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Product Development
A primer on the new coronavirus and COVID-19: BioCentury editors in conversation

The rapid pace at which COVID-19 has transformed society has rippled through the biopharma industry, affecting not only companies’ business strategies, but their product pipelines ...

COVID-19 roundup: Qiagen, BD-BioMedomics, Rendu, Vaxart, Cobra, GigaGen, Houston Methodist, Anaqua-WideTrial

FDA’s emergency use authorization for a Qiagen test Tuesday comes amid a flurry of advancements in therapeutic, vaccine and diagnostic COVID-19 programs, including GigaGen’s ...

Akero reports positive Phase IIa data for NASH; pandemic delays expansion cohort

Akero gained $4.02 (23%) to $21.20 Tuesday, adding around $115 million in market cap, after reporting that its lead candidate AKR-001 met primary and secondary endpoints in the ...

Emerging Company Profile
Affinia: Optimizing for AAV vector function

With a $60 million series A round, a pair of gene therapy veterans at the helm and a platform designed by the co-inventor of the AAV9 vector, Affinia Therapeutics is developing ...

Regulation
FDA preps for drug shortages via manufacturing disruption guidance

In anticipation of disruptions to drug supply chains and spikes in demand driven by the COVID-19 crisis, FDA issued guidance to

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Case closed: No penalties for Novartis as FDA ends review of Zolgensma scandal

Novartis appears to have convinced FDA that it cleaned house following last summer’s data manipulation debacle.

Uncovered during a July 24-Aug. 2 inspection ...

Politics, Policy & Law
FDA’s authorization of malaria drugs for COVID-19 looks like political science

FDA’s decision to grant Emergency Use Authorization for hydroxychloroquine and chloroquine to treat COVID-19 was unnecessary and unwise.

The EUA was ...

Deals
Lilly gains rights to Sitryx’s two most advanced immunometabolic programs in four-target deal

For its first pharma partnership, U.K.-based Sitryx is granting Lilly rights to its two most advanced immunometabolism programs in exchange for upfront cash and an equity ...

Brii Bio, Tsinghua, Third People’s Hospital to develop COVID-19 patient-derived neutralizing antibodies

Taking advantage of access to hospitals that have treated some of the earliest COVID-19 patients, Brii Bio has partnered with Tsinghua University and Third People’s Hospital of ...

Finance
March 31 Quick Takes: Cowen leads €47M addition to AM-Pharma's C round; plus Zucara, CellFe, Zentalis and Shanghai Junshi

AM-Pharma raises $52M series C extension
AM-Pharma B.V. raised €47 million ($51.7 million) in an additional close of its series C round, bringing the total ...

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