In this week’s news, US FDA wants input on excipients database, CDMOs may struggle to hit DSCSA deadlines and more

CDMOs and drug makers risk missing DSCSA deadline

Drug makers and CDMOs are lagging behind distributors in testing electronic connections with trading partners, according to a Healthcare Distributors Alliance (HDA) survey.

The requirement for testing is set out in the Drug Supply Chain Security Act (DSCSA), which requires that systems are in place by November next year.

According to the survey, 69% of manufacturers now plan to use a third party to connect, which is a seven-percentage-point increase from the previous survey. 

The HDA wrote “Supply chain partners have their work cut out for them over the next six quarters. While we acknowledge that many manufacturers have made progress to exchange data via EPCIS, very few are sending it in production.”

US FDA wants help streamlining inactive ingredients database

The US FDA has asked the industry for input on plans to rejig its inactive ingredients database (IID).

In a note this week, the US regulator asked drug makers, CDMOs and other stakeholders what it should do to streamline the database.

The FDA is required to do so under the generic drug user fee amendment (GDUFA II), the aim of which is to make the database more user friendly.

EMA and FDA laud scientific advice programme

The EMA and FDA say their collaboration benefits the pharmaceutical and CDMO sector.

The regulators spoke about the parallel scientific advice (PSA) program during a webinar last week, arguing that it “saves sponsors time and resources by bringing both health authorities to the table to hammer out solutions to complex scientific issues arising from their drug development packages.”

 

Also in the news 

The Pink Sheet reported that the pandemic has hampered the US FDA’s ability to attract talent.

The Wall Street Journal looked at drug companies that continue to supply Russia despite Vladimir Putin’s war against Ukraine.

Reuters reports that the US FDA will meet to discuss COVID-19 boosters next month.

Inside Health Policy looked at a proposed US rule that would help switch more prescription drugs to over-the-counter status, which HHS say could help lower health care costs.

SCRIP looked at the suspension of trial activity in Russia.

 

CDMO trends

Some developments of note in the contracting sector: 

Catalent has completed a $30 million project at its facility in Limoges, France, to transform the site into a European centre for biopharmaceutical development, drug product fill/finish services and packaging. 

Thermo Fisher Scientific will invest $97 million to expand its clinical research operations in Richmond, Virginia. 

Almac Pharma Services has expanded its state-of-the-art, ultra-low temperature commercial packaging, labelling and distribution solutions.

Novasep plans to invest €5.1 million to expand its production capacity for HPAPIs on its site in Le Mans, France.

CMC Pharmaceuticals has formed a partnership with Federal Equipment Company that grants CMC Pharma access to a wider range of equipment, expanding prototype preparation and manufacturing process development capabilities.