In this week’s news, PICS/tweaks trial supply manufacturing regulations, US FDA’s accelerated drug team looks overseas for inspiration and more.

PIC/S revises GMP guidelines to fit with new EU clinical trial regs

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has tweaked its GMP guide to reflect the new EU clinical trials regulation (CTR), which came into force on Monday.

The first revision relates to the manufacture of investigational medical products. According to the organisation “This is in line with the Co-operation Agreement between PIC/S and EMA, which states that the PIC/S and EU GMP Guides should be harmonised with the aim of keeping GMP standards equivalent, thus facilitating the exchange and use of information concerning the manufacture of medicinal products.”

The PIC/S also introduced a new measure – Annex 16, which brings rules on certification by authorized persons and batch release into line with the CTR.

US FDA finalizes combination drug guidelines

The US FDA has finalized guidance on premarket approval pathways for combination drug products.

The guidance document (available here) defines various combination products and recommends how developers should determine the type of premarket submission pathway they should follow for a particular product.

US FDA looks at accelerated approval programmes elsewhere

Officials at the US FDA have started looking at how regulators run accelerated drug approval programmes in a bid to improve agency processes.

The plan – outlined in an article in JAMA is based on the observation that health authorities in many markets take a time-limited approach to expedited approvals, while others limit them to new drugs only.

According to the FDA authors “these time-limited approaches may limit public exposure to stale claims of effectiveness that cannot be expeditiously substantiated.”

Also in the news

DCAT looked at how CDMO supply chains are evolving, citing both the pandemic and emerging markets as key drivers.

Bloomberg reported BioNTech’s plan to increase the size of its workforce at its vaccine plant in Marburg, north of Frankfurt. 

Sanofi says a high rise tower block developers plan to build next to its facility in Toronto, Canada would pose a national security threat according to a report by Endpoints.

The New York Times (NYT) reported findings that suggest COVID-19 related death rates in the US are higher than in other developed countries. 

The UK Financial Times looked at rumours suggesting that investors Blackstone, Carlyle are considering a joint takeover bid for Sandoz, Novartis’ generics arm.

CDMO trends

Some developments of note in the contracting sector:

Sharp has completed the construction of production suites to facilitate the packaging, storage and distribution of gene therapies, at its facility in Heerenveen, The Netherlands.

Alcami plans to invest $10 million to expand its laboratory in Durham, North Carolina. 

Catalent has completed a $10 million expansion at its facilities in Malvern, Pennsylvania, and Dartford in the UK. The firm has added containment capabilities for the micronization of highly potent drug compounds.

The US Government has contracted Recro Pharma to provide formulation development and cGMP manufacturing to support clinical development of a topical dermal treatment for skin cancer.

Korean CDMO Samsung Biologics has reached an agreement with Biogen for the buyout of Biogen’s stake in the Samsung Bioepis joint venture for USD $2.3 billion.

Atara Biotherapeutics has entered into a long term manufacturing agreement with Fujifilm Diosynth Biotechnologies (FDB). The deal will see Fujifilm will acquire Atara’s T-Cell Operations and Manufacturing (ATOM) facility in Thousand Oaks, California.