News
Following an investigation regarding antitrust practices against Pharmacosmos’ Monofer, CSL Vifor has proposed a sweeping multi-channel communication campaign designed to reverse allegedly misleading messages about its rival.
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After covering the Alzheimer’s space through every high and low, BioSpace’s Annalee Armstrong welcomes back Roche for the 2026 Alzheimer’s Renaissance.
Following FDA rejections, Regeneron and Scholar Rock are turning to other facilities to clear regulatory logjams created by quality problems at an ex-Catalent facility in Indiana. Novo Nordisk, meanwhile, has been tight-lipped about whether its own FDA applications have been affected.
As big pharmas including Takeda and Novo Nordisk flee the cell therapy space and smaller biotechs shutter their operations, these players are sticking around to take the modality as far as it can go.
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Zymeworks Inc. reported, as required by the New York Stock Exchange Listed Company Manual Rule 303A.08, an equity inducement award to Mr. Kenneth Galbraith, Zymeworks’ new Chair, President and Chief Executive Officer.
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Read our takes on the biggest stories happening in the industry.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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The company Thursday reported positive topline results for a Phase III trial of its Alzheimer’s-related agitation treatment, while also disclosing improprieties by a principal investigator.
The initiatives coincide with an increase in the volume of data submitted to CDER and CBER—particularly in cell and gene therapy.
Eli Lilly announced Thursday it will acquire former collaborative partner Sigilon Therapeutics to deepen its diabetic foothold with a potentially functional cure for Type 1.
Of the 30 patients given CellTrans’ Lantidra in two studies, 21 were insulin-free for at least a year and 10 were insulin-free for more than five years.
Phase I/II data on AbbVie and Genmab’s recently approved bi-specific antibody in a second cancer indication positions them to talk to regulators about filings to challenge Roche’s Lunsumio.
The company halted studies of the treatment for a rare, advanced form of eye cancer after clinical results showed just one response in 47 patients.
The funds will support a trial of a tuberculosis vaccine developed by GSK that could potentially be the first new TB shot in a century.
Providing extra benefits and perks to parents in the workplace can be polarizing, but it doesn’t have to be.
After a series of milestone approvals in the first half of 2023, the FDA is slated to decide on four more firsts before the year’s end.
While early, the Phase I study results for 12 patients represent a promising return on Bayer’s investment in BlueRock, which it launched with Versant Ventures in 2016 and fully acquired three years later.