Generic drug companies have been spurned by Wall Street in the past in favor of their brand manufacturing counterparts. With high generic use rates in Medicare Part D and a perceived inevitability of follow-on biologics, investment in pharmaceutical copycats is on the upswing.
Ramsey Baghdadi
When it comes to investing in health care, generic drugs don’t exactly get Wall Street’s heart racing. But based on...
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Aurobindo is confident its planned Lannett acquisition will meet US FTC standards after an attempt to acquire Sandoz assets was nixed in 2020. The deal also could widen Aurobindo’s US manufacturing presence.
Novartis failed to stop MSN from launching a generic Entresto and saw an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.
A Duke-Margolis working group is developing ideas to enable non-profit firms to seek US FDA approval for new indications for off-patent medicines. The former acting commissioner thinks citizen petitions might be the fastest route.
Innovator drug advocates argued that the number of patents asserted by industry is not too dissimilar to other fields. But should drugs be compared to golf balls?
The Pink Sheet takes an exclusive look at the complete response letter, which shows the information on application deficiencies that could become widely available if FDA leaders succeed in releasing CRLs in real time.
The arrangement, which implies a behind the scenes negotiated discount, may signal a trend toward less price transparency in foreign markets as manufacturers parry Trump’s Most Favored Nation price demands.
The pharmaceutical industry is edging closer to EU-wide clarity on how the bloc’s data privacy rules can be applied consistently to clinical trials and pharmacovigilance activities.
