IPP Bureau

Caplin Steriles gets USFDA approval for Ofloxacin ophthalmic solution
Caplin Steriles gets USFDA approval for Ofloxacin ophthalmic solution

By IPP Bureau - April 17, 2024

Ofloxacin Ophthalmic Solution USP 0.3% is indicated for treatment of eye infections caused during the conditions of conjunctivitis and corneal ulcers

USFDA grants ODD to NM5072 for treatment of Paroxysmal Nocturnal Hemoglobinuria
USFDA grants ODD to NM5072 for treatment of Paroxysmal Nocturnal Hemoglobinuria

By IPP Bureau - April 17, 2024

NM5072 is an anti-Properdin antibody that selectively blocks the alternative pathway while maintaining the integrity of the classical pathway required for fending off infections

AbbVie announces late-breaking data at AAN supporting efficacy of Atogepant for preventive treatment of migraine
AbbVie announces late-breaking data at AAN supporting efficacy of Atogepant for preventive treatment of migraine

By IPP Bureau - April 17, 2024

Interim analysis of an ongoing 156-week extension study supports long-term safety, tolerability and efficacy of atogepant 60 mg to prevent chronic and episodic migraine

AstraZeneca’s Imfinzi plus chemotherapy doubled overall survival rate for patients with advanced biliary tract cancer
AstraZeneca’s Imfinzi plus chemotherapy doubled overall survival rate for patients with advanced biliary tract cancer

By IPP Bureau - April 17, 2024

Longest survival follow-up ever reported for immunotherapy treatment in this setting

Alvotech and Teva get US FDA approval of Selarsdi
Alvotech and Teva get US FDA approval of Selarsdi

By IPP Bureau - April 17, 2024

SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva

Positive data for Roche multiple sclerosis injection
Positive data for Roche multiple sclerosis injection

By IPP Bureau - April 17, 2024

US FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and U.S. approval anticipated September 2024

Cipla Health strengthens its play in beauty and personal care
Cipla Health strengthens its play in beauty and personal care

By IPP Bureau - April 16, 2024

CHL is strengthening its play in the fast-growing beauty and personal care sector

Ami Organics accredited Gold Medal by EcoVadis
Ami Organics accredited Gold Medal by EcoVadis

By IPP Bureau - April 16, 2024

The Gold Medal distinction places the company in the top 5% of all organizations assessed within EcoVadis's rigorous framework globally

Moderna pauses plan to build mRNA manufacturing facility in Kenya
Moderna pauses plan to build mRNA manufacturing facility in Kenya

By IPP Bureau - April 16, 2024

The demand in Africa for COVID-19 vaccines has declined

Novartis reports data from trial of IgA nephropathy treatment
Novartis reports data from trial of IgA nephropathy treatment

By IPP Bureau - April 16, 2024

IgAN is a heterogeneous, progressive, rare kidney disease and is a major cause of chronic kidney disease worldwide

Suven Life Sciences to present phase-2 results on Samelisant at AAN 2024
Suven Life Sciences to present phase-2 results on Samelisant at AAN 2024

By IPP Bureau - April 16, 2024

Global Phase-3 study initiation expected in the second half of 2024

Laurus Labs forms JV company
Laurus Labs forms JV company

By IPP Bureau - April 16, 2024

KRKA holds 51% and Laurus Labs holds 49% shareholding

Croda and AAHI partner to drive innovation in vaccine development
Croda and AAHI partner to drive innovation in vaccine development

By IPP Bureau - April 15, 2024

The exclusive agreement between AAHI and Croda includes a collaborative effort in research and development

Teva confirms efficacy and safety of Ajovy for prevention of migraine
Teva confirms efficacy and safety of Ajovy for prevention of migraine

By IPP Bureau - April 15, 2024

Ajovy confirms efficacy in new Phase 3 data significantly reducing the number of migraine days per month

Novartis tender offer for MorphoSys commences
Novartis tender offer for MorphoSys commences

By IPP Bureau - April 15, 2024

The offer price corresponds to a premium of 142% on the volume-weighted average price during the last three months

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