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Amidst rising layoffs in key biotech hubs, global demand for specialized life sciences talent is driving a more borderless, distributed model of scientific work.
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During the pharma earnings season, which begins on Tuesday, Novo Nordisk will report the first revenue numbers from an oral GLP-1 medicine, while other companies are expected to address the FDA, drug pricing and Trump’s new tariffs.
Bringing patients into the drug development process early has proven to save time, money and resources.
The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare diseases. Executives at Rezolute and CERo Therapeutics recently had positive interactions with the agency, in which they told BioSpace reviewers have been “collaborative” and “curious.
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Novo Nordisk’s oral Wegovy has a few months’ head start on Eli Lilly’s newly approved pill. While the Indianapolis pharma has come from behind the Danish rival in the weight loss space before, last time it clearly had the better drug.
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Darovasertib, in combination with crizotinib, more than doubled progression-free survival in a registrational trial, leading Truist analysts to declare a “best-in-class efficacy profile” for the PKC inhibitor.
The licensing deal marks AbbVie’s first foray into new pain medicines, a space where Vertex currently enjoys a lead thanks to the NaV1.8 inhibitor Journavx.
Telix is Regeneron’s entry ticket into the radiopharma game, helping to better round out the company’s cancer portfolio, according to Truist Securities.
Replimune’s CEO Sushil Patel has already warned that the biotech will need to cut staff and substantially scale back its U.S. manufacturing operations.
Analysts are cautiously optimistic about an IPO rebound for biopharma. BioSpace is keeping track of companies that seek to trade on the public markets this year.
Since the FDA began publishing its rejections of drug approval filings in July last year, companies have become more forthcoming about the details of agency decisions in their own disclosures, according to biopharma and regulatory analysts.
Principal Scientist Anders Cai Holm Hansen explains how CDMO AGC Biologics uses its global, single-use network and a strategy emphasizing “scale-out” manufacturing, to derisk demand uncertainty, speed timelines and conserve cash for emerging drug developers.
The FDA in a complete response letter to Replimune maintained its original objection to the single-arm trial the biotech used to support the application for RP1.
Novo Nordisk’s oral Wegovy has a few months’ head start on Eli Lilly’s newly approved pill. While the Indianapolis pharma has come from behind the Danish rival in the weight loss space before, last time it clearly had the better drug.
In the future of AI-driven biopharma, reusable data is the most undervalued asset.