Hologic launched validated pooling protocol for COVID-19 testing
On Aug. 11, 2020, Hologic announced that it has validated use of its Aptima® and Panther Fusion® molecular…
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Gilead submited New Drug Application to FDA for Veklury (Remdesivir) for treatment of COVID-19
On Aug. 10, 2020, Gilead Sciences announced that it had submitted a New Drug Application (NDA) to the…
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Biotechnology | Disease | FDA | Therapeutics
FDA approved oral treatment for spinal muscular atrophy
On Aug. 7, 2020, the U.S. Food and Drug Administration (FDA) approved Genentech’s Evrysdi (risdiplam) to treat patients…
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FDA approved two emergency INDs for COVID-19 outpatient therapy
On Aug. 6, 2020, Organicell Regenerative Medicine, a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies,…
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Johnson & Johnson announces agreement with US Government for 100 million doses of investigational COVID-19 vaccine
On Aug. 5, 2020, Johnson & Johnson announced a $1 billion agreement with the U.S. government for the…
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Biotechnology | COVID-19 | Diagnostics | FDA
Precipio launched Covid-19 antibody test in its CLIA laboratory
On Aug. 4, 2020, Precipio announced it had completed the internal validation of the U.S. Food and Drug…
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OraSure’s OMNIgene-ORAL device included in EUA granted to Clinical Reference Laboratory for self-collected SARS saliva test
On Jul. 31, 2020, OraSure Technologies announced that its OMNIgene-ORAL (OM-505) saliva collection device is included in the…
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FDA approved new indication for drug containing an active Cannabis ingredient to treat seizures in rare genetic disease
On Jul. 31, 2020, the U.S. Food and Drug Administration (FDA) announced it had approved Epidiolex (cannabidiol) [CBD]…
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RedHill Biopharma initiated global phase 2/3 study for COVID-19
On Jul. 30, 2020, RedHill Biopharma announced that it has initiated a global Phase 2/3 clinical study evaluating…
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Biotechnology | COVID-19 | FDA
Precipio announced commercial launch of Covid-19 antibody test
On Jul. 30, 2020, Precipio announced it had entered into an agreement with ADS Biotec, based in Omaha,…
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Biotechnology | COVID-19 | Diagnostics | FDA | Therapeutics
LabCorp announced work wth public health authorities on no-charge antibody test program to accelerate COVID-19 blood plasma donation
On Jul. 30, 2020, LabCorp launched the LabCorp At Home COVID-19 Test Collection Service, the first seamless digital…
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PharmaCyte Biotech received CE Mark for licensed COVID-19 molecular tests
On Jul. 29, 2020, PharmaCyte Biotech announced that the COVID-19 Molecular tests it has licensed from Hai Kang…
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FDA authorized Quest Diagnostics lab method designed to increase COVID-19 molecular diagnostics capacity
On Jul. 29, 2020, Quest Diagnostics announced that the U.S. Food and Drug Administration (FDA) has granted emergency use…
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BARDA procured Regeneron’s REGN-EB3 investigational Ebola treatment for national preparedness
On Jul. 29, 2020, Regeneron announced that the Biomedical Advanced Research and Development Authority (BARDA) had entered into…
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LabCorp received authorization for COVID-19 sample pooling
On Jul. 25, 2020, LabCorp announced it received an Emergency Use Authorization from the FDA permitting diagnostic testing…
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Biotechnology | COVID-19 | FDA | Infectious Disease | NIH | Vaccine
Dynavax and Medigen announced collaboration to develop a novel adjuvanted COVID-19 vaccine candidate
On Jul. 23, 2020, Dynavax Technologies and Medigen Vaccine Biologics announced their collaboration to develop an adjuvanted vaccine…
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Biotechnology | Diagnostics | FDA | Oncology
BD received FDA approval for HPV test with extended genotyping capabilities
On Jul. 22, 2020, BD (Becton, Dickinson) announced that it had received approval for a pre-market approval (PMA)…
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Biotechnology | COVID-19 | FDA | Infectious Disease | NIH | Vaccine
Pfizer and BioNTech announced agreement with US government for up to 600 million doses of mRNA-based vaccine candidate against SARS-CoV-2
On Jul. 22, 2020, Pfizer and BioNTech announced execution of an agreement with the U.S. Department of Health…
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PerkinElmer released new dried blood spot based COVID-19 serology test
On Jul. 21, 2020, PerkinElmer announced the launch of a dry blood spot (DBS) based test for SARS-CoV-2…
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Bio-Techne announced launch of ExoCovid-19 test for detection of SARS-CoV-2 In patient samples
On Jul. 21, 2020, Bio-Techne announced that Exosome Diagnostics, a Bio-Techne brand, had completed validation testing for COVID-19…
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Luminex received FDA Emergency Use Authorization for COVID-19 antibody test
On Jul. 20, 2020, Luminex announced the Food and Drug Administration (FDA) had issued an Emergency Use Authorization…
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The FDA FDA Issued first Emergency Authorization for sample pooling in diagnostic testing
On Jul. 18, 2020, the U.S. Food and Drug Administration (FDA) reissued an emergency use authorization (EUA) to…
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Heron Therapeutics announced initiation of phase 2 clinical study of CINVANTI for treatment of COVID-19
On Jul. 16, 2020, Heron Therapeutics announced the initiation of the GUARDS-1 Study, a Phase 2 clinical study…
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Biotechnology | Clinical Research | Diagnostics | FDA | Medical Device | Non-Profit Research | Oncology | Rare Disease | Stem Cell | Therapeutics | U.S. Congress
Tufts Center for the Study of Drug Development reported faster new drug approval times were more than offset by longer clinical Times in US
On Jul. 16, 2020, the Tufts Center for the Study of Drug Development reported that although regulatory approval…
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Dynavax announced first participants dosed in phase 1 clinical evaluating Medicago’s COVID-19 vaccine candidate
On Jul. 14, 2020, Dynavax Technologies announced that the first participants have been dosed in the Phase 1…
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Pfizer and BioNTech granted FDA Fast Track Designation for two investigational mRNA-based vaccine candidates against SARS-CoV-2
On Jul. 13, 2020, Pfizer and BioNTech announced that two of the companiesﾒ four investigational vaccine candidates from…
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Mylan and Fujifilm Kyowa Kirin Biologics announced FDA approval of Hulio (adalimumab-fkjp)
On Jul. 9, 2020, Mylan and Fujifilm Kyowa Kirin Biologics announced the the U.S. Food and Drug Administration…
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LabCorp launched first digital COVID-19 service that improves the doctor and patient experience
On Jul. 7, 2020, LabCorp launched the LabCorp At Home COVID-19 Test Collection Service, the first seamless digital…
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Corvus Pharmaceuticals initiated clinical trial of novel immunotherapy for patients with COVID-19
On Jul. 7, 2020, Corvus Pharmaceuticals announced that it has initiated a Phase 1 study to investigate a…
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Biotechnology | COVID-19 | FDA | Infectious Disease | Influenza | Vaccine
The FDA issued an emergency use authorization for the third diagnostic test for detection and differentiation of the viruses that cause flu and COVID-19
On Jul. 6, 2020, the U.S. Food and Drug Administration (FDA) announced it had issued an emergency use…
