BioCentury | Mar 18, 2020
Regulation

FDA’s clinical trial guidance stresses patient safety, studies’ integrity amid outbreak

As disruptions begin to mount among biopharmas’ planned or ongoing clinical trials during the COVID-19 outbreak, newly issued FDA guidance clarified the agency’s thinking on how sponsors can ensure participants’ safety and implement modifications to...
BioCentury | Feb 29, 2020
Product Development

Coming competition in myasthenia gravis

A comparison of therapies that have shown promise, or failed to do so, in myasthenia gravis suggests targeting production of autoantibodies may be a less fruitful approach than blocking the effects of the autoantibodies or...
BioCentury | Jan 25, 2020
Product Development

A milestone year for Roche’s CNS gambit could kick off its plan for the decade

A ramped up focus on CNS that has been long in the making could start to pay off this year for Roche, which has two programs slated for launch and four others with late-stage readouts...
BC Extra | Jan 8, 2020
Clinical News

Apellis readies to compete with Soliris in PNH based on Phase III data

Apellis’ paroxysmal nocturnal hemoglobinuria candidate has beaten Soliris head-to-head on hemoglobin level improvement. Despite some ambiguity on how FDA will see the data, the company believes pegcetacoplan has a strong case for approval and could...
BC Extra | Nov 23, 2019
Clinical News

A first-in-class approval for rare anemia could be next step for Sanofi’s sutimlimab

Having met the primary endpoint in the pivotal CARDINAL trial, Sanofi’s sutimlimab could become the first approved therapy for primary cold agglutinin disease. According to the company, the data are the first Phase III results...
BC Extra | Nov 4, 2019
Clinical News

Halozyme to focus on Enhanze partnering after Phase III oncology miss

With the failure of Halozyme's lead cancer program in a Phase III trial, the company intends to exit the oncology R&D field entirely and focus on deriving partner revenue from its subcutaneous drug delivery technology...
BioCentury | Oct 19, 2019
Finance

Achillion’s journey to $1 billion

Alexion’s proposed takeout of Achillion would complete a 21-year journey that saw the latter evolve from an antiviral play into a complement pathway company. For Alexion, it represents the next step in its quest to...
BC Extra | Oct 17, 2019
Company News

Deal streak continues for Alexion as Achillion’s story hits $930M high note

Alexion’s proposed takeout of Achillion would complete a 21-year journey that saw the latter evolve from an antiviral play into a complement pathway company. For Alexion, it represents the next step in its quest to...
BioCentury | Oct 10, 2019
Product Development

UCB adding Ra’s rare immunology assets in $2.5B takeout

UCB is looking to build its rare disease immunology franchise through its proposed $2.5 billion acquisition of Ra Pharmaceuticals -- a price that more than doubles the biotech’s valuation. The deal would give UCB S.A....
BC Extra | Oct 9, 2019
Company News

With Japan submission nearing in NMOSD, Viela picks Mitsubishi as territorial partner

Just days after completing its IPO, Viela will receive another cash infusion from a partnership giving Mitsubishi Tanabe territorial rights to lead program inebilizumab to treat neuromyelitis optical spectrum disorder. Viela Bio Inc. (NASDAQ:VIE) will...
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