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VIEWPOINTS_Volker Wacheck_2024
VIEWPOINTS

Volker Wacheck Discusses the Approval of the Lonsurf Combination Drug for the Treatment of Colorectal Cancer

Shots:  Volker Wacheck sheds light on the recent approval of Lonsurf in combination with bevacizumab for patients with metastatic colorectal cancer  While sharing key insights from the pivotal P-III (SUNLIGHT) trial evaluating Lonsurf ± bevacizumab, Volker reveals that the combination drug is proven to prolong both OS and PFS along with QoL benefits and a…
January 2, 2024

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Insights+ Key Biosimilars Events of November 2023
INSIGHTS+

Insights+ Key Biosimilars Events of November 2023

Shots: Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency   Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients   During November, Amgen received US FDA approval for Wezlana, biosimilar of ustekinumab &…
December 6, 2023

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VIEWPOINTS_Mohamed Eid_2023
VIEWPOINTS

Unlocking Approval: Mohamed Eid Dives into the Exciting Approval of Jardiance for Adult CKD Treatment in a Captivating Chat with PharmaShots

Shots:  Mohamed Eid, VP of Clinical Development & Medical Affairs, Cardio-Renal-Metabolism & Respiratory Medicine, at Boehringer Ingelheim, in a stimulating conversation with PharmaShots sheds light on the recent approval of Jardiance for the treatment of adults with chronic kidney disease   Jardiance’s EMPA Kidney P-III trial results demonstrated a 28% relative risk reduction vs placebo. Jardiance…
December 5, 2023

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New Drug Designations - October 2023
INSIGHTS+

New Drug Designations – October 2023

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA and the EMA. This month’s report includes 2 biological drugs, 12 small molecules, 10 cell and gene therapies, 2 vaccines, 1 peptide, 1 exosome-based therapy and 3 devices  HuidaGene Therapeutics’ HG204 CRISPR RNA-editing therapy, focused on the treatment of MECP2 duplication…
November 20, 2023

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VIEWPOINTS_Boaz Hirshberg_2023
VIEWPOINTS

Boaz Hirshberg, SVP, Clinical Development at Regeneron Shares Insights from the US FDA Approval of Evkeeza (evinacumab-dgnb)

Shots: Boaz spoke about the US FDA approval of Evkeeza (evinacumab-dgnb) to treat children aged 5 to 11 with homozygous familial hypercholesterolemia (HoFH) Boaz also talked about the study design of the pivotal pediatric trial evaluating Evkeeza(evinacumab-dgnb) . He then extended his talk on HoFH and how Regeneron is creating awareness about the disease The…
July 31, 2023

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thoughtspot_Adrian Wallace
THOUGHTSPOT

4 Steps To Ensure Clinical Trial Compliance

When performing research studies, clinical trial compliance plays a vital part in ensuring the safety and effectiveness of the research. It means adhering to ethical and regulatory requirements established by governing bodies that guarantee the well-being of study participants and the legitimacy of study results. Sponsors, investigators, and study sites could face considerable legal and…
April 26, 2023

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