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IMMvention Therapeutix Partners with Novo Nordisk to Co-develop Oral BACH1 inhibitors for Chronic Conditions

Shots: IMMvention & Novo Nordisk have entered into a strategic collaboration & license agreement to jointly develop oral BACH1 inhibitors for SCD & other chronic conditions As per the terms, Novo Nordisk will get an exclusive worldwide license of the systemic BACH1 program, while IMMvention retains rights to develop brain-penetrant BACH1 inhibitors, targeting diseases…

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Novo Nordisk

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…

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Novo Nordisk Expands its Partnership with Valo Health to Discover and Develop Novel Therapies for Cardiometabolic Diseases

Shots: Novo & Valo have expanded their partnership to discover & develop 9 more novel drugs for obesity, T2D & CV diseases, utilizing the former’s expertise in cardiometabolic diseases & Valo’s Opal computational platform plus mutual ability in human data & genetics As per the terms, Valo will get upfront, equity & near-term milestones…

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Novo-Nordisk

Novo Nordisk’s Alhemo Receives the US FDA’s Approval as a Prophylactic Treatment of Hemophilia A or B with Inhibitors 

Shots:    The US FDA has approved Alhemo injection (QD) as a prophylactic treatment to reduce the frequency of bleeding episodes in hemophilia A or B patients (≥12yrs.) with inhibitors  Approval was based on the P-III (explorer7) study assessing Alhemo's efficacy and safety by comparing annual bleeding rates (ABR) in patients aged 12+ with hemophilia A…

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EMA Marketing Authorization of New Drugs in October 2024

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…

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Novo Nordisk

Novo Nordisk’s Alhemo Gains the CHMP’s Positive Opinion as a Prophylatic Treatment of Hemophilia A or B

      Shots:    The CHMP has recommended Alhemo (QD, SC) as a prophylactic treatment of hemophilia A/B with inhibitors in patients (≥12yrs.), with the EC’s decision anticipated within ~2mos.    The opinion was based on the P-III (explorer7) study assessing the efficacy & safety of Alhemo to treat haemophilia A or B with inhibitors. Alhemo will be available…

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