Market News & Trends
Catalent Expands Temperature-Controlled Clinical Supply Capabilities in Shanghai, China
Catalent recently announced it plans to expand its Waigaoqiao Free Trade Zone (FTZ) facility in Shanghai, China, to increase capacity for temperature-controlled storage and distribution…
BioXcel Therapeutics Presents Positive Data From Phase 2 Trial of BXCL701 in Aggressive Forms of Prostate Cancer
BioXcel Therapeutics, Inc. recently announced results from its ongoing Phase 2 trial of BXCL701, the company's investigational, oral innate immunity activator, in metastatic castration-resistant prostate…
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….
IsoPlexis’ Immune Monitoring Helps Identify Early Factors of Long COVID in Cell Publication
IsoPlexis Corporation recently announced the publication of a study in Cell, led by the Institute for Systems Biology and Seattle COVID consortium, in which researchers…
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…..
