BioCentury | Mar 22, 2021
Finance

Crossovers back Aura with $80M as it preps first pivotal test of virus-like particle conjugation tech

An $80 million crossover series E round will support 12-year-old Aura’s first pivotal trial based on its virus-like particle conjugation technology: a Phase III study in choroidal melanoma, an ocular cancer.  CEO Elisabet de los...
BioCentury | Mar 2, 2021
Regulation

Novavax preps for Q2 COVID vaccine EUA submission; plus Fibrogen, Inovio, J&J, Aslan, Merck, Oncopeptides and Athenex

Novavax Inc. (NASDAQ:NVAX) said in its 4Q20 earnings report that it is discussing COVID-19 vaccine NVX-CoV2373 with FDA and may submit a request for emergency use authorization of candidate next quarter. The biotech announced on...
BioCentury | Jan 27, 2021
Product Development

Leaving cancer behind, Agios preps submission after latest readout in rare anemia

With its oncology business in the rear view mirror, Agios is readying its first non-cancer candidate for a regulatory submission with more data in a rare anemia. After the bell Tuesday, Agios Pharmaceuticals Inc. (NASDAQ:AGIO)...
BioCentury | Jan 14, 2021
Regulation

After pushing FDA out of and back into COVID-19 LDT review, HHS turns to outsourcing

HHS is dealing with the fallout of its deregulatory push for COVID-19 lab tests by leaning on ex-FDA consultants for EUA reviews. The consulting and CDO firm NDA Partners, a subsidiary of The Planet Group...
BioCentury | Dec 22, 2020
Deals

Dec. 21-23 Deals Quick Takes: Cytokinetics regains European rights to heart failure program; plus Boehringer-Epizyme, Vertex-Skyhawk, Lilly-Prevail, GSK-Sosei Heptares, ImmunityBio-NantKwest and more

Cytokinetics regains European rights from Servier to heart failure programCytokinetics Inc. (NASDAQ:CYTK) regained European rights to heart failure treatment omecamtiv mecarbil from Servier. The deal termination comes a month after Amgen Inc. (NASDAQ:AMGN) returned its...
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...
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