TPI Expects To Receive GMP By End Of 2014; InVivo Reports FDA Approval to Expedite Enrollment for Pilot Trial Print
By Marilyn Mullen   
Tuesday, 16 December 2014 19:49

Below is a look at some of the headlines for companies that made news in the healthcare sector on December 16, 2014.
Tianyin Pharmaceutical Co., Inc. (NYSE MKT: TPI), a pharmaceutical company that specializes in patented biopharmaceutical, modernized traditional Chinese medicine (mTCM), branded generics and active pharmaceutical ingredients (API) updates it expects to receive the formal Good Manufacturing Practice (GMP) certificate for its Qionglai Facility's (QLF) from the China Food & Drug Administration's (CFDA) by the end of December 2014.

Prior to the official issuance of the GMP certificate, there is a public notice period which is likely to take place within this week. The public notice period is an important step of GMP certificate during which the pharmaceutical manufacturing facility's GMP application will be disclosed on the CFDA website. The public notice time will last for approximately 10 business days which is to be followed by immediate issuance of the GMP certificate.

TPI is currently preparing for the smooth transition of production capacity from the current Longquan facilities to the new QLF immediately following the official issuance of GMP certificate.


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InVivo Therapeutics Holdings Corp. (OTC: NVIV)
announced approval by the U.S. FDA for an expedited enrollment plan for the company’s ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury. Under the new plan, barring significant safety issues, InVivo will submit two months of safety data to the FDA for the first subject enrolled in October, and will then open enrollment for the second subject in mid-January (about three months after the first subject was enrolled). Upon enrollment of the second subject, InVivo will submit to the FDA one month of safety data for that subject together with the previous subject’s data; concurrent enrollment for the remaining three subjects will then begin (about two months after the second subject is enrolled). There will be no additional mandatory holds between enrollment of the final three subjects. This differs from the previous plan, which required a mandatory three-month hold between sequential enrollment of each of the five subjects.

Mark Perrin, InVivo’s CEO, said, “Over the last calendar year, we have cultivated a collaborative and fruitful relationship with the FDA, and we couldn’t be happier with today’s announcement. Under our new plan, it’s possible to reduce the duration of our pilot trial by up to one year. This, of course, is dependent on patient presentation, but with today’s approval, along with our previously-announced approval of increasing the number of clinical sites up to 20, we are much better positioned to execute and complete this trial in an expedited fashion. Although we cannot predict when subjects will present, we now anticipate full enrollment in the pilot trial in 2015.”

This is the company’s first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The IDE pilot study has been approved by the FDA and is intended to capture preliminary safety and effectiveness data of the Neuro-Spinal Scaffold in five subjects with acute thoracic spinal cord injury. InVivo then expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption (HDE).


 
Also Tuesday:



ActiveCare Inc. (OTCBB:ACAR)
, a leader in diabetes management products and services for self-insured employers nationwide, today announced an expanded relationship with The American Health Data Institute (AHDI).

Accuray Incorporated (Nasdaq:ARAY)
, announced today that its management is scheduled to present at the JP Morgan 33rd Annual Healthcare Conference in San Francisco on Monday, January 12, 2015 at 4:00 p.m. PST/7:00 p.m. EST.

Aldeyra Therapeutics, Inc. (Nasdaq:ALDX),
a biotechnology company focused on the development of products to treat diseases related to free aldehydes, today announced that novel anti-inflammatory data on its lead product candidate, NS2, has been accepted for a late-breaking poster presentation at the upcoming 2015 American Academy of Allergy Asthma & Immunology Annual Meeting, being held February 20-24, 2015 in Houston, Texas.

Alder BioPharmaceuticals, Inc. (Nasdaq:ALDR)
, a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics for the treatment of migraine, autoimmune and inflammatory diseases, announced today that it has been selected for addition to the NASDAQ Biotechnology Index (Nasdaq:^NBI).

Amedisys, Inc. (Nasdaq:AMED)
, a leading home health and

hospice company, today announced that its Board of Directors has named Paul B. Kusserow as President and

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Chief Executive Officer and
member of the Board of Directors. Kusserow will assume the role on December 16, 2014 from President and Interim CEO, Ronald LaBorde, who will remain a member of the senior management team in the role of Vice Chairman reporting directly to the CEO.

Anavex Life Sciences Corp. (OTCQX:AVXL)
today announced enrollment of the first patient in a multicenter Phase 2a clinical trial for ANAVEX 2-73, which is being evaluated for the treatment of Alzheimer's disease.

Auspex Pharmaceuticals, Inc. (Nasdaq:ASPX)
, a biopharmaceutical company dedicated to developing innovative medicines for people with movement disorders and other rare diseases, today announced positive topline efficacy and safety results from its Phase 3 registration trial evaluating SD-809 for the treatment of chorea associated with Huntington's disease (HD), called First-HD.

