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Essential Terms for UK Quality Regulations Post-Brexit

August 11th, 2022|Categories: Featured, Industry News|Tags: , , , |

Many biotechs are struggling with the uncertain state of quality regulations in the Post-Brexit UK. Understanding the new regulatory processes and requirements begins with understanding the key terms in a new MasterControl article, Joanna Blair breaks down the top 11 terms you need to know to navigate the current regulatory landscape to ensure compliance. To start, companies must know the importance of UKCA and CE markings.

US FDA Gives Quick Approval for First Low-HER2 Breast Cancer Drug

August 8th, 2022|Categories: Featured, Industry News|Tags: , , , , |

The US Food and Drug Administration (FDA) has approved Enhurtu, the first drug to treat metastatic or unresectable low-HER2 breast cancer, a recently defined category of the disease. The drug, developed by AstraZeneca and Daiichi Sankyo, received expedited approval from the agency, in part because of the potential for the breast cancer category, which covers over half of cases previously defined as HER2-negative.

EU Committee Supports New Roche and Eli Lilly Meds as Clovis’ Ovarian Cancer Drug is Rejected

July 25th, 2022|Categories: Featured, Industry News|Tags: , , , |

The European Committee for Medicinal Products for Human Use (CHMP) has given the nod to Eli Lilly for its type 2 diabetes drug Mounjaro and Roche’s macular degeneration drug Vabysmo. Clovis’ Rubraca, a third-line treatment for ovarian cancer, was not reccomended by the committee based on the manufacturer’s request. The drugmaker had already voluntarily pulled the drug in the US due to data linking the drug to increased mortality risk.

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