Encouraging Phase II results were released last week for Pluristem’s PLX-PAD, a placenta-based...
- Regenerative therapy for peripheral artery disease moves forward
- Shaky foundations: the flaws in animal research reporting
- Pharma underutilises avenues to attract and retain trial patients
- EMA approval for Trazimera: another win for trastuzumab biosimilars
- EHA 2018: competition is heating up in DLBCL for anti-CD19 CAR-T cell therapies
Aqueous Cleaning in Pharmaceutical Manufacturing
The use of aqueous cleaning in pharmaceutical manufacturing can provide numerous benefits in terms of effectiveness, minimal surface residue, and easier cleaning validation.
Regenerative therapy for peripheral artery disease moves forward
Encouraging Phase II results were released last week for Pluristem’s PLX-PAD, a placenta-based allogeneic stem cell therapy given intramuscularly, targeting peripheral artery disease (PAD). The positive results are great news for patients who suffer from PAD, a circulatory problem in which narrowed arteries reduce blood flow to the limbs, which has limited treatment options available.
Shaky foundations: the flaws in animal research reporting
A new systematic analysis has reiterated concerns over the quality of reporting for preclinical efficacy data from animal studies. With these findings in mind, what are the flaws in animal research reporting, and why aren’t regulators and industry sponsors kicking up more of a fuss about it?
ViiV ups the ante with positive topline data for its second two-drug HIV combo
On June 14, ViiV Healthcare announced positive topline results from its Phase III GEMINI 1 and GEMINI 2 studies.
Thailand: from medical tourism to contract manufacturing
Thailand hopes to use its strength in medical tourism to grow its pharmaceutical sector, claimed industry experts at the Thailand Board of Investment & TCELS Presents: Life Innovation - Business Opportunities in Research & Innovation in Thailand panel at the BIO convention in Boston, MA on Monday, June 4th.
Flexible Drug Containers for Parenteral Drugs
Self-medication is becoming more popular, driven by cost considerations. Valuable time of healthcare personnel and the high cost of hospital stays are outweighing the costs of treatment drastically.
Pharma underutilises avenues to attract and retain trial patients
Pharma companies can better attract patients to clinical trials through working with patient advocacy groups to generate feasible trial designs and offering to offset trial costs, said delegates at Arena International’s recent Outsourcing in Clinical Trials UK and Ireland 2018, held in London.
EMA approval for Trazimera: another win for trastuzumab biosimilars
On May 31, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) positively recommended a marketing authorization to be granted for Pfizer’s Trazimera (trastuzumab), a biosimilar to Herceptin (trastuzumab). This news comes as a positive leap for Pfizer following its rejection from the FDA in April 2018, which included a request for additional technical information that was not related to the safety or clinical data submitted in the application.
EHA 2018: competition is heating up in DLBCL for anti-CD19 CAR-T cell therapies
Numerous highly attended clinical data and educational sessions were hosted about CAR-T cell therapy at this year’s European Hematology Association (EHA) annual meeting.
EHA 2018: pivotal Phase III data for Daiichi Sankyo’s quizartinib
Daiichi Sankyo’s pivotal data presentation at this year’s European Hematology Association (EHA) annual meeting showed that its FLT3 inhibitor quizartinib significantly improved patient outcomes in relapsed/refractory (R/R) FLT3-ITD-mutated acute myeloid leukemia (AML), a population with a high unmet need and currently no approved targeted therapies.
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