In this week’s news, the EU lacks visibility on shortages says Medicines for Europe, there’s a raft of new med dev guidelines from FDA and more…
Pandemic has exposed EU vulnerability to shortages says generics group
EU generics trade group Medicines for Europe says the Covid-19 pandemic has exposed European countries’ poor visibility on medicine shortages.
In an interview last week, Medicines for Europe DG, Adrian van den Hoven, said “There’s almost no visibility of inventories held by hospitals or by governments with very few exceptions in Europe.”
He also suggested efforts to ensure vaccines and treatments for Covid are affordable may exacerbate potential shortages.
“For a lot of these medicines we’re talking about for COVID-19, the policy is to try and get the absolute lowest price. I understand that governments need to save money but this is not incentivising companies to invest in things like buffer stocks.”
Van den Hoven suggested improved communication channels between manufacturers, CDMOs and regulators would partly address the issue.
“We can improve the IT processes and the regulatory agencies and other areas to improve things. We can’t make it perfect but we can do better than we did during the first wave of Covid.”
See the full report here.
Industry calls for further roll out of risk-based virtual audits
Industry representatives say the use of virtual audits should be increased after the Covid-19 pandemic.
Pharma execs made the comments at a virtual round-table hosted by the Alliance for Regenerative Medicine last week.
Curran Simpson, chief operations and technology officer at REGENXBIO, told online attendees “I think virtual audits, if you do a risk-based approach and the audit partner has the ability to send documentation in an efficient way and you have experienced people doing this, I think you’re going to get the same flavour of an audit very quickly from the level of the documentation.”
US FDA plans update to device biocompatibility and biotin interference guidelines
The US FDA has published guidelines to help device manufacturers ensure there are biocompatibility with intact skin.
The draft document sets out the type of compatibility data that should be included in submissions for devices made from polymers and fabrics.
The agency pointed out that current guidelines will remain in effect until the draft update is finalized.
The agency also published final guidelines on biotin interference testing.
Biotin is a vitamin found in pills or supplements. It is also used in many in-vitro diagnostics IVD. Unfortunately, it can interfere with laboratory test and may cause test results that are incorrect.
The finalized document sets out recommendations for interference testing and communication of test results to the agency.
Also in the news
The Pink Sheet reported talks for PDUFA VII – legislation that sets FDA review timelines and fees that drug firms must pay – are underway. See more here (subscription required).
Politico reported Operation “Warp speed” – the US Governments efforts programme of support for Covid-19 countermeasures – has focused on SARS-CoV-2 vaccines to the detriment of mAb based therapies.
Bioprocess Insider looked at the impact J&J’s decision to temporarily halt a trial of its SARS-CoV-2 vaccine is likely to have on other jabs that use viral vectors.
Global Pharma Insights covered the CPhI annual report.
Developments of note in the contracting sector:
The US FDA has approved a drug made by Ajinomoto Bio-Pharma Services using its AJIPHASE synthesis tech, which combines solid phase and solution phase synthesis, using an anchor in place of a resin. The firm did not name the product.
US CDMO Abzena has spent $60m to increase cGMP manufacturing capacity at its Lusk facility in San Diego.
California Department of Public Health, Food and Drug Branch (FDB) has approved Argonaut Manufacturing Services to make drugs using the Bausch+Ströbel/SKAN isolator aseptic fill/finish line it recently installed at its plant in Carlsbad, California.
Pfizer and Biontech have added Rentschler Biopharma to the list of CDMOs working on BNT162b2, an mRNA-based vaccine against SARS-CoV-2 that is currently in a Phase III trial.
Thermo Fisher will spend $130 million on a sterile filling facility in Singapore. FiercePharma reports that when operational the plant will produce 30 million doses of drugs and vaccines a month.