Market News & Trends
RedHill Biopharma Announces New US Patent for its Experimental Ebola Therapy
RedHill Biopharma Ltd. recently announced the United States Patent and Trademark Office (USPTO) has issued a patent covering RedHill’s proprietary experimental therapy for the treatment of Ebola virus disease. The patent is expected to be valid until 2035.
Novel First-In-Class Immunotherapeutic APVO210 Features Unique Mechanism of Action Delivering IL-10
Aptevo Therapeutics Inc. recently announced the publication of preclinical data in Frontiers in Immunology highlighting the activity of APVO210 as a potent and selective immunosuppressive…
Elite Pharmaceuticals Announces Strategic Marketing Alliance With Glenmark Pharmaceuticals
Elite Pharmaceuticals, Inc recently announced the signing of a license, manufacturing, and supply agreement with Glenmark Pharmaceuticals, Inc., USA to market two Elite generic products…
FDA Accepts Larotrectinib NDA & Grants Priority Review
Loxo Oncology, Inc. recently announced the US FDA has accepted the company’s New Drug Application (NDA) and granted Priority Review for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring an NTRK gene fusion
Amunix Announces Report by Bioverativ on Unprecedented Half-Life Obtained in Patients Treated With Novel, Long-Acting FVIII Utilizing XTEN Technology
Amunix Operating Inc. recently reported that Bioverativ (a Sanofi company) has announced preliminary Phase 1/2a safety and pharmacokinetic clinical data for BIVV001 (rFVIIIFc-VWF-XTEN), a novel and investigational factor VIII therapy for people with hemophilia A that incorporates Amunix’s XTEN technology to improve circulatory half-life.
Bioasis & WuXi Biologics Announce Initial Strategic Development & Manufacturing Collaboration
Bioasis Technologies, Inc.andWuxi Biologics recently announced an initial strategic collaboration for the development and manufacturing of xB3-001, Bioasis’ lead investigational biological candidate to treat brain cancer.
MimiVax Announces Positive Interim Results from Phase II Trial of SurVaxM
MimiVax LLC recently announced positive interim results from a multicenter Phase II study of SurVaxM in patients with newly diagnosed glioblastoma (nGBM).
Nabriva Therapeutics Announces Positive Topline Results From Pivotal Phase 3 Clinical Trial of Oral Lefamulin
Nabriva Therapeutics plc recently announced positive topline results from its Lefamulin Evaluation Against Pneumonia (LEAP 2) clinical trial, the second of two global, pivotal Phase 3 clinical trials of lefamulin. LEAP 2 evaluated the safety and efficacy of 5 days of oral lefamulin compared to 7 days of oral moxifloxacin in adult patients with moderate community-acquired bacterial pneumonia (CABP).
Beta Bionics Receives IDE Approval From the FDA to Begin a Home-Use Clinical Trial Testing the a New Bionic Pancreas System
Beta Bionics, Inc. recently announced it has received FDA approval to begin recruitment for home-use studies testing the insulin-only configuration of its iLet bionic pancreas system in a series of groundbreaking trials in adults and children with type 1 diabetes (T1D).
SYGNIS Completes Acquisition of TGR Biosciences
SYGNIS AG recently announced the completion of the acquisition of TGR Biosciences (TGR), the Australian research reagents company.
NanoBio Announces Corporate Name Change to BlueWillow Biologics & Closes $10-Million Financing
NanoBio Corporation recently announced it has changed its corporate name to BlueWillow Biologics in conjunction with the closing of a $10-million Series A financing.
Ardena Acquires Syntagon & Strengthens API Offering
Contract development and manufacturing organization (CDMO) Ardena has acquired Syntagon, a leading contract manufacturer of novel active pharmaceutical ingredients (APIs) and excipients.
Bellerophon Reaches Agreement With FDA on Study Design of Phase 2b Trial
Bellerophon Therapeutics, Inc. recently announced that, following the receipt of minutes from a recent meeting with the US FDA, the company has reached agreement with the FDA on all key aspects of its planned Phase 2b study of INOpulse for the treatment of Pulmonary Hypertension Associated with Chronic Obstructive Pulmonary Disease (PH-COPD).
Flexion Therapeutics Presents Updated Results from Clinical Trial
Flexion Therapeutics, Inc. recently announced updated interim findings from its ongoing Phase 3b, open-label study to evaluate the overall safety and general tolerability of repeat administration of ZILRETTA (triamcinolone acetonide extended-release injectable suspension) in patients with osteoarthritis (OA) of the knee.
RedShiftBio Launches New Protein Characterization Instrument System
RedShift™ BioAnalytics, Inc. (RedShiftBio™) unveiled the AQS3™pro, a new protein characterization platform with powerful, integrated bioanalytics software that delivers automated, high sensitivity spectroscopic analysis for the development, formulation and manufacture of biotherapeutics.
WuXi STA to Build New R&D Center
STA Pharmaceutical Co., Ltd., a subsidiary of WuXi AppTec (WuXi STA), recently announced it has signed an investment agreement with the government of Shanghai, Jinshan District to build a new R&D center.
Thermo Fisher Scientific Unveils Gibco ExpiSf System
Thermo Fisher Scientific recently announced its Gibco ExpiSf system, the first-ever chemically defined insect protein expression system.
Advantagene Announces Clinical Trial Collaboration Clinical Study to Combine GMCI With Opdivo
Advantagene, Inc. recently announced that the company entered into a clinical trial collaboration with Bristol-Myers Squibb to evaluate the safety, tolerability, and preliminary efficacy of Advantagene’s investigational Gene Mediated Cytotoxic Immunotherapy (GMCI, aglatimagene besadenovec + valacyclovir), in combination with Bristol-Myers Squibb’s programmed death-1 (PD-1) immune checkpoint inhibitor, Opdivo (nivolumab), in newly diagnosed malignant glioma patients receiving standard of care (SOC) surgery and radiation with or without temozolomide.
Ritter Pharmaceuticals Selects Medpace as its CRO for Pivotal Phase 3 Trial
Ritter Pharmaceuticals, Inc. recently announced it has signed an agreement with the clinical research organization (CRO) Medpace to conduct the first of two pivotal Phase 3 clinical trials for RP-G28 in patients with lactose intolerance (LI).
Amerigen & Dipharma Announce Approval of First Generic of Miglustat
Amerigen Pharmaceuticals Limited and Dipharma S.A. recently announced that Amerigen’s Abbreviated New Drug Application (ANDA) for Miglustat 100 mg capsules has received final approval from the US Food and Drug Administration.
