Pharmaceutical Outsourcing Q2 2024 - 37

HORIZON LINES: A QUARTERLY REVIEW OF NDAs
SECTION TITLE
Approval
Date
03/05/2024
Drug Name
Wyost
03/07/2024
Talzenna
Active Ingredients
Denosumab-Bbdz
Submission
Classification*
BLA
Company
Sandoz Inc.
Type Of
Dosage/ Route
Injectable;
Subcutaneous
Talazoparib Tosylate
03/13/2024
Tevimbra
Tislelizumab-Jsgr
03/14/2024
Cabazitaxel
Cabazitaxel
Type 5
BLA
Pfizer
Capsule; Oral
Beigene
Type 5
03/14/2024 Cabazitaxel Injection
03/14/2024
Rezdiffra
Cabazitaxel
Type 5
Resmetirom
Type 1
Actavis
Injection;
Solution
Solution;
Intravenous
Actavis
Injectable;
Injection
Madrigal
Tablet; Oral
Tablet, For
03/15/2024
Edurant Ped
Rilpivirine Hydrochloride
Type 3
Janssen Pharmaceuticals
03/19/2024
Tryvio
03/21/2024
Duvyzat
Efavirenz,
03/22/2024
Emtricitabine and
Tenofovir Alafenamide
03/22/2024
Opsynvi
Aprocitentan
Givinostat Hydrochloride
Efavirenz, Emtricitabine
and Tenofovir Alafenamide
Type 1
Type 1
Idorsia Pharmaceuticals
Ltd.
Italfarmaco S.p.A.
Suspension;
Oral
Tablet; Oral
Suspension;
Oral
Type 4
Mylan
Tablet; Oral
For the treatment of HIV-1
First oral anti-hypertensive therapy which works
via a new therapeutic pathway.
First nonsteroidal treatment of
Duchenne Muscular Dystrophy (DMD)
To treat HIV infection
Macitentan; Tadalafil
Type 4
Actelion
Tablet; Oral
03/26/2024
Winrevair
Sotatercept-Csrk
03/27/2024
Vafseo
Vadadustat
BLA
Merck Sharp Dohme
Type 1
03/29/2024
Risvan
Risperidone
Type 3
Akebia Therapeutics Inc.
Laboratorios
Farmaceuticos ROVI, SA
Injectable;
Injection
Tablet; Oral
Injectable;
Suspension
First and only once-daily single-tablet combination
therapy for patients with Pulmonary Arterial
Hypertension (PAH)
First-in-Class treatment for adults with Pulmonary
Arterial Hypertension (PAH)
For the treatment of anemia due to chronic kidney
disease in adult patients on dialysis.
For the treatment of schizophrenia
BLA: Biologics License agreement, Type 1: New Molecular entity, Type 2: New active ingredient, Type 3: New dosage form, Type 4: New combination, Type 5 - New formulation or manufacturer, Type
10 - New Indication Submitted as Distinct NDA - Not Consolidated
pharmoutsourcing.com | 37 | April/May/June 2024
Comments
Interchangeable biosimilar to U.S.-licensed Xgeva
For breast cancer
Treatment of advanced or metastatic esophageal
squamous cell carcinoma
Treatment of patients with hormone-refractory
metastatic prostate cancer
For the treatment of patients with
hormone-refractory metastatic prostate cancer
For certain pediatric patients living with HIV-1

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Pharmaceutical Outsourcing Q2 2024

