Roche Inks Potential $1B AAV Vector Deal with Avista for Eye Disease
Pittsburgh-based Avista Therapeutics has inked a partnership deal with Swiss pharma company Roche to develop AAV gene therapy vectors for eye diseases. The collaboration will use Avista’s single-cell adeno-associated virus (AAV) engineering platform, scAAVengr, to...
Adhera Therapeutics Signs Letter of Intent to Acquire CD71-Targeted Cancer Therapy Paclitaxel Gallium Transferrin
Adhera Therapeutics, Inc. (OTCQB: ATRX), a clinical stage biopharmaceutical company, announces that the Company has entered a Heads of Terms (also known as a Letter of Intent) agreement with Bio Innovation Group to acquire Paclitaxel Gallium Transferrin, a novel...
Amylyx Pharmaceuticals Announces Partnership Agreement with Sunnybrook Research Institute to Identify Novel Drug Candidates for Neurodegenerative Diseases
Amylyx Pharmaceuticals Inc. (NASDAQ: AMLX) announced a two-year sponsored research agreement with Sunnybrook Research Institute (SRI) to expedite the identification of novel drug candidates that inhibit Bax and Bak with high potency, specificity, and appropriate...
Omega Gets FDA Nod to Start First-Ever Epigenomic Controller Trial
Development-stage biotech company Omega Therapeutics announced Thursday that the Investigational New Drug (IND) application for its hepatocellular carcinoma (HCC) candidate, OTX-2002, has received clearance from the U.S. Food and Drug Administration. This clearance...
Regeneron, Sanofi Look to Extend Dupixent into Young Kids with Eosinophilic Esophagitis
In the latest win for Regeneron Pharmaceuticals and Sanofi's Dupixent (dupilumab), the partners announced positive results from a Phase III trial of the blockbuster in kids ages one to 11 years with eosinophilic esophagitis (EoE). Dupixent has been approved globally...
Medical Record Translations: Why Multilingual Patient Records Are Necessary in Medicine Today
As heighted numbers of patients seek medical care in overseas markets and companies look to recruit patients from all walks of life, what role do accurate medical record translations play in enabling health care professionals to deliver more targeted, patient-focused...
Light at the End of Long Road as FDA Greenlights Novavax Vaccine
The U.S. Food and Drug Administration granted Novavax’s COVID-19 vaccine Emergency Use Authorization (EUA) after a lengthy and obstacle-riddled journey. It is authorized as a two-dose primary series for adults 18 years and older. On June 7, the FDA’s Vaccines and...
Providence Therapeutics Signs Licensing Agreement with SickKids for Immunotargeting Technology
Providence Therapeutics, Canada's premier mRNA medicines company, is pleased to announce that it has entered into an exclusive licensing agreement with The Hospital for Sick Children (SickKids) of Toronto, ON, for an immunotargeting technology platform. This platform...
Marrone Bio Innovations, Inc. Shareholders Approve Merger Agreement with Bioceres Crop Solutions Corp.
Marrone Bio Innovations, Inc. (MBI) announced that during a special shareholder meeting held on July 8, 2022, its shareholders approved a proposal to adopt the previously announced Agreement and Plan of Merger (Merger Agreement), dated as of March 16, 2022, by and...
Rational’s Experimental Herpes Vaccine Shows Preclinical Promise
Rational Vaccines' experimental vaccine candidate for herpes simplex virus type 2 (HSV-2), the primary cause of genital herpes, is showing promise in preclinical studies. Massachusetts-based Rational Vaccines said findings from a pilot study funded by the National...
BioSig Announces Purchase Agreement with Kansas City Heart Rhythm Institute at Overland Park Regional Medical Center
BioSig Technologies, Inc. ("BioSig" or the "Company"), a medical technology company advancing electrophysiology workflow by delivering greater intracardiac signal fidelity through its proprietary signal processing platform, announced that Kansas City Heart Institute...
Eyenovia Strategic Partner Arctic Vision Enrolls First Patient in Phase III Clinical Trial of ARVN003 (MicroLine) for Presbyopia in China
Eyenovia, Inc., an ophthalmic pharmaceutical technology company developing a pipeline of late-stage microdose array print (MAP™) therapeutics, announced that its strategic partner, Arctic Vision, a China-based biotech company concentrated on innovative ophthalmic...
FDA Clears Vertex to Continue Dosing in Diabetes Cell Therapy Trial
Vertex Pharmaceuticals announced Tuesday that the U.S. Food and Drug Administration has withdrawn its clinical hold on the company’s Phase I/II clinical trial of VX-880, a pancreatic islet cell replacement therapy for people with Type I Diabetes (TID). The lift on the...
Provention Bio Announces FDA Extension of Diabetes Drug Review
Provention Bio will have to wait a little bit longer to see if the U.S. Food and Drug Administration will approve its diabetes prevention drug, teplizumab. On Thursday, the company announced the regulatory agency extended its review period by three months for the...
Quality Assurance for Medical Translations: Back Translation for Patient Diaries
Nuance, culturally specific idioms, and unique terminology are part of any language, but in an industry where mistranslations could endanger human life, how does back translation ensure high-quality translation of patient diaries? In healthcare, patient diaries are...
Nurix Therapeutics Announces Clearance of Investigational New Drug Application For NX-1607 Supporting Plans to Expand Enrollment to U.S. Clinical Sites
Nurix Therapeutics, Inc., a clinical stage biopharmaceutical company developing targeted protein modulation drugs, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for the company's Investigational New Drug (IND)...
BriaCell Enters Research Agreement to Identify Novel Targets for Cancer Treatment
BriaCell Therapeutics Corp., a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, today announced a research collaboration agreement with Harvard Medical School in support of a project led by Joan S. Brugge, PhD, a faculty...
Pfizer, Roivant Unveil Priovant with High Potential TYK2/JAK1 Inhibitor
Pfizer and Roivant Sciences unveiled a new company called Priovant Therapeutics to develop and market new therapies for a wide range of autoimmune diseases with high mortality and morbidity rates. Priovant was initiated in September 2021 when Pfizer partnered with...
FDA Presses Pause on Astellas’ Pompe Disease Therapeutic
The U.S. Food and Drug Administration has placed Astellas Pharma's Phase I/II FORTIS trial on clinical hold after one of its study participants suffered a serious adverse event (SAE). The study, which is assessing the investigational adeno-associated virus gene...
Sanofi-GSK COVID-19 Vaccine Candidate Effective Against Omicron
Positive news continues to roll out for COVID-19 vaccine development and distribution efforts, with Sanofi and GSK announcing the success of their vaccine candidate against the Omicron variant. Outcomes from Stage 2 of the Phase III study of VAT08 including over...