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  1. Wacker Biotech to manufacture protein ingredients for MinervaX's late-stage GBS vaccine The vaccine is currently being prepared for Phase III trials, and aims to protect mothers and their babies from group B streptococcus infections
  2. Novartis' Kisqali plus ET bags FDA approval for HR+/HER2- breast cancer The decision comes off the back of the Phase III NATALEE clinical trial, which diminished the risk of disease recurrence by 25.1%
  3. AstraZeneca opens a 'people hub' at its Macclesfield site The energy-efficient building will offer AZ employees a collaborative space
  4. Ensuring cGMP compliance in cell and gene therapy manufacturing 3P discusses how companies can scale up their CGT manufacturing protocols while remaining compliant with stringent global regulations
  5. Piramal Pharma's sustainability goals get SBTi-validated The company wants to reduce its scope 1 and 2 GHG emissions by 42% by 2030, and is also working on developing a carbon reduction plan

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PCI hosts educational Serialisation and Anti-Counterfeiting Forum

Outsourcing services provider PCI Pharma Services, in collaboration with Antares, Crest Solutions, 3C Integrity, Multi-Packaging Solutions (MPS) and media partner Manufacturing Chemist, will host a free educational Serialisation and Anti-Counterfeiting Forum on 21 November at Heathrow Windsor Marriott Hotel, London, UK
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Manufacturing

The EU-FMD compliance project: is Europe ready?

For pharmaceutical manufacturers supplying the European market and their supply chain partners, 9 February 2017 marked the beginning of the 2 year countdown until the EU Falsified Medicines Directive (FMD) compliance mandate comes into force across Europe
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Packaging

The EU-FMD ‘Safety Features’ Delegated Act in 10 steps

Meeting the ‘Safety Features’ requirements of the EU Falsified Medicines Directive can be daunting, particularly as some details are as yet not well understood. Serialisation expert Christoph Krähenbühl summarises what is required from the final draft Delegated Act
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Regulatory

Serialisation: No more time to waste

One barrier to implementing product serialisation has been the variation and uncertainty of what would be required in the various regions around the world. Susan Birks talked to key players about how ready the industry is to meet the deadlines
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Packaging

Do not delay and pay the hard way

Former AstraZeneca serialisation expert Christoph Krähenbühl demystifies the arguments around compliance with the forthcoming Safety Features regulations in the EU Falsified Medicines Directive, and questions whether some countries are dangerously behind in their implementation strategies

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