Table of Contents for the Digital Edition of Pharmaceutical Outsourcing Q2 2024

EDITOR'S MESSAGE
EDITORIAL ADVISORY BOARD
SUPPLY CHAIN - Six of the Best Methods to Spark Distribution Improvement and Innovation for the Next Decade
CLINICAL TRIALS - Toward More Intelligent Collaboration: Implementing Data in Partnerships
CLINICAL TRIALS - Leveraging Machine Learning and Deep Learning for Natural Language Processing in Clinical Data Management
CLINICAL TRIALS - Beat the Clock: How an FSP Model Can Optimize a Follow-the-Sun Approach in Clinical Development Functions
CONTRACT RESEARCH - Elevating Laboratory and Manufacturing Equipment Health With AI-Predicted Health Score
AN INTERVIEW WITH GIANMARCO NEGRISOLI, FLAMMA USA
ROUNDTABLE - Pediatric Dosage Forms
SUPPLY CHAIN - Navigating Trends and Challenges Facing Pharmaceutical Supply Chains
HORIZON LINES
INDUSTRY NEWS
ADVERTISER'S INDEX
Pharmaceutical Outsourcing Q2 2024 - Cover1
Pharmaceutical Outsourcing Q2 2024 - Cover2
Pharmaceutical Outsourcing Q2 2024 - 1
Pharmaceutical Outsourcing Q2 2024 - EDITOR'S MESSAGE
Pharmaceutical Outsourcing Q2 2024 - 3
Pharmaceutical Outsourcing Q2 2024 - 4
Pharmaceutical Outsourcing Q2 2024 - 5
Pharmaceutical Outsourcing Q2 2024 - EDITORIAL ADVISORY BOARD
Pharmaceutical Outsourcing Q2 2024 - 7
Pharmaceutical Outsourcing Q2 2024 - SUPPLY CHAIN - Six of the Best Methods to Spark Distribution Improvement and Innovation for the Next Decade
Pharmaceutical Outsourcing Q2 2024 - 9
Pharmaceutical Outsourcing Q2 2024 - 10
Pharmaceutical Outsourcing Q2 2024 - 11
Pharmaceutical Outsourcing Q2 2024 - CLINICAL TRIALS - Toward More Intelligent Collaboration: Implementing Data in Partnerships
Pharmaceutical Outsourcing Q2 2024 - 13
Pharmaceutical Outsourcing Q2 2024 - CLINICAL TRIALS - Leveraging Machine Learning and Deep Learning for Natural Language Processing in Clinical Data Management
Pharmaceutical Outsourcing Q2 2024 - 15
Pharmaceutical Outsourcing Q2 2024 - 16
Pharmaceutical Outsourcing Q2 2024 - CLINICAL TRIALS - Beat the Clock: How an FSP Model Can Optimize a Follow-the-Sun Approach in Clinical Development Functions
Pharmaceutical Outsourcing Q2 2024 - 18
Pharmaceutical Outsourcing Q2 2024 - 19
Pharmaceutical Outsourcing Q2 2024 - CONTRACT RESEARCH - Elevating Laboratory and Manufacturing Equipment Health With AI-Predicted Health Score
Pharmaceutical Outsourcing Q2 2024 - 21
Pharmaceutical Outsourcing Q2 2024 - 22
Pharmaceutical Outsourcing Q2 2024 - 23
Pharmaceutical Outsourcing Q2 2024 - AN INTERVIEW WITH GIANMARCO NEGRISOLI, FLAMMA USA
Pharmaceutical Outsourcing Q2 2024 - 25
Pharmaceutical Outsourcing Q2 2024 - ROUNDTABLE - Pediatric Dosage Forms
Pharmaceutical Outsourcing Q2 2024 - 27
Pharmaceutical Outsourcing Q2 2024 - 28
Pharmaceutical Outsourcing Q2 2024 - 29
Pharmaceutical Outsourcing Q2 2024 - 30
Pharmaceutical Outsourcing Q2 2024 - 31
Pharmaceutical Outsourcing Q2 2024 - SUPPLY CHAIN - Navigating Trends and Challenges Facing Pharmaceutical Supply Chains
Pharmaceutical Outsourcing Q2 2024 - 33
Pharmaceutical Outsourcing Q2 2024 - 34
Pharmaceutical Outsourcing Q2 2024 - HORIZON LINES
Pharmaceutical Outsourcing Q2 2024 - 36
Pharmaceutical Outsourcing Q2 2024 - 37
Pharmaceutical Outsourcing Q2 2024 - INDUSTRY NEWS
Pharmaceutical Outsourcing Q2 2024 - 39
Pharmaceutical Outsourcing Q2 2024 - ADVERTISER'S INDEX
Pharmaceutical Outsourcing Q2 2024 - Cover3
Pharmaceutical Outsourcing Q2 2024 - Cover4
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