Merck Issues Statement Related to Role of PNEUMOVAX 23; Exactech Announces First Implantation of New Alteon™ Print E-mail
By Staff and Wire Reports   
Wednesday, 13 August 2014 19:31
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 13, 2014.
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today provided the following statement regarding the U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices’ (ACIP’s) updated pneumococcal vaccine recommendations for adults 65 years of age and older. These recommendations call for a two vaccine regimen utilizing a dose of the pneumococcal conjugate vaccine followed by a dose of Merck’s PNEUMOVAX® 23, at an interval to be determined by the ACIP, in adults 65 years of age and older who have not previously received pneumococcal vaccine. ACIP also voted that these recommendations for routine use of the pneumococcal conjugate vaccine in adults 65 years of age and older should be reevaluated in 2018 and revised as needed. ACIP will continue to monitor disease trends and the impact of these new recommendations.

“We are pleased PNEUMOVAX 23 will continue to play an integral role in helping to prevent pneumococcal disease in adults who are at increased risk,” said Mark Feinberg, MD, PhD, FACP, Chief Public Health and Science Officer for Merck Vaccines. “Pneumococcal disease is still a significant burden and millions of adults remain at risk because of low vaccination rates. It is also important for health care providers to fully implement the long-standing ACIP recommendation for use of only PNEUMOVAX 23 in adults 19 to 64 years of age with certain chronic conditions, such as diabetes and chronic heart disease, who are also at increased risk of pneumococcal disease.”



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Exactech, Inc. (Nasdaq: EXAC)
, a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, is proud to announce the first implantation of the Alteon™ Tapered Wedge Femoral Stem. The surgery took place at Franciscan St. Francis Health in Carmel, Ind., and was performed by orthopaedic surgeon Jeffery Pierson, MD, a member of the design team for this new hip replacement implant.

“It has been an incredibly gratifying experience to be directly involved in the design and development of a device that performed as well in surgery as I anticipated it would,“ said Pierson. “Clinically relevant improvements to devices, such as the ones we made with the new Tapered Wedge Stem, allow us to continue to provide the best standard of care to our patients.”

Over the past two years, Dr. Pierson and Michael Kang, MD, from the Insall-Scott-Kelly Institute in New York, N.Y., consulted with Exactech to bring to market a newly designed stem that addresses several clinical challenges that many surgeons face with current product design philosophies.

The Tapered Wedge Stem, which is currently in the pilot launch phase of release, incorporates specific features designed to achieve axial and rotational mechanical stability between the lateral and medial cortices of the femoral canal. This product will be expanding to a limited number of additional sites within the coming months, and company officials report a full launch within the U.S. is expected to take place in January of 2015.

“We are pleased to provide this technology to patients who can benefit from the Alteon Tapered Wedge Stem,” said Exactech CEO David Petty. “This design philosophy represents about 40 percent of the market for cementless stems in the U.S. This new products gives us an opportunity to reach many more patients needing total hip replacement.”




Also Wednesday:




Agios Pharmaceuticals, Inc. (Nasdaq:AGIO)
, a leader in the fields of cancer metabolism and rare genetic disorders of metabolism, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AG-221 for the treatment of patients with acute myelogenous leukemia (AML) that harbor an isocitrate dehydrogenase-2 (IDH2) mutation.

Anavex Life Sciences Corp. (OTCQB:AVXL)
, a clinical-stage biopharmaceutical company developing novel drug candidates to treat Alzheimer's disease, other diseases of the central nervous system (CNS) and various types of cancer, today reported financial results for the three and nine months ended June 30, 2014.

Argos Therapeutics, Inc. (Nasdaq:ARGS)
, a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis™ technology platform, today reported financial results for the second quarter ended June 30, 2014, and provided an update on the Company's clinical programs.

Bacterin International Holdings, Inc. (NYSE MKT:BONE)
, a leader in the development of revolutionary bone graft material and coatings for medical applications, is pleased to announce the addition of David Goodman, MD, MSE to the board of directors.

BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX)
today announced that the National Institute of Allergy and Infectious Diseases (NIAID) has exercised additional options to conduct Phase 1 clinical human safety trials of an intramuscular formulation of BCX4430, as well as efficacy studies in non-human primates to assess effective dose ranges and dose schedules.

