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The P-Ib/IIa trial assessed amycretin (Q1W) vs PBO in overweight or obese patients (n=125) in 5 parts
Part A (single ascending dose) assessed PK & determined the initial dose for Part B (multiple dose arm), which evaluated safety/tolerability over 36wks. Parts C, D, & E (PoC) evaluated weight loss with 3 doses (1.25mg,…
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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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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 & 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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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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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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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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Witness the journey of the biopharma companies over 20 years with this informative and engaging report. The report highlights the development of the biopharma industry and the key factors influencing them
In 2023, JNJ reclaims the topmost position in the list from Pfizer with a revenue of $85.16B, showcasing a sharp 10.30 percent vs…
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The first quarter of 2024 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The highlight of the quarter was Gilead's acquisition of CymaBay Therapeutics for an aggregate of ~$4.3B
This quarter also showcased multiple clinical trial results including Axsome Therapeutics P-III results for AXS-12 and BMS'…
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Novo Nordisk’s Awiqli (QW basal insulin icodec) has received CHMP’s positive opinion and recommending it for the final approval which is anticipated in next ~67days/ ~2mos
The opinion was supported by the six P-IIIa (ONWARDS) study assessing the safety & efficacy of Awiqli in type 1 & type 2 diabetes adults (n= >4,000) incl.…

