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Latest From Brenda Sandburg
Fate Of JHL Biotech's Biosimilars Uncertain As Judge Bars Use Of Genentech Trade Secrets
Court denies JHL motion to dismiss trade secret theft suit, bars development or sale of biosimilars that rely on information from Genentech documents; trial scheduled to begin in November 2020.
Bill To Revise US Subject Matter Patent Eligibility Standard Expected By 'Early Summer'
Senators emphasize need for legislative reform at IP subcommittee hearing; ask USPTO director Iancu how a drug can have 130 patents, alluding to Humira.
Novartis Can't Halt Janssen's Promo Comparing Their Psoriasis Drugs
US judge is 'troubled' by Janssen's omission of relevant safety data in summary of Tremfya v. Cosentyx study, but finds Novartis claim of irreparable harm is 'too speculative.'
Purdue Puts Forth FDA Decisions As Defense To Massachusetts Opioid Suit
Purdue says Commonwealth is trying to hold it liable for conduct FDA has authorized; citing agency's approval of long-term use of OxyContin for chronic pain, company asks court to dismiss complaint.
Legal News: Teva V. FDA, Pay-For-Delay, Citizen Petitions, User Fee Scheme
US court tosses Teva suit seeking generic Restasis exclusivity. FTC loses appeal challenging Shire's citizen petitions, settles Solvay pay-for-delay case. DoJ resolves FCA case alleging company made deal to avoid paying FDA user fees for two NDAs.
HHS' 2018 Greatest Hits: Azar Touts Record FDA Generic Approvals, Drug Pricing And Opioid Actions
In State of the Department speech and HHS annual report, Secretary Azar trumpets historic number of approvals by FDA, and price cuts, roll backs or freezes by 'more than a dozen drug companies.'