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Immuno-oncology and precision medicine will continue to lead emerging trends in the biopharmaceutical industry this year, the market research firm GlobalData reported. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) has released its list of planned new and revised guidances for calendar year 2021, an agenda that includes a large number of generic drug-related topics. Read More
The Pharmaceutical Research and Manufacturers of America (PhRMA) piled onto the industry challenge to the federal 340B drug discount program, filing a complaint Friday in the U.S. District Court for the District of Maryland against a regulation promulgated by the Trump administration. Read More
Anthony Fauci, the leading U.S. authority on infectious diseases, has cautioned against putting off second doses of Pfizer/BioNTech’s and Moderna’s vaccines to accelerate initial vaccinations, a strategy the UK is currently using and one President Biden has said he will adopt as vaccine makers experience delays in vaccine shipments. Read More
The U.S. International Trade Commission (ITC) has said it will investigate whether Chinese company Wuhan Healthgen Biotechnology is infringing two patents owned by Kansas-based Ventria Bioscience. Read More
The Biden administration has delayed an HHS rule that would have stopped community health centers from getting federal funds unless they charged low-income patients reduced out-of-pocket prices for insulin and injectable epinephrine. Read More
Italy is taking legal action against Pfizer for delays in supplying vaccine doses, contending the company is not honoring its supply contract and putting the country’s inoculation campaign at risk. Read More
The Biden administration is facing a tall order to meet its goal of vaccinating 100 million Americans in its first 100 days, given the weaknesses and ongoing delays in the country’s decentralized distribution and vaccination process. Read More
Janet Woodcock stepped into her new role as acting FDA Commissioner this week, pledging in an email to agency staff to maintain the agency’s science-based approach. “The American people can be certain that science — above all — will continue to guide the FDA’s regulatory actions now and into the future,” she said. Read More
Drugmakers contend that the 340B drug program’s expansion to include contract pharmacies not owned by covered entity hospital creates the potential for duplicate discounts. Read More