Market News & Trends
European Commission Approves Treatment of Moderate-to-Severe Plaque Psoriasis
AbbVie, a research-based global biopharmaceutical company, recently announced that the European Commission (EC) has approved SKYRIZI™ (risankizumab) for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.
Adynxx Announces Merger Agreement With Alliqua BioMedical
Adynxx, Inc. recently provided a business and clinical development update. Adynxx entered into a merger agreement with Alliqua Biomedical, Inc. that will result in Adynxx…
ExCellThera’s Lead Technology Receives FDA Regenerative Medicine Advanced Therapy Designation
ExCellThera Inc. recently announced the US FDA has granted regenerative medicine advanced therapy (RMAT) designation to its lead technology, ECT-001, in the treatment of hematologic…
Vyome Therapeutics Begins Dosing in Phase 2 Trial of Bactericidal Antibiotic Topical Gel
Vyome Therapeutics Inc. recently announced it has dosed the first patient in its Phase 2 trial of the company’s lead clinical candidate, VB-1953, for the…
OmniSeq & LabCorp Extend Exclusive Distribution Pact & Complete Follow-On Investment Agreement
OmniSeq and LabCorp recently announced an extension of their exclusive distribution agreement as well as an additional investment by LabCorp. The distribution agreement and LabCorp’s…
ChemioCare Announces Initiation of PETT-Based (Permeation Enhanced Transdermal Technology) Lenalidomide Program
ChemioCare USA Inc. recently announced it is initiating development of a transdermal formulation of lenalidomide, which is currently marketed in an oral form. ChemioCare believes…
Catalent Invests $14 Million at its Softgel Facility
Catalent recently announced that work is underway to expand integrated turnkey softgel capabilities at its facility in Eberbach, Germany. The $14-million expansion, which is scheduled…
QPS Outpaces Market Growth for Phase I Clinical Trials
QPS, a global contract research organization (CRO) providing discovery, preclinical, and clinical drug development services, recently announced its successful implementation of ClinSpark, an eSource technology platform for Phase I automation, to support double-digit growth in Phase I clinical trials.
Autolus Therapeutics Receives FDA Orphan Drug Designation
Autolus Therapeutics plc recently announced the US FDA has granted orphan drug designation to autologous enriched T-cells genetically modified with a retroviral vector to express two chimeric antigen receptors targeting CD19 and CD22 (AUTO3) for the treatment of acute lymphoblastic leukemia (ALL).
Cambrex Completes New Quality Control Laboratory for Generic API Development in Milan
Cambrex Corporation, the leading small molecule company providing drug substance, drug product and analytical services across the entire drug lifecycle, recently announced that it had opened a new 120m2 quality control (QC) laboratory at its site in Paullo, Milan, Italy.
CureVac Granted Patent Claiming the Combination of mRNA Vaccines With Anti-PD-L1 Antibodies
CureVac AG recently announced it has been granted a patent from the European Patent Office entitled, Combination of Vaccination and Inhibition of the PD-1 Pathway…
Rexahn & BioSense Global Announce Collaboration & License Agreement
Rexahn Pharmaceuticals, Inc. and BioSense Global LLC recently announced a collaboration and license agreement to advance the development and commercialization of RX-3117 for pancreatic cancer…
Kamada Announces FDA Acceptance of Inhaled AAT Program
Kamada Ltd. recently announced receipt of a letter from the US FDA stating the company has satisfactorily addressed the concerns and questions regarding its Inhaled…
Enesi Pharma & BARDA Drive Enter Public-Private Partnership to Develop Solid Dose Vaccine Delivery Technology
Enesi Pharma recently announced it has entered a public-private partnership with the US Biomedical Advanced Research and Development Authority’s (BARDA) DRIVe (Division of Research, Innovation,…
Fibrocell Announces Development & Commercialization Collaboration With Castle Creek Pharmaceuticals
Fibrocell Science, Inc. recently announced the completion of a collaboration agreement with Castle Creek Pharmaceuticals to develop and commercialize Fibrocell’s lead gene therapy candidate, FCX-007,…
Biotechpharma to Expand Process Development & GMP Manufacturing Capacity
Biotechpharma UAB recently announced further expansion of its fermentation capacity to 5,000 L, along with an additional state-of-the-art process development laboratory, investing more than $56…
Soligenix Achieves Significant Enrollment Milestone for its Pivotal Phase 3 Clinical Trial
Soligenix, Inc. recently announced today it has reached a significant milestone in the Phase 3 clinical study (the “DOM-INNATE” study) for SGX942 (dusquetide) in the treatment of oral mucositis in patients with head and neck cancer (HNC).
Hovione Technology Announces Acquisition of Global Rights to New Pulmonary Inhaler Device
Hovione Technology, a specialist in development of innovative inhalation device technology, recently announced it has secured global rights to develop and commercialize a new ultra-affordable, multi-use blister-based dry powder inhaler patented by inventor Dr. Klaus-Dieter Beller.
Paragon Bioservices to be Acquired for $1.2 Billion
Catalent, Inc. and Paragon Bioservices, Inc. and Catalent Inc. recently announced they have entered into a definitive agreement under which Catalent will acquire Paragon for $1.2 billion.
Sanofi & Alnylam Conclude Research & Option Phase of 2014 Rare Disease Alliance
Sanofi and Alnylam have agreed to conclude the research and option phase of the companies’ 2014 RNAi therapeutics alliance in rare genetic diseases. The material…
