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The introduction of biosimilars to certain European countries has lowered drug prices by 50 percent to 60 percent in certain therapy areas, a report says. Read More
AstraZeneca is suing the FDA in an exclusivity dispute over its anti-cholesterol drug Crestor, claiming that the agency’s interpretation of the FD&C Act unfairly subjects the drug to early generic competition. Read More
Senate Judiciary Committee members and generics makers in June both sung the praises of a bill aimed at preventing branded drugmakers from restricting access to their products. Read More
The U.S. Supreme Court has paved the way for the possibility of drugmakers collecting enhanced damages in patent cases, striking down an appellate standard in a unanimous 8-0 decision. Read More
Four foreign API makers have landed FDA warning letters accusing them of violations ranging from data falsification to finished product deficiencies. Read More
The European Union wants to expand ongoing trade talks between the U.S. and EU to address regulatory harmonization on drug approval requirements, guidelines and GMP compliance. Read More
The FDA is advising generic drugmakers looking to revise their labels without the fallback of a reference product that they have only one route: supplemental submissions. Read More