In this week’s news, EC says there is more to do to prevent shortages, US FDA details post-approval CMC change reporting and more.
EC calls for creation of drug shortages list and action plan
Drug shortages have become more common in the past decade according to an EC report, which suggests more uniform reporting would help detect issues faster.
The reportfound that, while shortage tracking has improved, “there remains considerable scope for improvement through greater adoption of harmonised definitions and criteria and uniform implementation of guidelines.”
The authors also provide recommendations to address the issue, including that regulators create a list of critical medicines in the EU susceptible to shortages and build an action plan around making them more widely available.
US FDA issues final guidelines for post-approval CMC changes
The US FDA has clarified which manufacturing changes should be submitted by biologics firms in their annual reports in new guidelines issued last week.
The guidance documentsplits post-approval CMC changes into four categories: major, for which developers must submit a prior approval supplement; moderate, which must be filed within 30 days; minor, which must be included in an annual report sent to the agency.
It also describes how modification should be listed in reports, explaining that a full description of the CMC change should be provided including details of manufacturing sites, the date the change was made, relevant validation protocols and supportive data.
Also in the news
Reuters reported that Moderna has agreed to supply GAVI with 150 million doses of its COVID-19 vaccine.
Fierce Pharma covered Novo Nordisk’s plan to invest $2.58 billion to expand production capacity. The firm plans to build three manufacturing facilities and expand its sprawling site in Kalundborg, Denmark.
STAT looked at shifting dynamics of the generics market in California. According to the publication a federal court judge has temporarily blocked a law that bans so-called pay-to-delay deals between pharmaceutical companies.
BiopharmaDive examined Eli Lilly’s growing reliance on researchers in China for its drug R&D.
Packaging Digest reported that BD and Aptar Pharma have launched several new biologic drug delivery technologies.
Some developments of note in the contracting sector:
Fareva has licensed three ApiJect Systems blow-fill-seal production lines for its facility in Annonay, France. The deal provides capacity for the processing of more than 500 million doses of vaccines and large molecule injectable drugs per year.
Bora Pharmaceuticals has partnered with Taishin Healthcare to set up a $108 million investment programme and expand its footprint in the CDMO sector. The firm also plans to enter the macromolecular/cell and gene therapy manufacturing space.
Merck & Co has hired Thermo Fisher Scientific to make Molnupiravir, its candidate oral COVID-19 antiviral, for distribution in Canada and the UK as well as markets in the European Union, Asia Pacific and Latin America.
In other news, Thermo Fisher has completed the acquisition of US CRO PPD. See press release.
BrainStorm Cell Therapeutics has transferred the technology needed to make NurOwn, a cell therapy for amyotrophic lateral sclerosis (ALS), to Catalent facility in Houston, Texas.
DCAT took a look at the firms that have shaped the CDMO sector in 2021.