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EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drug prices? To explore how Zelta can support your organization’s clinical data management needs, download the document below.
To learn more about the solutions provided by Paradigm Health, download the document below. How will RFK Jr’s American dream for vaccines play out? To serve both science and patients, the industry must embrace transformation before inefficiency puts progress out of reach. Sign up for our daily news round-up!
The document also confirms that deputy directors Scott Steele and Brittany Goldberg will continue to serve in their respective positions within the CBER executive committee. Give your business an edge with our leading industry insights.
The FDA says this should be done via Type V Drug Master File (DMF), a document that can be incorporated into drug applications to support approval. Companies will be encouraged to provide information on their proposed facilities, such as site operations layouts and quality control elements.
In addition, documentation of the material is required, along with clearly defined next steps for modification and expansion. How will RFK Jr’s American dream for vaccines play out? Such logistics requires specialists in cold chain logistics, who need to maintain a full chain of custody and ensure traceability.
Robert Barrie July 16, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Shares in London-listed GSK closed 1.19% down following the document release. Experts also identified poor tolerability of regimens and resulting uncertainty regarding proposed dose, as per a briefing document published on 15 July.
The net payment made by Sino to acquire LaNova will be approximately $500.9m, a figure that excludes the estimated cash and bank deposits, according to a company document outlining the terms of the transaction. How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights.
Comstock said it is not yet clear if the report will be turned into an official agency guidance document, but it will be made publicly available. How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights.
The concern of ocular toxicity was first highlighted in a document published ahead of the ODAC meeting that took place on 17 July. How will RFK Jr’s American dream for vaccines play out? The FDA will consider the recommendation of the committee as it finalises its review on Blenrep in advance of the 23 July PDUFA date.
In a later report in Süddeutsche Zeitung, it was claimed that internal government documents had been made available showing that the confidential pricing measure was included in the MFG as a condition for the decision to build the factory. Give your business an edge with our leading industry insights.
Having a long-term partner, who can help build an ecosystem for the long term help, and this has been well documented in the US, he added. Can pharma tariffs “Make America Manufacture Again”? He cited the example of VIB’s work with Belgian biotech argenx to develop an asthma treatment, ARGX-118, which argenx will now further develop.
Real-world roadblocks (and how to remove them) When you start implementing these requirements, you’ll face practical challenges that don’t appear in regulatory guidance documents. How will RFK Jr’s American dream for vaccines play out? Governance questions emerge immediately: Should you create a dedicated AI oversight committee?
GMP/GLP and PPE training are applied to all employees, contractors and casual staff working in a GMP environment, including manufacturing, packaging, labelling, distribution, QA, QC, development, validation, engineering, IT staff and anyone whose activities could affect product quality. Additional documents are included each month.
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