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Exclusive_Moitreyee Chatterjee-Kishore_2024
EXCLUSIVE

Decoding Approval: Moitreyee Chatterjee-Kishore from Astellas in an Exclusive Conversation with PharmaShots

Shots: Recently EC granted Marketing Authorization to Astellas’ VYLOY (zolbetuximab) in combination with chemotherapy for the treatment of patients with advanced gastric and GEJ cancers Zolbetuximab, a monoclonal antibody designed to target gastric tumor cells that express CLDN18.2 biomarker Today, at PharmaShots we have Dr. Moitreyee Chatterjee-Kishore the Head of Development, Immuno-Oncology and Cancer Cell…
September 26, 20240Comments

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Bristol Myers Squibb
News

BMS’ Cobenfy (Xanomeline and Trospium Chloride) Receives the US FDA Approval for Treating Schizophrenia 

Shots:    The US FDA has granted approval to BMS’ Cobenfy for treating schizophrenia in adults, based on its EMERGENT studies The EMERGENT studies comprised of P-III (EMERGENT-2 & 3) trials, evaluating the safety, efficacy & tolerability of Cobenfy vs PBO in schizophrenic adults for over 5wks., as well as two open-label trials assessing long-term safety…
September 26, 20240Comments

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News

Alvotech Reports the Initiation of Confirmatory Trial of AVT16 (Biosimilar, Entyvio) 

  Shots: Alvotech has begun the confirmatory trial of AVT16, biosimilar version of Entyvio (vedolizumab), that targets alpha-4-beta-7 protein for treating Ulcerative Colitis and Crohn’s disease The P-III (AVT16-GL-C01) trial is a double-blind, two-arm study comparing the efficacy, safety & immunogenicity of AVT16 vs Entyvio in patients of age 18-80yrs. with moderate to severe active…
September 25, 20240Comments

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IntraBio
News

IntraBio’s Aqneursa Receives the US FDA’s Approval for Treating Niemann-Pick Disease Type C 

Shots:    The US FDA has granted approval to Aqneursa (levacetylleucine) for treating adults & pediatric patients (≥15kg) with neurological manifestations of Niemann-Pick disease type C (NPC) Approval was supported by pivotal P-III (IB1001-301) study assessing the effect of Aqneursa vs PBO on neurological symptoms & functioning in pediatric (≥4yrs.) & adults (n=60) with confirmed NPC …
September 25, 20240Comments

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Insights+: EMA Marketing Authorization of New Drugs in August 2024
INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in August 2024

Shots:   The EC has approved to 5 Biologics and 3 New Chemical Entities in August 2024, leading to treatments for patients and advances in the healthcare industry  The major highlighted drugs were Johnson & Johnson’s Balversa to treat Metastatic Urothelial Carcinoma (mUC) and Takeda’s Adzynma for Congenital Thrombotic Thrombocytopenic Purpura (cTTP) PharmaShots has compiled a list…
September 24, 20240Comments

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Viewpoints_Sofie Berg
VIEWPOINTS

Unlocking Approval: Sofie Berg from AbbVie in an Illuminating Dialogue Exchange with PharmaShots

Shots: Recently, the European Commission approved AbbVie’s Skyrizi for the treatment of adults with moderate to severe active Ulcerative Colitis The approval was based on positive data from the P-III INSPIRE induction trial and COMMAND maintenance study  Today, at PharmaShots we have Sofie Berg, the therapeutic area head of international immunology, International Medical Affairs, at…
September 23, 20240Comments

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Pharmaceutical Automation and Digitalisation Congress - AUTOMA 2024
EVENTS

Pharmaceutical Automation and Digitalisation Congress – AUTOMA+ 2024

Pharmaceutical Automation and Digitalisation Congress (AUTOMA+ 2024 | Zurich, Switzerland, 18-19 November) is an annual event where attendees showcase their case studies and connect with industry experts, all with the goal of promoting effective digital transformation. The closed-door format of the Congress ensures that only decision-makers and key specialists are going to be there. AUTOMA+ 2024…
September 23, 20240Comments

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Henlius and Intas
News

Henlius and Intas’ Hetronifly (Serplulimab) Receives the CHMP’s Positive Opinion to Treat Extensive-Stage SCLC 

     Shots:   The positive opinion of Hetronifly (anti-PD-1 mAb) was supported by ASTRUM-005 study assessing it with CT vs PBO as a 1L treatment of ES-SCLC patients (n=585) in various regions. It is approved in China under the brand name Hansizhuang for the same Henlius partnered with Intas in 2023 to develop & commercialize…
September 21, 20240Comments

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