In this week’s news, FDA supporting Covid-19 vax firms, EU tweaks pharmacovigilance rules, bye-bye biosimilars? and more…

US FDA bids to help firms make and trial SARS-CoV-2 vax candidates

The US FDA wants to help biopharmaceutical companies and contractors trial SARS-CoV-2 vaccines.

The regulator issued new guidance last week, explaining it expects vaccine firms to follow traditional clinical development models.

“There are currently no accepted surrogate endpoints that are reasonably likely to predict clinical benefit of a COVID-19 vaccine. Thus, at this time, the goal of development programs should be to pursue traditional approval via direct evidence of vaccine safety and efficacy in protecting humans from SARS-CoV-2 infection and/or clinical disease.”

The guidance covers CMC, manufacturing and facility inspections as well as animal studies and clinical trial data requirements.

US to allow sponsors to send trial safety data electronically

The US FDA will soon let sponsors submit safety data from drug trials electronically after a successful pilot programme.

The US regulator announced the plan last week at a public meeting (see webcast) about its data strategy.

Meredith Chuk, MD, Acting Associate Director for Safety with FDA’s Office of Oncologic Diseases, said “The current method for submission of these reports is actually as PDF forms, and it’s extremely inefficient,” adding the agency receives half a million reports a year.

She added that a digital submission format with structured data elements “will allow us both to improve the data quality and also allow us to use new analytic tools.

EU relaxes pharmacovigilance rules during the pandemic

The European Medicines Agency (EMA), European Commission and Heads of Medicines Agencies (HMA) have tweaked pharmacovigilance rules in light of Covid-19.

In a document published last week the organisations gave drug firms license to adapt corrective and preventive actions (CAPAs), citing disruption caused by the pandemic as the basis for the move.

They wrote “During the pandemic situation MAHs might activate business continuity plans and prioritise activities. Therefore, in case MAHs are unable to continue standard management of corrective and preventive actions, for justified reasons relating to the pandemic, they should temporarily prioritise the deviations.”

The organisations also said firms could delay on-site pharmacovigilance inspections, explaining that such audits may not be possible due to travel and operational restrictions.

US FDA lauds AstraZeneca participation in project patient voice

AstraZeneca has become the first company selected for the FDA’s Project Patient Voice programme, which shares patient-reported symptoms from cancer trials for marketed drugs.

The FDA said, “Patient-reported data has historically been analyzed by the FDA during the drug approval process, it is rarely included in product labelling and, therefore, is largely inaccessible to the public.”

It added, “AstraZeneca is the first company to provide patient-reported outcome data for one of their FDA-approved drugs and has collaborated with the FDA to identify methods to display the information in a way that is informative to health care professionals and patients.

See full press release here.

US bye bye to biosimilars?

Last week Lachman Consultants asked if the Biologics Price Competition and Innovation Act (BPCIA) – the US FDA’s biosimilar pathway – is going to be abandoned by mistake.

The author suggests Trump administration efforts to get rid of the Affordable Care Act (ACA) – Obamacare – could leave the US without a biosimilar pathway because the BPCIA is a component of the legislation.

Also in the news

Wired reported the vaccines sector is turning to the microchip manufacturing sector for vial materials as a result of ongoing glass shortages.

Politico suggested the US Government’s $10bn “Warp speed” programme – which is designed to accelerate development of a SARS-CoV-2 vaccine – is risky because it may not generate an effective jab.

GEN reported that the industry 4.0 concept – use of data to drive and improve operations – could help biopharma manufacturers comply with ever stricter product quality requirements.

The Wall Street Journal looked at Moderna, the firm whose SARS-CoV-2 vaccine is widely considered the front runner.

CDMO tends

Some developments of note in the contracting space.

The Carlyle Group has bought a 20% stake in Piramal. The equity investment is one of the largest private equity deals in the Indian CDMO sector and is expected to close in 2020.

Grand River Aseptic Manufacturing has opened a large scale facility in Grand Rapids, MI. The CDMO spent $60m on the facility, which triples production capacity at the site.

Ajinomoto Bio-Pharma Services has launched a drug and vaccine manufacturing platform. The AJILITY system is designed to streamline tech transfer, production and shipping.

Lubrizol, Catalent, Lonza and Emergent execs spoke with BioPharm International about GMP difficulties the CDMO sector faces.

Catalent has acquired a clinical trial material packaging facility in Shiga, Japan. The site was owned by Teva-Takeda Pharmaceutical.