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Big Pharma Ramps up Expansion to Emerging Markets
How to Utilize FSPs for Better Outcomes
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Cellectis’ UCART22 Granted ODD and RPDD Status by FDA
BeiGene Opens Flagship U.S. Biologics Manufacturing and Clinical R&D Facility
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Cellectis’ UCART22 Granted ODD and RPDD Status by FDA
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Breaking News
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Trials & Filings
FDA Delays Approval of Novo Nordisk's Once-Weekly Insulin Icodec
Novo Nordisk does not expect to be able to fulfill the FDA’s requests during 2024.
07.11.24
Breaking News
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Trials & Filings
Verona Pharma’s Ohtuvayre Approved by FDA
Ohtuvayre is an inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in adult patients.
06.27.24
Breaking News
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Clinical Trials
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Drug Development
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Trials & Filings
Boehringer’s Survodutide Shows Breakthrough Improvement in MASH Trial
Builds on previously announced primary endpoint, which showed up to 83% of adults achieved statistically significant improvement in MASH versus placebo.
06.07.24
Breaking News
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Clinical Trials
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Collaborations & Alliances
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Trials & Filings
Lexicon Pharmaceuticals Selects Medidata Solutions to Help Advance PROGRESS Study
Will utilize Medidata’s Decentralized Clinical Trial (DCT) solutions to advance a Phase 2b study of LX9211.
05.29.24
Biologics, Proteins, Vaccines
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Breaking News
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Trials & Filings
BMS’s CAR T Cell Therapy Breyanzi Approved for Follicular Lymphoma
Overall response rate was 95.7%, as defined as the percentage of patients achieving a partial or complete response.
05.16.24
Breaking News
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Trials & Filings
FDA Approves Utility Therapeutics’ Pivya in UTIs
Clinical trial shows 62% of the 137 subjects achieved the composite response compared to 10% who received placebo.
04.25.24
Breaking News
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Drug Development
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Trials & Filings
Sanofi’s Rilzabrutinib Meets Primary Endpoint in ITP
Demonstrates significantly higher proportion of patients receiving rilzabrutinib achieved primary endpoint of durable platelet response versus placebo.
04.23.24
Breaking News
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Drug Development
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Trials & Filings
Genentech's Alecensa Approved in Early-Stage NSCLC
Phase III ALINA study demonstrates Alecensa reduced the risk of disease recurrence or death by 76%.
04.19.24
Drug Development
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Trials & Filings
Genentech’s Columvi Meets Primary Endpoint in DLBCL
Phase III study demonstrated that people lived longer when treated with Columvi in combination with gemcitabine and oxaliplatin.
04.15.24
Breaking News
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Drug Development
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Trials & Filings
AdrenoMed’s Enibarcimab Fast Tracked for Septic Shock
Enibarcimab has the potential to become the first treatment addressing the under-lying pathophysiology of sepsis.
04.10.24
Breaking News
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Drug Development
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Trials & Filings
AstraZeneca, Daiichi Sankyo's Enhertu Approved in Solid Tumors
Becomes first tumor-agnostic approval of a HER2-directed therapy and ADC by the FDA.
04.08.24
Biologics, Proteins, Vaccines
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Breaking News
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Trials & Filings
ViiV Healthcare Receives FDA Approval for Dovato for Adolescents
Expanded indication marks the first time an oral, two-drug, single-tablet regimen is available for adolescents between 12 & 18 living with HIV.
04.08.24
Biologics, Proteins, Vaccines
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Breaking News
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Trials & Filings
BMS, 2seventy bio Win FDA Approval for Abecma in Multiple Myeloma
Expands Abecma’s indication, making it available in earlier lines of therapy.
04.05.24
Drug Development
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Trials & Filings
FDA Filings Roundup
Basilea's antibiotic ZEVTERA approved for three indications, Vanda Pharmaceuticals' Fanapt approved for acute Bipolar I Disorder.
Online Exclusives
04.04.24
Breaking News
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Drug Development
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Trials & Filings
Vanda Pharmaceuticals' Fanapt Approved for Acute Bipolar I Disorder
Significantly increases the commercial opportunity for Fanapt.
04.04.24
Breaking News
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Drug Development
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Trials & Filings
Basilea’s Antibiotic ZEVTERA Approved for Three Indications
Staphylococcus aureus bloodstream infections, acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia.
04.04.24
Breaking News
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Industry News
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Trials & Filings
Fanapt Approved by FDA for Treatment of Bipolar I Disorder
Gives patients and service providers a new treatment option for managing bipolar I disorder.
04.03.24
Breaking News
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Trials & Filings
Voydeya Approved as Add-on Therapy to Treat Extravascular Haemolysis in PNH
Results showed that Voydeya met the primary endpoint of change in haemoglobin from baseline to week 12 and all key secondary endpoints.
04.01.24
Breaking News
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Trials & Filings
Gilead's Vemlidy Approved to Treat Chronic HBV Infection in Patients as Young as 6
The expanded indication was supported by data from a Phase 2 clinical trial.
04.01.24
Breaking News
|
Trials & Filings
AbbVie’s ELAHERE Granted Full Approval by FDA for Ovarian Cancer
Full approval was based on data from the confirmatory Phase 3 MIRASOL trial.
03.25.24
Breaking News
Piramal Pharma Revenue Increases 12% YoY in Q1
Cellectis’ UCART22 Granted ODD and RPDD Status by FDA
BeiGene Opens Flagship U.S. Biologics Manufacturing and Clinical R&D Facility
Pace Life Sciences Completes Successful FDA Inspection of Operations in Oakdale, MN
Emmes, Miimansa AI Partner on Generative AI in Clinical Research
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CURRENT ISSUE
July/August 2024
Big Pharma Ramps up Expansion to Emerging Markets
How to Utilize FSPs for Better Outcomes
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