Market News & Trends
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.
Syndax & Nektar Therapeutics Announce Immuno-Oncology Clinical Trial Collaboration
Syndax Pharmaceuticals, Inc and Nektar Therapeutics recently announced a non-exclusive, clinical collaboration to evaluate the safety and efficacy of Nektar’s NKTR-214, a CD122-biased agonist, in combination with entinostat, Syndax’s oral, small molecule Class 1 specific HDAC inhibitor, in patients with metastatic melanoma who have previously progressed on treatment with an anti-PD-1 (programmed death receptor-1) agent.
TxCell Names Lonza as its CAR-Treg Cellular Product Manufacturer
TxCell SA and Lonza Pharma & Biotech recently announced entering into a Master Service Agreement for the manufacture of TxCell’s HLA-A2 CAR-Treg cellular product (TX200), which is in development for the prevention of chronic rejection after organ transplantation.
Ajinomoto Althea, Inc. Announces Additions to Management Team as it Transforms Into a Global CDMO
We are excited to welcome both Darwin and Bert to our leadership team at Althea,” said J. David Enloe, Jr., President and CEO of Althea. “Between them, they bring more than 60 years of commitment to manufacturing excellence, product quality and improving patients’ lives.
NEOMED-LABS Renews Strategic Agreement With GSK
Laval headquartered NEOMED-LABS, a global leader in the clinical immunology field, recently announced a 3-year extension of their strategic agreement with GSK, the world’s largest vaccine manufacturer.
RenovoRx Announces $10-Million Financing for Innovative Treatment for Advanced Pancreatic Cancer
RenovoRx, Inc., a medical technology company developing an innovative catheter-based approach to treating pancreatic cancer, recently announced a $10-million financing round of which the company…
AIT Therapeutics Presented Data From Inhaled Nitric Oxide Study
AIT Therapeutics, Inc. recently announced the results of its study titled Nitric Oxide Inhalations in CF Patients Infected with Mycobacterium Abscessus Complex: A Prospective, Open-Labeled Multi-Center Pilot Study at the 2018 American Thoracic Society (ATS) Conference in San Diego, CA.
Beyond the PBM: A New Order for Healthcare Delivery
The ongoing migration of healthcare currency, from volume to value, is reshaping the healthcare ecosystem. A recent spate of vertical integration, the arrival of new players and partnerships, and the reinvention of the PBMs, continue to disrupt and transform the healthcare value chain.
