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A federal appeals court has ruled that Genentech must face a lawsuit filed by cancer treatment centers over its cancer blockbuster Herceptin (trastuzumab). Read More
The FDA issued a draft guidance answering commonly asked questions about the Orange Book, the agency’s reference book for generic drug substitutions, including how it deals with patent listings. Read More
Two watchdog groups are pressing the U.S. Office of Government Ethics to reclassify the “vaccine czar” position President Trump recently filled, making it a government job requiring disclosure of all conflicts of interest instead of a private contractor position not bound by disclosure regulations and criminal ethics laws. Read More
President Trump announced Friday that the U.S. will sever its financial ties to the World Health Organization (WHO), claiming the organization failed to implement requested reforms and was receiving an unfair proportion of its funding from the U.S. Read More
Top pharmaceutical executives pushed back yesterday against the World Health Organization’s plan for sharing patent rights and product data for COVID-19 countermeasures. Read More
The AIDS Law Project of Pennsylvania has filed a class action lawsuit in California against Gilead Sciences after the drug maker sent envelopes to users of its HIV prevention drugs with the return address “HIV Prevention Team” in red lettering. Read More
The FDA spelled out in a new guidance released yesterday how it will conduct formal meetings and deal with new drug applications during the COVID-19 pandemic. Read More
A Seattle-based study of how COVID-19 spreads through the community has put its project on hold at the FDA’s request until it receives an Emergency Use Authorization (EUA) for its lab-developed test and self-swab kit. Read More
Anthony Fauci, director of the NIH’s National Institute for Allergy and Infectious Diseases (NIAID), said yesterday that he still believes a COVID-19 vaccine could be deployed by the end of the year. Read More
Following considerable public outcry over potential conflicts of interest for government officials who are working on the Trump administration’s initiative to develop COVID-19 treatments and vaccines, Janet Woodcock is temporarily stepping down as director of the Center for Drug Evaluation and Research (CDER). Read More