Formulation Development
Cidara Therapeutics Announces FDA Acceptance of its Investigational New Drug Application for CD388 for Universal Prevention & Treatment of Influenza
Cidara Therapeutics, Inc. recently announced the US FDA has accepted its Investigational New Drug (IND) application for its lead flu drug-Fc conjugate (DFC), CD388 –…
Decibel Therapeutics Reports on Continued Progress of Lead Gene Therapy Product Candidate & Presents Promising Preclinical Data Supporting Importance of Cell-Selective Transgene Expression Across Gene Therapy Pipeline
Decibel Therapeutics recently announced the presentation of preclinical data on its lead gene therapy product candidate, DB-OTO, as well as preclinical data highlighting the identification of proprietary, cell-selective promoters….
CureVac Doses First Participant in Phase 1 Study With Multivalent Influenza Vaccine Candidate Based on Second-Generation mRNA Backbone Developed in Collaboration With GSK
CureVac N.V. recently announced it has dosed the first participant in a Phase 1 study of its seasonal influenza second-generation mRNA vaccine candidate, CVSQIV, developed…
Denali Therapeutics Announces Continued Progress in DNL310 Program for MPS II (Hunter Syndrome) Supporting Planned Initiation of Phase 2/3 Clinical Trial
DNL310 is an investigational brain-penetrant enzyme replacement therapy intended to treat both central nervous system (CNS) and peripheral manifestations of MPS II (Hunter syndrome). ….
Opiant Pharmaceuticals Announces Positive Pharmacokinetic, Safety & Tolerability Results From a Multi-Dose Study for OPNT003, Nasal Nalmefene
Opiant Pharmaceuticals, Inc. recently announced positive topline results from a multi-dose pharmacokinetic (PK) study for OPNT003, nasal nalmefene, an investigational treatment for opioid….
Dyadic & Phibro Animal Health Announce Exclusive License Agreement to Develop & Commercialize Animal Health Vaccine
Dyadic International, Inc. and Phibro Animal Health recently announced they have entered into an exclusive license agreement for a Phibro targeted disease. This agreement follows…
Berkshire Sterile to Offer Formulation, Lyophilization & Method Development Services
Berkshire Sterile Manufacturing (BSM) MA, has recently added formulation, lyophilization, and method development capabilities to complement their clients’ drug productions…..
Adial Pharmaceuticals Announces Positive In Vivo Data for Purnovate’s PNV-5032 as a Potential Treatment for Asthma
Purnovate, Inc., a wholly owned subsidiary of Adial Pharmaceuticals, Inc. recently announced positive in vivo data for PNV-5032, as a potential treatment for….
TriRx Completes Acquisition of Elanco Manufacturing Facility in Speke, UK
TriRx Pharmaceutical Services, LLC, a leading international CDMO, recently announced it has finalized and closed on its agreement with Elanco Animal Health Incorporated to acquire the ownership and operations of….
Regio Biosciences Enters License Agreement With AstraZeneca for Phase 2a Asset in Peripheral Artery Disease
Regio Biosciences recently announced it has entered into an exclusive license agreement with AstraZeneca to further develop REG-101, a novel therapeutic acting on reverse cholesterol….
SEngine Precision Medicine & Oncodesign Announce Collaboration Agreement for the Discovery of New Personalized Cancer Treatment for Aggressive & Untreatable Tumors
SEngine Precision Medicine Inc. and Oncodesign recently announced the signature of a research collaboration agreement for R&D of a new personalized cancer treatment for aggressive and…..
Gattefossé Strengthens its CSR Approach & Reaches Two Major Milestones
In line with its CSR commitment, Gattefossé has received ISO 14001:2015 certification for its main production site in France and has been ranked in the…
Xanadu Bio Obtains Licenses & Options to Novel Platform Technologies From Yale University to Develop Intranasal SARS CoV-2 mRNA Vaccine Booster
Xanadu Bio recently announced a broad exclusive license agreement from Yale University for a next-generation polymeric nanoparticle delivery platform known as PACE. Additionally, the company has executed….
Ocuphire Completes Enrollment in MIRA-3 Pivotal Phase 3 Clinical Trial
Ocuphire Pharma, Inc. recently announced it has completed enrollment in MIRA-3, the second Phase 3 FDA registration trial evaluating the safety and efficacy of Nyxol eye drops to reverse pharmacologically….
Ovid Therapeutics & Healx to Enter Strategic Partnership
Ovid Therapeutics and Healx recently announced Healx has secured from Ovid an exclusive option to license rights to develop and commercialize gaboxadol. Under the agreement, Healx plans to….
Eyenovia Concludes Type A Meeting With FDA Related to MydCombi NDA Resubmission
Eyenovia, Inc. recently announced that the company successfully completed a Type A meeting with the US FDA related to the refiling of the NDA for…
Recce Pharmaceuticals Announces Positive Safety Data From Third Cohort of Phase 1 Clinical Trial
Recce Pharmaceuticals Ltd recently reported Phase 1 intravenous (IV) clinical trial of RECCE 327 (R327) cohort three at 500mg (tenfold increase on cohort one 50mg…
CDMO INNOVATION - How a Global CDMO Puts Innovation at the Forefront of its Business Strategy
Kai Vogt, Senior Vice President Corporate Development/Legal/Corporate Compliance/IT, Vetter, explains how a global CDMO puts innovation at the forefront of its business strategy.
Valneva & Pfizer Report Further Positive Phase 2 Data for Lyme Disease Vaccine Candidate
Valneva SE and Pfizer Inc. recently reported further positive Phase 2 data for their Lyme disease vaccine candidate, VLA15. Based on these new results….
Kintara Therapeutics Announces Issuance of New US Patent Related to VAL-083 & MGMT Resistance: Implications for Targeting Brain Tumor Stem Cells
Kintara Therapeutics, Inc. recently announced the US PTO has issued to Kintara United States Patent No. 11,234,955 covering a method of treating brain tumors including…
