News
Fallout from the resignation of FDA Commissioner Marty Makary continues as several other senior regulators are removed from their posts; pharma’s top paid CEOs make up to 358 times more than their employees; Revolution Medicine’s pancreatic cancer results highlight movement in the deadly disease space; more.
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Biotech is increasingly financed, governed and regulated as though it were a mature pharmaceutical industry rather than a discovery system built around scientific uncertainty. Structural changes are needed to sustain the sector’s strategic innovation.
BioSpace examines how the FDA approval of Eli Lilly’s oral obesity drug Foundayo has ignited a key race with Novo Nordisk.
Nusano will bring a massive new radioisotope facility in Salt Lake City online by the end of the year, establishing a supply of starting materials for the next generation of radiopharmaceuticals.
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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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The layoffs are a result of Sumitomo’s decision announced in April to combine its seven subsidiaries into one company.
The companies have signed two other pacts over the last year. In the latest deal, Takeda gains access to F-star’s platform to produce tetravalent antibodies for undisclosed oncology targets.
The Inflation Reduction Act could put an end to blockbuster runs like that of Merck’s Keytruda, experts told BioSpace. In the meantime, the drug keeps picking up more indications and positive clinical results.
The company has signed a memorandum of understanding and land collaboration agreement to develop medicines exclusively for Chinese use.
The pharmaceutical giant is tapping the world’s largest biomanufacturing facility operated by Samsung Biologics for biosimilar production.
Citing insufficient safety evidence for one of the drug’s main ingredients, the regulator in a Complete Response Letter rejected the company’s application for Parkinson’s disease candidate IPX203.
The companies have filed their own suit against the Federal Trade Commission, claiming the FTC’s attempt to legally block their $28 billion merger is unconstitutional.
After initial Phase II data for the oral IL-23 receptor antagonist licensed from Protagonist Therapeutics spooked investors, Janssen provided a fuller readout and advanced the candidate.
Topline results for its Daiichi Sankyo-partnered antibody-drug conjugate showed statistically significant improvement. However, AstraZeneca shares dropped around 6% in early Monday trading.
Pharmas, advocacy groups and regulatory bodies have made moves to put each other in legal crosshairs in 2023. Follow along with BioSpace’s Lawsuit Tracker to see what’s piling up on the docket.