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title
Reviva to Present RECOVER Phase 3 Clinical Trial Data for Brilaroxazine in Schizophrenia at the SIRS 2024 Annual Meeting
Aerovate Therapeutics to Present Patient Baseline Characteristics of the Phase 2b Portion of the Phase 2b/Phase 3 IMPAHCT Tria
Reviva Announces FDA Alignment on Brilaroxazine Clinical Trials for NDA in Schizophrenia
IMFINZI® (durvalumab) plus chemotherapy doubled overall survival rate at three years for patients with advanced biliary tract
Courts clear FDA to OK Liquidia's dry powder PAH drug Yutrepia
Merck aims to 'outnumber' pulmonary arterial hypertension
Tenax Therapeutics to Host KOL Event: “LEVEL Setting: the Scientific Rationale for Levosimendan as a Potential First ...
Insmed to Present New Data from Across its Respiratory Portfolio at the American Thoracic Society 2024 International Conferenc
Inhibikase Therapeutics Issues Letter to Shareholders and Provides Update on Development Programs
Regulatory tracker: FDA offers Pfizer's Tivdak full nod in cervical cancer
Chiesi buys into Gossamer's Winrevair rival
Merck touts newly approved Winrevair as example of BD acumen
Inhibikase Therapeutics Reports First Quarter Financial Results and Highlights Recent Period Activity
Aerovate Therapeutics Presents Baseline Data from the Phase 2b Portion of the IMPAHCT Trial at the American Thoracic Society
Gossamer Bio Announces First Quarter 2024 Financial Results and Provides Business Update
Insmed Reports First-Quarter 2024 Financial Results and Provides Business Update
Gossamer Bio and Chiesi Group Announce Transformative Global Collaboration to Develop and Commercialize ...
[Trial Change] Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA)
Tenax Therapeutics Reports First Quarter 2024 Financial Results and Provides a Corporate Update
[Trial Change] Multinational Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
AstraZeneca Full year and Q4 2023 Financial Results
AstraZeneca furthers ambition to transform outcomes in early lung cancer and ​redefine metastatic breast cancer treatment at AS
Infinant Health Appoints New Team Members to assist with Drug Development
[Trial Change] A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Ex
[Trial Change] A Study of Macitentan in Japanese Pediatric Participants With Pulmonary Arterial Hypertension
Intellia Therapeutics Announces Fourth Quarter and Full-Year 2023 Financial Results and Highlights Recent Company Progress
[Trial Change] A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension
FDA speeds Sanofi, Regeneron's application for Dupixent in COPD
[Trial Change] A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial Hypertension
[Trial Change] Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
New data presented at AAD showcase continued commitment to advance treatments for inflammatory dermatologic diseases
Incyte Announces New Data from Phase 2 Study Evaluating Ruxolitinib Cream (Opzelura®) in Patients with Mild-to-Moderate
Syndax Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Clinical and Business Update
Dupixent® sBLA accepted for FDA Priority Review for treatment of COPD with type 2 inflammation
[Trial Change] Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON
TRuE-PN2: A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)
Sanofi, Regeneron Secure FDA Priority Review for Dupixent in COPD
New data presented at AAAAI highlight Sanofi’s scientific leadership across inflammatory diseases
MorphoSys AG Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update
Incyte Reports 2023 Fourth Quarter and Year-End Financial Results, Provides 2024 Financial Guidance and Highlights R&D Prio
United States Pharmaceuticals 4 Mar 24 - INDUSTRY SNAPSHOTS
Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials
Regulatory tracker: FDA offers Pfizer's Tivdak full nod in cervical cancer
Dupixent® (dupilumab) sBLA Accepted for FDA Priority Review for Treatment of Adolescents with Chronic Rhinosinusitis wit
Kymera Therapeutics Presents New Preclinical Data for KT-621, a First-In-Class, Oral STAT6 Degrader at the ATS Annual Meet
Japan First in the World to Approve Dupixent® (dupilumab) for Chronic Spontaneous Urticaria (CSU)
Galderma Announces Regulatory Filing Acceptance for Nemolizumab in Prurigo Nodularis and Atopic Dermatitis in the U.S. and
Regulatory tracker: England's NICE rejects AZ and Daiichi's Enhertu in HER2-low breast cancer
CORRECTING and REPLACING, Galderma Announces Regulatory Filing Acceptance for Nemolizumab in Prurigo ...
France Pharmaceuticals 6 Mar 24 - INDUSTRY SNAPSHOTS
Galderma Receives Filing Acceptances for Nemolizumab in Prurigo Nodularis and Atopic Dermatitis in Four Additional ...
