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The House Select Subcommittee on the Coronavirus Crisis is questioning how vaccines are being chosen for accelerated development under the U.S. government’s Operation Warp Speed and calling for details on possible conflicts of interest among those who are making the choices. Read More
Fee-paying drug sponsors who submit investigational new drug (IND) applications to the FDA generally get high-quality responses and communications from the agency, according to an independent assessment by Lexington, Mass.-based Eastern Research Group. Read More
In a final guidance released yesterday, the FDA explains how and when drug sponsors should notify the agency about products that they plan to withdraw from the market or that will not be offered for sale. Read More
The World Health Organization (WHO) will need $100 billion to pay for COVID-19 vaccines but it has only received commitments for 10 percent of that amount, according to the organization’s Director General Tedros Adhanom Ghebreyesus. Read More
The European Medicines Agency (EMA) has updated its advice on impurity testing for nitrosamines, expanding it to include some biological medicines. Read More
Bristol Myers Squibb and collaborator Pfizer prevailed in a patent ruling last week when a Delaware federal judge upheld two patents for their blockbuster blood thinner Eliquis (apixaban). Read More
Sponsors of investigational new drug (IND) applications or biologic license applications (BLAs) for a therapeutic protein should take a risk-based approach to assess the need for drug-drug interaction (DDI) studies, the FDA said in a new draft guidance. Read More
Drugmakers successfully completed a majority of postmarketing requirements and commitments in fiscal 2019, the FDA said it its latest annual report. Read More
In a move that’s likely to shake up the entire U.S. drug supply chain, President Trump signed an executive order yesterday directing the federal government to buy “essential drugs” from domestic companies. Read More
The FDA released guidance for sponsors of drugs for treatment of life-threatening ailments seeking approval under the agency’s Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) program. Read More
Almost three dozen state attorneys general have called on the federal government to bypass Gilead Sciences’ remdesivir patents and begin producing the COVID-19 treatment. Read More
The FDA has updated its Purple Book to include all licensed biological products overseen by the Centers for Biologics Evaluation and Research (CBER) and Drug Evaluation and Research (CDER). Read More