FDA finds major lapses at Moderna’s Covid vax facility, Servier ordered to pay millions in deadly Mediator scandal

By PharmaCompass

2023-12-21

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In this week’s Phispers, the Food and Drug Administration (FDA) has reportedly found serious quality lapses at Moderna’s manufacturing facility in the United States where its Covid jab Spikevax is produced.

In what is possibly the worst health scandal in France’s history, a French court ordered drugmaker Servier to pay € 430 million in connection with the deadly weight-loss pill Mediator.

With the US presidential election less than a year away, the Biden administration continues to come after pharma companies. This week, the president claimed Big Pharma is “ripping off the American people” as 48 drugs used in Medicare were made subject to tax rebates due in January 2024.

With America’s opioid epidemic at its peak, the FDA approved the first test that uses DNA to assess whether certain individuals may have an elevated risk of developing opioid use disorder (OUD).

The wealthiest charitable organization in the world, the Novo Nordisk Foundation, announced it is committing DKK 1.8 billion (US$ 260 million) to establish a revolutionary state-of-the-art research and vaccine development initiative to generate immunity in the airway itself for some of the deadliest respiratory diseases.

FDA inspection uncovers quality lapses at Moderna’s Covid vax facility

According to an exclusive Reuters report, an FDA inspection at Moderna’s manufacturing facility in Norwood, Massachusetts, found lapses in the company’s quality management system.

The inspection, which was conducted between September 11 and 21, resulted in the agency issuing a Form 483 with five separate observations. One of the major concerns highlighted was that Moderna had released eight batches of an active ingredient used to produce mRNA COVID vaccines using equipment that had failed cleaning validation. It is not known if those batches were released to the public.

Inspectors found more than 2,000 expired items in Moderna’s warehouse and cold storage which were not held separately from other materials. This observation raised concerns over Moderna’s material management system as there was a risk of expired materials being used to make vaccines.

Moderna issued a statement saying, "Upon receipt of the FDA’s findings, Moderna immediately and comprehensively updated the specific procedures identified and is confident that the actions taken will be satisfactory to regulators."

French drugmaker Servier ordered to fork up US$ 471 mn in deadly Mediator scandal

In what is possibly the worst health scandal in France’s history, a French court ordered drugmaker Servier to pay € 430 million (US$ 471 million) in connection with the deadly weight-loss pill Mediator (benfluorex). Developed as a therapy in overweight diabetics, Mediator stayed on the market for 33 years and studies have shown that it killed anywhere between 500 to 2,000 people between 1976 and 2009.

The Paris court of appeals held that Servier was guilty of fraud as it intentionally concealed the risk of heart problems from doctors and patients and that it illegally obtained approval and renewals. In the initial ruling in 2021, France's medical regulator was fined over € 300,000 for its role in the scandal.

Servier must also pay about € 9 million in criminal fines, € 5 million in legal costs and € 1 million in damages on top of what it has already paid victims. Former deputy boss Jean-Philippe Seta was handed a four-year suspended prison sentence in the manslaughter case. The scandal was exposed by French pulmonologist Dr Irène Frachon.

Biden to impose inflation rebates on dozens of drugs over ‘price gouging’

For the second time in as many weeks, the Biden administration has come after pharma companies, this time to crack down on “price gouging” of drugs used in Medicare – the government’s health insurance program for those aged 65 and over and some disabled people.

Joe Biden’s Inflation Reduction Act allows for drugmakers to be penalized by requiring them to pay rebates should they raise prices faster than the rate of inflation.

The White House identified 48 drugs whose prices spiked faster than inflation in Q4 and may be subject to rebates come January 2024. The money will be used to lower out-of-pocket costs of Medicare enrollees. Included in the list are chemotherapies, hematologic treatments, vaccines and growth hormones used to treat endocrine disorders.

Reducing drug prices is a central Biden campaign promise in the 2024 presidential election as it was in 2020.

AstraZeneca, Sanofi to provide more RSV jabs: The Biden administration has also been in an ongoing conversation with Sanofi and AstraZeneca to increase the supply of Beyfortus (nirsevimab-alip), their respiratory syncytial virus (RSV) immunization for infants, to meet the winter demand. The French and Anglo-Swedish drugmakers will deliver an additional 230,000 doses in January, the White House said. This follows 77,000 additional doses that were delivered in November. RSV is the number one cause of infant hospitalization in the US.

FDA greenlights first test to identify opioid addiction risk

The FDA approved the first test that uses DNA to assess whether certain individuals may have an elevated risk of developing opioid use disorder (OUD). Private company SOLVD Health developed the AvertD test, and the approval was granted to its unit AutoGenomics. It is administered to those over 18 years old before they are first exposed to oral opioid pain medications. Among people being considered are those who will get 4-to-30-day prescriptions for the treatment of acute pain, including those intending to get surgeries.

A DNA swab is used to determine if there is a combination of genetic variants that make an individual more prone to developing OUD. America’s opioid epidemic has cost the lives of 645,000 people between 1999 and 2021. What’s more is that the number of people who died from a drug overdose in 2021 has skyrocketed to over six times more than in 1999.

Novo owner announces revolutionary vaccine initiative

The Novo Nordisk Foundation, which controls Danish drugmaker Novo Nordisk, said it is committing DKK 1.8 billion (US$ 260 million) to establish a major new state-of-the-art research and vaccine development initiative to fight deadly airborne infections. It will be the first vaccine initiative in the world to focus solely on understanding how to generate immunity in the airway itself for some of the deadliest respiratory diseases, including tuberculosis (TB), influenza, and Group A Streptococcus (GAS), which collectively cause more than 2.5 million deaths per year.

The Novo Nordisk Foundation will be partnering with the University of Copenhagen and the Danish government’s Statens Serum Institut (SSI) to develop what could be a revolutionary way of blocking infection and preventing airborne diseases from spreading among humans.

BioNTech handed win in CureVac battle, aims to start Rwanda mRNA site in 2025

A German court has handed BioNTech a win by ruling against its embattled domestic rival CureVac, with regards to claims for a share of the over US$ 40 billion it made with Pfizer with Covid-19 vaccine Comirnaty. Small-cap CureVac has no less than eight ongoing patent litigations against BioNTech after its own mRNA-based COVID-19 vaccine failed to come to fruition, and one of those patents was invalidated by the court. CureVac intends to appeal the decision. Analysts had said that even a small fraction of the revenues in question could have a huge impact on the company’s finances.

BioNTech announced it is targeting commencing production at its mRNA vaccine factory in Kigali, Rwanda, in 2025. The German drugmaker’s facility will be the first foreign company mRNA vaccine manufacturing site in Africa. The continent will now have one of the most advanced manufacturing facilities in the world, the company said.

BioNTech, the sole funder of the facility, is expected to employ about 100 people and has pledged US$ 150 million in total.

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