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A federal judge ruled that Apotex’s biosimilars of Amgen’s Neulasta and Neupogen do not infringe on a patent that covers a protein refolding process. Read More
Sen. Chuck Grassley (R-Iowa) has deemed Mylan’s response to his inquiry on the cost of the company’s allergy drug EpiPen “incomplete,” asking for further detail on its price-setting analyses and the product features. Read More
The FDA intends to clarify its expectations for demonstrating the interchangeability of biosimilars with reference products, an FDA official said. Read More
The UK’s price watchdog recommended against the reimbursement of Roche’s Cotellic and Zelboraf for the treatment of BRAF V600 mutation-positive melanoma, citing the expensive list price for the products. Read More
The New York attorney general’s office is conducting an investigation to determine if Mylan engaged in anticompetitive practices when entering contracts to sell its allergy therapy EpiPen to schools. Read More
The UK’s price watchdog has recommended reimbursement for Bayer’s prostate cancer drug Xofigo for an expanded indication, provided that the company delivers discounted prices as promised. Read More
Presidential hopeful Hillary Clinton has unveiled a plan to rein in exorbitant drug costs for lifesaving treatments that would penalize drugmakers for price-gouging. Read More
The California Supreme Court ruled that state courts have the jurisdiction to hear cases filed by out-of-state residents, clearing the path for an amended suit against Bristol-Myers Squibb that contends the company’s blood-thinner Plavix led to patient injuries. Read More