In this week’s news, the US Gov wants more money for FDA, the CDMO sector sees more COVID-19 related work and more…
FDA issues testing guide for CDMOs making drugs for feeding tube administration
The US FDA has issued draft guidelines for CDMOs that make drugs administered by feeding tube in a bid to ensure such products are properly tested.
The document sets out best practices for “consistent in vitro testing of oral drug products to demonstrate their suitability to be administered via enteral tube.”
The agency wrote that, “It is critical that each drug administered via enteral tube is delivered at the correct dose in a manner that preserves the drug’s expected safety and efficacy profile and does not compromise the integrity of the tube.”
According to the agency current in vitro testing practices are inconsistent, which means that labelling varies product to product. It said the draft guidance is designed to address this issue.
US Government seeks more funding for FDA in 2022
In other news the US Government has sought $6.5 billion of funding for the FDA in 2022 under a budget proposal unveiled last week.
According to the request – which is some 8% higher than in the 2021 budget – the money will fund “critical public health infrastructure, core food safety and medical product safety programs and other vital public health programs.”
Experts forecast second wave of biosimilars
CDMOs are likely to see more opportunities in biosimilars according to an expert at the Association for Accessible Medicine annual meeting.
The comments were made during a panel discussion (available here) focused on development of the biosimilar drug market.
The panel based its optimism on the prediction that the Biden Government will be able to rework the Medicare Part D reimbursement programme that – the AAM says – limit the uptake of biosimilar drugs.
Also in the news
Reuters examined Lonza’s role in making COVID-19 vaccines for Moderna. The CDMO has added a new drug substance line at its facility in Geleen, in the Netherlands.
The surge in COVID-19 cases in India has impacted US FDA oversight of CDMOs making APIs and drug in the country according to a Pink Sheet report.
Ex FDA chief Scott Gottlieb urged industry and Governments to prepare for future pandemics in an Op-ed in the Wall Street Journal.
The Pink Sheet looked at a funding freeze at the US Biomedical Advanced Research and Development Authority may prompt industry to abandon development of COVID-19 therapies.
Novavax has signed a non-binding memorandum of understanding (MoU) with the Ministry of Health and Welfare of Korea (MOHW) and CDMO SK bioscience to explore cooperation in the development and manufacturing of vaccines, including NVX-CoV2373. See press release.
In Japan the Ministry of Health, Labor and Welfare’s (MHLW) says the manufacture and use of cannabis-derived drugs should be permitted if a mechanism for controlling production is put in place. Read more at Pharma Japan.
Some developments of note in the contracting sector:
Cambrex has upgraded its facility in Tallinn, Estonia to support production of pharmaceutical intermediates under current good manufacturing practice (CGMP) conditions.
Innova Medical Group has partnered with Sharp to set up a COVID-19 test manufacturing facility in Caerphilly, Wales.
Archimica has expanded its development laboratories in its Lodi, Italy site, more than doubling API and GMP Building Block custom process development capacity.
Moderna has hired Samsung Biologics to provide large scale, commercial fill-finish manufacturing for mRNA-1273, Moderna’s COVID-19 vaccine.
CoreRx has acquired Nucleo Life Sciences, a boutique CDMO based in San Rafael, California. The firms said Nucleo complements its development services and provides a site on the US West Coast.