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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
The UK’s price watchdog is backing coverage for Pfizer’s Bosulif at a new discounted price, broadening access to the drug that was previously only available through the now-revamped Cancer Drugs Fund. Read More
In a blow to the biosimilars industry, the federal appellate court has reiterated its position that biosimilars makers must give reference product holders six months’ notice before going to market. Read More