This week in pharma… 22nd April

In this week’s news, Australia contracts CDMO to boost RNA capacity, device contractors concerned about FDA shortage guidelines and more.

Australia grants Biocina AU$3m for RNA vaccine development

The Australian Government has given BioCina a grant to develop RNA vaccines and therapeutics.

The grant from the Australian Government Department of Industry, Science, Energy and Resources is intended to help BioCina address the post-pandemic mRNA demand for specific and essential attributes of new RNA products.

This comes as part of a three-year collaborative project with a total value of over $11.9m Australian dollars with industry and academic partners, Cytiva and the University of Adelaide.

Devices industry raises concerns about US FDA draft shortage guidance

US FDA draft guidance on medical device shortages during public health emergencies are too broad and will require too many developer resources, according to industry groups.

The FDA posted comments it received in response to the draft guidelines last week. Medical device group, AdvaMed, said it is worried about the amount of data the agency wants from companies during shortages, saying:

“We believe the scope of requested information is too broad and in some cases requests information that is duplicative of information the agency already maintains.”

The Medical Imaging and Technology Alliance (MITA) raised similar concerns and suggested the scope of the guidance should be narrower.

Also in the news

Contract Pharma quizzed CDMO sector leaders about the trends likely to shape third-party manufacturing over the next year.

Bioprocess Insider looked at regulatory and technology trends in the gene therapy contract manufacturing and wider production sector.

SGS-owned CDMO, Quay Pharma, is to develop live biotherapeutics for Korean developer, Liveome, according to Biopharma Reporter.

The Korean Biomedical Review covered GC Cell’s acquisition of BioCentriq, a US cell and gene therapy contractor.

CDMO tends

Some developments of note in the contracting sector:

Immunotherapy developer, Ilya Pharma, has acquired bioanalysis services contractor, Nordic Bioanalysis.

Bora Pharmaceuticals has announced plans to invest more than $10 million over the next two years to expand its oral solid dose capabilities across facilities in Zhunan, Taiwan and Mississauga, Ontario.

Asahi Kasei Medical will buy Bionova Scientific. Parent firm, Asahi Kasei Group, said the deal represents a complementary addition to its bioprocess business.

Samsung Biologics has completed the purchase of Biogen’s stake in the Samsung Bioepis joint venture for $2.3 billion.

Aptar CSP Technologies has launched its Activ-Vial system in China. The vial will be produced at the company’s facility in Guangzhou.

Asymchem Laboratories has completed construction of a new building at its Dunhua, China site. The expansion adds 500 meters of batch capacity. In addition, an active pharmaceutical ingredient (API) building expansion was completed at the company’s Tianjin site.

Jubilant Ingrevia Limited has announced a new three-year multi-million dollar manufacturing contract.