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covidtest sep28 The U.S. Food and Drug Administration said it now intends to review only a small subset of new emergency use authorization or EUA requests for diagnostic tests. As per an updated COVID-19 test policy with a view to ensure continued access to tests, the regulator further urged developers of all test types seeking marketing authorization to pursue traditional premarket review for most test types.

Citius Pharmaceuticals, Inc. (CTXR) has submitted a Biologics License Application to the FDA for denileukin diftitox, an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma. I/ONTAK is a purified and more bioactive formulation...

UroGen Pharma Ltd. (URGN) announced the FDA has authorized an extension of the in-use period for JELMYTO for pyelocalyceal solution admixture from 8 hours to 96 hours following reconstitution of the product. The company noted that the extension has implications for all stakeholders including physicians,...

Dutch biopharmaceutical company Pharming Group N.V. (PHAR) announced that the US Food and Drug Administration has accepted for priority review its New Drug Application or NDA for leniolisib to treat the rare primary immunodeficiency activated phosphoinositide 3-kinase delta syndrome or APDS in adults...

Avidity Biosciences, Inc. (RNA) announced the FDA has placed a partial clinical hold on new participant enrollment in the phase 1/2 MARINA clinical trial of AOC 1001 in adults with myotonic dystrophy type 1. The partial clinical hold is in response to a serious adverse event reported in a single participant...

Innocoll Pharmaceuticals Limited, a portfolio business of Gurnet Point Capital, and DURECT Corporation (DRRX) announced the commercial launch of POSIMIR in the United States. As per the terms of the collaboration between Innocoll and DURECT, Innocoll will make a $2 million payment to DURECT triggered...

CSL Seqirus, a business of CSL Limited, reported data highlighting the significant burden influenza places on hospitals and healthcare resource use. A new study suggested that when COVID-19 and influenza viruses are co-circulating, the U.S. influenza immunization rate should be raised from 45 percent...

Biopharmaceutical company Atea Pharmaceuticals, Inc. (AVIR) announced Monday that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to AT-752, a novel, orally administered, direct-acting antiviral for the treatment of dengue virus infection. AT-752, a novel, orally administered...

Pfizer Inc. (PFE) and BioNTech SE (BNTX) announced Monday that they have completed a submission to the U.S. Food and Drug Administration requesting Emergency Use Authorization or EUA of a 10-g booster dose of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of...

Ionis Pharmaceuticals, Inc. (IONS) said topline results from the phase 2bSOLANO study in patients with hypercholesterolemia showed that 60mg of ION449 administered monthly achieved a statistically significant 62.3% reduction in low-density lipoprotein cholesterol levels after 28 weeks compared to placebo,...

AstraZeneca PLC (AZN.L, AZN) announced Ultomiris has been approved in Europe as an add-on to standard therapy for the treatment of adult patients with generalised myasthenia gravis who are anti-acetylcholine receptor antibody-positive. The approval follows the positive opinion of the Committee for Medicinal...

Veracyte, Inc. (VCYT) said new data show that the company's Decipher Prostate Genomic Classifier may help identify African American men with early, localized prostate cancer who are most likely to harbor more aggressive disease. The data from the VANDAAM Phase 2 study suggest that the genomic test...

GSK plc (GSK, GSK.L) and Spero Therapeutics, Inc. (SPRO) have entered into a licence agreement for tebipenem pivoxil hydrobromide or tebipenem HBr, a late-stage antibiotic being developed by Spero, as the first oral carbapenem antibiotic to potentially treat complicated urinary tract infections. GSK...

AstraZeneca (AZN.L, AZN) said Lynparza has been approved in China for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to 1st-line platinum-based chemotherapy in combination with bevacizumab,...

British drug major AstraZeneca Plc (AZN.L, AZN) Wednesday said its Tezspire (tezepelumab) has been approved in the European Union for the treatment of severe asthma. Tezspire is approved as an add-on maintenance treatment in patients 12 years and older with severe asthma who are inadequately controlled...

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