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Assessors should include information about the drug substances’ general properties and physical characteristics, plus solubility in solvents involved in manufacturing or cleaning processes. Read More
Pharmathen is seeking damages equal to the amount paid to Lachman, the revenues it would have earned from the ANDA and its research and development costs. Read More
The FDA warned a Korean manufacturer over significant GMP violations observed during an inspection in March, including its failure to test incoming components. Read More
A class of indirect purchasers filed an antitrust suit against Allergan over the transfer of its Restasis patents to the St. Regis Mohawk tribe and other anticompetitive practices that inflated the drug’s price. Read More
Pfizer reached a $94 million settlement with a class of direct purchasers over claims it used fraudulent patents to keep generic competition off the market for its anti-inflammatory drug Celebrex. Read More
President Trump’s nominee for the next secretary of HHS, former Eli Lilly executive Alex Azar, told the Senate’s health committee Wednesday he agrees prescription drug prices are too high, and would welcome congressional action if appointed to the post. Read More