In this week’s news, EMA guides on vaccine development, calls for new FDA pathway for complex generics and more…

EMA offers advice for vaccine firms and CDMOs on Covid-19 vaccine modifications

The EMA has produced guidance for companies modifying SARS-CoV-2 vaccines to protect against emerging variants that includes details for firms hiring new CDMOs.

The document – available here – sets out how and when vaccine firms should notify the agency of changes to approved Covid-19 vaccines.

The EMA wrote, “Based on the pandemic situation, it could be necessary to have vaccines available that allow dedicated response to different variants circulating.

The guidance specifies how the vaccine firm should let the agency know when it adds a new contract manufacturing organisation (CMO) to the network of organisations making the product.

US FDA issued new guide on drug safety reporting

The US FDA has set out new safety report requirements for “sponsors” involved in filing IND applications or running bioavailability/bioequivalence (BA/BE) studies.

The draft guidance document covers how “sponsors” should comply with the expedited safety reporting requirements for drug and biological products that are being investigated under an IND or as part bioavailability (BA) or bioequivalence (BE) study.

According to the FDA the document “provides sponsors and sponsor-investigators recommendations regarding expedited safety reporting requirements for human drug and biological products that are being investigated under an IND and for drugs that are the subject of BA and BE studies that are exempt from the IND requirement.”

The draft is the latest iteration of a document originally released in 2015. It includes several minor revisions prompted by feedback from firms like GSK and Teva and industry group BIO.

Industry wants new bioequivalence pathway for complex generics

In other news, industry has asked the FDA’s Office of Generic Drugs (OGD) for an alternative bioequivalence pathway for some complex generics as well as for guidance on assessing the bioequivalence of metered-dose inhalers.

Industry representatives made the requests at a workshop held late last month.

Also in the news

US politicians have expanded their investigation of Emergent Biosolutions, the CDMO tasked with making AstraZeneca and J&J’s Covid-19 vaccines.

Scrip took a look at Pfizer’s decision to go it alone with the production of its own Covid-19 vaccine rather than as part of the US Government’s Warp Speed programme.

The Wall Street Journal looked at the role Lonza, Samsung Biologics and Aldevron played in the production of Moderna’s Covid-19 vaccine.

Reuters reported a South Korean consortium that includes manufacturing firm GL Rapha is to make the Sputnik V SAR-CoV-2 vaccine. Also see press release from the Russian Direct Investment Fund.

Earlier the newswire reported that the WHO is concerned about the Pharmstandard-UfaVITA filling plant in the republic of Bashkortostan where the vaccine is made.

Pharma Japan looked at Government plans to try and regulate the delivery of prescription pharmaceutical by drone.

CDMO trends

Some developments of note in the contracting sector:

Catalent announced it is to acquire RheinCell Therapeutics GmbH, a developer and manufacturer of GMP-grade human induced pluripotent stem cells (iPSCs).

Piramal Pharma’s contracting division has acquired Hemmo an API developer and manufacturer according to VCCircle.

PerkinElmer has announced its intention to buy viral vector technology firm Sirion Biotech. See press release.

ValenzaBio has hired Lonza to make VB421, a candidate anti-insulin-like growth factor 1 receptor (anti-IGF-1R) antibody being developed to treat thyroid eye disease (TED) and other inflammatory disorders.

Lonza has also signed an agreement with CellPoint that will see the latter use its Cocoon manufacturing platform to make CAR-T cell therapies.

Topical drug contractor Encube Ethicals has raised 120 million from Quadria Capital and its co-investors including Gulf Islamic Investments in a funding round completed this week.