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Aug 29 2016

Cynapsus Receives FDA Fast Track Designation for APL-130277 for the Treatment of OFF Episodes in Patients with Parkinson’s Disease

Aug 29 2016

TORONTO, Aug. 29, 2016 (GLOBE NEWSWIRE) — Cynapsus Therapeutics Inc. (NASDAQ:CYNA) (TSX:CTH), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for APL-130277, a product candidate for the treatment of OFF episodes in patients with Parkinson’s disease (PD).

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Aug 23 2016

Cempra Announces European Medicines Agency Validates MAA for Solithromycin for Treatment of CABP

Aug 23 2016

CHAPEL HILL, N.C., Aug. 23, 2016 (GLOBE NEWSWIRE) — Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced that the European Medicines Agency (EMA) has validated the company’s marketing authorization application (MAA) seeking approval of oral capsule and intravenous formulations of solithromycin for the treatment of community-acquired bacterial pneumonia (CABP, also referred to as community-acquired pneumonia (CAP) in the EU).

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Aug 22 2016

Versartis Announces Completion of Enrollment in Phase 3 VELOCITY Trial of Somavaratan in Pediatric GHD

Aug 22 2016

MENLO PARK, Calif., Aug. 22, 2016 (GLOBE NEWSWIRE) — Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing somavaratan (VRS-317), a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), today announced the completion of enrollment in the Phase 3 VELOCITY trial of somavaratan in pediatric GHD. With 137 patients enrolled, the trial is powered at > 90% to demonstrate non-inferiority of somavaratan compared to daily rhGH. Patients will be followed for the primary trial endpoint of height velocity at 12 months, as well as safety and pharmacodynamic secondary endpoints. Top-line results are anticipated in Q3 2017.

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Aug 18 2016

Aclaris Therapeutics Announces Positive Results in Phase 2 Clinical Trial of A-101 for Treatment of Common Warts

Aug 18 2016

MALVERN, Pa., Aug. 18, 2016 (GLOBE NEWSWIRE) — Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage specialty pharmaceutical company, today announced positive results from its Phase 2 clinical trial (WART-201), of A-101 Topical solution (A-101) for the treatment of common warts (verruca vulgaris).  A-101 is a proprietary formulation of high-concentration hydrogen peroxide currently under development as a prescription treatment for common warts.

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Aug 15 2016

Cynapsus Announces Positive Opinion from Data and Safety Monitoring Board on Phase 3 Parkinson’s Disease Clinical Study Allowing for At-Home Titration

Aug 15 2016

TORONTO, Aug. 15, 2016 (GLOBE NEWSWIRE) — Cynapsus Therapeutics Inc. (NASDAQ:CYNA) (TSX:CTH), a specialty central nervous system (CNS) pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with Parkinson’s disease (PD), announced today that its Data Safety and Monitoring Board (DSMB) has completed a review of the safety data from the Company’s Phase 3 program including both the CTH-300 and CTH-301 clinical trials. Based on the DSMB’s recommendations, the CTH-300 trial will continue as planned. In addition, as a result of the DSMB’s review of the early safety data from both CTH-300 and CTH-301, the six-month open label CTH-301 study will be amended to allow for at-home titration, after the patient’s initial visit to the clinic.

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Aug 10 2016

Protagonist Therapeutics Announces Pricing of Initial Public Offering

Aug 10 2016

MILPITAS, Calif., Aug. 10, 2016 /PRNewswire/ — Protagonist Therapeutics, Inc. (NASDAQ: PTGX), a clinical-stage biopharmaceutical company with a proprietary technology platform focused on discovering and developing peptide-based new chemical entities to address significant unmet medical needs, today announced the pricing of its initial public offering of 7,500,000 shares of common stock, at a price to the public of $12 per share, before underwriting discounts and commissions. The shares are expected to begin trading on The NASDAQ Global Market on August 11, 2016, under the symbol “PTGX.” In addition, Protagonist has granted the underwriters a 30-day option to purchase up to 1,125,000 additional shares at the initial public offering price, less underwriting discounts and commissions. This offering is expected to close on August 16, 2016, subject to customary closing conditions.

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Aug 9 2016

Teijin Limited and Versartis Enter Strategic Alliance for Commercialization of Somavaratan Long-Acting Growth Hormone in Japan

Aug 9 2016

TOKYO and MENLO PARK, Calif., Aug. 09, 2016 (GLOBE NEWSWIRE) — Teijin Limited (TSE:3401) and Versartis, Inc. (NASDAQ:VSAR) today announced that the companies and their wholly owned subsidiaries (collectively “Teijin” and “Versartis”, respectively) have entered into an exclusive license and supply agreement for the development and commercialization of somavaratan (VRS-317) in Japan.  Versartis, an endocrine-focused biopharmaceutical company, has been developing somavaratan, a novel, long-acting form of rhGH, for pediatric and adult growth hormone deficiency (GHD) in Japan.  Teijin Pharma Limited, the core company of the Teijin Group’s medical and pharmaceutical business, markets a variety of pharmaceutical products throughout Japan, including in the areas of metabolic and endocrine disease.

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Jul 15 2016

Synergy Pharmaceuticals provides update on ongoing FDA review of plecanatide CIC NDA and IBS-C clinical development program

Jul 15 2016

NEW YORK– Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced it has reached the Food and Drug Administration (FDA) mid-cycle review milestone for the plecanatide new drug application (NDA) in chronic idiopathic constipation (CIC). Additionally, the company is providing an update on the ongoing irritable bowel syndrome with constipation (IBS-C) program.

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Jul 13 2016

Loxo Oncology Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for LOXO-101

Jul 13 2016

STAMFORD, Conn., July 13, 2016 (GLOBE NEWSWIRE) — Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to LOXO-101, a selective inhibitor of tropomyosin receptor kinase (TRK), “for the treatment of unresectable or metastatic solid tumors with NTRK-fusion proteins in adult and pediatric patients who require systemic therapy and who have either progressed following prior treatment or who have no acceptable alternative treatments.”

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Jul 13 2016

CoolSculpting(R) by ZELTIQ(R) Receives Approval From China Food and Drug Administration for Fat Reduction

Jul 13 2016

PLEASANTON, CA — (Marketwired) — 07/13/16 — ZELTIQ® Aesthetics, Inc. (NASDAQ: ZLTQ), a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology, today announced that it received approval from the China Food and Drug Administration (CFDA) for fat layer reduction of the abdomen and flanks. Comprehensive multi-center clinical studies have validated that the CoolSculpting® procedure non-invasively reduces fat cells by an average of 20-25% in the treated area based on histological and ultrasound assessment.

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