BioTelemetry, Inc. (Nasdaq:BEAT)
, the leading wireless medical technology company focused on the delivery of health information to improve quality of life and reduce cost of care, will visit the NASDAQ MarketSite in Times Square.

Capricor Therapeutics, Inc. (OTCBB:CAPR)
, a biotechnology company focused on developing novel therapeutics to prevent and treat diseases, with a primary focus on heart disease, today provided a business and financial update for the second quarter ended June 30, 2014.

MedAssets, Inc., (Nasdaq:MDAS)
today announced it signed a definitive agreement to acquire privately held SG-2, LLC (Sg2) for approximately $142 million.

MELA Sciences, Inc. (Nasdaq:MELA)
, developer of the MelaFind® system, a non-invasive optical diagnostic tool that assists dermatologists in the diagnosis of melanoma at its most curable and cost-effective stage and that has received both FDA Pre-Market Approval (PMA) for the U.S. and CE Marking certification for the European Union, today announced financial results for the three and six months ended June 30, 2014.

Nuvilex, Inc. (OTCQB:NVLX)
, a clinical-stage, international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that it is providing shareholders with an update on the status of Nuvilex's preclinical studies to be conducted by Translational Drug Development (TD2) in Scottsdale, Arizona.

Ohr Pharmaceutical, Inc. (Nasdaq:OHRP)
, an ophthalmology research and development company, today announced additional interim data from the Phase II study evaluating Squalamine Eye Drops (OHR-102) for the treatment of the wet form of age-related macular degeneration ("wet-AMD").

Onconova Therapeutics, Inc. (Nasdaq:ONTX)
, a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today provided a corporate update and reported financial results for the second quarter ended June 30, 2014.

Otonomy, Inc. (Nasdaq:OTIC)
, a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, today announced the pricing of its initial public offering of 6,250,000 shares of its common stock at a price to the public of $16.00 per share.

Phibro Animal Health Corporation (Nasdaq:PAHC)
Chairman, President and Chief Executive Officer Jack Bendheim and Chief Financial Officer Richard Johnson will address financial analysts and investors at the Morgan Stanley 2014 Global Healthcare Unplugged Conference.

PositiveID Corporation (OTCQB:PSID)
, a developer of biological detection and diagnostics solutions, announced today that it will exhibit at the 2014 Military Health System Research Symposium (MHSRS) Conference on August 18-21, 2014, at the Marriott Harbour Beach Resort in Fort Lauderdale, FL.

RedChip Companies, Inc., today announced it has issued a research update on SANUWAVE Health, Inc. (OTCQB:SNWV), a shock wave technology company focused on the development and commercialization of patented non-invasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures.

RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL)
, an Israeli biopharmaceutical company focused on late clinical-stage drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, and RESprotect GmbH ("RESprotect"), a privately-held biotech company located in Dresden, Germany, today announced that they have entered into a binding exclusive option agreement for the acquisition of the oncology drug candidate RP101 and next generation compounds.

Sharps Compliance Corp. (Nasdaq:SMED)
, a leading full-service provider of solutions for the cost-effective management of medical waste, used healthcare materials and unused dispensed medications, today reported financial results for the fourth quarter and fiscal year 2014, ended June 30, 2014.

Spine Pain Management, Inc. (OTCQB:SPIN)
, a technology-driven, financial service, medical device and healthcare solution company servicing the multi-billion dollar spine injury sector, is proud to announce the addition of Michael K. Smith as VP and Director of Sales & Marketing for the Quad Video Halo subsidiary.

Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM)
, a leading developer of RNA interference (RNAi) therapeutics, today announced its financial and operating results for the second quarter ended June 30, 2014 and provided a corporate update.

Tengion, Inc. (OTCQB:TNGN)
, a leader in regenerative medicine, today reported key clinical data along with financial and operating results for the quarter ended June 30, 2014.

Urologix®, Inc. (OTCQB:ULGX)
will host a conference call to present fourth quarter and fiscal year 2014 results on Tuesday, August 19, 2014 at 4:00 p.m. CT, following the Company's post-market press release on the same day.

Zafgen, Inc. (Nasdaq:ZFGN)
, a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity, today announced its second quarter 2014 financial results.



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