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STAT+: Here’s how Insmed grows to be the next $100 billion biotech

STAT

Insmed CEO Will Lewis keeps a newspaper story from 2014 framed on the wall of his office. This is the online version of Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up  here  to get it delivered to their inbox. The headline reads, “Insmed joins the biotech trash heap.” 

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The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

FDA Law Blog: Biosimilars

Indeed, since 2014, DPD facilitatedthe publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents ( g. , Publishing virtually every GDUFA guidance and MAPP since 2014 to fulfill FDAs GDUFA commitments.

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STAT+: After Canada required pharma to pay fees, drug agency recommended coverage more often

STAT

The arm of the agency that handles submissions for medicines began requiring fees in September 2014, while the other unit overseeing cancer drugs took that step in April 2015.

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New biosimilar pathways – key takeaways from the EMA’s draft reflection paper

European Pharmaceutical Review

Guideline On Similar Biological Medicinal Products, CHMP/437/04 Rev 1. European Medicines Agency. Guideline On Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins As Active Substance: Non-Clinical and Clinical Issues, EMEA/CHMP/BMWP/42832/2005 Rev1. Guillen E, Ekman N, Barry S, et al.

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Pharmaceutical Negotiations Decoded: Lessons from the Trenches

Drug Patent Watch

The collapsed talks between Pfizer and AstraZeneca in 2014 highlight the need for flexibility, realistic valuations, and a deep understanding of regulatory hurdles in cross-border deals. Jane Smith, pharmaceutical industry analyst. Insights from Failed Negotiations Learning from unsuccessful negotiations is equally important.

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Patient Care Process

RX Note

In 2014, the Joint Commission for Pharmacy Practitioners (JCPP) - representing 11 national pharmacy organizations - endorsed a framework for providing clinically oriented patient care services called the Pharmacist's Patient Care Process.

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The Issue with Reissue: PTE Edition

FDA Law Blog: Biosimilars

In the generic filers view, the regulatory review period should have started in January 2014 when the patent was reissued rather than in April 2004, when the IND was opened, because the reissued patent did not exist in April 2004. The plain text of 35 U.S.C.