BioCentury | Nov 30, 2020
Management Tracks

New CMO and Takeda alum Palmer adds to Ascletis’ push into NASH

Ascletis is looking to Takeda veteran Melissa Palmer to move its pipeline of in-licensed and homegrown NASH programs forward. Ascletis Pharma Inc. (HKEX:1672) announced Monday that Palmer, the former head of liver disease clinical development at...
BioCentury | Nov 24, 2020
Product Development

Nov. 23 Quick Takes: NIH panel says bamlanivimab should not be considered COVID-19 SOC; plus Eiger, Shionogi-Roche, Kiniksa, Schrödinger, Halozyme-Horizon and Immunicum-DCPrime

NIH panel says bamlanivimab should not be considered standard-of-care for COVID-19NIH’s COVID-19 Treatment Guidelines Panel said there is not enough data to recommend either for or against use of bamlanivimab from Eli Lilly and Co. (NYSE:LLY)...
BioCentury | Nov 20, 2020
Regulation

WHO counters FDA as it recommends against Veklury for COVID-19

The WHO’s new guidance counters FDA’s October approval of Gilead’s Veklury for hospitalized patients, adding to the debate around the drug’s use and variable performance in randomized, controlled trials. In The BMJ on Thursday, the WHO issued a...
BioCentury | Nov 20, 2020
Regulation

Dec. 10 FDA panel could be gateway to first emergency authorization of COVID-19 vaccine

A Dec. 10 FDA advisory committee meeting could be the springboard for emergency use authorization for BNT162b2, enabling high-risk patients to receive by mid-December the first doses of the mRNA vaccine candidate against SARS-CoV-2 from BioNTech and Pfizer....
BioCentury | Nov 19, 2020
Product Development

EUAs for BioNTech-Pfizer, Moderna COVID-19 vaccines, readouts from AZ and J&J could come in December

The U.S. government is finalizing plans for review, allocation prioritization, and distribution in December of two COVID-19 vaccines in the wake of the completion of a Phase III trial of an mRNA vaccine candidate from...
BioCentury | Nov 19, 2020
Product Development

Preclinical POC for Codiak’s IL-12 therapy highlight retention benefits of exosomes

Data presented at SITC last week provide preclinical proof of concept for Codiak’s IL-12 therapy and highlight the ability of its exosome-based approach to extend retention in the tumor microenvironment. Codiak BioSciences Inc. (NASDAQ:CDAK) uses...
BioCentury | Oct 30, 2020
Product Development

José Baselga on how new modalities and biomarkers are shaping AZ’s oncology strategy

AstraZeneca’s oncology R&D chief José Baselga sees the pharma’s push into ADCs as prologue for its quiet move into cell therapies, as the company builds up a stable of new modalities and targets...
BioCentury | Oct 27, 2020
Product Development

Disclosure by Pfizer of COVID-19 vaccine readout now unlikely by month’s end

Weeks after Pfizer’s Albert Bourla had suggested a pivotal efficacy readout for its COVID-19 vaccine was likely by the end of October, the chairman and CEO is now signaling that an announcement probably won’t come...
BioCentury | Oct 23, 2020
Finance

SPAC to the future: an old-time IPO alternative may be back to stay

Investors and bankers believe specialist-backed SPACs could become a cyclical part of biotech’s fund-raising equation with some clear advantages over traditional IPOs for the right type of company. But...
BioCentury | Oct 17, 2020
Finance

Novartis Venture Fund’s move to earlier, riskier bets starting to pay off

Over the last three and a half years, Novartis Venture Fund has remade its team and narrowed its remit to early-stage opportunities in therapeutics. The fund’s 2020 exits suggest the strategic shift may...
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