In this week’s news, US FDA updates regs for compounders and medical device firms, BARDA backs US API precursor production and more…
The US FDA has updated its compounding guidance for drugs used to treat Covid-19 patients.
According to the agency the guidance documents cover both independent compounders and those registered as outsourcing facilities.
From now on compounders will be required to report their activities weekly to let hospitals identify which Covid-19 related medicines are being made where. The overall aim is to prevent shortages.
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The US FDA will let device firms modify their technology without submitting a premarket approval (PMA), a humanitarian device exemption (HDE) supplement or a 30-day notice during the covid-19 pandemic.
The agency relaxed the rules this week, explaining the aim is to give device makers flexibility to address supply chain issues resulting from shortages or facility closures.
The FDA said, “Numerous manufacturers may need to make immediate changes such as adjusting manufacturing processes to allow for social distancing, adapting their manufacturing or design due to supply chain disruption, or to moving device production to a region that is less impacted by COVID-19.”
Nipro Pharma Packaging will spend $60 million to increase capacity at its glass tube-draw facilities in France and the US.
According to Nipro first production is scheduled to start in 2021 with the remainder of the expansion due to complete by 2024. The firm said it will hire an additional 70 employees.
BARDA has granted Phlow a $354m contract to manufacture precursor chemicals for APIs in drugs used to treat patients hospitalized with Covid-19.
US industry group PhRMA says the global nature of pharmaceutical supply chains is positive for patients and drug makers.
Senator Gary Peters introduced bills to address vulnerabilities in the medical supply chain and increase capacity for domestic advanced manufacturing of critical drugs and medical devices in the US.
AgencyIQ predicts the US FDA will make greater use of quality metrics as a result of travel restrictions caused by the Covid-19 pandemic.
Pharmajet will supply Abnova with needle free injection technology for a SARS-CoV-2 vaccine it is developing. See press release.
Some developments of note in the contracting sector.
PCI Pharma plans to build a packaging facility at site in Tredegar, Wales according to the South Wales Argus.
The US has contracted Thermo Fisher Scientific to supply viral transport media (VTM) for COVID-19 sample collection. See press release.
Catalent has bought a clinical trial supply facility in Japan.
GSK has struck a deal with Samsung Biologics for additional manufacturing capacity.
ApiJect Systems America has been given a $138m US Department of Health and Human Services contract to accelerate construction of a prefilled syringe facility.
J&J has added Vibalogics to the list of CDMOs helping manufacture its candidate SARS-CoV-2 vaccine. Read more at Bioprocess Insider.
Piramal has completed a private equity financing deal according to FiercePharma.
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