Market News & Trends
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.
Pharma 4.0 – A New Initiative to Help Design the Pharma Facility of the Future
The pharma industry is continuously evolving which creates value for both the industry itself and the patients that rely on the ever-more varied and targeted drugs it manufacturers. An initiative that is strongly reflective of this evolution and one actively affecting the industry itself is Pharma 4.0.
Haselmeier & Common Sensing Enter Connected Injectable Medicine Collaboration
Haselmeier and Common Sensing recently announced a partnership agreement to develop smart connected monitoring and support solutions for users of injectable medicines. Worldwide, over 16 billion injections of medicine are administered every year. Smart connected monitoring solutions for users of injectables is aimed helping them to properly administer those medicines to improve efficacy and quality of therapies.
ARCA biopharma & Medtronic Extend Gencaro Clinical Trial Collaboration Agreement
ARCA biopharma, Inc. recently announced that Medtronic, Inc. has extended the US, Canadian, and European Clinical Trial Collaboration Agreement with ARCA for an additional year…
Q Therapeutics Announces Joint Venture With REPROCELL
Q Therapeutics, Inc., a developer of clinical-stage cell therapies for central nervous system (CNS) diseases, and REPROCELL Inc., Japan’s first induced pluripotent stem cell (iPSC)…
Bormioli Pharma Addresses Drug Stability & Value-Added Medicines With Packaging Innovation
Bormioli Pharma, one of the world’s leading glass and plastic packaging manufacturers for the pharmaceutical sector, offers its innovative dual-chamber AccuRec system as a solution…
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…
AMRI Expands NMR Spectroscopy Capabilities
AMRI recently announced it will expand its nuclear magnetic resonance (NMR) spectroscopy capabilities in Europe with the addition of the Bruker AVANCE NEO 600 MHz…
