Regulatory

Some changes to the contentious social security financing bill have been made, but industry and the government remain at odds over a €1.2bn drugs overspend.

Generics Bulletin reviews the latest regulatory developments across the world.

The Swedish biotech has held positive talks with US regulators about the Phase III design for its pancreatic cancer candidate, mitazalimab. Now it needs to pin down a partner.

In an ongoing effort to accelerate the commercialization of select innovative drugs and medical devices, Korea’s MFDS is launching a new program for certain products that will receive regular regulatory consultations until they reach the approval stage.

Kostaive is the first self-amplifying mRNA COVID-19 vaccine to receive approval from the European Commission and could provide serious competition to Pfizer/BioNTech's Comirnaty and Moderna's Spikevax.

The Swedish company is celebrating approval for the first treatment for MCT8 deficiency

Brazil’s drug regulator ANVISA has also published its first post-marketing authorization monitoring reports on advanced therapies Yescarta, Zolgenma, Kymriah, Carvykti and Luxturna.

Restrictions on commonly used chemicals, increased reporting requirements and enhanced environmental risk assessments are just some of the new EU sustainability and environmental rules pharmaceutical companies are potentially facing. While some measures are multi-sectoral, others are pharma specific. The Pink Sheet takes a look at some of the developments in 2024 and expectations for 2025 and beyond.

Etuvetidigene autotemcel, Fondazione Telethon’s investigational gene therapy for Wiskott-Aldrich syndrome, is among the latest drugs that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Despite significant investments in weight loss treatments, pharmaceutical companies face criticism for neglecting to study their drugs in obese patients, possibly leading to incomplete labeling and patient risks, prompting calls for the FDA to enforce more inclusive clinical trials and updated drug information.