Harvoni Approved For The Treatment Of Chronic Hepatitis C; TapImmune Provides Update on PolyStart™ Vaccine Platform Print E-mail
By William Kent   
Wednesday, 22 October 2014 19:04
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 22, 2014.
The U.S. FDA announced October 10, 2014 that Gilead Sciences (NASDAQ: GILD) Harvoni® (ledipasvir/sofosbuvir) product was approved for the treatment of chronic hepatitis C, genotype 1 infection in adults. Harvoni® is the first oral combination therapy approved for the treatment of hepatitis C and is also the first treatment regimen that does not require administration with pegylated interferon or ribavirin.

Harvoni® is a once-daily, fixed-dose tablet that combines 90 mg of the NS5A inhibitor ledipasvir with 400 mg of the nucleotide analog polymerase inhibitor sofosbuvir. Sofosbuvir was approved by the FDA under the trade name Sovaldi® in December 2013. The duration of treatment with Harvoni® is eight, 12 or 24 weeks, depending on the patient's prior treatment history, cirrhosis status and baseline viral load. Harvoni's® efficacy has been established in patients with chronic hepatitis C in three Phase 3 studies: ION-1, ION-2 and ION-3.

Hepatitis C is a viral disease that causes inflammation of the liver, which can lead to diminished liver function or liver failure. Some individuals with chronic hepatitis C infection may develop cirrhosis, in which liver tissue is replaced by scar tissue, eventually preventing the liver from functioning properly. According to the Centers for Disease Control and Prevention, approximately 3.2 million Americans are infected with hepatitis C. Unlike other serious or chronic diseases, hepatitis C can be cured with treatment.

Harvoni® was granted priority review and breakthrough therapy designation by the FDA as a medicine with the potential to offer major advances in treatment over available therapies. Harvoni® is a product of Gilead Sciences, based in Foster City, California.



TapImmune, Inc. (OTCBB: TPIV)
, provides an update on the status of its PolyStartTM  vaccine technology platform in light of recent global concerns regarding pandemic infections and emerging viral threats such as Ebola and Enterovirus. While the current focus of the Company’s PolyStart technology is on TapImmune’s cancer program (e.g., Her2/neu and folate receptor alpha antigens), the Company none-the-less strongly reaffirms that this core technology has widespread applicability in the development of vaccines for viral disease. 

The use of the Company’s PolyStart technology increases the production of proprietary antigenic peptides of the vaccine by as much as FOUR-fold, thereby increasing vaccine potency (presenting more antigen), and potentially making manufacturing  and commercialization of large volume vaccines more cost effective. While additional preclinical development is in progress, we fundamentally believe that our technology will have a significant impact in the development of vaccines for both cancer and emerging viral-disease (e.g., Ebola, Enterovirus etc).

Successful proof-of-concept studies conducted in collaboration with Mayo Clinic  clearly demonstrated that human cells containing a PolyStart construct containing vaccinia virus (“smallpox”) antigens (antigenic peptides) could naturally express, process and present these antigens on the cell surface and that cell surface presentation occurred in a manner recognizable by immune system cells (e.g., CD8+ killer T-cells).  Importantly, CD8+ T-cells recognizing a PolyStart-encoded antigenic peptide on the cell surface will destroy that cell.  In addition, T-cells recognizing the antigenic peptide are stimulated to expand in number, thereby providing a strong longer-lived capacity to destroy many more cells infected with the virus.

TapImmune is actively seeking partnerships and collaborations for development of PolyStart for the treatment of emerging viral threats.

Also Wednesday:

Air Methods Corporation (Nasdaq:AIRM)
, the global leader in air medical transportation, provided an update on third quarter results.

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, broke ground on a new 100,000 square foot biomanufacturing facility in the Research Triangle Park area in Durham, North Carolina.

Atara Biotherapeutics, Inc. (Nasdaq:ATRA),
a drug development company with a focus on innovative therapies for patients with debilitating diseases, today announced dosing of the first patient in its Phase 1 clinical study of STM 434, an Activin inhibitor, in patients with ovarian cancer and other solid tumors.
Bacterin International Holdings, Inc. (NYSE MKT:BONE)
, a leader in the development of bone graft material and coatings for medical applications, presented preclinical results of a robust and efficacious antimicrobial coating for orthopedic hardware at the 2014 Orthopaedic Trauma Association (OTA) Annual Meeting.

BioTelemetry, Inc. (Nasdaq:BEAT)
will release its third quarter 2014 earnings on Thursday, October 30, 2014 at 4:00 PM Eastern Time.

DBV Technologies (Nasdaq: DBVT)
, a clinical-stage specialty biopharmaceutical company, will visit the Nasdaq MarketSite in Times Square in celebration of its initial public offering (IPO) which will occur today, October 22.

