Formulation Development
Polyplus Acquires e-Zyvec to Expand Expertise in Plasmid DNA Vector Engineering
Polyplus recently announced the acquisition of e-Zyvec, a provider of DNA design and production services for tailor-made DNA vectors for gene therapy, bio-manufacturing, and research.…
ANAVEX2-73 (Blarcamesine) AVATAR Phase 3 Trial Met Primary & Secondary Efficacy Endpoints for the Treatment of Adult Patients With Rett Syndrome
Anavex Life Sciences Corp. recently reported positive top-line results from the Phase 3 randomized, double-blind, placebo-controlled AVATAR trial of ANAVEX2-73 (blarcamesine) in adult female….
Biogen Exercises Option to Participate in the Development & Commercialization of a Late-Stage Bispecific Antibody
Biogen Inc. recently announced it exercised its option to participate in the development and commercialization of mosunetuzumab. Biogen will pay a $30-million one-time option fee…
Biofrontera Inc. provides Update on Patient Recruitment for Phase 3 Study for the Treatment of sBCC With Ameluz-PDT
Biofrontera Inc. recently provided an update on the patient recruitment for the Phase 3 clinical study for the treatment of superficial basal cell carcinoma (sBCC)…
Arcutis Completes Enrollment of STRATUM Pivotal Phase 3 Trial of Topical Roflumilast Foam in Individuals With Seborrheic Dermatitis
Arcutis Biotherapeutics, Inc. recently announced the enrollment of the last subject in its STRATUM Phase 3 pivotal trial for topical roflumilast foam in patients with….
Skye Bioscience Reports Potential Neuroprotective Benefit of SBI-100 In Preclinical Glaucoma Model
Skye Bioscience, Inc. recently announced that in a preclinical study assessing the neuroprotective properties of its SBI-100 ophthalmic nanoemulsion, the treated group demonstrated a trend…
Veru Enters Clinical Trial Collaboration & Supply Agreement With Eli Lilly & Company
Veru Inc. recently announced it has entered into a clinical trial collaboration and supply agreement with Eli Lilly and Company. The objective of the collaboration is to evaluate the efficacy and safety of….
Aravive Announces First Patient Dosed in Phase 2 Study of Batiraxcept in Clear Cell Renal Cell Carcinoma
Aravive, Inc. recently announced it has dosed the first patient in the Phase 2 portion of the Phase 1b/2 study of batiraxcept for the treatment of clear cell renal cell carcinoma (ccRCC)…..
Altimmune Announces FDA Clearance of Pemvidutide (ALT-801) IND for Obesity
Altimmune, Inc. recently announced the US FDA has cleared the company’s Investigational New Drug (IND) application for its Phase 2 clinical trial of pemvidutide for…
Viridian Therapeutics Announces FDA Clearance of Investigational New Drug Application to Initiate Clinical Development of VRDN-002, a Next-Generation IGF-1R Antibody for the Treatment of Thyroid Eye Disease
Viridian Therapeutics, Inc. recently announced the US FDA clearance of its investigational new drug (IND) application of VRDN-002. The Company’s next generation IGF-1R antibody, VRDN-002,…
Celsion Corporation Advances Proof of Concept to Non-human Primate Challenge Study Against SARS-CoV-2 With In-Process Vaccine Candidate
Celsion Corporation recently announced it has engaged BIOQUAL, Inc., a preclinical testing contract research organization, to conduct a non-human primate (NHP) challenge study with Celsion’s DNA-based approach for….
Veru Announces FDA Grant of Fast Track Designation for Sabizabulin for the Treatment of Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome
Veru Inc. recently announced the US FDA has granted Fast Track designation to the Phase 3 registration program for the investigation of sabizabulin, a novel,…
Biogen Reaches Agreement With Samsung Biologics to Sell Equity Stake in Their Biosimilar Joint Venture for up to $2.3 Billion
Biogen Inc. recently announced it has entered into an agreement whereby Samsung Biologics will acquire Biogen’s equity stake in the Samsung Bioepis joint venture for an aggregate consideration of up to….
Enable Injections Announces $215-Million Financing
Enable Injections, Inc. recently announced $215 million in Series C financing. Magnetar Capital (Magnetar) led the financing along with new institutional investments from….
atai Life Sciences Launches Invyxis to Accelerate Discovery of Next-Generation Mental Health Treatments
atai Life Sciences N.V. recently launched Invyxis, a new, wholly owned platform company committed to developing new chemical entities (NCEs) and to further pioneering next-generation…
Yamo Pharmaceuticals Announces Enrollment of First Patient in Phase 2 Study of L1-79 in Autism Spectrum Disorder
Yamo Pharmaceuticals recently announced the first patient has been treated in a Phase 2 study of L1-79 in adolescents and young adults with ASD at…
Cocrystal Pharma Selects Two Lead Antiviral Drug Candidates for its COVID-19 Oral Drug Program
Cocrystal Pharma, Inc. has selected two investigational novel antiviral drug candidates for further development as oral treatments for SARS-CoV-2, the virus that causes COVID-19…..
TFF Pharmaceuticals Completes Enrollment in Phase 1 Study Evaluating Inhaled Formulation of Niclosamide to Treat COVID-19
TFF Pharmaceuticals, Inc. recently announced it has completed enrollment of 40 healthy subjects in its Phase 1 clinical trial (CT.gov identifier NCT05168644) of a dry…
PDS Biotech Announces Preclinical Data for PDS0202 Universal Influenza Vaccine
PDS Biotechnology Corporation recently announced preclinical data for its universal flu vaccine, which was shown to be effective against….
Provectus Biopharmaceuticals Provides Update on Research into PV-10 Immunotherapy as an Immune Adjuvant for Making Vaccines Work Better
Provectus recently provided an update on research of its investigational immunotherapy PV-10 (rose bengal sodium, a halogenated xanthene small molecule) as an immune adjuvant in…
