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AbbVie has prevailed in a lawsuit alleging that it violated antitrust laws by exploiting the patent system and making deals with companies for its blockbuster drug Humira (adalimumab). Read More
The EMA said it will continue to monitor available data on the use of medicines during the pandemic and is working with other regulators to provide advice on the safe use of medicines. Read More
Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases (NIAID), said that forcing price controls on pharmaceutical companies developing COVID-19 products will drive them away, expressing optimism that drugmakers will do the right thing on their own. Read More
The FDA yesterday released a temporary final guidance allowing drug companies to ship samples directly to a patient’s home during the pandemic, as long as their practitioner has given permission. Read More
The FDA has launched a pilot program with the National Telecommunications and Information Administration (NTIA) to curb illegal opioid sales online. Read More
The Association of American Physicians and Surgeons (AAPS) has filed a lawsuit against the heads of the FDA, HHS and the Biomedical Advanced Research and Development Authority (BARDA) over what they call “irrational interference” to limit the use of hydroxychloroquine (HCQ) for treating COVID-19 patients. Read More
Thirty-one conservative groups have sent a letter to Congress challenging a proposal by Democrats to limit COVID-19 drug prices by denying patents, exclusivity and intellectual property rights. Read More
The European Commission is asking for comments on a new, wide-ranging strategy aimed at ensuring patients have access to safe, affordable and high-quality drugs across Europe. Read More
Citing a substantially increased volume of requests for expanded access to investigational drugs to treat COVID-19, the FDA has issued a final guidance that clarifies the conditions under which it will consider sponsor and investigator requests for waivers from full IRB review. Read More
The Trump administration has reportedly selected five COVID-19 vaccine candidates from a list of 14 to be evaluated under Operation Warp Speed. The five frontrunners are being developed by Moderna, Johnson & Johnson, AstraZeneca, Merck and Pfizer. Read More