This week in pharma…18th June

18th June, 2021

In this week’s news – warning against import restrictions, FDA to probe “accelerate” drug labelling, EC issues plan for medical device regs and more…

Industry think tank warns against protectionism

European drug supply chains stood up well to the pandemic and blanket policies protecting the few products that were disrupted would be detrimental according to an industry think tank.

The European Centre for International Political Economy (ECIPE) issued the warning in a report last week, writing that call for steps to lessen dependency on third countries or other protectionist policies could do “irreparable harm.”

The authors wrote, “EU27 imports have not been impacted except for a marginal increase in March/April 2020 significantly by COVID-19, although the visibility of imports and dependencies has increased and captivates policy makers today.”

Analysis by ECIPE revealed that only 0.8% and 6.1% of EU27 imports are classified as ‘vulnerable’, while 94-99% of EU27 imports are either experiencing limited or low levels of import vulnerability.

The authors wrote, “Therefore, for the 94-99% of EU27 imports, no policies are needed, and arguably – given strong global supply chain performance in 2020 and 2021 – also not for the vulnerable 1%-6%.”

They added that, “Any such policies would more likely do irreparable harm. If the EU27… wants to increase its strategic resilience further, we believe that policies that could lead to tit-for-tat reactions globally are not the way to go. Neither are policies that would reduce the EU economy’s agility and flexibility to adjust.”

EC outlines plan for impending medical device regulations

The EC shared an implementation plan for the In Vitro Diagnostic Medical Devices Regulation (IVDR) with CDMOs and others working in the device space.

The plan – which is designed to help the device sector prepare for the regulation coming into force next May – explains how manufacturers should prepare for “systemic risks to the availability of devices and consider steps to mitigate those risks.”

And preparation is vital according to the Commission’s Medical Device Coordination Group (MDCG) which wrote, “Despite the efforts undertaken by all, the implementation of the IVDR remains a serious challenge.

“EU stakeholder organisations have reported that significant uncertainty hampers planning and preparation of their members for compliance with the IVDR.”

US FDA to probe understanding of accelerated approval

In other FDA news, the agency has announced a plan to test public understanding of its accelerated approval pathway.

In a post in the US Federal Register the FDA’s Office of Prescription Drug Promotion (OPDP) said it the aim is to find out if websites marketing drugs approved through the accelerated state this as they are required to do.

The agency under its labelling rules drugs cleared through the pathway much state the indication and a “succinct description of the limitations of usefulness of the drug and any uncertainty about anticipated clinical benefits . . .”

The FDA also called for feedback from industry and patients.

Also in the news

DCAT looked at the CDMO sector’s performance in 2021 and found that COVID-19 related work remains a major growth driver.

The US Government has shared details of the supply chain taskforce it is setting up. The statement outlines plans for greater use of Quality Metrics, increased domestic API manufacturing, and the local production of 50-100 Essential Medicines.

The US National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) has announced $4.6M to fund 10 biopharmaceutical manufacturing projects.

The Wall Street Journal reported that various COVID-19 vaccine makers have called on the US Government to block efforts to oppose a patent waiver for jabs.

Kiromic Biopharma has announced plans to expand cGMP manufacturing capacity at its headquarters in Houston, Texas.

CDMO trends

Some developments of note in the contracting sector:

Piramal predicted the ADC market and demand for related services will increase significantly over the next few years according to a report by Bioprocess Insider.

AGC Biologics will supply plasmid DNA (pDNA) starting material for the Pfizer-BioNTech COVID-19 vaccine under a newly announced contract.

WuXi XDC and LegoChem Biosciences have partnered to develop antibody-drug conjugates (ADCs). LCB will have access to mAb, linker, payload, analytical and formulation services as well as drug substance and product manufacturing.

Bio-Techne has joined the Cell and Gene Therapy Catapult process analytical technology (PAT) consortium. The group is focused using technology to improve process analytics in the cell and gene therapy industry.

Richter-Helm plans to triple manufacturing capacity at its Bovenau, Germany site to meet increased demand for flexible manufacturing. Read more at Fierce Pharma.