IPP Bureau

Glenmark Pharmaceuticals USA to launch Micafungin for injection USP, 50 mg/vial and 100 mg/vial
Glenmark Pharmaceuticals USA to launch Micafungin for injection USP, 50 mg/vial and 100 mg/vial

By IPP Bureau - August 19, 2025

According to IQVIA sales data for the 12-month period ending June 2025, the Mycamine for Injection, 50 mg/vial and 100 mg/vial market achieved annual sales of approximately $60.7 million

Alkem launches ceramide-boosting moisturizing lotion for skin barrier repair
Alkem launches ceramide-boosting moisturizing lotion for skin barrier repair

By IPP Bureau - August 19, 2025

Alembic receives USFDA final approval for Macitentan Tablets, 10 mg
Alembic receives USFDA final approval for Macitentan Tablets, 10 mg

By IPP Bureau - August 19, 2025

Macitentan tablets are an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension

Novo Nordisk's Wegovy approved in the US for the treatment of MASH
Novo Nordisk's Wegovy approved in the US for the treatment of MASH

By IPP Bureau - August 19, 2025

The accelerated approval is supported by results from part 1 of the ESSENCE trial

FDA approves first immunotherapy for recurrent respiratory papillomatosis
FDA approves first immunotherapy for recurrent respiratory papillomatosis

By IPP Bureau - August 19, 2025

Tonix receives FDA approval of Tonmya for treatment of fibromyalgia
Tonix receives FDA approval of Tonmya for treatment of fibromyalgia

By IPP Bureau - August 19, 2025

Sarepta advances siRNA collaboration and sale of arrowhead equity investment
Sarepta advances siRNA collaboration and sale of arrowhead equity investment

By IPP Bureau - August 19, 2025

Sarepta has also entered into an agreement with Arrowhead to transfer 2,660,989 shares of Arrowhead common stock in satisfaction of $50 million of the company’s previously announced $100 million milestone payment obligation

BioAge Labs doses first patient in BGE-102 phase 1 trial
BioAge Labs doses first patient in BGE-102 phase 1 trial

By IPP Bureau - August 19, 2025

The randomized, double-blind, placebo-controlled Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGE-102 in healthy participants

Pfizer’s sickle cell disease candidate fails Phase III trial
Pfizer’s sickle cell disease candidate fails Phase III trial

By IPP Bureau - August 19, 2025

Inclacumab was generally well tolerated in THRIVE-131

Shanmuga Hospital commissions advanced PH impedance and manometry system
Shanmuga Hospital commissions advanced PH impedance and manometry system

By IPP Bureau - August 18, 2025

This system enables comprehensive diagnosis of both acid and non-acid reflux, along with esophageal motility disorders.

Kwality Pharma receives product registration of Bleomycin 15 IU per vial in Mexico
Kwality Pharma receives product registration of Bleomycin 15 IU per vial in Mexico

By IPP Bureau - August 18, 2025

The projected business potential is around US$ 1 million in the first year

Merck and mantro launch EdiMembre to transform alternative protein industry
Merck and mantro launch EdiMembre to transform alternative protein industry

By IPP Bureau - August 18, 2025

Merck and mantro GmbH have established EdiMembre, Massachusetts, U.S.A., a Deep Tech spin-out in the alternative protein industry

FDA grants breakthrough therapy designation to Ifinatamab Deruxtecan for lung cancer patients
FDA grants breakthrough therapy designation to Ifinatamab Deruxtecan for lung cancer patients

By IPP Bureau - August 18, 2025

Fourteenth breakthrough therapy designation granted by FDA across the oncology portfolio of Daiichi Sankyo

European Commission grants approval of Ogsiveo
European Commission grants approval of Ogsiveo

By IPP Bureau - August 18, 2025

OGSIVEO is the first and only therapy to receive marketing authorization in the EU for the treatment of desmoid tumors

Xspray Pharma licenses patent rights to Handa Therapeutics, secures royalty agreement
Xspray Pharma licenses patent rights to Handa Therapeutics, secures royalty agreement

By IPP Bureau - August 17, 2025

Its lead product, Dasynoc, is awaiting FDA approval with a PDUFA date of October 7, 2025

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