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About mkulwiec

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So far mkulwiec has created 17 blog entries.

Tarsa Therapeutics’ NDA for TBRIA(TM), the First Oral Calcitonin for the Treatment of Postmenopausal Osteoporosis, Accepted for Filing

Need for Safe and Effective New Therapies Highlighted by Limited Existing Treatment Options and Large Population of Underserved Osteoporosis Patients
PHILADELPHIA, PA – October 19, 2015 — TARSA Therapeutics, Inc. today announced that its New Drug Application (NDA) for TBRIATM (calcitonin-salmon delayed release tablets) submitted to the U.S. Food and Drug Administration (FDA) in […]

Tarsa Therapeutics Secures $10 Million and Adds Industry Veteran Daniel Soland as a Director

PHILADELPHIA, PA – August 13, 2014 — Tarsa Therapeutics, Inc. today announced that it has secured a $10 million senior credit facility from Oxford Finance LLC and Square 1 Bank. The company intends to use the proceeds to support its plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration […]

Tarsa Therapeutics Raises $7 Million to Prepare for Filing NDA for Ostora, Its Oral Calcitonin for the Treatment of Postmenopausal Osteoporosis

Recently Revised Label for Marketed Calcitonin Products Has Helped Clarify the Regulatory Landscape in the U.S.
Industry Veteran Nicholas LaBella Joins Tarsa as Vice President, Global Regulatory Affairs and Will Oversee the NDA Submission Process
PHILADELPHIA, PA – May 29, 2014 — Tarsa Therapeutics, Inc. today announced that it raised $7 million to prepare for filing a New Drug […]

Tarsa Therapeutics Presents Meta-analysis at ASBMR 2013 Showing Calcitonin Does Not Appear to be Associated with Increased Risk of Cancer

Study is First to Analyze All Relevant Clinical Trials of Oral and Intranasal Calcitonin in Women
Results are Consistent with Calcitonin’s 30-Year Safety Record and the Lack of Biological Plausibility
BALTIMORE, MD and PHILADELPHIA, PA – October 7, 2013 — Tarsa Therapeutics, Inc. today announced that it presented a new meta-analysis showing that salmon calcitonin does not appear to be […]

Tarsa Therapeutics Reports Positive Results from Phase II Trial of Its Oral Calcitonin in Prevention of Post-Menopausal Osteoporosis

Oral Presentation at ASBMR 2012 Annual Meeting Shows Tarsa’s Oral Calcitonin Tablet Achieved Efficacy Endpoint with Good Safety Profile
Poster Presentation at ASBMR 2012 Concludes One-Year Use of Tarsa’s Oral Calcitonin Is Not Associated with Increased Risk of Cancers
MINNEAPOLIS, MN and PHILADELPHIA, PA – October 16, 2012 — Tarsa Therapeutics, Inc. today announced that a Phase II […]

Tarsa Therapeutics to Assist Therapicon in Its Challenge to CHMP’s Recommendation to Limit Use of Calcitonin

Request of Italian Marketer of Nasal Calcitonin Spray for Reexamination of Recent CHMP Recommendation Has Been Accepted
Study Slated for Presentation at ASBMR 2012 Assesses Whether Tarsa’s Oral Calcitonin Was Associated with Increased Cancer Risk in Two Year-Long Postmenopausal Osteoporosis Trials
Second ASBMR Presentation Discusses Results of Phase II Trial of Tarsa’s Oral Calcitonin in the Prevention […]

Tarsa Therapeutics Completes $28 Million Series B Financing to Advance Ostora™ Oral Calcitonin

PHILADELPHIA, PA – March 16, 2012 — Tarsa Therapeutics, Inc. today announced completion of a $28 million Series B equity financing led by new investor Foresite Capital.  James Tananbaum, MD, Foresite’s founder and CEO, is joining Tarsa’s Board of Directors.  Tarsa’s existing venture capital investors—Novo A/S, MVM Life Science Partners and Quaker Partners—all participated in the […]

Tarsa Therapeutics Signs Commercial Supply Agreement for Its Ostora™ Oral Calcitonin Product with QS Pharma

PHILADELPHIA, PA – March 21, 2012 —Tarsa Therapeutics today announced it has entered into a commercial supply agreement with QS Pharma for the bulk manufacture of its OSTORA™ oral recombinant salmon calcitonin tablet.  The OSTORA tablets, which will be manufactured in QS Pharma’s state-of-the-art facility in Pennsylvania, will be used for product launch and commercial sale.

This […]

Tarsa Therapeutics Targets 2012 NDA Submission for Its Ostora™ Oral Calcitonin

PHILADELPHIA, PA – December 13, 2011 —Tarsa Therapeutics today confirmed that it is planning to submit a New Drug Application (NDA) to the Food and Drug Administration (FDA) in the second half of 2012 for OSTORA™, the company’s oral recombinant salmon calcitonin tablet for the treatment of postmenopausal osteoporosis.  This follows a formal pre-NDA dialogue with […]

Tarsa Therapeutics Presents Positive Efficacy and Safety Data Comparing Its Oral Calcitonin to Nasal Calcitonin and Placebo in Phase III Osteoporosis Treatment Trial

Data Presented at ASBMR 2011 Annual Meeting Show Tarsa’s Oral Calcitonin Tablet OSTORA™ Achieved Positive Results on Efficacy Endpoints
SAN DIEGO, CA and PHILADELPHIA, PA – September 18, 2011 —Tarsa Therapeutics today presented positive safety and efficacy data from its Phase III ORACAL trial of OSTORA™, the company’s oral recombinant salmon calcitonin tablet in development for the […]