BioMark Diagnostics Inc. (CSE: BUX, FSE:20B)
is excited to announce that it will be presenting at the inaugural equities.com Small-Cap Stars Conference at the world-famous NASDAQ MarketSite on December 18, 2014.

Cancer Genetics, Inc. (Nasdaq:CGIX)
, an emerging leader in DNA-based cancer diagnostics, announced today the addition of Venkatadri Bobba to Cancer Genetics India's Board of Directors.

Capstone Therapeutics (OTCQB:CAPS)
and its joint venture affiliate, LipimetiX Development, LLC ("JV"), announced today the completion of and results for its investigational AEM-28 (Apo E mimetic peptide) Phase 1b/2a human clinical trial in cholesterol and lipid reduction.

Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX),
a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today announced with great sadness the loss of Co-Founder and director, Hubert E. Huckel, M.D. Dr. Huckel, a founding shareholder and director of Catalyst since its formation in January 2002, passed away on December 13, 2014.

Celladon Corporation (Nasdaq:CLDN)
, a clinical-stage biotechnology company with industry-leading expertise in the development of cardiovascular gene therapy, today announced that it has been added to the NASDAQ Biotechnology Index, through the annual update that will become effective prior to market open on Monday, December 22, 2014.

CombiMatrix Corporation (Nasdaq:CBMX),
a molecular diagnostics company specializing in DNA-based testing services for pre- and postnatal developmental disorders, today announced the launch of its Targeted Array for Prenatal Analysis.

Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP)
, a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders today announced enrollment of 486 patients, continuation to final analysis and recommendations of the independent Data and Safety Monitoring Board (DSMB) of the Company's Phase 3 SEAMLESS study of oral sapacitabine capsules in acute myeloid leukemia (AML).

FutureWorld Corp. (OTCQB; FWDG)
, a leading provider of advanced technologies and solutions to the global cannabis industry, announced that CB Scientific, a subsidiary of FutureWorld Corp., has received the "Product of the Year" from the Cannabis Business Awards.

Harvard Bioscience, Inc. (Nasdaq:HBIO)
, a global developer, manufacturer, and marketer of a broad range of equipment, instruments and solutions to advance life science, will present at the inaugural equities.com Small-Cap Stars Conference at the NASDAQ MarketSite in New York City on December 18, 2014.

Hemispherx Biopharma, Inc. (NYSE MKT:HEB)
, announced today further progress on developing Ampligen® (rintatolimod) as a potential therapeutic complement to a new molecular class of anti-tumor drugs termed immune checkpoint inhibitors or PD-1 inhibitors (also called Programmed Death inhibitors).

Hemp, Inc. (OTC:HEMP)
announced today that it is one of the major sponsors of the 1st Annual "Cultural Creatives" Ascent Expo in Los Angeles, CA, February 27 – March 1, 2015 which will be held at the Los Angeles Convention Center.

Kite Pharma, Inc., (Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT™) products for the treatment of cancer, announced today that it has been selected for addition to the NASDAQ Biotechnology Index® (Nasdaq:^NBI), which will become effective upon market open on Monday, December 22, 2014.

Landec Corporation (Nasdaq:LNDC)
will hold a conference call on Wednesday, January 7, 2015 at 8 a.m. Pacific time to discuss its results for the second quarter fiscal year 2015.

MergeWorthRx Corp. (Nasdaq:MWRX)
, a special purpose acquisition company focused on the U.S. healthcare services market, announced today that its sponsors are offering to transfer up to 800,000 shares of MWRX common stock to certain investors (the "Investors") in exchange for either the purchase or retention by the Investors of up to 4,000,000 shares of MWRX common stock.

Nuvilex, Inc. (OTCQB:NVLX)
, a clinical-stage biotechnology company providing cell solutions for the treatment of diseases, today announced a shareholder update on the Company's cancer and diabetes programs utilizing its Cell-in-a-Box® cellulose-based live cell encapsulation technology.

Relypsa, Inc. (Nasdaq:RLYP)
, today announced that Stephen D. Harrison, M.A., Ph.D., has joined the company as senior vice president and chief scientific officer.

Stemline Therapeutics, Inc. (Nasdaq:STML)
announced today the initiation of a clinical trial with SL-401 in four rare myeloproliferative neoplasms (MPN).

Trinity Biotech plc. (Nasdaq:TRIB)
, a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, today announced that a CLIA waiver has been received for Syphilis Health Check – a point-of-care rapid test for the detection of Syphilis.

Zafgen, Inc. (Nasdaq:ZFGN)
, a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, today announced that the Company was recently selected for addition to the NASDAQ Biotechnology Index (Nasdaq:NBI), effective upon market open on December 22, 2014.




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