=20140929

The poster, presented by Sanjiv S. Agarwala, MD, of St. Luke's University Hospital and Professor of Medicine at Temple University, based upon abstract #1120P, was entitled, "Subgroup Efficacy in Patients Receiving Intralesional Rose Bengal to All Existing Melanoma in Phase II Study PV-10-MM-02." It can be accessed via the following link:  http://www.pvct.com/publications/Provectus-ESMO-2014-09-28.pdf

Commenting on the poster, Dr. Agarwala said, "Although the primary ablative effect of PV-10 can lead to rapid regression of injected lesions, durability of response may signal the effects of an immunologic process secondary to ablation. In addition to offering the potential to relieve symptoms of cutaneous melanoma, a robust, tumor-specific immunologic response could have the potential of changing the course of the disease."

Eric Wachter, PhD and Chief Technology Officer of Provectus, said, "We are very pleased to share the patient-level PFS data at ESMO that defined our design parameters for the upcoming phase 3 trial. These study results demonstrate the potential of an intralesional approach to delay progression while alleviating symptoms of locally advanced melanoma."


 
Also Monday:

 
Affinor Growers(CSE:AFI) (FRANKFURT:1AF)(OTCQB:RSSFF)
is pleased to announce that, further to its press release dated September 11, 2014, it expects to complete its previously announced acquisition of all the issued and outstanding securities of 0993341 BC Ltd. ("RoofTop"), pursuant to the definitive agreement dated September 11, 2014, in exchange for a cash payment of $500,000 and the issuance of 1,636,363 common share of the Corporation, as soon as the City of Vancouver executes the lease assignment.

Athersys, Inc. (Nasdaq:ATHX)
announced today that Gil Van Bokkelen, Chairman and CEO will present at the 4th Annual Partnering Forum, part of the Stem Cell Meeting on the Mesa to be held October 7-9 in La Jolla, CA.

AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG)
today announced that it has entered into a definitive agreement to acquire Lumara Health Inc., a privately-held pharmaceutical company specializing in women's health, for $675 million ($600 million in cash and $75 million in stock) and additional contingent consideration of up to $350 million based on achievement of certain sales milestones.

Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS)
, a biotechnology company focused on the development of diagnostics and therapeutics for Alzheimer's disease, Parkinson's disease and orphan ophthalmological disorders, today announced it has submitted a request to the FDA for a review and written feedback of the Phase IIb clinical trial design for Eltoprazine in levodopa-induced dyskinesia (LID), a common side effect of levodopa treatment in Parkinson's disease (PD) patients.

Applied Genetic Technologies Corporation (Nasdaq:AGTC)
, a clinical stage biotechnology company developing adeno-associated virus (AAV)-based gene therapies for the treatment of rare eye diseases, today announced that company management will present at two upcoming conferences.

athenahealth, Inc. (Nasdaq:ATHN)
, a leading provider of cloud-based services and mobile tools for medical groups and health systems, today announced that it will hold a conference call for investors on Friday, October 17, 2014, at 8:00 a.m. ET.

Cerulean Pharma Inc. (Nasdaq:CERU)
, a leader in Dynamic Tumor Targeting™, today announced the appointment of Alejandra Carvajal as Vice President, General Counsel.

Cesca Therapeutics Inc. (Nasdaq:KOOL)
, an autologous cell-based regenerative medicine company, today reported financial results for the fourth quarter and year-ended fiscal 2014.

Endologix, Inc. (Nasdaq:ELGX)
, developer and marketer of innovative treatments for aortic disorders, announced today that it will conduct the first ever prospective randomized clinical study to compare outcomes in endovascular repair of abdominal aortic aneurysms (EVAR).

Endologix, Inc. (Nasdaq:ELGX)
, developer and marketer of innovative treatments for aortic disorders, announced today that it has completed patient enrollment in the EVAS FORWARD – Global Registry.

The Ensign Group, Inc. (Nasdaq:ENSG)
, the parent company of the Ensign™ group of skilled nursing, rehabilitative care services, home health care, hospice care, assisted living and urgent care companies, announced today that it acquired Sherwood Village Assisted Living and Memory Care, a 135-unit assisted living facility in Tucson, Arizona. The acquisition was effective Wednesday, September 24, 2014.

Hemispherx Biopharma, Inc. (NYSE MKT:HEB),
announced today a widened set of research collaborations designed to develop therapeutic cocktails against Ebola which may potentially overcome the emergence of drug resistance due to Ebola virus mutation.

MannKind Corporation (Nasdaq:MNKD)
today announced that it had received a $150 million upfront payment in connection with an exclusive worldwide collaboration and licensing agreement with Sanofi for development and commercialization of Afrezza® (insulin human) Inhalation Powder, a new rapid-acting inhaled insulin therapy for adults with type 1 and type 2 diabetes.

MediciNova, Inc., (Nasdaq:MNOV)
, a biopharmaceutical company traded on the NASDAQ Global Market  and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that principal investigator Benjamin Rix Brooks, MD, Director, Carolinas Neuromuscular/ALS-MDA Center at Carolinas HealthCare System Neurosciences Institute in Charlotte, NC, will present an overview of MediciNova's clinical trial of MN-166 (ibudilast) in amyotrophic lateral sclerosis (ALS) at The 13th Annual NEALS Meeting to be held October 22 - 24, 2014 in Clearwater Beach, Florida.

NeoStem, Inc. (Nasdaq:NBS)
, a leader in the emerging cellular therapy industry, announced today that it has entered into a Loan and Security Agreement (the "Loan Agreement") with Oxford Finance LLC ("Oxford") pursuant to which Oxford has agreed to make a term loan to the Company in the principal amount of up to $20 million, and has made the initial disbursement of $15 million.

Ocera Therapeutics, Inc. (Nasdaq:OCRX)
, a clinical stage biopharmaceutical company focused on acute and chronic orphan liver diseases, today announced that company management will be presenting at the 13th Annual BIO Investor Forum being held at the Palace Hotel in San Francisco, California.

OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED)
, a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, presented promising data on safety and anti-tumor activity from the ALPINE and PINNACLE Phase 1b clinical studies of tarextumab (anti-Notch2/3, OMP-59R5) at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid, Spain.

Pazoo, Inc. (OTCQB: PZOO) (German WKN#: A1J3DK)
is pleased to report it participated in, and donated to, the annual Care Plus Foundation, Inc. Golf Outing.

Sabra Health Care REIT, Inc. (Nasdaq:SBRA)
announced today that it plans to offer 6,000,000 shares of its common stock in an underwritten public offering.

Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP)
and its development and commercialization partner, Takeda Pharmaceuticals (Takeda), today announced the launch of a pilot direct-to-consumer advertising campaign in select U.S. markets for AMITIZA® (lubiprostone) for adults with chronic idiopathic constipation (CIC).

TESARO, Inc. (Nasdaq:TSRO)
announced today the closing of its previously announced underwritten public offering of $201.25 million aggregate principal amount of its 3.00% convertible senior notes due 2021 (the "notes"), including the notes issued pursuant to the full exercise of the underwriters' option to purchase up to $26.25 million aggregate principal amount of additional notes on the same terms and conditions.

VeriTeQ Corporation (OTC Markets:VTEQ)
, a provider of implantable medical device identification and radiation dose measurement technologies, announced today that it has received an order for 100 units of its new Q Inside readers for breast implants.

Vitae Pharmaceuticals, Inc. (Nasdaq:VTAE)
, a clinical stage biotechnology company, today announced the closing of its initial public offering of 6,875,000 shares of common stock at an initial public offering price of $8.00 per share.



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