This week in pharma…17th September

17th September, 2021

In this week’s news, regulatory collaboration on generics, EMA focuses on real-world evidence and more…

EMA and FDA focus on complex generics

The EMA and FDA have teamed up to develop a pilot scheme for complex generic products.

The scheme – detailed here – is part of an effort to provide parallel scientific advice (PSA) to firm’s working on complex generic drugs.

According to the agencies “collaboration may provide applicants with a deeper understanding of the basis of regulatory decisions, optimize product development, and avoid unnecessary replication of studies or unnecessary testing methodologies.”

EMA planning real-world evidence catalogue

The EMA plans to create a usable catalogue of metadata to aid the scientific community in identifying real-world evidence.

The Amsterdam-based agency outlined the plan earlier this month, explaining the idea is to help drug developers collect the data they need to assure the safety and efficacy of candidate products.

The EMA wrote “accurate metadata information can contribute to identifying the data sources suitable for a specific study, facilitate description of the data sources planned to be used in a study protocol or research proposal and contribute to assessing the evidentiary value of the results of studies using multiple data sources.”

US FDA tweaks ANDA guidelines with pandemic in mind

The US FDA has updated its guidelines for generic drug firms working during the COVID-19 pandemic.

The document addresses likely disruption of bioequivalence (BE) studies caused COVID-19 public health emergency, setting out certain flexibilities the agency has introduced.

One of the main revisions covers the expiry of reference products used to test the bioequivalence of generic candidates. According to the FDA “It may be acceptable to utilize a different batch of unexpired reference product to complete a BE study, so long as the prospective applicant provides adequate scientific justifications.”

Also in the news

DCAT looked at trends in the CDMO space, specifically the evolution of the “one-stop-shop” model through which contractors aim to provide a range of services.

The Pink Sheet looked at US efforts to prepare for future pandemics. There will be a major focus on vaccine production capacity.

Fierce looked at contamination issues associated with the production of Moderna’s SARS-Cov_2 vaccine.

BioLife Solutions has closed its acquisition of Sexton Biotechnologies, a developer of packing technologies for cell therapies.

Umoja Biopharma has started work on a manufacturing facility in Louisville, Colorado. The firm said the plant represents an important next step in bringing effective and accessible CAR T therapies to cancer patients.

CDMO trends

Some developments of note in the contracting sector:

Catalent plans to acquire Bettera for $1bn, citing demand from the nutraceuticals market as a driver for the deal.

Thermo Fisher Scientific has announced plans to establish a facility in Nashville dedicated to the production of single-use technologies (SUT) manufacturing technologies.

Bioprocess Insider reports that CDMOs are acquiring cell and gene therapy production facilities.

Recro Pharma and BioCorRx have expanded their relationship with a new development and manufacturing agreement. The CDMO will provide analytical validation services and cGMP manufacturing services.

Researchers at Aston University will help Catalent develop the Zydis orally disintegrating tablet (ODT) technology.