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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 [rDNA origin] delayed release tablets) submitted to the U.S. Food and Drug Administration (FDA) [...]

Tarsa Therapeutics’ NDA for TBRIA(TM), the First Oral Calcitonin for the Treatment of Postmenopausal Osteoporosis, Accepted for Filing2018-09-10T00:00:49+00:00

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 Secures $10 Million and Adds Industry Veteran Daniel Soland as a Director2018-09-10T00:00:49+00:00

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 [...]

Tarsa Therapeutics Raises $7 Million to Prepare for Filing NDA for Ostora, Its Oral Calcitonin for the Treatment of Postmenopausal Osteoporosis2018-09-10T00:00:49+00:00

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 [...]

Tarsa Therapeutics Presents Meta-analysis at ASBMR 2013 Showing Calcitonin Does Not Appear to be Associated with Increased Risk of Cancer2018-09-10T00:00:49+00:00

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 [...]

Tarsa Therapeutics Reports Positive Results from Phase II Trial of Its Oral Calcitonin in Prevention of Post-Menopausal Osteoporosis2018-09-10T00:00:49+00:00

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 [...]

Tarsa Therapeutics to Assist Therapicon in Its Challenge to CHMP’s Recommendation to Limit Use of Calcitonin2018-09-10T00:00:49+00:00

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 Completes $28 Million Series B Financing to Advance Ostora™ Oral Calcitonin2018-09-10T00:00:49+00:00

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. [...]

Tarsa Therapeutics Signs Commercial Supply Agreement for Its Ostora™ Oral Calcitonin Product with QS Pharma2018-09-10T00:00:49+00:00

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 Targets 2012 NDA Submission for Its Ostora™ Oral Calcitonin2018-09-10T00:00:49+00:00

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 [...]

Tarsa Therapeutics Presents Positive Efficacy and Safety Data Comparing Its Oral Calcitonin to Nasal Calcitonin and Placebo in Phase III Osteoporosis Treatment Trial2018-09-10T00:00:49+00:00