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 17, 2020

Another U-turn for COVID-19 testing regulation as HHS requires FDA to re-prioritize LDT review

...faced by the labs that developed them. Under the Public Health and Emergency Preparedness Act (PREP...
BioCentury | Oct 16, 2020

VectivBio prepping pivotal GI trial with $110M crossover round that could presage IPO

A public listing could be VectivBio’s next financial step now that it has raised $110 million in a crossover round that will fund its planned Phase III trial in short bowel syndrome, as well as...
BioCentury | Oct 7, 2020
Politics, Policy & Law

FDA to stop reviewing COVID-19 lab tests, raising concerns in Congress

...EUA), comes at a steep cost to clinical laboratories. Public Health and Emergency Preparedness Act (PREP...
...not available to clinical laboratories opting to use LDTs without FDA premarket review or authorization.”The PREP...
BioCentury | Sep 30, 2020

As China’s CStone preps for launches, Pfizer buys equity stake and local rights to PD-L1 program

A deal giving Pfizer local rights to CStone’s PD-L1 inhibitor will add at least $200 million to the Suzhou-based biotech’s balance sheet as it prepares for a series of drug approvals, while taking advantage of...
BioCentury | Aug 21, 2020

Aug. 20 Quick Takes: Funding for Alzheon’s Alzheimer’s Phase III; plus Merck, FDA guidance, LumiraDx, RACE for Children, blood plasma and Novo-Evotec

Alzheon preps trial with $47M grantNIH’s National Institute on Aging (NIA) will provide $47 million to Alzheon Inc. over five years to conduct a Phase III study of ALZ-801 to treat early Alzheimer’s disease in...
BioCentury | Aug 21, 2020

New Wild West on horizon as HHS allows COVID-19 lab-developed tests to bypass FDA

...Tests with EUA are protected from liability under the Public Readiness and Emergency Preparedness Act (PREP...
...from the market. LDTs that come on the market without EUA are not eligible for PREP...
BioCentury | Aug 13, 2020
Management Tracks

NHC’s Boutin to head patient advocacy at Novartis; plus changes at Moderna, PIC, Atea, Terns, NBE and Omega

National Health Council CEO Marc Boutin has joined Novartis AG (NYSE:NVS; SIX:NOVN) as global head of patient engagement and advocacy. The NHC is  an umbrella group comprising more than 140 healthcare organizations and businesses that...
BioCentury | May 21, 2020

With repurposed antiviral, Atea draws $215M as it preps Phase II COVID-19 trial

Led by veteran biotech entrepreneur Jean-Pierre Sommadossi, Atea believes an antiviral it had been developing to treat HCV has promise to treat COVID-19 in a population that extends beyond hospitalized patients. The company said Wednesday...
BioCentury | Apr 14, 2020

New U.S. policies complicate regulatory calculus for COVID-19 antibody tests

...PREP (Public Readiness and Emergency Preparedness Act) Act. And they may receive immunity under the PREP...
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