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Viewpoints_Baldo Scassellati Sforzolini
VIEWPOINTS

Unlocking Approval: Baldo Scassellati Sforzolini from Galderma in a Stimulating Dialogue Exchange with PharmaShots

Shots: Galderma’s Nemluvio (nemolizumab) was recently approved by the US FDA for the treatment of adults with prurigo nodularis, following positive Phase III results from the OLYMPIA study. Today at PharmaShots, we have Baldo Scassellati Sforzolini, Global Head of Research & Development at Galderma, to discuss the study’s design and the potential of Nemluvio in…
October 23, 20240Comments

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Teva and Alvotech
News

Alvotech and Teva Reports the US FDA’s Approval for the Additional Presentation of Selarsdi (Biosimilar, Stelara)

Shots: Alvotech and Teva have received the US FDA’s approval of Selarsdi’s new dosing presentation of 130mg/26mL (5mg/mL) solution in a single-dose vial for IV infusion for the same indications as Stelara (ustekinumab). It will be launched in the US during Q1’25 The US FDA, in Apr 2024, approved Selarsdi’s dosing of 45mg/0.5mL & 90mg/mL…
October 22, 20240Comments

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Viewpoints_Mark Mikhael
VIEWPOINTS

Enhancing Accessibility: Mark Mikhael from Olympia Pharmaceuticals in a Riveting Conversation with PharmaShots

Shots: Compounding pharmacies can help significantly by providing customized medications tailored to individual patient needs, bridging the gap in medicine delivery during a drug shortage, and enhancing accessibility.  Today, at PharmaShots, we have Mark Mikhael, CEO of Olympia Pharmaceuticals, an FDA-registered 503B outsourcing facility. Currently licensed in 47 states of the US, Olympia hosts two…
October 21, 20240Comments

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News

Dong-A ST Receives the CHMP’s Positive Opinion for Imuldosa (Biosimilar, Stelara) 

Shots: Following the MAA submission by Accord Healthcare (Intas’ subsidiary) in 2023, the EMA’s CHMP has granted positive opinion to Imuldosa, a biosimilar version of Stelara (ustekinumab) Intas Pharmaceuticals with its subsidiaries (Accord BioPharma & Accord Healthcare) will commercialize the biosimilar across the US, EU, UK & Canada while Meiji & Dong-A ST will provide…
October 21, 20240Comments

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News

Lindis Biotech’ Korjuny (Catumaxomab) Receives the CHMP’s Positive Opinion to Treat Malignant Ascites (MA) 

  Shots:   The CHMP has granted a positive opinion to Korjuny (trifunctional anti-CD3 x anti-EpCAM Ab) for treating malignant ascites in adults with EpCAM+ carcinomas, not eligible for systemic anti-cancer treatment. EC’s decision is anticipated by YE’24, & will be valid in the EU plus Norway, Iceland & Liechtenstein The opinion was based on P-II/III…
October 21, 20240Comments

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AstraZeneca & Ionis
News

AstraZeneca and Ionis’ Wainzua (Eplontersen) Receives the CHMP’s Positive Opinion to Treat Hereditary Transthyretin-Mediated Amyloidosis with Polyneuropathy 

  Shots:   The opinion of Wainzua for ATTRv-PN (stage 1/2 polyneuropathy) was supported by its P-III (NEURO-TTRansform) study vs external PBO for over wk.66, with a follow-up until wk.85 & an end-of-trial evaluation. Eligible patients could then enter an ongoing OLE study Study depicted sustained benefits in co-1EPs of serum transthyretin (TTR) levels & neuropathy…
October 21, 20240Comments

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ThoughtSpot_Fatima Batool
THOUGHTSPOT

Ohio Study Finds that Thousands of US Communities Are In a “Pharmacy Desert”

The recently hugely reduced number of pharmacies in many areas of the US—due to more frequently occurring pharmacy closures—is creating a phenomenon known as “pharmacy deserts.” Concerningly, pharmacy deserts affect the ability of local communities to access affordable pharmacy resources in their vicinity. This can cause healthcare disparities between socioeconomic groups and, worse, impair the…
October 18, 20240Comments

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ThoughtSpot_Fatima Batool
THOUGHTSPOT

Mastering a Changing Landscape: How to Stay Current with Healthcare Industry Changes

The healthcare industry is constantly changing, with new technologies, regulations, policies, and best practices emerging daily. Therefore, healthcare professionals need to stay up to date and informed to provide quality care, improve their skills, and advance their careers. Staying current with industry changes — and mastering a constantly changing healthcare landscape — is paramount across…
October 18, 20240Comments

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