A roundup of some of the biggest stories from Italian pharma and healthcare, including Italfarmaco’s FDA approval for its DMD treatment; Alfasigma’s acquisition of Galapagos’s Jyseleca, the antibiotics deal between Venatorx Pharmaceuticals and Menarini, and the country’s drop in healthcare spending.


Stevanato Group Announces Public Offering of Ordinary Shares (Yahoo Finance)

Stevanato Group S.p.A., a leading global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries, today announced the launch of an underwritten public offering of an aggregate of $300,000,000 of its ordinary shares.

Stevanato Group is offering $150,000,000 of its ordinary shares, and Stevanato Holding S.r.l., an affiliate and major shareholder of the Company, which currently holds approximately 78% of Stevanato Group’s outstanding ordinary shares, is offering $150,000,000 of its ordinary shares.


Adare Pharma Solutions Initiates Expansion of Pessano Facility in Italy (Contract Pharma)

Adare Pharma Solutions, a global technology-driven CDMO focused on oral dosage forms, is adding packaging capabilities and further warehousing capacity at its Pessano facility in Milan, Italy.

The 20,400 square meter Pessano facility provides R&D services to expedite formulation and process development, with a seamless integrated transition to manufacturing. It can manufacture a wide range of solid dosage forms at both clinical and commercial scales, including granules, capsules, and tablets. The facility also provides controlled substance and organic solvent capabilities.


Italfarmaco nabs FDA approval for new Duchenne med, teeing up sparring match with Sarepta (Fierce Pharma)

At a watershed moment for Duchenne muscular dystrophy (DMD) treatment, privately held Italian drugmaker Italfarmaco has added a new therapeutic option to the armamentarium against the debilitating muscle-wasting disorder.

Late Thursday, the U.S. FDA gave a thumbs-up to Italfarmaco’s histone deacetylase (HDAC) inhibitor Duvyzat, also known as givinostat.

The approval makes the product the first nonsteroidal drug approved to treat patients with all genetic variants of DMD in the U.S., the FDA said in an approval announcement. Duvyzat, which is taken orally, is specifically cleared to treat DMD in patients ages 6 and older, Italfarmaco said in a separate release.


EuroAPI’s troubles mount as audit reveals manufacturing lapses in Italy, spurring 2024 guidance suspension (Fierce Pharma)

Beleaguered Sanofi spinout EuroAPI can’t seem to catch a break. After reporting ballooning losses and a four-year restructuring plan last month, the company revealed Thursday that manufacturing lapses at an Italian plant have temporarily derailed its guidance for the year.

EuroAPI’s Italian subsidiary is suspending production of all active pharmaceutical ingredients (APIs) at its plant in Brindisi after an internal audit uncovered quality control deficiencies “due to potential local misconduct,” the company said in a release.


Alfasigma to acquire Galapagos’ Jyseleca business (The Pharma Letter)

Privately-held Italian drugmaker Alfasigma has signed an agreement with Belgium’s Galapagos (Euronext: GLPG) to acquire the latter’s Jyseleca (filgotinib) business.

The agreement follows the signing of a Letter of Intent as announced on October 30, 2023 and marks a significant milestone in Alfasigma’s ongoing growth strategy.


Venatorx and Menarini sign commercial deal for antibiotic (Pharmaceutical Technology)

Venatorx Pharmaceuticals and the Menarini Group have signed an agreement for the commercialisation of the antibiotic cefepime-taniborbactam in 96 countries, contingent upon regulatory approvals. Menarini will obtain the sole rights for the marketing of the antibiotic in the Commonwealth of Independent States, Europe, Latin America, the Middle East, North Africa and Turkiye.

Cefepime-taniborbactam is an investigational intravenous beta-lactam/beta-lactamase inhibitor antibiotic combination to treat complicated urinary tract infections (cUTIs).


Italy’s healthcare system under threat, experts warn (Euractiv)

Italy’s national healthcare system faces intense scrutiny from regional authorities, scientists, and a Nobel laureate, who challenge the government’s handling of the system in the wake of the COVID-19 crisis. Funding for Italian healthcare has reached a 17-year low, as highlighted in a recent report to parliament by the Corte dei Conti. This report revealed a significant decline in Italy’s national health fund compared to countries like Germany and France.

Specifically, the ratio of healthcare spending to GDP has dropped from 6.8% to 6.3%, and it will stay the same on average for the next couple of years. The OECD and EU average is 7.1%, while France and Germany are around 10%.