IPP Bureau

Abbott’s Volt PFA System gets FDA nod
Abbott’s Volt PFA System gets FDA nod

By IPP Bureau - December 24, 2025

AFib is a progressive condition where timely intervention is critical to disease management and, ultimately, the patient's quality of life

Enveda launches Phase 1 trial for first-in-class Oral IBD therapy
Enveda launches Phase 1 trial for first-in-class Oral IBD therapy

By IPP Bureau - December 24, 2025

The Phase 1 study will evaluate the safety, tolerability, and pharmacokinetics (PK) of ENV-6946 in healthy volunteers

Asahi Kasei Pharma to move R&D hub to Shonan iPark in 2027
Asahi Kasei Pharma to move R&D hub to Shonan iPark in 2027

By IPP Bureau - December 24, 2025

Shonan iPark was chosen for its globally connected life-science ecosystem, which unites pharmaceutical firms, next-generation medicine developers, AI and digital health innovators, venture capital, and academia

Neurocrine’s Valbenazine fails to show benefit in largest dyskinetic cerebral palsy trial
Neurocrine’s Valbenazine fails to show benefit in largest dyskinetic cerebral palsy trial

By IPP Bureau - December 24, 2025

Adverse events were consistent with valbenazine’s established safety profile

Novo Nordisk’s Wegovy pill approved in US as first oral GLP-1 for weight management
Novo Nordisk’s Wegovy pill approved in US as first oral GLP-1 for weight management

By IPP Bureau - December 23, 2025

Wegovy pill showed a mean weight loss of 16.6% in the OASIS 4 trial

Bayer wins Japan nod for finerenone in broad heart failure population
Bayer wins Japan nod for finerenone in broad heart failure population

By IPP Bureau - December 23, 2025

Finerenone is the first therapy targeting the mineralocorticoid receptor pathway to demonstrate cardiovascular benefits in heart failure patients

China approves first-in-class TGCT drug, marking global first for pimicotinib
China approves first-in-class TGCT drug, marking global first for pimicotinib

By IPP Bureau - December 23, 2025

FDA grants breakthrough therapy designation to Enhertu for high-risk early breast cancer
FDA grants breakthrough therapy designation to Enhertu for high-risk early breast cancer

By IPP Bureau - December 23, 2025

This Breakthrough Therapy Designation highlights the impressive clinical benefit of Enhertu over the current standard of care

SRM Global Hospitals performs Tamil Nadu’s first TactiFlex radiofrequency ablation to save 80-yr-old patient
SRM Global Hospitals performs Tamil Nadu’s first TactiFlex radiofrequency ablation to save 80-yr-old patient

By IPP Bureau - December 23, 2025

TactiFlex, the world’s first catheter with a flexible tip and contact?force sensing, allows doctors to deliver energy precisely and safely.

LATIFY Phase III trial of Ceralasertib fails to improve survival in advanced lung cancer
LATIFY Phase III trial of Ceralasertib fails to improve survival in advanced lung cancer

By IPP Bureau - December 23, 2025

The study focused on patients without actionable genomic alterations whose disease had progressed after prior immunotherapy and platinum-based chemotherapy

FDA go-ahead to Roche’s one-minute follicular lymphoma therapy
FDA go-ahead to Roche’s one-minute follicular lymphoma therapy

By IPP Bureau - December 23, 2025

Full approval will depend on verification of clinical benefit in a confirmatory trial

Zambon Biotech launches European Phase 3b trial for innovative Parkinson’s drug
Zambon Biotech launches European Phase 3b trial for innovative Parkinson’s drug

By IPP Bureau - December 23, 2025

The trial will evaluate the efficacy and safety of IPX203 versus immediate-release levodopa/carbidopa

FDA nod to MYQORZO for obstructive hypertrophic cardiomyopathy
FDA nod to MYQORZO for obstructive hypertrophic cardiomyopathy

By IPP Bureau - December 23, 2025

The drug is designed to improve functional capacity and reduce symptoms by inhibiting cardiac myosin motor activity

Glenmark Pharmaceuticals USA launches Epinephrine Injection USP, multiple-dose vial
Glenmark Pharmaceuticals USA launches Epinephrine Injection USP, multiple-dose vial

By IPP Bureau - December 23, 2025

According to IQVIA sales data for the 12-month period ending October 2025, the Epinephrine Injection USP, 30 mg/30 mL (1 mg/mL) market2 achieved annual sales of approximately $67.6 million

Biocon Biologics expands FKB deal to secure global rights for Adalimumab biosimilar
Biocon Biologics expands FKB deal to secure global rights for Adalimumab biosimilar

By IPP Bureau - December 23, 2025

Production at Biocon Biologics’ own facilities is scheduled to begin once technology transfers and regulatory approvals are finalized

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