Medtronic Reports the European CE Mark of MiniMed 780G System for Automated Insulin Delivery

Shots:Medtronic has received CE mark to extend label of MiniMed 780G system to pts (≥2yrs.), pregnant women & T2D pts; application is under the FDA’s review for T2D, plus US trial for use in pts (2-6yrs.) is underwayApproval was backed by extensive clinical data incl. LENNY trial data in T1D pts (2–6 yrs), showing a…

ByRidhi Rastogi2 days ago

News

Novo Nordisk Enters a ~$2.2B Deal with Septerna to Develop Oral Small Molecules for Cardiometabolic Diseases

Shots:Septerna & Novo Nordisk to identify, develop & market oral small molecules for obesity, T2D & other cardiometabolic diseases under an exclusive global collaboration & license agreementAs per the deal, Septerna will receive ~$2.2B, incl. over $200M in upfront & near-term milestones, plus research, development, & commercial milestones, along with net sales-based tiered…

ByRidhi RastogiMay 15, 2025

News

Eli Lilly Reported the Data from P-III (ACHIEVE-1) Trial Evaluating an Oral GLP-1, Orforglipron

Shots:The P-III (ACHIEVE-1) trial assessed orforglipron vs PBO in T2D adults (n=559) having inadequate glycemic control with diet & exercise alone; subjects started at 1mg QD, with dose escalation at every Q4W till assigned doses of 3, 12mg (via 1, 3 & 6mg), or 36mg (via 1, 3, 6, 12, & 24mg)Trial met…

ByPrince GiriApril 18, 2025

News

Novo Nordisk Reveals P-III (REDEFINE 2) Trial data of CagriSema for Weight Loss in Obese/Overweight and T2D Patients

Shots:Novo Nordisk has reported P-III (REDEFINE 2) trial data assessing CagriSema (cagrilintide 2.4mg + semaglutide 2.4mg, QW, SC) vs PBO in 1,206 obese/overweight pts (~102Kg) and type 2 diabetes for 68wks., and followed flexible dosing protocol with 61.9% pts reaching highest dose after 68wks. Trial met its co-1EPs demonstrated 15.7% superior weight loss…

ByRidhi RastogiMarch 11, 2025

News

Novo Nordisk Reports the US FDA’s Approval for Ozempic to Reduce Risk of Kidney Disease Progression & Cardiovascular Death in Type 2 Diabetes & Chronic Kidney Disease (CKD) Adults

Shots:The US FDA has approved Ozempic to reduce the risk of kidney disease worsening & CV death in adults with type 2 diabetes & CKD Approval was based on P-IIIb (FLOW) trial assessing Ozempic (1mg, Q1W, n=1767) vs matching PBO (n=1766) in type 2 diabetes & CKD pts (N=3533) Study met its 1EP of 24% relative…

ByDipanshu DixitFebruary 3, 2025

News

Novo Nordisk Reports Headline Results from P-IIIb (STEP UP) Study of Semaglutide 7.2mg in Obese Adults without Diabetes

Shots:The P-IIIb (STEP UP) study assessed semaglutide (7.2mg) vs semaglutide (2.4mg) & PBO as an adjunct to lifestyle intervention in obese adults (n=1,407; BMI ≥30kg/m^2) without diabetes for 72wks. STEP program also includes STEP UP T2D study of semaglutide (7.2mg) in obese adults (n=512) with T2D for 72wks. Study met its 1EP, depicting…

ByRidhi RastogiJanuary 20, 2025

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 industryIn 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…

BySaurabh ChaubeyJanuary 23, 2024

INSIGHTS+

Top Performing Drug – Ozempic (September Edition)

Shots: PharmaShots’ next episode on the top-performing drug of the month, based on 2021 revenue, focuses on Ozempic, a drug developed and marketed by Novo Nordisk Ozempic (semaglutide) is a human GLP-1 receptor agonist (or GLP-1 analog). It, when taken along with diet and exercise, is proven to improve blood sugar in adults with type 2…

BySenior EditorSeptember 27, 2023

VIEWPOINTS

Ruud Dobber Shares Insights from RWE Data from the REVEAL-CKD Presented at the ERA-EDTA’23

Shots:Ruud talked about the key findings from the new RWE data at ERA-EDTA'23 which demonstrated the staggeringly low rate of diagnosis in chronic kidney disease (CKD)He then discussed the risk factors of CKD and the urgent need to act on the growing global burden of CKD and how this disease is impacting the…

BySenior EditorSeptember 25, 2023

INSIGHTS+

Top Performing Drug of 2021 – Trulicity (February Edition)

Active Ingredient: dulaglutideDosage Forms & Strengths: Injection: 0.75 mg/0.5 mL, 1.5 mg/0.5 mL, 3 mg/0.5 mL, 4.5 mg/0.5 mL solution in a single-dose pen Mechanism of Action: GLP-1 receptor agonistFirst Approval: US (Sep 18, 2014), EU (Nov 25, 2014) Revenue Analysis1Trulicity is used for the treatment of type 2 diabetes and to reduce the risk…

BySenior EditorFebruary 22, 2023

Medtronic Reports the European CE Mark of MiniMed 780G System for Automated Insulin Delivery

Novo Nordisk Enters a ~$2.2B Deal with Septerna to Develop Oral Small Molecules for Cardiometabolic Diseases

Eli Lilly Reported the Data from P-III (ACHIEVE-1) Trial Evaluating an Oral GLP-1, Orforglipron

Novo Nordisk Reveals P-III (REDEFINE 2) Trial data of CagriSema for Weight Loss in Obese/Overweight and T2D Patients

Novo Nordisk Reports the US FDA’s Approval for Ozempic to Reduce Risk of Kidney Disease Progression & Cardiovascular Death in Type 2 Diabetes & Chronic Kidney Disease (CKD) Adults

Novo Nordisk Reports Headline Results from P-IIIb (STEP UP) Study of Semaglutide 7.2mg in Obese Adults without Diabetes

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

Top Performing Drug – Ozempic (September Edition)

Ruud Dobber Shares Insights from RWE Data from the REVEAL-CKD Presented at the ERA-EDTA’23

Top Performing Drug of 2021 – Trulicity (February Edition)

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