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- Read more about Advaxis’s Phase 2 Head and Neck Cancer Study of AXAL Advances to Second Stage
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.
- Read more about Mallinckrodt acquire Stratatech Corporation, regenerative medicine company
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.
- Read more about SANUWAVE Health Submits de novo Petition for FDA Review and Classification of the dermaPACE System
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®).
- Read more about Lilly gets DMC recommendation to continue MONARCH 2 phase 3 trial of abemaciclib without modification
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.
- Read more about Proteostasis Therapeutics complete preclinical milestone in Astellas collaboration
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.
- Read more about Shire launch Vonvendi, a recombinant treatment for adults affected by VWD in US market
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).
- Read more about U.S. FDA Approve Heron Therapeutic’s SUSTOL Extended-Release Injection
Heron Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved SUSTOL® (granisetron) extended-release injection. SUSTOL is a serotonin-3 (5-HT3) receptor antagonist indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.
- Read more about US FDA issues updated recommendations on submitting new 510(k) for medical device modifications
The US Food and Drug Administration (FDA) issued draft updated recommendations to help manufacturers determine when they are required to notify the FDA about modifications made to certain medical devices already on the market, including a separate guidance applicable to software devices.
- Read more about Coherus Biosciences Submits 351(K) BLA To U.S.FDA For CHS-1701
Coherus BioSciences, Inc. announced submission of the biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate, to U.S. FDA under the 351(k) pathway.

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- Read more about Coherus Biosciences Positive Phase Three Results For CHS-1420 In Patients With Psoriasis
Coherus BioSciences, Inc. reported topline results from an ongoing Phase 3 clinical study of CHS-1420, an adalimumab (Humira®) biosimilar candidate. This study met its primary endpoint demonstrating similarity between CHS-1420 and Humira with respect to percentage of subjects achieving 75% improvement in psoriasis area and severity index (PASI-75) at Week 12.