Regulatory Roundup: FDA Clears Infant Rotavirus Vaccine
ePT--the Electronic Newsletter of Pharmaceutical Technology
FDA Clears Infant Rotavirus Vaccine
FDA stated on May 14, 2010, that US healthcare practitioners can resume the use of Rotarix (Rotavirus Vaccine, Live, Oral) used to treat the disease in infants, effective immediately. This action supersedes the agency’s March 22 recommendation, which called for healthcare providers to halt its use. FDA has determined that the presence of porcine circovirus type 1 (PCV-1) in the vaccine poses no safety risk.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Drug Solutions Podcast: Applying Appropriate Analytics to Drug Development
March 26th 2024In this episode of the Drug Solutions Podcast, Jan Bekker, Vice President of Business Development, Commercial and Technical Operations at BioCina, discusses the latest analytical tools and their applications in the drug development market.
Shilpa Medicare Launches ‘Hybrid CDMO’ at DCAT Week 2025
March 17th 2025This model is being positioned by Shilpa as a dual approach that offers comprehensive discovery, clinical, and commercial outsourcing services in addition to commercially ready, “off-the-shelf” novel formulations for b2b licensing.
Benuvia Granted GMP Certification by Brazil National Health Surveillance Agency
March 14th 2025The certification allows Benuvia to produce pharmaceutical products for companies, either local to Brazil or international, that may be looking for compliant and high-quality production capabilities in the Brazilian pharmaceutical market.
