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U.S. Pharmaceutical company improved quality of overall documentation saving time and filing delays

Syner-G

Challenge Syner-G was contracted by a US Pharmaceutical Company to help improve the quality of submission documentation generated during the manufacture of a Drug Substance intended for Phase II trials. Results Syner-G reviewed each documentation and provided suggestions/comments/guidance to the CDMO to bridge the gaps observed.

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STAT+: As Humira biosimilars take over the market, CVS has created a new ploy: the drug ‘rebate credit’

STAT

The biggest enticement that large pharmacy benefit managers offer to the employers that hire them is drug rebates — a steady stream of money sent back to their clients, a tangible symbol of the discounts that PBMs are able to wrangle out of pharmaceutical companies. Continue to STAT+ to read the full story…

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Leading patient adherence pharmaceutical companies

Pharmaceutical Technology

Discover the leading patient adherence pharmaceutical companies. Pharmaceutical Technology has listed the top patient adherence pharmaceutical companies based on our intel, insights and decades-long expertise in the sector. Patient adherence.

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STAT+: Nostrum Laboratories and its CEO — who once defended Shkreli price hikes — to pay up to $50 million over Medicaid rebates

STAT

A pharmaceutical company and its chief executive — who once defended Martin Shkreli for raising drug prices to controversial heights — agreed to pay up to $50 million to settle allegations of purposely underpaying Medicaid rebates. Department of Justice.

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STAT+: ‘A cascade of failures’: FDA cites Indian drugmaker for numerous quality control problems

STAT

In a stunning rebuke, the Food and Drug Administration accused a drugmaker of a “cascade of failures” for a litany of quality-control problems at a manufacturing plant, the latest instance in which the regulator has castigated an Indian pharmaceutical company for such lapses.

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NICE recommends first licenced treatment for AL amyloidosis

European Pharmaceutical Review

According to the Janssen Pharmaceutical Companies of Johnson & Johnson and NICE, DVCd is recommended for the rare bone marrow disorder, only if daratumumab is stopped after 24 cycles of treatment, or earlier if the condition progresses.

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STAT+: To push antibiotic makers to be more green, a new system will certify manufacturing practices

STAT

Pharmaceutical companies that obtain a certificate can then use the document to satisfy customers — such as government agencies — that are increasingly incorporating environmental metrics in purchase agreements.