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AstraZeneca and Amgen’s Tezspire (Tezepelumab) Secures the EU Approval for Severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Shots:The EU approved Tezspire as an add-on treatment with intranasal corticosteroids for adults with severe CRSwNP unresponsive to standard therapies; regulatory review is ongoing in China, Japan, and several other countriesApproval was based on the P-III (WAYPOINT) study assessing Tezspire (SC) vs PBO to treat adults with severe CRSwNP for 52wks., followed by…
5 days ago

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Samsung Bioepis ans NIPRO
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Samsung Bioepis Collaborates with NIPRO to Commercialize Biosimilar Candidates in Japan 

Shots:Samsung Bioepis & NIPRO have entered into a license, development & commercialization agreement for various biosimilar candidates, incl. SB17, a biosimilar version of Stelara (ustekinumab) in JapanAs per the deal, NIPRO will be responsible for commercialization of the biosimilar candidates in Japan, with Samsung Bioepis handling development, manufacturing & supply activitiesUstekinumab is…
June 9, 2025

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Sanofi & Regeneron
NEWS

Sanofi and Regeneron’s Dupixent Receives the MHLW’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD)

Shots:Japan’s MHLW has approved Dupixent to treat COPD in adults whose disease is inadequately controlled with existing therapyApproval was based on P-III (BOREAS) trial assessing Dupixent + SoC vs PBO in uncontrolled COPD adults with elevated blood eosinophils, which showed reduced exacerbations & improved lung function; data from BORUS & its replicate P-III (NOTUS)…
March 28, 2025

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BridgeBio
NEWS

BridgeBio Receives the MHLW’s Approval for Beyonttra (Acoramidis) for Transthyretin-Mediated Amyloidosis Cardiomyopathy (ATTR-CM)

Shots:Japan’s MHLW has approved Beyonttra to treat ATTR-CM in adult pts based on P-III (ATTRibute-CM) study assessing Beyonttra (BID, oral) vs PBO (n=632) in ATTR-CM pts; commercialization to begin in H1’25Trial showed 42% decrease in composite ACM & recurrent CVH events, plus 50% reduction in cumulative frequency of CVH events at 30mos., with pts…
March 28, 2025

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Countries in Health Innovation Top 20 2024
TOP 20

Top 20 Countries in Health Innovation in 2024

Top 20 Countries in Health Innovation in 2024Shots:By leveraging high-quality research, PharmaShots brings a meticulously prepared guide to the Top 20 Countries in Health InnovationUsing quantitative and qualitative analysis of several aspects encompassing healthcare innovations, PharmaShots dedicatedly navigated the core focus areas of innovations in healthcare while considering trending practices like the…
October 10, 2024

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VIEWPOINTS_Moitreyee Chatterjee-Kishore1_Kohei Shitara2_2024
VIEWPOINTS

Unlocking Approval: Moitreyee Chatterjee-Kishore from Astellas & Kohei Shitara in Conversation with PharmaShots

Shots: East Asia and East Europe report significant incidences of Gastric Cancer. In 2022, Japan registered around 44,000 mortalities due to Gastric Cancer VYLOY, an anti-claudin 18.2 (CLDN18.2) monoclonal antibody, received Japan’s approval in combination with chemotherapy for patients with HER2 -ve, CLDN18.2+ve, unresectable, advanced, or recurrent gastric cancer Today, at PharmaShots we have Moitreyee…
June 24, 2024

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VIEWPOINTS_Andrew Menzies-Gow1_Michael Wechsler2_2024
VIEWPOINTS

EGPA Remission with Fasenra: Michael Wechsler and Andrew Menzies Gow in Conversation with PharmaShots

Shots: An already established biologic treatment for SEA in the US, EU5 & Japan. Fasenra is now showing exemplary remission for the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA) Today, at PharmaShots, we have a distinguished panel of speakers shedding light on advancements under the P-III MANDARA study and the recent publication of the study…
May 15, 2024

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NEWS

Boan Biotech Highlights Clinical Updates for BA6101 (biosimilar, Prolia) and BA1102 (biosimilar, Xgeva) to Treat Various Indications 

Shots:The company has completed patient enrolment in P-III trial which evaluates the safety, efficacy, PK & immunogenicity of BA6101 & BA1102 vs reference drugs (Prolia & Xgeva) for the treatment of various indication across Europe, United States & Japan Boan also conducted a meeting in Germany to highlight the PK results from the…
January 15, 2024

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Disease of the Month: IgA Nephropathy
INSIGHTS+

Disease of the Month: IgA Nephropathy

Shots:To create a wholesome environment for the current and the future generation, it’s totally up to life science companies and decision-makers to embrace and integrate every prospect of the underlying disease conditions and address those issues to find curesPharmaShots brings this month an informative take on the disease IgA nephropathyOften known as…
March 13, 2023

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