Industry News

Quidel Corporation  announced that it has received clearance from the United States Food and Drug Administration (FDA) to market its Solana® Trichomonas assay for the detection of nucleic acids isolated from clinician-collected vaginal swabs and female urine specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis, a sexually transmitted disease attributable to infection from the Trichomonas vaginalis parasite. The Solana® Trichomonas Assay is intended for use only with the Solana® instrument.

Portola Pharmaceuticals Inc. announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for AndexXa™ (andexanet alfa). An FDA-designated Breakthrough Therapy, AndexXa is in development for patients treated with a direct (apixaban, rivaroxaban, or edoxaban) or indirect (enoxaparin) Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Currently, there is no FDA-approved antidote for Factor Xa inhibitors.

Ascendis Pharma A/S, a clinical stage biopharmaceutical company that applies its innovative TransCon technology to address significant unmet medical needs, announced the initiation of the global phase 3 TransCon Growth Hormone heiGHt Trial in children with growth hormone deficiency (GHD).

Advaxis, Inc. announced that its Phase 2 “window of opportunity” clinical study of its lead immunotherapy candidate, axalimogene filolisbac (AXAL), in patients with late-stage HPV-associated oropharyngeal cancer (HPVOPC) met its stage 1 primary objective and is advancing into the second stage of the clinical study.

Mallinckrodt plc, a leading global specialty pharmaceutical company, announced that it has entered into a merger agreement with Stratatech Corporation, a privately held regenerative medicine company focused on the development of unique, proprietary skin substitute products. Developmental products include StrataGraft regenerative skin tissue and a technology platform for genetically enhanced skin tissues. Financial terms of the transaction were not disclosed.

SANUWAVE Health, Inc. announced that it has submitted to the U.S. Food and Drug Administration (FDA) a de novo petition requesting Agency review and classification of the dermaPACE System for treating Diabetic Foot Ulcers (DFU) as a Class II device. Through the course of two trials, 336 patients were randomized in double-blind, parallel group, sham controlled, multicenter, 24-week pivotal clinical trials that were designed to quantify the safety and effectiveness of the noninvasive procedures with the dermaPACE System (dermaPACE®).

Eli Lilly and Company announced that following a pre-planned interim analysis for MONARCH 2, an independent Data Monitoring Committee (DMC) provided the recommendation to continue the study without modification as the interim efficacy criteria were not met. The MONARCH 2, phase 3 trial compares abemaciclib plus fulvestrant versus placebo with fulvestrant in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer.

Proteostasis Therapeutics, Inc., a clinical stage biopharmaceutical company developing small molecule therapeutics to treat diseases caused by dysfunctional protein processing, announced that it has successfully completed a key preclinical milestone in its collaboration with Astellas Pharma Inc. (Astellas). The milestone, which triggered an undisclosed payment from Astellas, demonstrated that selective modulation of the Unfolded Protein Response (UPR) pathway in vitro is potentially an effective disease-modifying approach in the treatment of multiple diseases with few or no therapies currently available.

Shire plc, a leading global biotechnology company, announced the US launch of Vonvendi [von Willebrand factor (Recombinant)], the only recombinant treatment for adults living with von Willebrand disease (VWD).