Market News & Trends
Akcea & Ionis Announce European Union Drug Approval for Ultra-Rare Disease
Akcea Therapeutics, Inc. and Ionis Pharmaceuticals, Inc. recently announced that WAYLIVRA has received conditional marketing authorization from the EC as an adjunct to diet in adult patients with genetically confirmed FCS and at high risk for pancreatitis, in whom response to diet and triglyceride-lowering therapy has been inadequate.
Eloxx Pharmaceuticals Presents Positive New Data at ARVO
Eloxx Pharmaceuticals, Inc. recently presented new findings related to preclinical inherited retinal disease therapeutic development at the ARVO 2019 Annual Meeting in Vancouver, BC, on…
Calixar Signs Exclusive Licensing Agreement With Regeneron
Calixar SAS (Calixar), a biotechnology company specialized in native membrane protein stabilization, recently announced it has entered into an exclusive licensing agreement with Regeneron Pharmaceuticals,…
Emendo Biotherapeutics Enters Licensing Option Agreement With Takeda
Emendo Biotherapeutics Inc. recently announced the company signed a licensing option agreement with Takeda Pharmaceutical Company Limited. As part of the transaction, Emendo will receive…
International Stem Cell Completes Enrollment & Dosing in its Parkinson's Disease Clinical Trial
International Stem Cell Corporation recently announced the completion of subject enrollment in its Phase 1 clinical trial of ISC-hpNSC for the treatment of Parkinson’s disease.…
Catalent Invests $40 Million to Increase Patient-Centric Dose Form Manufacturing Capabilities
Catalent recently announced it is investing up to $40 million at its manufacturing facility in Winchester, KY. The investment will see the installation of new…
Braun Medical Uses Needle-Trap from Schreiner MediPharm for New Prefilled Heparin Syringe
Schreiner MediPharm has collaborated with B. Braun Medical Inc. who recently launched its prefilled syringe of Heparin Sodium Injection, USP utilizing Schreiner MediPharm’s label-integrated Needle-Trap…
Emisphere Provides Development Update on Novo Nordisk Drug Using its Eligen SNAC Carrier Technology
Novo Nordisk recently announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for oral semaglutide, a glucagon-like peptide-1 (GLP-1) analogue in a tablet taken once-daily, for the treatment of adults with type 2 diabetes.
Oculos & Optceutics Partner to Bring Expanded Services to Ophthalmic Innovators
Oculos and Optceutics recently announced they are entering into a co-promotion arrangement to provide broader services for clients spanning from early research through product approval.
Caris Life Sciences Acquires Pharmatech
Caris Life Sciences recently announced it has acquired Pharmatech, Inc., a pioneer of the original Just-In-Time research system with the largest research-ready oncology network.
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.
