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With Commissioner Marty Makary’s exit, the FDA will enter a period of “unprecedented” and “prolonged” leadership vacuum, analysts at Capital Alpha predicted, noting that the government will have trouble finding someone who will want to take the FDA’s reins.
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After years of suffering from a bear market and more than 14 months of geopolitical turmoil shaking the macroenvironment, biotech appears to be moving on.
New guidelines from two leading medical associations suggest that efforts to reduce bad cholesterol should focus on maintaining low levels of two key lipoproteins. Big pharma is all in, looking to improve on the standard statins to help vanquish America’s number one killer: heart disease.
The FDA’s decision last year to make complete response letters public provides new insight into why therapies sometimes fail to get the regulatory greenlight. Analysts say the information could help sponsors refine their regulatory strategies.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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In a difficult disease, Revolution Medicines achieved what the pancreatic cancer community has long desired: a significant improvement in survival. The Phase 3 results will support global regulatory filings.
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.
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.
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.