Industry news

• 2024 drug approvals: Small companies loom large with several key FDA nods

  13 January 2025 FiercePharma

  Comparing the FDA new drug approval lists from 2023 and 2024 reveals a significant difference in the size of the companies that achieved the regulatory triumphs. In 2023, among the 68 FDA approvals highlighted in Fierce Pharma’s annual report, 43 (63%) were sponsored or co-sponsored by companies that generated at least $3 billion in revenue in 2023. That stands in contrast to the 2024 approval list, which shows that among 55 FDA nods, just 23 (42%) were sponsored or co-sponsored by companies with sales that reached $3 billion in 2023. 

• Special Regulations for Foreign-Packaged Medicines Extended Until the End of 2025

  13 January 2025 GxP news

  The Russian government has decided to extend the special regulations for the circulation of medicines in foreign packaging, complete with Russian-language labels, through 2025. This decision was made to prevent shortages and ensure a stable supply of medications in pharmacies and medical institutions.

• Russia Begins Production of Terbium-161 Isotope for Cancer Therapy

  10 January 2025 GxP news

  Russia has commenced the production of the innovative medical isotope terbium-161, intended for cancer therapy. This production process has been established by specialists at the Institute of Reactor Materials, part of Rosatom’s scientific division, located in the Sverdlovsk region. The first experimental batch of the isotope will be used for testing at the Russian Research Center for Radiology and Surgical Technologies (RNCRH), which specializes in nuclear medicine research and the development of radiopharmaceuticals.

• FMBA has begun clinical trials of a vaccine against five serotypes of meningococcus

  10 January 2025 GxP news

  The Federal Medical and Biological Agency of Russia has initiated the first phase of clinical trials for an innovative vaccine against meningococcus, named MCV-5. According to the agency’s press service, the vaccine’s safety, immunogenicity, and protective properties were established during preclinical trials.

• FDA issues first recommendations on AI for drug development

  09 January 2025 Catherine Eckford / European Pharmaceutical Review

  The new US Food and Drug Administration (FDA) guidance will enhance credibility of AI models in drug and biological product regulatory submissions.

• Personal Data in European Medicine Regulation

  28 December 2024 BioPharm International

  EMA and HMA have published revised guidelines on identification of commercially confidential information and personal data used in marketing authorization applications.

• Belarus Republic creates production of oncology drugs for 1.5 billion rubles

  27 December 2024 GxP news

  A new pharmaceutical production facility has been launched in the Minsk Free Economic Zone. The enterprise of the Onco Solutions company will focus on the production of sterile parenteral forms of antitumor drugs.

• Tyumen Medical University has developed a lancet for diagnosing five socially significant diseases

  27 December 2024 GxP news

  Tyumen State Medical University specialists have created a patented lancet-type diagnostic device that enables quick testing for five important diseases: HIV, syphilis, tuberculosis, and hepatitis B and C.

• Nanoparticle drug delivery innovation could enhance drug development

  26 December 2024 Catherine Eckford / European Pharmaceutical Review

  With advantages such as utilising bio-compatible materials, the biomolecule-based drug delivery system enables potentially safer drug development, according to the researchers.

• Antibody drug has promise as “next frontier” in inflammatory bowel disease

  26 December 2024 Catherine Eckford / European Pharmaceutical Review

  With its best-in-class potential, the biologic could provide a new treatment option for patients with inflammatory bowel disease (IBD), say Teva Pharmaceuticals and Sanofi.