New analysis published in the British Medical Journal has found that almost half...
- Bias remorse: are cancer drug trials clear enough on outcomes?
- Pharma Technology Focus: access to PrEP
- Data shows non-inferiority of SC administration of Roche’s Perjeta and Herceptin
- Janssen’s Darzalex outperforms standard of care in newly diagnosed multiple myeloma
- ViiV submits NDA for drug indicated for multi-drug resistant HIV
Accelerated Paths to Commercialisation and Cold Chain Supply Impact
With five FDA programmes moving drugs through approval to commercialisation, the speed of scale-up is quickening, shortening time to market by months.
Cleaning Validation for Pharmaceutical Manufacturing
Cleaning validation is a requirement for pharmaceutical manufacturing, which adheres to current good manufacturing practice (cGMP) and quality systems regulations (QSR).
Bias remorse: are cancer drug trials clear enough on outcomes?
New analysis published in the British Medical Journal has found that almost half of pivotal trials forming the basis of EMA approvals of new cancer drugs were at high risk of bias based on their design, conduct or analysis. What exactly are the problems with cancer trial design and administration, and what needs to change? Study co-author Dr Huseyin Naci lends his insight.
Promethera closes Series D funding round to support expansion
Cell-based drugs developer Promethera Biosciences has closed a Series D financing round to support its expansion in Asian markets, along with the development of liver disease programmes.
Data shows non-inferiority of SC administration of Roche’s Perjeta and Herceptin
Roche has published data demonstrating non-inferiority of a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) administered through subcutaneous (SC) injection to standard intravenous (IV) infusions of the two drugs in HER2-positive early breast cancer.
Janssen’s Darzalex outperforms standard of care in newly diagnosed multiple myeloma
Johnson & Johnson subsidiary Janssen has presented promising results from two Phase III trials of Darzalex (daratumumab) in newly diagnosed multiple myeloma patients who are ineligible for surgery or high-dose chemotherapy.
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