BioCentury | Oct 23, 2020
Regulation

Gilead’s Veklury becomes first FDA approved COVID-19 therapy, with NIH adaptive trial as focal point

Data from NIH’s master protocol trial was the cornerstone for the first FDA approval of a COVID-19 therapy, granted to Gilead’s Veklury Thursday. The approval highlights the critical role of master protocols for generating substantive evidence...
BioCentury | Jul 11, 2020
Product Development

Gilead’s RWD comparison for remdesivir is ‘not in the same league of evidence’ as controlled studies, says Bach

As real-world data continue to take on a more prominent role in clinical development, Gilead’s comparison of severe COVID-19 patients in a clinical trial of remdesivir versus a real-world cohort raises questions of how and...
BioCentury | Jul 7, 2020
Politics, Policy & Law

FDA credibility on the line with White House pressure on hydroxychloroquine

Demands from President Donald Trump that FDA issue a second Emergency Use Authorization for the use of hydroxychloroquine to treat COVID-19 test agency chief Stephen Hahn’s commitment to public health again, and pose challenges to...
BioCentury | Jun 2, 2020
Product Development

More data needed to determine best use of remdesivir in COVID-19 patients

The latest remdesivir data in moderate COVID-19 patients suggest that the therapy’s Emergency Use Authorization should cover only a five-day course of treatment, which would stretch supplies to treat more patients. But the question remains...
BioCentury | Jan 12, 2020
Emerging Company Profile

Borisy newco aims to offer ‘radically’ cheaper drugs by disrupting biopharma’s traditional model

Alexis Borisy has launched EQRx to disrupt the biopharma world by developing and launching innovative therapies at “radically lower” prices than commercial competitors. With its first drug expected to hit the market in five years,...
BioCentury | Dec 13, 2019
Finance

NanoDimension backs sight-restoring therapy developer Arctos in series A

Newly launched Arctos will use CHF8 million in series A money to conduct preclinical work on a vector-delivered technology it believes can restore eyesight in patients whose retinal cells have degenerated, rather than those whose...
BioCentury | Nov 23, 2019
Politics, Policy & Law

Debating the fate of innovation

No one believes that H.R. 3, the Democratic House leadership’s drug pricing bill, will be enacted into law , but that hasn’t stopped it from precipitating frenzied debates. The bill has become a strawman for advocates...
BioCentury | Nov 13, 2019
Politics & Policy

CMS, BIO spin Part B data in opposite directions

CMS and the biopharma industry are presenting conflicting explanations for a spike in Medicare Part B premiums and deductibles. CMS says the increases are “largely due to rising spending on physician-administered drugs” (see “Medicare Part...
BioCentury | Sep 6, 2019
Regulation

Lackluster U.S. biosimilars market sparks radical recommendations

The lackluster U.S. biosimilars market has led to calls for a new regulatory paradigm that could slash the cost of development. Biosimilars developers and critics of the sector agree on one thing: as it has...
BioCentury | Jul 18, 2019
Distillery Therapeutics

Inhibition of BACH1 or the genes it controls for metastatic lung cancer

DISEASE CATEGORY: Cancer INDICATION: Lung cancer Inhibiting the pro-metastatic transcription factor BACH1 or its gene targets MCT1, HMOX1, HK2 and GADPH could treat metastatic lung cancer. In patients with metastasized lung cancer, levels of BACH1...
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