Formulation Development
Zealand Pharma Completes Enrollment in Phase 3 Trial of Dasiglucagon in Children With Congenital Hyperinsulinism
Zealand Pharma A/S recently announced completion of patient enrollment in the second Phase 3-trial, 17103, of dasiglucagon for the treatment of Congenital hyperinsulinism (CHI) in….
Neurocentria Obtains FDA Approval to Conduct Pivotal Phase 2b/3 Clinical Trial for Testing Safety & Efficacy of Drug Candidate NRCT-101SR in Adults With ADHD
Neurocentria Inc. has recently received FDA approval to conduct a pivotal Phase 2b/3 human clinical trial to test the efficacy and safety of its leading…
OKYO Pharma Announces Successful Completion of Pre-IND Meeting With FDA on the Development of OK-101 to Treat Dry Eye Disease
OKYO Pharma Limited recently announced the successful completion of a pre-IND (Investigational New Drug) meeting with the US FDA regarding the development plans for OK-101…
Cerevel Therapeutics Announces Positive Topline Results for Darigabat in Phase 1 Clinical Trial in Acute Anxiety
Cerevel Therapeutics recently announced positive results from its Phase 1 healthy volunteer clinical trial to evaluate darigabat, a novel alpha-2/3/5 selective GABAA receptor positive allosteric modulator….
AC Immune & Janssen Pharmaceuticals Report Interim Results for Phase 2 Tau Vaccine Program
AC Immune SA recently announced new interim 10-week data from the high-dose cohort of a placebo-controlled Phase 1b/2a trial evaluating ACI-35.030, a first-in-class phosphorylated-Tau (pTau) vaccine candidate in….
PDS Biotech Announces Clinical Trial With Mayo Clinic to Study PDS0101 in Early Stage Pre-Metastatic- HPV-Associated Head & Neck Cancer
PDS Biotechnology Corporation recently announced the initiation of an Investigator-Initiated Trial (ITT), MC200710, for PDS0101 alone or in combination with the checkpoint inhibitor, KEYTRUDA, in patients…
Integrity Bio & LakePharma Become Curia
Curia, formerly AMRI, a leading contract research, development and manufacturing organization, recently announced that Integrity Bio and LakePharma, two companies that it acquired….
Revive Therapeutics Provides Update on Phase 3 Clinical Trial for Bucillamine in COVID-19
Revive Therapeutics Ltd. recently provided an update on the company’s US FDA Phase 3 clinical trial (NCT04504734) to evaluate the safety and efficacy of….
Collegium to Acquire BioDelivery Sciences Broadening Pain Portfolio
Collegium Pharmaceutical, Inc. and BioDelivery Sciences International, Inc. recently announced a definitive agreement pursuant to which Collegium will acquire BDSI for….
Pardes Biosciences Presents Interim Clinical Data From Ongoing PBI-0451 Phase 1 Trial
Pardes Biosciences, Inc. recently announced interim clinical data from its ongoing PBI-0451 Phase 1 trial in healthy adult volunteers has been made available to registered…
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….
