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The U.S. has begun vaccinations with Johnson & Johnson’s (J&J) single-dose vaccine following the FDA’s authorization over the weekend but confronting a small initial rollout the drugmaker is accelerating dose production and working with multiple manufacturers in the U.S. and at sites in Europe, India and South Africa to meet its supply commitments. Read More
A Government Accountability Office (GAO) review of COVID-19 vaccine development efforts found that vaccine producers are facing significant manufacturing hurdles as they scale up operations. Read More
Fresenius Kabi Oncology (FKO) has agreed to plead guilty to hiding and destroying records prior to a 2013 FDA inspection and will hand over $50 million in fines and forfeiture, the U.S. Department of Justice revealed. Read More
Merck plans to acquire Massachusetts-based Pandion Therapeutics for an estimated $1.85 billion to broaden its portfolio of autoimmune disease therapies. Read More
Despite facing significant delays in supplying the European Union with its ordered AstraZeneca (AZ)/Oxford COVID-19 vaccine doses, AZ has said that it is using a large number of doses made via its international supply chain to meet its second-quarter supply commitments with Europe. Read More
While access to cardiovascular drugs in lower-income countries has expanded, a significant gap still exists between access afforded to them and the access enjoyed by higher-income nations when it comes to these medications. Read More
AZ’s phase 3 trial failed to meet primary endpoints as required to keep its approval for the drug for previously treated adults with locally advanced or metastatic bladder cancer. Read More
Pfizer has allegedly demanded that certain Latin American governments put up assets as collateral in order to secure supply deals of its COVID-19 vaccine, a nonprofit investigative news organization in the UK has claimed. Read More
Cognate is expected to generate revenue of approximately $140 million in 2021 and to grow by at least 25 percent annually over the next five years. Read More
AbbVie and Medytox have settled with Evolus over allegations that it and Daewoong Pharmaceuticals had pilfered trade secrets in order to market a competitor to AbbVie’s Botox wrinkle treatment called Jeuveau. Read More