News

Oct 10 2019

Aclaris Therapeutics Announces Divestiture of RHOFADE®

Oct 10 2019

WAYNE, Pa., Oct. 10, 2019 (GLOBE NEWSWIRE) — Aclaris Therapeutics, Inc. (Nasdaq: ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced it has divested RHOFADE® (oxymetazoline hydrochloride) cream, 1% (RHOFADE) and related intellectual property assets to EPI Health, LLC (EPI Health). The divestiture of RHOFADE is a key component of Aclaris’ recently announced strategic plan to refocus resources on the development of its immuno-inflammatory development programs.

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Oct 9 2019

Zosano Pharma Announces CEO Transition

Oct 9 2019

FREMONT, Calif., Oct. 08, 2019 (GLOBE NEWSWIRE) — Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced that Steven Lo, veteran biotechnology and pharmaceutical executive, will become president and chief executive officer of Zosano effective October 21, 2019. He will also serve on the company’s board of directors. Upon retiring after 48 years in the healthcare industry, John Walker will continue as the chairman of the company’s board of directors.

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Oct 8 2019

AVROBIO Announces First Patient Dosed in Phase 1/2 Trial of Gene Therapy for Cystinosis

Oct 8 2019

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Oct. 8, 2019– AVROBIO, Inc. (NASDAQ: AVRO) (the “Company”) today announced that the first patient has been dosed in the Company’s AVR-RD-04 investigational gene therapy program for cystinosis, a devastating lysosomal storage disease, in an ongoing Phase 1/2 clinical trial sponsored by academic collaborators at the University of California San Diego. The gene therapy is derived from the patient’s own hematopoietic stem cells, which are genetically modified to produce functional cystinosin, a crucial protein that patients with cystinosis lack.

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Oct 7 2019

ADMA Biologics Announces Data Presented At IDWeek 2019

Oct 7 2019

RAMSEY, N.J. and BOCA RATON, Fla., Oct. 07, 2019 (GLOBE NEWSWIRE) — ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a vertically integrated commercial biopharmaceutical and specialty immunoglobulin company that manufactures, markets and develops specialty plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases, announces that a poster presentation was given at IDWeek 2019, the combined annual meeting of IDSA, SHEA, HVMA and PIDS in Washington, D.C. The poster detailed data obtained from the compassionate use of ASCENIV™ (formerly referred to as RI-002) in the treatment of Respiratory Syncytial Virus (“RSV”) infection in two immunocompromised children.

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Sep 17 2019

U.S. FDA Approves Supplemental New Drug Application (sNDA) For ERLEADA® (Apalutamide) For The Treatment Of Patients With Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Sep 17 2019

HORSHAM, Pa., Sept. 17, 2019 — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved ERLEADA® (apalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).1 Today’s approval follows FDA Priority Review Designation of the supplemental New Drug Application (sNDA) that was submitted in April 2019 and reviewed through the FDA Real-Time Oncology Review program. The new indication for ERLEADA® will make this androgen receptor inhibitor available for the approximately 40,000 people in the U.S. diagnosed with mCSPC annually.

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Sep 16 2019

Aclaris Therapeutics’ A-101 45% Topical Solution Meets Primary and All Secondary Efficacy Endpoints in Pivotal Phase 3 Trial for the Treatment of Common Warts (THWART-2)

Sep 16 2019

WAYNE, Pa., Sept. 16, 2019 (GLOBE NEWSWIRE) — Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory and dermatological diseases, today announced positive results from its Phase 3 clinical trial, THWART-2 (WART-302), of A-101 45% Topical Solution (A-101 45% Topical Solution), an investigational new drug for the treatment of common warts (verruca vulgaris). A-101 45% Topical Solution met the primary and all secondary efficacy endpoints, achieving clinically and statistically significant clearance of common warts. A-101 45% Topical Solution is a proprietary high-concentration hydrogen peroxide topical solution being developed as a potential prescription treatment for common warts.

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Sep 9 2019

Alexion And Bridgebio Announce Japanese License Agreement For Eidos’ Transthyretin Amyloidosis (ATTR) Investigational Medicine

Sep 9 2019

BOSTON & SAN FRANCISCO–(BUSINESS WIRE)–Sep. 9, 2019– Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and BridgeBio Pharma, Inc.’s (NASDAQ:BBIO) subsidiary Eidos Therapeutics, Inc. (NASDAQ:EIDX) today announced an agreement that grants Alexion an exclusive license to develop and commercialize AG10 in Japan. AG10 is a small molecule designed to treat the root cause of transthyretin amyloidosis (ATTR) – destabilized and misfolded transthyretin (TTR) protein – by binding and stabilizing TTR in the blood. Eidos is currently evaluating AG10 in a Phase 3 study in the U.S. and Europe for ATTR cardiomyopathy (ATTR-CM) – a progressive, fatal disease caused by the accumulation of misfolded TTR amyloid in the heart – and plans to begin a Phase 3 study in ATTR polyneuropathy (ATTR-PN) – a progressive, fatal disease caused by the accumulation of misfolded TTR amyloid in the peripheral nervous system.

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Sep 3 2019

Aeglea BioTherapeutics Announces Positive 20-Dose Data for Pegzilarginase in Patients with Arginase 1 Deficiency at the 2019 SSIEM Symposium

Sep 3 2019

AUSTIN, Texas, Sept. 03, 2019 (GLOBE NEWSWIRE) — Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company that engineers next-generation human enzymes to provide solutions for diseases with unmet medical need, today presented positive 20-dose data on 14 patients from the Company’s completed Phase 1/2 trial and ongoing Phase 2 open-label extension (OLE) trial for pegzilarginase in patients with Arginase 1 Deficiency (ARG1-D) at the 2019 Symposium of the Society for the Study of Inborn Errors of Metabolism (SSIEM).

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Sep 3 2019

Cidara Therapeutics And Mundipharma Form Strategic Partnership To Develop And Commercialize Rezafungin

Sep 3 2019

SAN DIEGO, Calif. & CAMBRIDGE, England–(BUSINESS WIRE)–Sep. 3, 2019– Cidara Therapeutics, Inc. (Nasdaq: CDTX) and Mundipharma announced today that they have entered into a strategic partnership to develop and commercialize rezafungin for the treatment and prevention of invasive fungal infections. Rezafungin is a novel, once-weekly echinocandin antifungal being developed for the first-line treatment of candidemia and invasive candidiasis as well as for the prophylaxis of invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation, for which no new therapies have been approved in over 13 years.

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Aug 22 2019

ADMA Biologics Announces Commercial Relaunch and its First Commercial Sales of BIVIGAM®

Aug 22 2019

RAMSEY, N.J. and BOCA RATON, Fla., Aug. 22, 2019 (GLOBE NEWSWIRE) — ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a vertically integrated commercial biopharmaceutical and specialty immunoglobulin company that manufactures and markets three approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases, announces the commercial relaunch and its first commercial sales of BIVIGAM®.

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