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Product Development

July 1 Quick Takes: Amgen gains on court win; plus Hua, J&J, argenx, Seattle Genetics-Genmab, Interprotein

Appeals court upholds Enbrel patents  Amgen Inc. (NASDAQ:AMGN) shares rose 8% Wednesday, adding more than $11 billion to the company’s market cap, after the U.S. Court of Appeals for the Federal Circuit upheld a 2019...

BioNTech, Pfizer vaccine yields highest titers to date, but benchmark itself remains an open question

BioNTech and Pfizer have unveiled early clinical data from the first of four COVID-19 vaccine candidates, becoming the first to disclose neutralizing antibody titers that surpass FDA’s recommended titer of 160 for convalescent plasma. Pfizer...

Histology data builds on growing confidence around Akero’s NASH candidate

Akero’s biopsy data is the positive news the NASH field needed after FDA declined to approve what would have been the first drug for the indication earlier this week. Akero Therapeutics Inc. (NASDAQ:AKRO) rose $8.45...

Accelerating the fight against COVID-19 with real-world data on tests

Almost every aspect of the fight against COVID-19 depends on the ability to determine whether an individual is or has been infected with SARS-CoV-2, but more than six months into the pandemic there is still...

Inovio COVID-19 vaccine data highlight questions about antibody versus T cell responses

A chilly market reception for Inovio’s Phase I COVID-19 vaccine data suggests antibody titers are the key benchmark investors are looking for. The move raises questions about how to value vaccines when the correlates of...

The U.K.’s push for COVID-19 master protocols pays off again with definitive data on lopinavir-ritonavir

The U.K.’s RECOVERY trial and broader strategy to encourage master protocol participation are proving their value again, this time with data showing that the lopinavir-ritonavir antiviral cocktail has no clinical benefit in hospitalized patients not...

Vertex, NHS in deal to make CF triplet available in England once EC approves

It took four years for Vertex to reach an agreement with England’s NHS for access to its first combination cystic fibrosis therapy. But there won’t be any wait for the biotech’s highly anticipated triple therapy...

Data Bytes: COVID-19 pipeline growth begins to slow down

Sixteen COVID-19 countermeasures entered the pipeline this week, down from 25 entrants last week. BioCentury’s COVID-19 Resource Center is now tracking 640 preclinical and clinical COVID-19 vaccines and therapeutics. Studies expected to start this week...

Remdesivir’s price, RWD’s moment & a genomics breakup: a BioCentury Podcast

Gilead has done the biopharma industry a favor by giving remdesivir a Goldilocks price, according to BioCentury Washington Editor Steve Usdin. On the latest edition of the BioCentury This Week podcast , Usdin discusses remdesivir’s price,...

CanSino vaccine first to gain approval as Gilead reveals remdesivir price

CanSino received “military specially-needed drug approval” in China for its vaccine, making it the first vaccine to be authorized for use albeit in a limited population. The announcement came as Gilead Sciences Inc. (NASDAQ:GILD) announced...

Low-stakes 2018 deal with Regeneron leads to bump for Kiniksa on pericarditis readout

Pivotal data for rilonacept in recurrent pericarditis put Kiniksa on track to bring its first program to market and gain rights from Regeneron to additional indications. Kiniksa Pharmaceuticals Ltd. (NASDAQ:KNSA) shares rose $2.97 (13%) to...

Second death in Audentes gene therapy trial may highlight need for more careful dosing

The report of a second patient death in a trial of an AAV8-based gene therapy from Audentes and Astellas renewed decades-old concerns over the modality’s safety, but the adverse events may reflect a need for...

A mechanistic view of four compounds that disrupt interleukin pathways to treat severe COVID-19

Master protocols for COVID-19 clinical trials are testing half a dozen molecules that aim to prevent respiratory distress in patients with severe disease by targeting the host immune system -- four of these compounds intervene...

BARDA no longer funding immunomodulators as support for the therapeutic class to treat COVID-19 grows

A slew of therapies entered the clinic this week aimed at tamping down the immune system to treat excessive lung inflammation in COVID-19 patients, even as BARDA announced it would no longer fund the class...

Modeling harmony: learning from preclinical coordination of COVID-19 countermeasures

The all-hands-on-deck COVID-19 response provides a glimpse of what’s possible when drug developers converge around solving a problem. One of the most important developments might be in preclinical research where consensus on harmonized models and...