Market News & Trends
4P-Pharma & Delta 4 Join Forces to Find & Develop Treatments for a Rare Autoimmune Chronic Liver Disease
4P-Pharma and Delta 4 recently announced the signing of a collaboration agreement in which both companies will jointly identify and develop first-in-class drug candidates for a rare autoimmune chronic liver….
Teon Therapeutics Announces FDA Acceptance of IND Application for Novel, Oral Immune Checkpoint Inhibitor
Teon Therapeutics recently announced the acceptance by the US FDA of Teon’s Investigational New Drug (IND) application for the study of TT-816. TT-816 is a novel, oral cannabinoid CB2 receptor….
PDS Biotechnology Granted FDA Fast Track Designation for Lead Candidate
PDS Biotechnology Corporation recently announced the US FDA has granted Fast Track designation to PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab). PDS0101 in combination…
Biogen & Samsung Bioepis’ & Biogen's BYOOVIZ (ranibizumab-nuna) Launches in the US
Samsung Bioepis Co., Ltd. and Biogen Inc. recently announced BYOOVIZ (ranibizumab-nuna), a biosimilar referencing LUCENTIS (ranibizumab), has been launched….
Vaxart Reports Positive Preliminary Data from Phase 1b Trial of its Oral Norovirus Vaccine Candidates in Elderly Adults
Results of the trial show a robust immune response across all doses, with a dose-dependent production of IgA antibody secreting cells (ASCs), consistent with previous…
CordenPharma Increases xRNA-based Capabilities with a Strategic Investment in LNP Formulation Services at its Caponago Injectable Facility
CordenPharma has recently increased its xRNA capabilities at its sterile injectable facility in Caponago, Italy. The company reports that it is investing over €10M in new Lipid Nanoparticle (LNP) formulation,….
Lonza Completes Dedicated Early Clinical Phase Development & Manufacturing Facility in Bend (OR)
Lonza has enhanced its offering for customers in the early phases of their clinical trials by adding a dedicated Early Phase Clinical Manufacturing facility at…
Eagle Pharmaceuticals Announces Submission of NDA to FDA for a Beta-1 Adrenergic Blocker
Eagle Pharmaceuticals, Inc. recently announced that AOP Orphan Pharmaceuticals GmbH, a member of the AOP Health Group, with whom Eagle entered into a licensing agreement…
Gattefossé Strengthens its International Footprint & Breaks Ground on its Production Site in Texas
Gattefossé will break ground on its first North American manufacturing facility in Lufkin city, TX. Gattefossé as well as officials of Lufkin city will attend the ceremony. This asset will manufacture….
ISR Signs Agreement With Gerresheimer for Clinical-Scale Production of IcoOne Nasal Inhalers
The drug development company ISR has recently signed an agreement with Gerresheimer for large-scale production of the IcoOne nasal inhaler, for its Phase 3 study of its dry powder….
Denali Therapeutics & Biogen Announce Initiation of Phase 2b Study of LRRK2 Inhibitor in Parkinson’s Disease
Denali Therapeutics Inc. and Biogen Inc. recently announced that dosing has commenced in the global Phase 2b LUMA study to evaluate the efficacy and safety…
SciSparc to Collaborate With Polyrizon for Brain Targeting Using Intranasal Hydrogel Systems
SciSparc Ltd. recently announced it has signed a collaboration agreement with Polyrizon Ltd., a biotech company focused on the development of innovative medical device hydrogels delivered in….
Agenus Advances Portfolio With 6 Clinical Collaborations
Agenus Inc. recently announced it has entered into three new clinical collaborations with Targovax, Oxford BioTherapeutics, and Immunogenesis, doubling its current number of….
Fortress Biotech Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating Dotinurad for the Treatment of Gout in the US
Fortress Biotech, Inc. recently announced its subsidiary company, UR-1 Therapeutics, Inc., dosed the first patient in a Phase 1 clinical trial evaluating Dotinurad for the…
Timber Pharmaceuticals Receives FDA Breakthrough Therapy Designation for the Treatment of Congenital Ichthyosis
Timber Pharmaceuticals, Inc. recently announced the US FDA has granted Breakthrough Therapy designation to TMB-001, a topical isotretinoin formulated using the company’s patented IPEG delivery…
Hepion Pharmaceuticals Highlights Upcoming Phase 2 Clinical Trials of Recofilstat at 5th Global NASH Congress
Hepion Pharmaceuticals, Inc. recently announced that its Chief Medical Officer, Todd Hobbs, MD, gave a clinical presentation titled Recofilstat (CRV431): A liver-targeting drug candidate for…
Purple Biotech Presents Phase 1 Interim Monotherapy Data for NT219 Demonstrating Encouraging Safety & Efficacy Profile
Purple Biotech Ltd. recently announced positive interim safety and efficacy data from the Phase 1 study of NT219 in adults with advanced solid tumors…..
DFE Pharma Opens New Center of Excellence in India to Provide Fast-Track Formulation Services
DFE Pharma recently announced the launch of its new Center of Excellence Closer to the Formulator (C2F) in Hyderabad, India. The C2F center is based in Genome Valley….
Yingli Pharma Doses First US Patient in Phase 1 Study of YL-13027 for Patients With Advanced Solid Tumors
Yingli Pharma US, Inc. recently announced the first patient has been dosed in its Phase 1 clinical study evaluating YL-13027, a potent and selective TGFβ…
Oncotelic Therapeutics Receives FDA Clearance for Phase 2 Clinical Trial of OT-101/Pembroluzimab Combination for Mesothelioma (M201)
Oncotelic Therapeutics, Inc. recently announced the clearance of the Phase 2 clinical trial protocol for mesothelioma after filing the protocol to the US FDA. Oncotelic…
