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Evonik Increases Global Supply of Pharma-Grade Plant-Derived Cholesterol for mRNA Vaccines & Gene Therapies
Evonik has boosted its supply of plant-derived cholesterol, one of the most critical components for the manufacture of mRNA vaccines and gene therapies. The large-scale production of….
Aeterna Zentaris Announces Notice of Allowance for US Patent Covering AEZS-150 for the Potential Treatment of Chronic Hypoparathyroidism
Aeterna Zentaris Inc. recently announced that its licensor, The University of Sheffield, has received a notice of allowance from the USPTO for its patent application No. 16/608,611…..
CDMOs Need to be Prepared for the Revision of the EU-GMP-Annex 1
Annex 1 of the EU-GMP-Guide Manufacture of Sterile Medicinal Products is considered the most important European regulatory standard for the manufacture of sterile pharmaceutical products. The current revision will have to….
After 25 Years, There is a CEO Transition at Hovione!
Hovione recently announced the Board of Directors and the shareholders have approved the appointment of Dr. Jean-Luc Herbeaux as Hovione’s Chief Executive Officer, effective….
Santhera Signs Gene Therapy Agreement With SEAL Therapeutics
Santhera recently entered into an agreement with SEAL Therapeutics, a spin-off company from the Biozentrum of the University of Basel, which will further develop a….
TFF Pharmaceuticals Announces Inhaled Niclosamide Significantly Inhibits Viral Replication of the Omicron Variant of SARS-CoV-2
TFF Pharmaceuticals, Inc. recently announced that results from its recently completed in vitro neutralization and viral replication assays indicate that the company’s inhaled niclosamide product candidate completely….
Rani Therapeutics Unveils High-Capacity RaniPill Device for Oral Delivery of Biologics
Rani Therapeutics Holdings, Inc. recently announced the development of a high-capacity oral biologics device known as the RaniPill HC (High Capacity), capable of delivering up to….
Hovione & Zerion Pharma Announce Strategic Partnership
Hovione recently announced a strategic partnership with Zerion Pharma to market and commercialize Dispersome, Zerion´s proprietary solubility enhancement….
Medigene & BioNTech Announce Global Collaboration to Advance T Cell Receptor Immunotherapies Against Cancer
Medigene AG and BioNTech SE recently announced they have entered a multi-target research collaboration to develop T cell receptor (TCR) based….
Enteris BioPharma Highlights Progress in Oral Feasibility Program
Enteris BioPharma, Inc. recently provided an update on its oral feasibility programs involving the company’s Peptelligence and ProPerma oral peptide and small….
Recipharm Announces Acquisition of Vibalogics & Arranta Bio
Recipharm is continuing to build its service offerings in new biologic modalities through the acquisition of Vibalogics and Arranta Bio….
Zai Lab Announces Breakthrough Therapy Designation
Zai Lab Limited recently announced the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation for investigational….
Celsion Reports Data Safety Monitoring Board Unanimous Recommendation to Continue Dosing Patients in the Phase 2 Portion of the OVATION 2 Study With GEN-1 in Advanced Ovarian Cancer
Celsion Corporation recently announced that following a pre-planned interim safety review of 81 as treated patients randomized in the Phase 1/2 OVATION 2 Study with….
Hillstream BioPharma Receives Orphan Drug Designation for Uveal Melanoma Treatment
Hillstream BioPharma Inc. recently announced the FDA granted Orphan Drug Designation to HSB-1216 for Uveal Melanoma (UM). Hillstream continues to….
Adial Pharmaceuticals Announces Closing of $10 Million Financing
Adial Pharmaceuticals, Inc. recently announced the closing of its previously announced registered direct offering, whereby a single accredited institutional investor purchased approximately….
Skye Bioscience Reports Positive Results for SBI-100 in GLP Toxicology Study
Skye Bioscience, Inc. recently announced it has completed a good laboratory practice (GLP) nonclinical toxicology study of its SBI-100 ophthalmic nanoemulsion in support of the company’s….
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….
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….
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….