The Pharma & Biopharma Outsourcing Association (PBOA) has helped negotiate reduced fees for CMOs in the FDA’s proposed reauthorisation of the Generic Drug User Fee Amendment (GDUFA).
Biosimilar makers have been vocal about product names not differentiating from their reference biologics, so why does the newly-approved Humira copy appear to reference its sponsor, Amgen?
Sarepta Therapeutics says it is considering selling its FDA priority review voucher to support manufacturing scale-up for Exondys 51, its approved Duchenne Muscular Dystrophy drug.
Shire says it will appeal a decision invalidating a patent surrounding the controlled-release composition of its ulcerative colitis drug Lialda (mesalazine).
Regulatory approvals are driving interest in West's Smartdose and Crystal Zenith delivery technologies, the firm says ahead of the launch of a monthly-dose version of Amgen's Repatha.
A restructuring programme which closed two US facilities and slashed hundreds of jobs has paid off says Amgen, attributing increased margins to better manufacturing efficiencies.
Expect industry guidance on product communication soon says US FDA Commissioner Robert Califf, though a more pragmatic approach to social media will be taken.
The US FDA has published draft revisions to a thirteen-year old CMC guidance it says will increase the flexibility of post-approval changes for drugmakers.
Sanofi is poised to terminate its Auvi-Q marketing deal says PDL Biopharma, citing manufacturing issues last year which led to a complete recall of the epinephrine injection product.
