BioCentury | Nov 21, 2020
Product Development

Nov. 20 Quick Takes: uniQure hemophilia therapy hits pivotal endpoint; plus data from Gilead in HIV, Aivita  in GBM and a setback for Poxel

uniQure hemophilia therapy hits co-primary Phase III endpointuniQure N.V. (NASDAQ:QURE) said gene therapy etranacogene dezaparvovec met one primary endpoint of the Phase III HOPE-B trial to treat hemophilia B. The adeno-associated viral serotype 5 (AAV5)...
BioCentury | Nov 21, 2020

Nov. 20 Quick Takes: Approvals in Europe for Alnylam, Alexion therapies; plus FDA priority review for ADC, Sanofi and more

EC approves Alnylam, Alexion therapiesAlnylam Pharmaceuticals Inc. (NASDAQ:ALNY) said the European Commission approved Oxlumo lumasiran, an RNAi therapy targeting the HAO1 mRNA that encodes glycolate oxidase, to treat primary hyperoxaluria in all age groups. The...
BioCentury | Nov 10, 2020
Product Development

Reata, Calliditas make good on renewed interest in kidney disease with Phase III successes

Two renal diseases are on track for their first approvals after a pair of Phase III studies hit primary endpoints, suggesting renewed interest in the therapeutic area is paying off for patients and investors....
BioCentury | Nov 7, 2020
Targets & Mechanisms

Product profiles that could make interferons effective against COVID-19

The recent failure of IFNβ in WHO’s master protocol trial for COVID-19 notwithstanding, there are plenty of reasons to suspect that interferons should be effective treatments for the infection. An analysis...
BioCentury | Oct 28, 2020

Supply constraints loom as Regeneron reports positive data on COVID-19 mAb

Days before FDA is expected to decide about their emergency use authorization requests, Regeneron released new data confirming the efficacy of its COVID-19 mAb cocktail and Lilly announced that the U.S. government has contracted to...
BioCentury | Sep 18, 2020
Product Development

Harmonizing limits of detection for FDA-authorized COVID-19 diagnostics

Comparing the limits of detection for COVID-19 molecular diagnostic tests offers a window into their relative sensitivity and potential to produce false negative results. New data published by FDA, based...
BioCentury | Sep 10, 2020

Casma to advance muscle dystrophy candidate into the clinic with $50M series B

...see “Tailoring Autophagy Targets to Indications”).Its DMD program targets TRPML1... has in vitro data showing that TRPML1...
...primary response gene 88 SNCA – ɑ synuclein TRPML1 (MCOLN1) – Mucolipin 1 Danielle...
BioCentury | Sep 9, 2020
Product Development

COVID-19 roundup: SpyBiotech-Serum Institute of India send HBV-based COVID-19 vaccine to clinic; plus Vaxart, Inovio-Thermo Fisher and RedHill

SpyBiotech, Serum Institute of India start vaccine trialU.K. biotech SpyBiotech Ltd. and its partner the Serum Institute of India on Tuesday started a Phase I/II trial of a virus-like particle (VLP)-based COVID-19 vaccine. The vaccine...
BioCentury | Sep 2, 2020
Product Development

EMA evaluating dexamethasone for COVID-19 as WHO meta-analysis of three steroids reiterates benefit

EMA includes RECOVERY data in review of dexamethasone MAAEMA said it has begun evaluating dexamethasone from Taw Pharma to treat hospitalized COVID-19 patients, and is considering CHMP’s review of the U.K’s RECOVERY trial data in...
BioCentury | Sep 1, 2020
Product Development

Aug. 31 Quick Takes: Mylan, Biocon launch cheaper insulin in U.S.; plus: AZ, bluebird, Lipocine, Amgen, AbbVie-Morphic, Polyphor-Fosun and Milestone

Mylan, Biocon launch long-acting insulin biosimilar in U.S. Mylan N.V. (NASDAQ:MYL) and Biocon Ltd. (NSE:BIOCON; BSE:532523) launched Semglee insulin glargine in the U.S. at a wholesale acquisition cost (WAC) of $147.98 per package of five...
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