ERBA Diagnostics, Inc. (NYSE MKT:ERB)
today announced its fully integrated portfolio of in vitro diagnostics platforms and reagents for Hematology and Clinical Chemistry are now available to hospitals, references labs and physician clinics in Brazil.

Evogene Ltd. (NYSE:EVGN) (TASE:EVGN)
, a leading company for the improvement of crop quality, productivity and economics for the food, feed and biofuel industries, announced today that it will release its financial results for the third quarter of 2014 on Monday, November 10, 2014.

Flexion Therapeutics, Inc. (Nasdaq:FLXN)
, a specialty pharmaceutical company focused on the development and commercialization of novel non-opioid pain therapies, will visit the Nasdaq MarketSite in Times Square.

Immunomedics, Inc., (Nasdaq:IMMU)
today announced that Dr. David M. Goldenberg, Chairman, Chief Scientific Officer, and Chief Medical Officer, will present updated results from Phase 2 clinical trials of the Company's two solid-tumor antibody-drug conjugates (ADCs), isactuzumab govitecan (IMMU-132) and labetuzumab govitecan (IMMU-130), at two upcoming conferences.

Innocoll AG (Nasdaq:INNL)
, a global, commercial-stage, specialty pharmaceutical company that develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, today posted to shareholders a proposal to elect Joseph Wiley, M.D., a principal at Sofinnova Ventures, to its Supervisory Board.

IPC The Hospitalist Company, Inc. (Nasdaq:IPCM),
a leading national hospitalist physician group practice, today announced financial results for the third quarter ended September 30, 2014.

Harris & Harris Group, Inc. (Nasdaq:TINY)
, an investor in transformative companies enabled by disruptive science, continues its track record of early stage investments in emerging new technologies through a capital commitment and formation of TARA Biosystems (www.tarabiosystems.com).

LDR Holding Corporation (Nasdaq:LDRH),
a global medical device company focused on designing and commercializing novel and proprietary surgical technologies for the treatment of patients suffering from spine disorders, announced today that it will report financial results for the third quarter ended September 30, 2014 after the market close on Wednesday, November 5, 2014.

Merge Healthcare Incorporated (Nasdaq:MRGE)
, a leading provider of innovative enterprise imaging, interoperability and clinical systems that seek to advance healthcare, announced today the scheduling of its third quarter 2014 earnings call, which will be held at 8:30 AM ET on Wednesday, October 29, 2014.

Nanosphere, Inc. (Nasdaq:NSPH)
, a leader in the development and commercialization of advanced molecular diagnostics systems, today announced the pricing of its previously announced underwritten public offering of 40,000,000 shares of its common stock at a public offering price of $0.50 per share.

Natural Health Trends Corp. (OTCQB:NHTC)
, a leading direct selling company that markets premium quality personal care, wellness and "quality of life" products under the NHT Global brand, today announced that management will conduct a conference call to discuss its financial results for the quarter ended September 30, 2014.

Natus Medical Incorporated (Nasdaq:BABY)
today announced financial results for the three months ended September 30, 2014.

OXiGENE, Inc. (Nasdaq:OXGN)
, a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, will hold a conference call and webcast on Wednesday, November 12, 2014 at 4:30 p.m. ET (1:30 p.m. PT).

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, today announced that Adi Frish, RedHill's Senior VP Business Development and Licensing, will be presenting at the 20th Annual BIO-Europe International Partnering Conference, on Tuesday, November 4, 2014, at 10:00 a.m., in the Transparenz room of the Portalhaus Messe Frankfurt, in Frankfurt, Germany.

Relypsa, Inc. (Nasdaq:RLYP)
, today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market Patiromer for Oral Suspension (Patiromer FOS) for the treatment of hyperkalemia, a serious condition defined as abnormally elevated levels of potassium in the blood.

Tandem Diabetes Care®, Inc. (Nasdaq:TNDM)
, a medical device company and manufacturer of the t:slim® Insulin Pump, plans to release its third quarter 2014 results after the financial markets close on Thursday, November 6, 2014.

TearLab Corporation (Nasdaq:TEAR) (TSX:TLB)
expects to announce its Q3 2014 financial results after market closes on Wednesday November 5, 2014.

TESARO, Inc. (Nasdaq:TSRO)
will announce its third-quarter 2014 financial results on Wednesday, November 5, 2014, after the close of the U.S. financial markets. TESARO's senior management team will host a conference call and live audio webcast at 4:15 p.m. ET on November 5, 2014 to discuss the Company's results in greater detail.

Tornier N.V. (Nasdaq:TRNX)
, a global medical device company focused on providing surgical solutions to orthopaedic extremity specialists, announced today that it will report financial results for the third quarter ended September 28, 2014 after the close of the regular trading market on Thursday, November 6, 2014.

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