In this week’s news, US FDA rolls out new ICH guidelines, US advises on master protocols for Covid-19 studies and more…

FDA publishes six new ICH guides for drug makers

The US FDA has rolled out six new ICH guidance documents for pharma firms and CDMOs.

The documents – available here – cover topics including how manufacturers should test for elemental impurities and asses any health risk raw materials pose, as well as technical advice for lifecycle management.

The US regulators publication of the guidelines – which have been developed by the ICH over the past decade – was taken as a sign the agency is getting back to normal after the disruption caused by the pandemic.

Clinical trials for Covid-19 candidates

The FDA may be getting back to normal, but Covid-19 still occupies much of its time. In addition to the ICH guidelines the agency also published guidelines for firms trialling drugs to treat or prevent the disease.

The document – available here details how developers should construct master protocols, which the agency describes as “an overarching protocol designed to answer multiple questions.”

The FDA wrote, “Master protocols that are well designed and executed can accelerate drug development by maximizing the amount of information obtained from the research effort.”

These advantages are of particular importance during a public health emergency such as the current SARS-CoV-2 pandemic, where there is a critical need for efficient drug development.

Manufacturing facility inspections

The FDA also published a new set of guidelines for manufacturing facility inspections during the pandemic.

The update guidelines here set out how the agency will conduct inspections in light of recent relaxation of pandemic control restrictions in the US and overseas.

Also in the news

The Wall Street Journal reported that more workers are needed to manufacture Covid-19 vaccines to cope with increasing demand.

Indian manufacturer the Serum Institute is struggling to maintain Covid-19 production according to the New York Times.

The US Federal Trade Commission has called for input on its oversight of pharma industry M&A activity in a note published this week.

US cancer vaccine biotech Northwest Biotherapeutics has asked the UK MHRA to certify a new facility in Sawston, UK. If approved, the plant will make the firm’s DCVax range of personalized immune therapies for solid tumours.

Hong Kong firm Antengene says its manufacturing centre at the Binhai Life Science and Healthcare Industrial Zone in Shaoxing is ready for business. The plant is kitted out to makeoral medicines, including a candidate cancer drug selinexor.

CDMO trends

Some developments of note in the contracting sector:

Aenova is building a sterile production area at its site in Latina, Italy to support the manufacture of biologics, including vaccines against the SARS-CoV-2 virus.

Novasep has announced plans to increase capacity at its API plant in Le Mans, France citing growing demand from firms making cancer medicines.

WuXi Biologics and WuXi STA have set up a joint venture company named WuXi XDC that will focus on production of bioconjugates including antibody-drug conjugates (ADCs).

Perkin Elmer plans to buy Nexcelom Bioscience, a manufacturer of automated cell counting instruments, image cytometry workstations and other technologies used by firms working in the cell and gene therapy space.

Buzzard Pharmaceuticals has hired 3P Biopharmaceuticals to make its IL-1 inhibitor Isunakinra, which is a recombinant protein being developed or cancer indications.