BioCentury | Nov 21, 2020
Regulation

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
Regulation

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

The latest switchback in the U.S.’s regulation of COVID-19 tests sees HHS requiring FDA to review tests it previously said the agency lacked authority over, highlighting the challenge of pursuing a deregulatory agenda in the midst...
BioCentury | Oct 16, 2020
Finance

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

In a move that raises concerns about the accuracy of tests, as well as liability protections for laboratories, FDA announced Wednesday that it will no longer review emergency use authorization requests for laboratory-developed tests to...
BioCentury | Sep 30, 2020
Deals

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
Deals

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
Regulation

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

HHS’s decision to exempt laboratory-developed tests for COVID-19 from FDA oversight could repeat the fallout from FDA’s short-lived policy to allow antibody tests on the market without regulatory review. On Wednesday, HHS posted a notice...
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
Finance

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
Regulation

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

Guidelines released by CMS, HHS and FDA over the past week raise further questions about the flood of antibody tests that have come on the U.S. market without FDA review. At issue is whether the...
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