Formulation Development
CalciMedica Announces Peer-Reviewed Publication of Positive COVID-19 Data & Initiation of Blinded, Placebo-Controlled Trial
CalciMedica Inc. recently announced the publication in the peer-reviewed medical journal Critical Care of results from a randomized, controlled, open-label clinical study showing substantially improved…
G1 Therapeutics Announces Acceptance & Priority Review of NDA
G1 Therapeutics, Inc. recently announced the US FDA has accepted the New Drug Application (NDA) for trilaciclib for small cell lung cancer (SCLC) patients being…
Avacta & LG Chem Life Sciences Expand Partnership
Avacta Group plc recently announced the expansion of its existing multi-target collaboration and development agreement with LG Chem Life Sciences to include new programs incorporating…
Ajinomoto Bio-Pharma Services Expands Small Molecule Manufacturing Capabilities at its India Facility
Ajinomoto Bio-Pharma Services recently announced a major expansion of small molecule manufacturing capabilities with the addition of a new production facility in Visakhapatnam, India. Construction…
Scioto Biosciences Receives $26.5 Million Series B Investment From Genome & Company
Scioto Biosciences recently announced the closing of a strategic investment of up to $26.5 million from Genome & Company and other investors to join in an upcoming tranche….
Protalix BioTherapeutics & Chiesi Global Rare Diseases Announce US FDA Acceptance of Biologics License Application
Protalix BioTherapeutics, Inc. together with its development and commercialization partner Chiesi Global Rare Diseases recently announced the US FDA has accepted the Biologics License Application (BLA) and granted….
MyoKardia & LianBio Form Strategic Development & Commercialization Partnership
MyoKardia, Inc. and LianBio recently announced they have entered into a strategic collaboration to develop and commercialize….
GigaGen Announces Publication of Research Describing a New Class of Drugs, Recombinant Hyperimmunes, Including its Novel COVID-19 Therapy, GIGA-2050
GigaGen presents a novel technology for producing a new class of drug, which it calls recombinant hyperimmunes…..
Multiple Headlands Research Sites Selected for AstraZeneca’s Phase 3 COVID-19 Vaccine Trial
Headlands Research recently announced its research centers have been selected to participate in AstraZeneca’s upcoming Phase 3 COVID-19 vaccine trial. Headlands has built an industry-leading…
FDA Clears Appili Therapeutics to Expand its Phase 2 Clinical Trial of Favipiravir for the Potential Prevention of COVID-19
Appili Therapeutics Inc. recently announced the US FDA has granted the company clearance to proceed after Appili’s filing of an investigational new drug (IND) application…
Eyenovia & Arctic Vision Announce Exclusive Collaboration & License Agreement
Eyenovia, Inc. and Arctic Vision recently announced they have entered into an exclusive license agreement for Arctic Vision to develop and commercialize MicroPine for the…
Immutep Granted US Patent for Eftilagimod Alpha in Chemo-Immunotherapy Combination
Immutep Limited, a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune disease, recently announced the grant of a new patent (number 10,736,940) titled…
Clearside Biomedical Announces US FDA Acceptance of IND Application
Clearside Biomedical, Inc. recently announced the US FDA has accepted its Investigational New Drug (IND) application for CLS-AX (axitinib injectable suspension), enabling initiation of a…
Arcturus Therapeutics Announces Dosing of its COVID-19 Vaccine Candidate in Phase 1/2 Study
Arcturus Therapeutics Holdings Inc. recently announced that all subjects in the first cohort have been dosed in the Phase 1/2 clinical study with its ARCT-021…
Biogen & Denali Sign Co-Development/Co-Commercialization Agreement
Biogen Inc. and Denali Therapeutics Inc. recently announced they have signed a binding agreement to co-develop and co-commercialize Denali’s small molecule inhibitors of leucine-rich repeat kinase 2 (LRRK2) for….
RedHill Biopharma’s Phase 2/3 COVID-19 Study Approved in Mexico
RedHill Biopharma Ltd. recently announced approval from the Mexican Federal Committee for the Protection against Sanitary Risks (COFEPRIS) for the company’s Clinical Trial Authorization (CTA) application for….
Immatics Extends Cell Therapy Manufacturing Collaboration With UTHealth
Immatics N.V. recently announced the extension of its cell therapy manufacturing collaboration with The University of Texas Health Science Center at Houston (UTHealth)….
Catalent Adds Potent Manufacturing Capabilities at its Buenos Aires Site
Catalent recently announced that it will expand its Argentinian site in Loma Hermosa, Buenos Aires. The expansion, which will add over….
Immunic, Inc. Reports Positive Top-line Data From Phase 2 EMPhASIS Trial
Immunic, Inc. recently announced positive top-line data from its phase 2 EMPhASIS trial of lead asset, IMU-838, the company’s selective oral DHODH inhibitor, in patients…
FDA Approves Two Emergency INDs for COVID-19 Outpatient Therapy
Organicell Regenerative Medicine, Inc. recently announced the US FDA approved two outpatient Emergency Investigational New Drug Applications (eINDs) for treating mild-to-moderate respiratory distress due to…
