Fresenius 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
Shareholders Turn Down Tender Offer to Take BioCanCell Private
Approximately 5.9 million shares were necessary for the tender to be accepted. Source: BioSpace
China-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
Doctors 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
FDA Issues New Class Warning, Requirements for Gadolinium Contrast Agents
The FDA is mandating a new class warning and labeling changes for all gadolinium-based contrast agents — as well as requiring manufacturers to conduct additional human and animal safety studies.…
Quality System Deficiencies Dominate MHRA’s GDP Deficiency Report
Problems with quality topped the list of major good distribution practice deficiencies in 2016, according to the UK’s Medicines and Healthcare products Regulatory Agency. Source: Drug Industry Daily
Canadian Drugmaker Warned for Sterility, Verification, Procedural Issues
The FDA issued a warning letter to Deserving Health International after an inspection of the drug manufacturer’s facility in Richmond, British Columbia in July revealed sterility problems, failure to verify…
FDA Flags Impax Laboratories for Equipment Problem
The FDA cited Impax Laboratories after an inspection revealed a significant discrepancy in the operational qualification of its packaging line’s tablet counter/elevator. Source: Drug Industry Daily
PTAB Says Sovereign Immunity Traded Away By Filing Infringement Suits in Court
The PTO’s Patent Trial and Appeal Board dismissed a patent owner’s claims of sovereign immunity from the proceedings — in a move that might have implications for Allergan’s Restasis patent…
Shire Plans to Hire in 2018 for its Georgia Manufacturing Site
Shire filed its first submission to the FDA for its new plasma manufacturing site in Covington, Georgia. Source: BioSpace
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