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Insights+: EMA Marketing Authorization of New Drugs in December 2023
INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in December 2023

Shots:  The EMA approved 3 BLA while 4 New Chemical Entities in December 2023, leading to treatments for patients and advances in the healthcare industry In December 2023, the major highlighted drugs were Jempreli to treat dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer and Zilbrysq for the treatment of Generalized Myasthenia Gravis   PharmaShots has compiled a list of a…
January 23, 2024

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Insights+ Key Biosimilars Events of December 2023
INSIGHTS+

Insights+ Key Biosimilars Events of December 2023

Shots:  Stay up to date with PharmaShots Biosimilars Report, a monthly digest designed to keep you familiarized with the recent developments in biologics  Biosimilars are cost-effective alternatives to branded drugs but are very much alike when it comes to safety and efficacy  Check out the developments in the Biosimilars with PharmaShots’ illuminating report. PharmaShots has…
January 9, 2024

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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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