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Viewpoints_Mina Makar
VIEWPOINTS

Cardiology Care and Beyond: Mina Makar from AstraZeneca in a Riveting Dialogue Exchange with PharmaShots

Shots: At ESC 2024, AstraZeneca presented insights from the real-world OverTTuRe study, exploring the challenges of early diagnosis in transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) Mina Makar, SVP and Commercial Lead of the Global Cardiovascular, Renal, and Metabolism (CVRM) Biopharmaceuticals Business Unit at AstraZeneca, shared real-world insights on how ATTR-CM manifests as cardiac symptoms Mina highlighted the…
January 27, 2025

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Astrazeneca
NEWS

AstraZeneca’s Calquence (Acalabrutinib) Plus Chemoimmunotherapy Secures the US FDA’s Approval for Mantle Cell Lymphoma (MCL)

Shots: The US FDA has approved Calquence + bendamustine & rituximab for untreated MCL in patients not for autologous HSCT, also transforming its accelerated approval (Oct 2017) to full approval for previously treated MCL. The combination is under review in Australia, Canada, Switzerland, the EU, Japan & other regions Approval was based on P-III…
January 20, 2025

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Daiichi Sankyo & Astrazeneca
NEWS

Daiichi Sankyo and AstraZeneca Receives the US FDA Approval for Datroway (Datopotamab Deruxtecan-dlnk) to Treat HR+/HER2- Metastatic Breast Cancer

Shots: The FDA has approved Datroway to treat unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer in patients receiving endocrine-based therapy & CT. Submissions are under review in the EU, China, & other areas Approval was based on a global P-III (TROPION Breast01) trial, assessing Datroway (6mg/kg; IV, Q21D)…
January 20, 2025

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Astrazeneca & Daiichi Sankyo
NEWS

AstraZeneca and Daiichi Sankyo Report the US FDA’s BLA Acceptance of Datopotamab Deruxtecan with Priority Review for EGFR-mutated NSCLC

Shots: FDA has accepted & granted priority review to the BLA of datopotamab deruxtecan (Dato-DXd) for treatment-experienced patients with LA/M EGFR-mutated NSCLC (PDUFA: Q3’25) which also received BTD from US FDA BLA & designation were based on P-II (TROPION-Lung05) & P-III (TROPION-Lung01) trials along with supporting data from P-I (TROPION-PanTumor01) study. The combined findings…
January 15, 2025

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NEWS

AstraZeneca and RQ Biotechnology Reports the CHMP’s Positive Opinion of Kavigale (Sipavibart) to Prevent COVID-19 in Immunocompromised Individuals

Shots: The EMA’s CHMP has granted positive opinion to Kavigale for the prevention of COVID-19 in immunocompromised individuals (≥12yrs.). It was reviewed under the EMA’s accelerated pathway Kavigale consists of an antiviral human IgG1 mAb, sipavibart, as its API that offers passive protection against SARS-CoV-2 by targeting the spike protein's receptor-binding domain Sipavibart was…
January 9, 2025

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NEWS

AstraZeneca and RQ Biotechnology Reports the CHMP’s Positive Opinion of Kavigale (Sipavibart) to Prevent COVID-19 in Immunocompromised Individuals

Shots:     The EMA’s CHMP has granted positive opinion to Kavigale for the prevention of COVID-19 in immunocompromised individuals (≥12yrs.). It was reviewed under the EMA’s accelerated pathway  Kavigale consists of an antiviral human IgG1 mAb, sipavibart, as its API that offers passive protection against SARS-CoV-2 by targeting the spike protein's receptor-binding domain  Sipavibart was discovered…
January 9, 2025

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Viewpoints_Richard Watts
VIEWPOINTS

Enhancing Diagnostic Care: Richard Watts from Qiagen in a Stimulating Conversation with PharmaShots

Shots:  Recently, Qiagen entered into a collaboration agreement with AstraZeneca to develop companion diagnostics for chronic diseases using Qiagen’s QIAstat-Dx system  Today, at PharmaShots, we are joined by Richard Watts from Qiagen, who sheds light on their collaboration agreements with AstraZeneca and Eli Lilly, leveraging their syndromic testing platform, QIAstat-Dx  Qiagen has partnered with over…
November 27, 2024

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EMA Marketing Authorization of New Drugs in October 2024
INSIGHTS+

EMA Marketing Authorization of New Drugs in October 2024

Shots:    The EMA’s CHMP has granted positive opinions to 5 Biologics and 1 New Chemical Entity in October 2024, leading to treatments for patients and advances in the healthcare industry   The major highlighted drugs were Novo Nordisk’s Alhemo to treat Haemophilia A or B with inhibitors and AstraZeneca & Ionis’ Wainzua for Hereditary Transthyretin-Mediated Amyloidosis  PharmaShots has…
November 21, 2024

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Viewpoints_Mina Makar
VIEWPOINTS

AstraZeneca at ERA’24: Mina Makar in a Stimulating Conversation with PharmaShots

Shots:  Recently, AstraZeneca presented findings from the real-world IMPACT CKD study, which evaluated the multifaceted impact of CKD on patients, healthcare systems, and broader society, projecting future implications through 2032.  The study emphasizes the importance of mitigating the economic burden on healthcare by implementing early, targeted screening, diagnosis, and treatment for CKD.  In collaboration with…
October 28, 2024

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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, 2024

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