News

CHAPEL HILL, N.C., July 7, 2015 (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 the completion of enrollment for the global Solitaire-IV Phase 3 trial of solithromycin in adult patients with moderate to moderately severe community-acquired bacterial pneumonia (CABP). Top-line efficacy and safety data from this study are expected to be announced by the end of the year.

ANN ARBOR, MI -- (Marketwired) -- 07/07/15 -- Esperion Therapeutics, Inc. (NASDAQ: ESPR), an emerging pharmaceutical company focused on developing and commercializing first-in-class, oral, low-density lipoprotein cholesterol (LDL-cholesterol) lowering therapies for the treatment of hypercholesterolemia and other cardiometabolic risk markers, today announced the U.S. Food and Drug Administration (FDA) has removed the 240 mg partial clinical hold on ETC-1002 (bempedoic acid). This action by FDA will now allow ETC-1002 to be used at doses above 240 mg in clinical studies. Esperion plans to initiate the Phase 3 clinical program for ETC-1002 in the fourth quarter of this year using the already optimized 180 mg dose.

MENLO PARK, Calif., July 6, 2015 (GLOBE NEWSWIRE) -- Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing VRS-317, a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), today announced that the US Food and Drug Administration (FDA) has removed the partial clinical hold on the Company's Investigational New Drug Application for VRS-317. With this action, the Company will proceed with the Phase 3 registration trial, VELOCITY, of VRS-317 in children with GHD.

July 1, 2015 – Ithaca, NY – As previously mentioned in the June 5, 2015 announcement of the signing of the Merger Agreement, effective July 1, 2015, Beijing Bohui Innovation Technology, Ltd. completed the acquisition of Advion, Inc.

Funding to Drive Global Expansion of its MRI-Guided Radiation Therapy Business June 30, 2015 CLEVELAND, June 30, 2015 — ViewRay™, makers of MRIdian™, the world’s first and only clinical MRI-guided radiation therapy system, announced today that the company has secured up to $50 million in debt financing from CRG (formerly Capital Royalty L.P.), a premier healthcare investment firm.

RAMSEY, N.J., June 30, 2015 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq:ADMA), a late-stage biopharmaceutical company, announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. patent application 14/592,721 entitled Compositions and Methods For The Treatment of Immunodeficiency.

CTH-300 Clinical Trial to Assess Effectiveness and Safety of APL-130277 TORONTO – (Marketwired) – Cynapsus Therapeutics Inc. (NASDAQ: CYNA) (TSX: CTH) (the “Company”) today announced enrollment of the first patient in the CTH-300 clinical trial, a pivotal Phase 3 study to examine the efficacy, safety and tolerability of APL-130277 for the acute treatment of OFF episodes in patients with Parkinson's disease (PD).

APL-130277, Sublingual Apomorphine, for On-Demand Treatment of OFF Episodes Associated with Parkinson’s Disease TORONTO – (Marketwired) – Cynapsus Therapeutics Inc. (NASDAQ: CYNA) (TSX: CTH) (the “Company”) today announced that it presented data from clinical trials of APL-130277, a sublingual apomorphine thin film under development for the on-demand treatment of OFF episodes associated with Parkinson’s disease (PD). Data from the Company’s CTH-105, CTH-104 and CTH-103 clinical studies, presented at the 19th International Congress of Parkinson's Disease and Movement Disorders (MDS) in San Diego, California, showed APL-130277 significantly improved PD symptoms (as measured by MDS-UPDRS Part III), rapidly turned patients from the OFF to ON state and was generally safe and well tolerated.

NEW YORK-- Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) announced today the initiation of the second of two pivotal phase 3 clinical trials evaluating the efficacy and safety of two different plecanatide treatment doses (3.0 mg and 6.0 mg), taken as a tablet once-a-day, in patients with irritable bowel syndrome with constipation (IBS-C).

- First of Two Planned Phase 3 Clinical Trials of Paratek's Lead Antibiotic Candidate - Studies Designed to Support Submission for Approval in Two Indications: Acute Bacterial Skin and Skin Structure Infections and Community Acquired Bacterial Pneumonia BOSTON, June 23, 2015 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry today announced the dosing of the first patient in its Phase 3 clinical trial of its lead drug candidate, omadacycline, for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). This global Phase 3 study will assess the efficacy and safety of omadacycline compared with linezolid in ABSSSI.