Archive for December 2017
Kmart to Settle FCA Violation Allegations for $32.2 Million
Kmart agreed to pay a $32.3 million settlement over charges that its in-store pharmacies failed to report discounted drug prices to federal programs and, therefore, were reimbursed at inflated prices. Source: Drug Industry Daily
Read MoreSenators Call on DEA for Guidance on ‘Partial Fill’ of Opioid Prescriptions
Six U.S. senators called on the Drug Enforcement Administration to update regulations on partial filling of Schedule II drugs to help address the opioid addiction crisis. Source: Drug Industry Daily
Read MoreFDA to Commit to Faster End-of-Phase Meetings in Guidance to Developers
FDA released two guidance documents focusing on communications between the agency and drug developers to make drug development more efficient and to help sponsors avoid costly delays. Source: Drug Industry Daily
Read MoreDoctors Accuse NextSource Biotech for Hiking the Price on Key Cancer Drug Nine Times
The cost of a vital cancer drug has gone up 15-fold in four years after its new owner hiked prices on nine separate occasions. Source: BioSpace
Read MoreChina-Focused Life Science Investor Acquires 37% of NovaBay for $28M
After the transaction, it will be NovaBay’s largest shareholder with 6.6 million shares, 37% of the total. Source: BioSpace
Read MoreShareholders Turn Down Tender Offer to Take BioCanCell Private
Approximately 5.9 million shares were necessary for the tender to be accepted. Source: BioSpace
Read MoreFresenius SE Allegedly Ignored Hundreds of Bad Quality Tests at Plant in India
The agency inspected the plant from May 15 to May 24, 2017, and observed that staffers at the plant were basically gaming the quality control system. Source: BioSpace
Read MoreKeryx, Norwich Pharma Mutually Terminate Manufacturing Agreement
The deal was originally inked on Jan 17, 2014. Source: BioSpace
Read More4 Top-Performing S&P 500 Biotech Stocks of 2017
It was a pretty good year for the stock market, but how about for biotech stocks? Source: BioSpace
Read MoreFDA Accepts GW Pharma's Epidiolex NDA With Priority Review for Lennox-Gastaut Syndrome and Dravet…
The PDUFA goal date for completion of the FDA review of the Epidiolex NDA is June 27, 2018. Source: BioSpace
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