In this week’s news, EU and US share COVID-19 task force plan and more…
US-EU COVID-19 task force wants industry input on supply chains
The US and EU have outlined a plan to end the COIVD-19 pandemic that places significant emphasis on vaccine manufacturing.
According to a joint statement the task force will “monitor global supply chains for COVID-19 vaccines and therapeutics through assessment of global demand and supply of these items, their production and ancillary supplies, and through identification of supply chain bottlenecks.”
“The Joint task force intends to engage vaccine and therapeutics manufacturers and suppliers to assess supply chain bottlenecks and develop a joint approach to supply chain monitoring for key vaccine inputs, notably disposables and consumables, which are especially constrained globally.”
New Q&A guide for generics sector
The US FDA Office of Pharmaceutical Quality (OPQ) has issued a new Q&A document for generic drug firms that covers correspondence.
The document addresses common questions the agency receives from generic drug makers and CDMOs. The questions covered include several involving the removal of endotoxins, use of so-called bracketing and container closure systems.
FDA outlines thoughts on OTC drugs
In other news, the US FDA shared its thoughts on over-the-counter drugs in a note posted this week.
WHO seeks input on next batch of BCS biowaivers
The World Health Organization (WHO) wants drug firms and CDMOs to help it prioritize drugs for biopharmaceutics classification system (BCS)-based biowaivers, which will make it easier to develop generic versions.
The WHO issued the call in a document this week. It also proposed a list of medicines it wants to prioritize including treatments for cardiovascular disease and anti-infective medicines, as well as the antidepressant drug amitriptyline.
It wrote, “The aim of the WHO biowaiver guidance document is to reduce the risk of ‘bioinequivalence’ to an acceptable level when granting biowaivers supporting pharmaceutical development and access to medicines.”
Also in the news
The New York Times reported that COVID-19 vaccine developers are under pressure to share the technologies on which their products are based.
The Pinksheet looked at the development of South Korea’s vaccine manufacturing sector.
The Financial Times covered concerns about efforts to develop drugs to treat tropical diseases.
STAT examined political efforts to reduce pharmaceutical process in the US.
The Pharma Times looked at UK researchers efforts to test existing drugs for efficacy against breast cancer.
The Pinksheet covered the EMA’s launch of an online GMP inspection portal that drug companies and EU/EEA inspectorates can use will drive greater efficiency.
Some developments of note in the contracting sector:
Thermo Fisher Scientific plans to invest $82.5M to expand its manufacturing facility in St. Louis County. The plant makes a range of biologic drug substances.
Recro Pharma has signed an agreement with Georgia Power to buy 1.2 million renewable energy credits (RECs). The RECs will support the generation of renewable electricity from low – or zero – emission resources.
Lonza invest in additional drug product manufacturing capabilities at its facility in Stein, Switzerland.
Microbiome-focused List Labs has partnered with Genome and Company to create what they claim is the first global live biotherapeutic drug Development organization and CDMO.
Hikma Pharmaceuticals has agreed to acquire Custopharm, a US-based generic sterile injectables company.