News

Oct 24 2019

Aclaris Therapeutics’ A-101 45% Topical Solution Meets Primary and All Secondary Efficacy Endpoints in Second Successful Pivotal Phase 3 Clinical Trial for the Treatment of Common Warts (THWART-1)

Oct 24 2019

If approved, A-101 45% Topical Solution would be the first FDA-approved prescription treatment for common warts

  • Highly statistically significant results for the primary efficacy endpoint
  • Highly statistically significant results for all secondary efficacy endpoints
  • Management to host conference call at 4:30 PM ET today

WAYNE, Pa., Oct. 24, 2019 (GLOBE NEWSWIRE) — Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced positive results from its second Phase 3 clinical trial, THWART-1 (WART-301), of A-101 45% Topical Solution (A-101 45%), an investigational new drug, for the potential treatment of common warts (verruca vulgaris). A-101 45% met the primary and all secondary efficacy endpoints, achieving clinically meaningful and statistically significant clearance of common warts. A-101 45% is a proprietary high-concentration hydrogen peroxide topical solution being developed as a potential prescription treatment for common warts.

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Oct 22 2019

ADMA Biologics Named Company of the Year by BioFlorida

Oct 22 2019

RAMSEY, N.J. and BOCA RATON, Fla., Oct. 22, 2019 (GLOBE NEWSWIRE) — ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and the prevention of certain infectious diseases, today announced that it has been named Company of the Year by BioFlorida, in recognition of ADMA’s significant achievements over the past year.

“We are honored to receive this award from BioFlorida and to be recognized for the recent achievements at our Boca Raton, Florida biologics manufacturing and laboratory campus,” stated Adam Grossman, President and Chief Executive Officer. “Over the past year, we were granted two U.S. Food and Drug Administration (“FDA”) biologic product approvals for ASCENIV™ and BIVIGAM®, improved our current good manufacturing practice (“cGMP”) compliance classification with FDA, and secured funding that will support our ongoing commercial product launches and operations. We are extremely proud of these accomplishments and attribute our success to our passionate and dedicated team who worked so hard to revitalize our biologics manufacturing business. We look forward to continuing to contribute to the growing pharma and biotech community in Florida and to continue to expand our operations and grow our workforce to support the increasing demand of our therapeutic products.”

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Oct 21 2019

ADMA Biologics Announces First Commercial Sales of ASCENIV

Oct 21 2019

RAMSEY, N.J. and BOCA RATON, Fla., Oct. 21, 2019 (GLOBE NEWSWIRE) — ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and the prevention of certain infectious diseases, today announced the first commercial sales of ASCENIV (formerly known as RI-002).  ASCENIV received approval from the U.S. Food and Drug Administration (“FDA”) on April 1, 2019.

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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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