Market News & Trends
Ajinomoto Althea Celebrates 20 Years in San Diego & Opening of New Facility
Ajinomoto Althea, Inc., a leading contract development and manufacturing organization, celebrated its 20th year in operation, making it one of the true anchors of the…
Gerresheimer Gx Solutions Developing Packaging Solutions for Complex Injectable Drugs of Tomorrow
New sophisticated and sensitive injectable drugs require a new generation of custom-tailored pharmaceutical primary packaging. Gerresheimer is combining its expertise into a specialized team called…
UPM Pharmaceuticals Appoints New Director of Analytical Development
UPM Pharmaceuticals, a Contract Development and Manufacturing Organization (CDMO) focused on oral solid and semi-solid drug dosage forms, has appointed Dr. Chi-Chang Wung to the…
Global Contract Research Organization Announces $7.8-Million Extension Agreement
A major full-service, global contract research organization (CRO) has expanded its existing partnership with OmniComm Systems, Inc., a leading global provider of clinical data management technology.…
Adverum Biotechnologies Announces IND Active for ADVM-022, a Novel Gene Therapy
Adverum Biotechnologies, Inc. recently announced its Investigational New Drug (IND) application is active for the planned multi-center, open-label, Phase 1, dose-escalation study of ADVM-022, a…
SunGen Pharma Establishes Injectable Division, Forms Manufacturing Relationship
SunGen Pharma recently announced it has entered into a Manufacturing Agreement with Grand River Aseptic Manufacturing (GRAM) to manufacture generic injectable pharmaceutical products.
Cynata’s Stem Cell Therapy Meets All Safety & Efficacy Endpoints in Trial
Australian stem cell and regenerative medicine company Cynata Therapeutics Limited recently announced that CYP-001, its lead Cymerus mesenchymal stem cell (MSC) product candidate, met all clinical endpoints in a Phase 1 trial for the treatment of steroid-resistant acute graft-versus-host disease (GvHD).
Emergent BioSolutions to Acquire ADAPT Pharma
ADAPT Pharma recently announced it has entered into a definitive agreement to be acquired by Emergent BioSolutions. Adapt is solely focused on helping address the opioid overdose and addiction crisis.
Phillips-Medisize Continues to Attract Industry Thought Leaders to Connected Health Team
Phillips-Medisize, a Molex company and global leader in the design, development, and commercial manufacturing of Connected Health solutions, recently announced the expansion of its Connected Health…
Novan Announces Promising Clinical Results With SB414
Novan, Inc. recently announced an update on the SB414 nitric oxide-releasing cream product candidate and its application to two therapeutic indications: atopic dermatitis and psoriasis.…
Immunocore Announces Start of Phase I ImmTAC Study in Patients with Solid Tumors
Immunocore Limited recently announced it has dosed the first patient in a Phase I study, part of an ongoing collaboration with GlaxoSmithKline (GSK). The study,…
RedHill Biopharma Receives Allowance for New US Patent Covering Encapsulated Bowel Preparation
RedHill Biopharma Ltd. recently announced it has received a Notice of Allowance from the US Patent and Trademark Office (USPTO) for a new formulation patent…
Q BioMed Announces FDA Filing for Strontium Chloride Sr89 Injection USP for Relief of Metastatic Cancer Bone Pain
Q BioMed Inc. and BioNucleonics recently announced submission of a supplemental regulatory filing to the FDA for the approval of a new manufacturing facility. Once…
Evotec & Novo Nordisk Form Strategic Research Alliance
Evotec AG recently announced a strategic alliance with Novo Nordisk to discover and develop novel small molecule therapies to treat patients suffering from diabetes and…
CCAB Partners With ImmunoBiochem as it Launches New Co-Development Strategy to Advance Early-Stage Biotech Companies
The Centre for the Commercialization of Antibodies and Biologics (CCAB) and ImmunoBiochem Corporation have announced an agreement that will see CCAB provide a new investment to help advance ImmunoBiochem’s novel breast cancer therapeutic candidate one step closer to the clinic.
Rexahn Pharmaceuticals Announces Clinical Collaboration With Merck
Rexahn Pharmaceuticals, Inc. recently announced it has entered into a clinical trial collaboration agreement with Merck (known as MSD outside the United States and Canada) to evaluate the combination of Rexahn’s RX-5902 and Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in a Phase 2 trial in patients with metastatic triple negative breast cancer (TNBC).
Pfizer & Astellas Amend Clinical Research Protocols for Two Phase 3 Trials
Pfizer Inc. and Astellas Pharma Inc. recently announced amendments to the protocols for two registrational Phase 3 trials, ARCHES and EMBARK, designed to evaluate the safety and efficacy of XTANDI (enzalutamide) in men with hormone-sensitive prostate cancer (HSPC).
Orchard Therapeutics Announces $150-Million Financing to Advance Pipeline
Orchard Therapeutics recently announced the completion of an oversubscribed $150 million Series C financing. Deerfield Management led the financing with significant new investments from RA…
Stemline Therapeutics Announces FDA Accepts ELZONRIS BLA & Grants Priority Review
Stemline Therapeutics, Inc. recently announced US FDA has accepted for filing the company’s Biologics License Application (BLA) for ELZONRIS (tagraxofusp; SL-401) for the treatment of…
MeiraGTx Announces AAV-CNGA3 Has Received Orphan Drug Designation
MeiraGTx Holdings Plc recently announced that the US FDA has granted orphan drug designation (ODD) for its AAV-CNGA3 gene therapy product candidate for the treatment…
