Select News

Apr 24 2017

Paratek Pharmaceuticals and Zai Lab Announce Collaboration, Development and License Agreement for Omadacycline in China

Apr 24 2017

BOSTON, April 24, 2017 (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 that it has entered into a collaboration with Zai Lab (Shanghai) Co., Ltd., a biopharmaceutical company based in China, to support the development and commercialization of omadacycline for patients in China.

READ MORE

Apr 18 2017

Verona Pharma Receives Authorization from the U.S. FDA to Proceed with Clinical Investigation of RPL554 with the Acceptance of Investigational New Drug Application

Apr 18 2017

18 April 2017, London – Verona Pharma plc (AIM: VRP) (“Verona Pharma” or the “Company”), a clinical-stage biopharmaceutical company focused on developing and commercialising innovative therapeutics for the treatment of respiratory diseases, announced today that the U.S. Food and Drug Administration has authorized the initiation of a pharmacokinetic (“PK”) clinical trial in the U.S. for the Company’s product candidate, RPL554, with the acceptance of an Investigational New Drug application (“IND”). RPL554 is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 designed to have anti-inflammatory as well as bronchodilator properties, currently in development for the treatment of chronic obstructive pulmonary disease and cystic fibrosis.

READ MORE

Apr 10 2017

Syros Announces FDA Acceptance of IND to Advance SY-1365, its First-in-Class Selective CDK7 Inhibitor, into Phase 1 Clinical Trial in Patients with Advanced Solid Tumors

Apr 10 2017

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Apr. 10, 2017– Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of disease-driving genes, announced today that the U.S. Food and Drug Administration (FDA) accepted the Company’s Investigational New Drug (IND) application to advance SY-1365, its first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor, into a Phase 1 clinical trial in patients with advanced solid tumor malignancies, including transcriptionally dependent cancers such as triple negative breast, small cell lung and ovarian cancers. Syros is on track to initiate the Phase 1 trial in the second quarter of 2017.

READ MORE

Apr 6 2017

Zavante Therapeutics’ ZOLYD™ Met Primary Endpoint in Pivotal ZEUS Study for Treatment of Complicated Urinary Tract Infections

Apr 6 2017

SAN DIEGO, April 6, 2017 /PRNewswire/ — Zavante Therapeutics, Inc., a biopharmaceutical company focused on developing novel therapies to improve the outcomes of hospitalized patients, today announced that the company’s investigational product candidate, ZOLYD™ (fosfomycin for injection, also known as ZTI-01), met the primary endpoint of statistical non-inferiority to piperacillin/tazobactam in the pivotal ZEUS™ clinical trial in patients with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP). ZOLYD is a first-in-class injectable epoxide antibiotic with a differentiated mechanism of action and broad spectrum of activity against Gram-negative and Gram-positive pathogens, including multi-drug resistant (MDR) pathogens. The ZEUS study was a multi-center, randomized, double-blind Phase 2/3 trial designed to evaluate the safety and efficacy of ZOLYD in the treatment of hospitalized adults with cUTI or AP. The primary endpoint of overall success, defined as clinical cure plus microbiologic eradication, was assessed in the microbiologic-modified intent-to-treat population at the test-of-cure visit (Day 19). In the study, ZOLYD met the primary endpoint of statistical non-inferiority compared to piperacillin/tazobactam, with an overall success rate of 64.7% (119/184 patients) versus 54.5% (97/178 patients), respectively, a treatment difference of 10.2% (95% CI: -0.4, 20.8). Clinical cure rates were high and similar between treatment groups (90.8% vs. 91.6%, respectively). Zavante plans to present the complete ZEUS study results at an upcoming infectious disease conference, and expects to submit a new drug application to the U.S. Food and Drug Administration in early 2018.

