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Along an almost entirely Democratic party line vote, the House of Representatives voted 221 to 212 yesterday to pass a continuing resolution funding the government through Feb. 18 of next year. Hours later the Senate passed the bill in a 69-28 vote. Read More
The FDA has sent a complete response letter (CRL) to BeyondSpring Pharmaceuticals denying approval of the company’s new drug application (NDA) for plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia (CIN), an abnormally low white blood cell count. Read More
Negotiations hit an impasse in the House yesterday on a stopgap measure to fund federal agencies beyond an upcoming deadline on Friday night. Read More
With government funding set to expire on Friday, the House could vote as soon as today on a stopgap measure to avert a shutdown and keep federal agencies operating. Read More
Amid the increasing travel bans, cancelations and worry caused by the new Omicron variant of the SARS-CoV-2 virus, Acting FDA Commissioner Janet Woodcock said yesterday that the FDA is ready to quickly collaborate with industry in whatever way is needed. However, immunogenicity studies would be required if vaccine makers need to modify their vaccines. Read More
Attorneys for two Ohio counties said the overdose deaths, overwhelmed courts, social services agencies and law enforcement cost each of the counties approximately $1 billion. Read More
The FDA has issued recommendations for sponsors who are hoping to use real-world data from registries to support regulatory approval of a new drug or biologic. Read More
In a pair of tweets, U.S. Trade Representative Katherine Tai said the U.S. would persist in pressing for members of the World Trade Organization (WTO) to move ahead with an intellectual property framework for COVID-19 vaccines. This, after an important in-person WTO ministerial meeting this week was postponed due to the fast-spreading Omicron variant. Read More
The European Union appears to have reversed its previous stance on intellectual property (IP) waivers for COVID-19 vaccines and therapeutics. Instead of threatening to veto IP waivers in ongoing World Trade Organization (WTO) negotiations, it is now backing them. Read More