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A U.S. Food and Drug Administration review of drug approvals and denials over a 12-year period shows many delays could be avoided if drugmakers submitted more accurate and useful information. Read More
In a 9-0 decision, the U.S. Supreme Court ruled Jan. 22 that the patent holder bears the burden of proof for infringement, regardless of whether it is the plaintiff or defendant in a patent lawsuit. Read More
Brand drugmakers last month denied accusations they’d joined forces with a lobbying group in a covert campaign to block proposed patent law changes that would improve access to generics in South Africa. Read More
Japanese officials launched an investigation Jan. 10 into claims that falsified clinical trial data were used in an Alzheimer’s study involving several major drugmakers, marking an expansion of the country’s scrutiny of trial data misuse. Read More
In an effort to build opposition to the FDA’s proposed generic drug safety labeling rule, GPhA is warning that spending on generics will rise by $4 billion per year if the rule is finalized. Read More
Government auditors Monday criticized the FDA for its ongoing drug shortages problem, while House lawmakers chastised the agency at a hearing for not taking more action. Read More
Merck has agreed to pay $100 million to settle thousands of liability claims alleging the drugmaker’s NuvaRing contraceptive causes potentially fatal venous thromboembolisms. Read More
Just when things were starting to turn around for Teva, the Israeli drugmaker said Monday it was under federal investigation for potential marketing violations of its drugs Copaxone and Azilect. Read More
The Centers for Medicare and Medicaid Services (CMS) has relaxed the deadline for submitting 2013 data under the Physician Payment Sunshine Act, giving drugmakers until late spring to report the details of payment information. Read More
A new report from PricewaterhouseCoopers claims that value and volume of pharmaceutical mergers and acquisitions increased in the last quarter of 2013. Read More
The U.S. experienced 38 drug shortages during the first three quarters of 2013, a substantial drop from 2012 when 117 drug shortages were reported, according to FDA figures released Friday ahead of a scheduled House hearing on the issue. Read More