In this week’s news, the US is looking at ability to respond to the next pandemic, Europe may change manufacturing rules and more…
US HHS aims to assess domestic pandemic drug and vaccine capacity
The US HHS and BARDA want to know how much additional domestic capacity there is for the production of drugs and vaccines for Covid-19.
The Department of Health and Human Services (HHS) asked industry to share details of existing capacity last week, explaining the aim is to calculate the country’s ability to respond to the current pandemic as well as any future outbreaks.
“Information is requested for the purpose of determining availability of pharmaceutical manufacturing capacity from domestic sources for current and future pandemic response.
Input is requested from firms manufacturing pharmaceutical consumables and raw materials as well as those engaged in drug production and manufacturing that “are interested in or are currently executing manufacturing capacity expansion efforts.”
The HHS also asked industry which manufacturing and technology advances would improve the domestic supply chain.
EC looking at manufacturing rules to improve access to innovative drugs
The European Commission has started reviewing laws of regions within the drug industry with the aim of fostering innovation and making drugs more affordable.
The review is designed to identify hurdles to drug development and to encourage the industry to work on new treatments, including novel antibiotics.”
The EC wrote “It aims to foster innovation including in areas of unmet medical need (such as in antimicrobials) and to enhance security of supply while adapting to new scientific and technological developments and reducing regulatory burden where possible.
“Drawing lessons from the COVID-19 pandemic, it will support a future-proof and crisis-resistant pharmaceuticals system.”
EMA and FDA sign kids’ cancer drug pact
The EMA and US FDA have teamed up to encourage industry to make cancer drugs for kids.
The regulators announced the collaboration last week, explaining the idea is to create a development framework that both encourages and guides the creation of paediatric treatments for cancer.
Much of the framework will focus on trials according to the FDA which wrote “Given the global nature of cancer drug development and the relative rarity of childhood cancer, which impacts study populations for clinical trials, the demand for international collaboration in study design and conduct has intensified.”
Also in the news
DCAT looked at how the contracting sector is coping with disruption caused by the pandemic.
The US Biomedical Advanced Research and Development Authority (BARDA) has pledged to help expand production of materials and supplies needed to make Covid-19 vaccines. Read more at the Pink Sheet (subscription).
Moderna thanks US CDMO Catalent for its role in making its Covid-19 vaccines, the 100 millionth dose of which shipped this week.
Mastercontrol blogged about how CDMOs are speeding up development of the personalized medicines sector.
Some developments of note in the contracting sector:
Boehringer Ingelheim has hired Oxford BioMedica to manufacture and supply viral vectors for its cell and gene therapy pipeline.
CureVac has hired Celonic for the production of its mRNA-based COVID-19 vaccine candidate, CVnCoV.
SK Group has completed the acquisition of French cell and gene therapy CDMO Yposkesi.
J&J has updated on work with Emergent Biosolutions and the US FDA to address quality issues encountered with the production of its coronavirus vaccine.
Gracell Biotechnologies has hired Lonza to make its FasTCAR-enabled CAR-T cell product candidates in the US.
The KD Pharma Group has acquired the manufacturing assets of Rohner AG to further expand its CDMO business.
Piramal Pharma Solutions will buy Indian API firm Hemmo Pharmaceuticals.