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Novartis finds itself in a tough spot after a federal judge refused the company’s request to toss a whistleblower lawsuit that could cost the Swiss-based pharma giant hundreds of millions of dollars. Read More
Increased transparency in the supply chain is the key to lowering insulin prices, patient advocates and health professional told members of the House Energy and Commerce committee on Tuesday. Read More
The FDA is weighing changes to biologics regulations that would get rid of required tests for mycoplasma in vaccines—a change the agency believes will help encourage innovation. Read More
Australia’s Therapeutic Goods Administration on Monday issued guidance to help sponsors comply with “minimum” drug quality requirements under a new standard that went into effect on March 31. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released guidance for EU drugmakers shipping medicines by air freight to the UK in the event of a no Brexit agreement. Read More
The FDA released a final guidance on pediatric labeling of prescription drugs that, among other recommendations, calls for black box warnings on medicines with inactive ingredients that might be dangerous to babies and children. Read More