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Product Development

Understanding and weaponizing immune responses to COVID-19

Human B and T cell responses to the novel coronavirus provide natural biomarkers and blueprints for COVID-19 countermeasures. Virtual presentations hosted Thursday by BioCentury and Repertoire Immune Medicines Inc. showcased emerging work on SARS-CoV-2 antigens...

Making sense of the deluge of early COVID-19 vaccine data

It’s been a big couple of weeks for COVID-19 vaccine data, and the findings are simultaneously encouraging and disheartening. While they hint that some level of protection is achievable -- by multiple candidates -- more...

Making sense of the deluge of early COVID-19 vaccine data

It’s been a big couple of weeks for COVID-19 vaccine data, and the findings are simultaneously encouraging and disheartening. While they hint that some level of protection is achievable -- by multiple candidates -- more...

Hot topics at ASCO 2020

Center stage at this year’s virtual ASCO meeting are a series of hot topics that demonstrate the transformative potential of a single data readout or regulatory update. Areas to watch include next-generation checkpoint targets, where...

TIGIT breaks through as next-generation checkpoint target

Next-generation checkpoint inhibitors will take the limelight at the 2020 virtual ASCO meeting, with all eyes on TIGIT as the first to back up the noise with data. Genentech is poised to present Phase II...

NIH’s detailed remdesivir data show ventilated COVID-19 patients unlikely to benefit

Three weeks after FDA issued Emergency Use Authorization for Gilead’s remdesivir to treat severe COVID-19, detailed preliminary data that informed the decision support the antiviral’s use but also show the drug isn’t likely to benefit...

A guide to serum virus neutralization assays

While the level of neutralizing antibody titers needed to protect against SARS-CoV-2 infection in humans remains an open question, the assays to test them will be an essential tool for COVID-19 vaccine developers.   Figure:...

Further delays at FDA for Intercept’s NASH therapy

Four months after Intercept disclosed FDA had pushed out the PDUFA date for its non-alcoholic steatohepatitis therapy to June 26, the company is now expecting a further delay in the agency’s review of obeticholic acid....

Monkey rechallenge data provide COVID-19 neutralizing antibody benchmark for vaccine developers

As IMV and Vaxart prepare to advance their COVID-19 vaccine candidates into the clinic, monkey data from a Harvard-led team provide not only evidence of protective immunity following COVID-19 resolution, but also an antibody benchmark...

May 21 Quick Takes: EC approves Zolgensma for SMA; plus Sunovion, Kadmon, Sorrento, tafasitamab, Zentalis’ new JV

Immediate access to Zolgensma in France  The European Commission conditionally approved Zolgensma onasemnogene abeparvovec from Novartis AG (NYSE:NVS; SIX:NOVN) to treat spinal muscular atrophy in babies and young children who have SMA Type 1 or...

With AZ deal, Operation Warp Speed takes first step to train guns on coronavirus

Operation Warp Speed, along with its promises and dangers, is coming into sharp focus. Its investment of up to $1.2 billion in a COVID-19 vaccine candidate is testimony to the risks it is prepared to...

Industry is a white knight right now. Don’t throw it away

Biopharma is having a moment. All eyes are on drug, diagnostic and vaccine developers to get us out of this crisis and back to work. Now, companies -- individually and collectively -- must make good...

Translate Bio brings chronic disease-scale manufacturing to COVID-19 mRNA vaccine

Translate Bio and Sanofi’s bid to develop a COVID-19 mRNA vaccine highlights how manufacturing capacity is among the most visible differentiating factors at this stage in the pandemic counter-response. The partners’ program is one of...

Deal flow, diagnostics and defeating COVID-19: a BioCentury podcast

Venture money is flowing. Deals are being completed at a healthy pace. Diagnostics are sitting in the spotlight. And all the while, there’s no sign of where the bottom of the COVID-19 crisis will be....

May 20 Quick Takes: Filgotinib meets in ulcerative colitis; broader labels for Lynparza, Tecentriq, plus updates from Eiger, eGenesis and more

High dose filgotinib meets ulcerative colitis endpoints  A 200 mg dose of filgotinib from Gilead Sciences Inc. (NASDAQ:GILD) and Galapagos N.V. (Euronext:GLPG; NASDAQ:GLPG) met the primary endpoints in the placebo-controlled Phase IIb/III SELECTION trial to...