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Two research groups at odds over who invented the game-changing CRISPR gene-editing technology appeared before the U.S. Patent and Trademark Office (USPTO) on Friday to argue their cases. Read More
A group of drug and device companies is asking the U.S. Court of Appeals for the D.C. Circuit to toss out its recent decision to revive a lawsuit in which plaintiffs are seeking to hold the companies liable for aiding in the funding of acts of terror in Iraq. Read More
FDA’s top cancer specialist is already waving a red flag at sintilimab, saying the Eli Lilly-licensed Chinese oncology drug — scheduled for review by an FDA advisory committee this week — might not be suitable for a U.S. approval based on its single-country pivotal trial data. Read More
As his confirmation to the top spot at the FDA hangs precariously in the balance, Robert Califf seems to be making a lot of concessions to lawmakers even as support for his nomination from the medical community and the industry swells. Read More
The FDA has finalized its guidance to help drug sponsors develop population pharmacokinetic (PK) analyses used in drug development to fine-tune dosing regimens. Read More
In a 269-page submission to U.S. Trade Representative, Katherine Tai, the Pharmaceutical Research and Manufacturers of America (PhRMA) spelled out the group’s objections to efforts by the World Health Organization (WHO) and other organizations to expand COVID-19 vaccines and treatments at the expense of intellectual property rights. Read More
To try to avoid supply chain disruptions based on licensing uncertainties, the FDA has issued a proposed rule on the standards for licensing wholesale drug distributors and third-party logistics providers. Read More