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Johnson & Johnson (J&J) said it plans to release late-stage trial data for its COVID-19 vaccine candidate next week — a single-dose shot that could help the Biden administration exceed its goal of 100 million vaccinations in 100 days. Read More
The EU’s dispute with AstraZeneca (AZ) over the supply of the company’s vaccine intensified yesterday as European Commission (EC) officials met with the company and called on it to release the full terms of its European supply contract. Read More
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