SIGA announced Public Health Agency of Canada contract to purchase $33 million of Oral TPOXX
On Jan. 13, 2021, SIGA Technologies announced that the Public Health Agency of Canada had awarded a contract…
Rising protocol design complexity reported driving rapid growth in clinical trial data volume
On Jan. 12, 2021, the Tufts Center for the Study of Drug Development (Tufts CSDD) reported that ever…
Biotechnology | CRISPR | FDA | Therapeutics
FDA cleared initiation of the Editas Medicine’s EDIT-301 clinical trial using CRISPR/Cas12a gene editing
On Jan. 11, 2021, Editas Medicine announced the U.S. Food and Drug Administration (FDA) had cleared the initiation…
Roche’s Xofluza approved by the EC for treatment of influenza, first new influenza antiviral in almost 20 years
On Jan. 11, 2021, Roche announced that the European Commission (EC) had approved Xofluza (baloxavir marboxil) for the…
Biotechnology | Diagnostics | Disease | Oncology | Radiology | Therapeutics
American Cancer Society reported largest one-year drop in cancer mortality from 1991-2017
On Jan. 8, 2021, the American Cancer Society reported that the death rate from cancer in the U.S….
In vitro study showed Pfizer-BioNTech COVID-19 vaccine elicited antibodies that neutralize SARS-CoV-2 with mutation
On Jan. 8, 2021, Pfizer and BioNTech announced results from an in vitro study conducted by Pfizer and…
Twist Bioscience supplied Centers for Disease Control and Prevention with custom SARS-CoV-2 synthetic RNA controls
On Jan. 7, 2021, Twist Bioscience announced it would supply the U.S. Centers for Disease Control and Prevention…
CytoDyn research on critically Ill COVID-19 patients published in Journal of Translational Autoimmunity
On Dec. 31, 2020, CytoDyn announced a research manuscript submitted by Nicholas J. Agresti, M.D. had been accepted…
COVID-19 | Neurology | NIH | Therapeutics
NIH study uncovered blood vessel damage and inflammation in COVID-19 patients’ brains but no infection
On Dec. 30, 2020, the NIH researchers announced that an in-depth study of how COVID-19 affects a patient’s…
Biotechnology | COVID-19 | FDA | NIH | Therapeutics
Medigen Vaccines obtained TFDA phase 2 IND approval for COVID19 vaccine
On Dec. 30, 2020, Medigen Vaccine Biologics announced that it had obtained TFDA Phase 2 IND approval of…
Mateon global study for OT-101/ TGF-inhibitor against COVID-19 treated its first patient
On Dec. 30, 2020, Mateon Therapeutics announced that it had enrolled and treated its first sentinel Part 1…
Biotechnology | Disease | FDA | Therapeutics
FDA approved first generic of drug used to treat severe hypoglycemia
On Dec. 28, 2020, the U.S. Food and Drug Administration approved the first generic of glucagon for injection…
The Serum Institute of India launched India’s first indigenously developed pneumococcal vaccine
On Dec. 28, 2020, Serum Institute of India announced the launch of India’s first indigenously developed pneumococcal vaccine…
AIM ImmunoTech announced availability of ME/CFS clinical trial of drug Ampligen for enrollment to COVID-19 ‘Long Haulers’
On Dec. 24, 2020, AIM ImmunoTech announced that the post-COVID-19 ‘Long Hauler’ portion of the active AMP-511 Expanded…
Biotechnology | COVID-19 | FDA | Therapeutics
Sorrento announced it had submitted an EUA application to the FDA for COVI-STIX rapid test for detection of SARS-CoV-2 antigen
On Dec. 22, 2020, Sorrento Therapeutics announced that an Emergency Use Authorization (EUA) Application had been submitted to…
RedHill’s phase 2/3 COVID-19 study of opaganib passed second DSMB with unanimous recommendation
On Dec. 22, 2020, RedHill Biopharma announced that the global Phase 2/3 study with orally-administered opaganib (Yeliva, ABC294640)1…
Cocrystal Pharma selected lead compound for further development against Coronaviruses
On Dec. 22, 2020, Cocrystal Pharma announced the selection of CDI-45205 as the lead compound for further development…
European Commission approved Aimmune’s PALFORZIA as first-ever treatment for peanut allergy in the EU
On Dec. 21, 2020, Aimmune Therapeutics announced that the European Commission (EC) had approved PALFORZIA [defatted powder of…
Pfizer and BioNTech to supply the European Union with 100 million additional doses of COMIRNATY
On Dec. 19, 2020, Pfizer and BioNTech announced they supplying an additional 100 million doses of COMIRNATY the…
Biotechnology | Diagnostics | Disease | FDA | Oncology | Radiology | Therapeutics
FDA approved first adjuvant therapy for most common type of lung cancer
On Dec. 18, 2020, the the U.S. Food and Drug Administration (FDA) approved AstraZeneca’s Tagrisso (osimertinib) as the…
National Research Council of Canada supported development of 4 COVID-19 therapeutic candidates
On Dec. 18, 2020, the National Research Council of Canada (NRC) announced it was providing advisory services and…
Lilly began pragmatic study of neutralizing antibody bamlanivimab (LY-CoV555) for COVID-19 in New Mexico
On Dec. 18, 2020, Eli Lilly announced plans to begin a new pragmatic study of bamlanivimab (LY-CoV555) in…
RedHill’s phase 2/3 COVID-19 candidate opaganib reduced ARDS-related blood clotting in preclinical model
On Dec. 15, 2020, a months long study to determine the number of Houstonians carrying COVID-19 antibodies revealed…
Aurinia and Lonza announced exclusive agreement for dedicated Voclosporin manufacturing capacity
On Dec. 15, 2020, Aurinia Pharmaceuticals announced the funding and initiation of an open-label exploratory trial evaluating the…
INOVIO to develop DNA-encoded monoclonal antibody (dMAb) candidates to treat COVID-19
On Dec. 15, 2020, Inovio Pharma announced the company and a team of scientists from The Wistar Institute,…
Anixa Biosciences Covid-19 therapy demonstrated comparable potency to remdesivir in pre-clinical testing
On Dec. 14, 2020, Anixa Biosciences announced that it and partner OntoChem GmbH had verified that one of…
Biotechnology | CRISPR | FDA | Therapeutics
CIRM-funded project targeting sickle cell disease received green light for clinical trial
On Dec.14, 2020, the US Food and Drug Administration (FDA) announced they had granted Investigational New Drug (IND)…
Incyte announced results of phase 3 study of Ruxolitinib (Jakafi) as treatment for patients with COVID-19 associated cytokine storm
On Dec. 14, 2020, Incyte announced that the Phase 3 RUXCOVID study evaluating the safety and efficacy of…
AI test ruled out a COVID-19 diagnosis within one hour in Emergency Departments
On Dev. 11, 2020, the University of Oxford reported that an Artificial Intelligence test had been shown to…
COVID-19 | FDA | Therapeutics
Data from ACTT-2 trial of Baricitinib in hospitalized COVID-19 patients supportive of the EUA published in NEJM
On Dec. 11, 2020, Eli Lilly and Incyte announced The New England Journal of Medicine had published the…