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Biosimilar Reference Products Expected to Grow
• Logistic complications create high demand for the expertise of comparator suppliers • Reference batches can be sourced from...
Diabetic Neuropathy Patient Stratification, Chances Boosted
• Phase II signals encouraging for positive Phase III translation • Capsaicin as stratification tool shows promise for responder...
J&J may suffer over AbbVie,Amgen in renewed biologic USpayer contracts as Celltrion’sbiosimilar loom
• Remsima use may be forced ahead of Remicade, but not Humira or Enbrel • Celltrion needs to emphasize Remsima clinical...
Array/Novartis’ Binimetinib Expected to Best Chemotherapy in Phase III Trial Despite Protocol Change
• Enrollment criteria expanded mid-trial to reflect shifting treatment landscape • Inhibiting MEK elicits enthusiasm for NRAS...
The Unrealized Potential of Stem Cell Therapy
Over the last decade or so, I have observed a tempering of what was once a large and growing interest in stem cell therapies by patients,...
Novartis’ LCZ696 for CHFdraws approval optimism aftermeeting difficult Phase IIIendpoints
• Superiority to standard therapy bodes well for approvals • Regulators may require dropout explanation • Good potential for first...
Celgene's Revlimid has experts optimistic about potential in Phase III non-del (5q) MDS trial in tr
• Historical responses meaningful, but approvability based on transfusion changes unclear • Gene expression based screening could...
Merck's Phase III Tecemotide Vaccine Trial in NSCLC in Asian Patients Could Show Benefit, but ..
• Marginal OS benefit found in Asian patients in previous trial lends optimism • Vaccine combination with PD1/PDL-1 checkpoint...
AstraZeneca’s pipeline projections a tough sell, Pfizer will struggle to drive combined value
• Valuations unreliable given large timeframe to market • Likely EU/US pricing pressures to impact revenue forecasting • Combined...
AstraZeneca's Phase I/II AZD9291 Shows Promise in EGFR Inhibitor Refractory Patients - Oncologists
"Targets T790M mutation to overcome EGFR inhibitor resistance Could be effective in the first-line setting as well Selectivity...
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