NEWS Archives - PharmaShots

NEWS

IDEAYA Biosciences Partners with Servier to Develop and Commercialize Darovasertib for Uveal Melanoma (UM)

Shots: IDEAYA has entered an exclusive licensing agreement granting Servier global regulatory and commercial rights to darovasertib, while retaining all the US rights IDEAYA & Servier will co-develop darovasertib & share costs, with Servier leading regulatory & commercial efforts worldwide excl. the US, in exchange for $210M upfront, ~$100M on approval, ~$220M in commercial milestones,…

58 minutes ago

Polpharma Biologics Enters into Licensing Deals with MS Pharma for Multiple Biosimilar Candidates

Shots: Polpharma has entered into licensing deals with MS Pharma to commercialize PB016 (vedolizumab), PB018 (ocrelizumab), & PB019 (guselkumab) biosimilars across the Middle East & North Africa (MENA) region As per the deal, MS Pharma will be responsible for registration, marketing, & distribution of the 3 biosimilars in MENA, while Polpharma will handle development, manufacturing,…

2 hours ago

OMass Therapeutics Collaborates with Genentech to Develop and Commercialize Small Molecule for Inflammatory Bowel Disease

OMass has entered into an exclusive collaboration & license deal with Genentech to develop & commercialize its preclinical oral small molecule program for inflammatory bowel disease As per the deal, OMass will receive $20M upfront & over $400M in preclinical, development, commercial, & sales milestones, with tiered royalties based on net sales Collaboration leverages OMass’…

3 hours ago

Novartis Reports P-IV (V-DIFFERENCE) Trial Findings on Leqvio (Inclisiran) for Hypercholesterolemia

Shots: Novartis has reported P-IV (V-DIFFERENCE) trial results evaluating Leqvio (n=898) vs PBO (n=872), both added to personalized lipid-lowering therapy (LLT), in 1,770 hypercholesterolemia pts not at guideline-recommended LDL-C goals Trial showed 85% vs 31% achieved their guideline-recommended LDL-C target after 90 days of treatment, with benefits seen as early as day 30 (81% on…

5 hours ago

GE HealthCare Launches Vivid Pioneer for Enhanced Cardiac Imaging

Shots: GE HealthCare has launched Vivid Pioneer, a cardiovascular ultrasound for 2D, 4D, & color flow imaging, following the European CE Mark approval & the US FDA’s 510(k) clearance Vivid Pioneer is powered by cSound architecture & XDclear tech to provide superior resolution, color sensitivity, & 4D imaging, allowing structure visualization & cardiac function assessment…

6 hours ago

Novo Nordisk Reports STEER Real-World Study Data on Wegovy for Obesity and Cardiovascular Disease

Shots: The STEER real-world study data assessed the risk of major adverse cardiovascular events (MACE) with Wegovy (semaglutide 2.4mg) vs tirzepatide among overweight or obese pts with CVD, but no diabetes in the US Study showed that continuous treatment (>30 days no gap) with Wegovy reduced risk of heart attack, stroke, CV or all-cause death…

7 hours ago

Abbott’s Navitor TAVI System Receives European CE Mark for Aortic Stenosis in Patients at Low or Intermediate-Risk for Surgery

Shots: Abbott has received the CE Mark approval for Navitor transcatheter aortic valve implantation(TAVI) system to expand its use in people with symptomatic, severe aortic stenosis who are at low or intermediate risk for open-heart surgery Approval was backed by VANTAGE study of Navitor TAVI, which met its safety & efficacy 1EPs in above pts Trial showed…

1 day ago

AstraZeneca Reports P-III (BaxHTN) Trial Data on Baxdrostat for Uncontrolled or Treatment Resistant Hypertension

Shots: The P-III (BaxHTN) trial assessed baxdrostat (1 or 2mg) vs PBO on top of SoCs in 796 pts with uncontrolled or treatment resistant hypertension over 12wks.; P-III (Bax24) trial readout is expected in late 2025 Trial met its 1EP, reducing mean seated SBP at 12wks. by 15.7 (2mg) & 14.5 mmHg (1mg), with PBO-adjusted…

1 day ago

The NMPA Grants Conditional Approval to Boehringer Ingelheim’s Hernexeos for HER2-Mutant NSCLC

Shots: China’s NMPA has granted conditional approval to Hernexeos (zongertinib) for treating pts with inoperable, locally advanced or metastatic NSCLC harboring HER2 (ERBB2) mutations who have received prior systemic therapy Approval was based on P-Ib (Beamion LUNG-1) trial assessing Hernexeos alone, which showed improved ORR of 71% (N=75: 7% CR), mDoR of 14.1mos. & mPFS…

1 day ago

Merck Reports P-III (VICTOR) Trial Data of Verquvo (Vericiguat) for Chronic Heart Failure and Reduced Ejection Fraction (HFrEF)

Shots: Merck has reported P-III (VICTOR) trial data assessing Verquvo (n=3,053) vs PBO (n=3,052) in pts with stable chronic heart failure & reduced ejection fraction Trial did not meet its 1EPs of reducing CV death or HF hospitalization (18% vs 19.1%); however, 2EPs showed numerically lower rates of CV death (9.6% vs 11.3%) & HF…

1 day ago

NEWS

IDEAYA Biosciences Partners with Servier to Develop and Commercialize Darovasertib for Uveal Melanoma (UM)

Polpharma Biologics Enters into Licensing Deals with MS Pharma for Multiple Biosimilar Candidates

OMass Therapeutics Collaborates with Genentech to Develop and Commercialize Small Molecule for Inflammatory Bowel Disease

Novartis Reports P-IV (V-DIFFERENCE) Trial Findings on Leqvio (Inclisiran) for Hypercholesterolemia

GE HealthCare Launches Vivid Pioneer for Enhanced Cardiac Imaging

Novo Nordisk Reports STEER Real-World Study Data on Wegovy for Obesity and Cardiovascular Disease

Abbott’s Navitor TAVI System Receives European CE Mark for Aortic Stenosis in Patients at Low or Intermediate-Risk for Surgery

AstraZeneca Reports P-III (BaxHTN) Trial Data on Baxdrostat for Uncontrolled or Treatment Resistant Hypertension

The NMPA Grants Conditional Approval to Boehringer Ingelheim’s Hernexeos for HER2-Mutant NSCLC

Merck Reports P-III (VICTOR) Trial Data of Verquvo (Vericiguat) for Chronic Heart Failure and Reduced Ejection Fraction (HFrEF)

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