READ MORE

Apr 3 2017

Paratek Announces Positive Phase 3 Study of Omadacycline in Community-Acquired Bacterial Pneumonia

Apr 3 2017

BOSTON, April 03, 2017 (GLOBE NEWSWIRE) — Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today positive top-line results from a global, pivotal Phase 3 clinical study comparing its once-daily oral and IV, broad spectrum investigational antibiotic, omadacycline, to moxifloxacin in the treatment of patients with community-acquired bacterial pneumonia (CABP). This study represents the second positive Phase 3 registration study of omadacycline, which will be used to support marketing applications to the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

READ MORE

Mar 30 2017

Promentis Pharmaceuticals, Inc. Announces $26M Series C Financing and Elects Four New Board Members

Mar 30 2017

Milwaukee, WI – March 30, 2017 – Promentis Pharmaceuticals, Inc., a privately-held biopharmaceutical company focused on the discovery and development of first-in-class therapies to treat central nervous system disorders, today announced it has completed a third round of equity investment totaling $26,000,000. The Series C investment is led by OrbiMed, F-Prime Capital Partners (formerly Fidelity Biosciences) and Aisling Capital. Existing investors, including Black Pearl GmbH, the Golden Angels Investors and individual investors, also participated in the Series C financing. This financing will enable Promentis to advance its lead compound SXC-2023 through Phase 2 clinical proof of concept. SXC-2023 is a novel small molecule designed to engage System XC-, a CNS target addressing glutamatergic dysfunction and oxidative stress, with a compelling profile across a range of pre-clinical studies.

READ MORE

Mar 27 2017

Allergan and Paratek Announce Positive Results From Two Phase 3 Trials of Sarecycline for the Treatment of Moderate to Severe Acne

Mar 27 2017

DUBLIN, Ireland and BOSTON, March 27, 2017 (GLOBE NEWSWIRE) — Allergan plc, (NYSE:AGN), a leading global pharmaceutical company and Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry, announced that two (2) Phase 3 trials of sarecycline for the treatment of moderate to severe acne met their 12 week primary efficacy endpoints. Sarecycline is a once-daily, oral, narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties for the potential treatment of moderate to severe acne in the community setting. Based on these data, Allergan plans to file a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) in the second half of this year.

READ MORE

Mar 20 2017

Esperion Announces FDA Confirmation Regarding Regulatory Pathway to Approval for an LDL-C Lowering Indication for Bempedoic Acid

Mar 20 2017

ANN ARBOR, Mich., March 20, 2017 (GLOBE NEWSWIRE) — Esperion Therapeutics, Inc. (NASDAQ:ESPR), the lipid management company focused on developing and commercializing convenient, complementary, cost-effective, once-daily, oral therapies for the treatment of patients with elevated low density lipoprotein cholesterol (LDL-C), today announced the U.S. Food and Drug Administration (FDA) recently confirmed that Esperion’s LDL-C lowering program is adequate to support approval of an LDL-C lowering indication for bempedoic acid.

READ MORE

Mar 8 2017

Intersect ENT Submits New Drug Application to FDA for Office-Based RESOLVE Steroid Releasing Implant for Recurrent Chronic Sinus Disease

Mar 8 2017

Menlo Park, Calif. – March 8, 2017 – Intersect ENT, Inc. (Nasdaq: XENT), a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, today announced submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for review and approval of the company’s investigational RESOLVE steroid releasing implant. Placed during a routine physician office visit, the RESOLVE steroid releasing implant is designed to provide a less invasive treatment option for patients with recurrent ethmoid sinus obstruction, including polyps, who might otherwise warrant a repeat surgical procedure.

READ MORE

Mar 7 2017

Biohaven Closes Second Tranche Of Private Placement And Appoints Two New Directors To Board

Mar 7 2017

NEW HAVEN, Conn., March 7, 2017 /PRNewswire/ — Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”), a privately-held, clinical stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases, including rare disorders, announced today that it has completed the second tranche of its previously disclosed $80 million private financing. Together with the proceeds raised under the first tranche, Biohaven has now raised over $100 million in private capital since its inception.  The financing was led by Venrock and joined by other leading biotech investors including Vivo Capital, RA Capital Management, Aisling Capital, Rock Springs Capital, John W. Childs, Greg Bailey, Knoll Capital Management, Osage University Partners, Aperture Venture Partners, Connecticut Innovations, and Litmore Capital. All investors who participated in the first tranche also participated in the second tranche.

READ MORE