Incyte Gets Phase II Win, Targets Blockbuster Dupixent in Skin Disease
New Data from Incyte’s Growing Dermatology Portfolio to be Presented at the 2024 American Academy of Dermatology (AA
American Academy of Dermatology Meeting
Sanofi's BTK inhibitor readout in chronic hives sets up phase 3 push
Dupixent® continues scientific leadership with late-breaking results showing reduced airway inflammation and mucus plugging
Japan Pharmaceuticals 5 Mar 24 - INDUSTRY SNAPSHOTS
After FDA says no on Dupixent for hives disorder, Japan says yes
Praluent® (alirocumab) Injection Receives FDA Approval to Treat Children with Genetic Form of High Cholesterol
Galderma @ AAD 2024: New Data Demonstrate the Long-Term Efficacy of Nemolizumab in Prurigo Nodularis and Its Durability
Regulatory tracker: Pfizer, Moderna COVID shots cleared of potential link to postmenopausal bleeding in Europe
Regulatory tracker: GSK's Jemperli gets NICE nod as Sanofi's Xenpozyme comes up short
United Kingdom Pharmaceuticals 12 Mar 24 - INDUSTRY SNAPSHOTS
Sanofi leans on COPD as 'next major growth pillar' for its immunology star Dupixent: CEO
Incyte to Highlight Data From its Oncology Portfolio at the 2024 ASCO Annual Meeting and EHA2024 Congress
Syndax Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Clinical and Business Update
Regulatory tracker: J&J's Darzalex gains NICE combo nod in AL amyloidosis
Incyte Presents New Late-Breaking Data from Phase 2 Study Evaluating Povorcitinib in Patients with Prurigo Nodularis
Incyte Corp Files United States Patent Application for Ruxolitinib for the Treatment of Prurigo Nodularis
Regulatory tracker: Takeda, Eli Lilly plot key launches in India
Global Pharmaceuticals 13 Mar 24 - INDUSTRY SNAPSHOTS
Regulatory tracker: Regeneron's Praluent wins FDA label expansion in genetic cholesterol condition
Madrigal to grapple with lack of awareness about NASH ahead of potential FDA approval
Written communication by the subject company relating to a third party tender offer
Sanofi Korea expands Dupixent indication to address chronic nodular pruritic rash
Media Update: New results from rilzabrutinib phase 2 study show potential to be first advanced oral treatment for moderate-to-sev
Trevi Therapeutics Reports Fourth Quarter and Year End 2023 Financial Results and Provides Business Updates
AbbVie's Skyrizi proves a worthy Humira successor with nearly matching sales ahead of potential UC nod
Regeneron reveals potential delay for Dupixent in COPD, stagnant sales for Eylea
Press Release: Rilzabrutinib LUNA 3 phase 3 study met primary endpoint in immune thrombocytopenia
Intellia Therapeutics Announces First Patient Dosed in the Phase 3 MAGNITUDE Study of NTLA-2001 as a Single-Dose CRISPR
Japan First in the World to Approve Dupixent® (dupilumab) for Chronic Spontaneous Urticaria (CSU)
FDA Approves Xolair as First and Only Medicine for Children and Adults With One or More Food Allergies
Enanta Pharmaceuticals Reports Financial Results for its Fiscal First Quarter Ended December 31, 2023 with Webcast and Confer
Blueprint Medicines Highlights AYVAKIT® (avapritinib) Long-Term Efficacy and Safety Data and Advances in Mast Cell Dise
[Trial Change] A Trial to Learn if Dupilumab is Safe for and Helps Adult and Adolescent Participants With Eosinophilic Gastritis
Celldex Announces Upcoming Presentation of Barzolvolimab Phase 2 Results in Chronic Spontaneous Urticaria at AAAAI 2024
Groundbreaking! Phase II Data of LP-003 Unveiled by Longbio Pharma at AAAAI2024
New data presented at AAAAI highlight Sanofi’s scientific leadership across inflammatory diseases
MANDARA Phase III data published in New England Journal of Medicine show remission is an achievable goal in eosinophilic g
ARS Pharma Announces Favorable Topline Results from Repeat Dosing Study of neffy® (Epinephrine Nasal Spray) Under Nas
Amgen/AstraZeneca's Asthma Drug Tezspire Vs. Sanofi/Regeneron's Blockbuster Dupixent - Analyst Gives His Pick
After FDA says no on Dupixent for hives disorder, Japan says yes
Dupixent® continues scientific leadership with late-breaking results showing reduced airway inflammation and mucus plugging
FDA speeds Sanofi, Regeneron's application for Dupixent in COPD
GEMINI-NSCLC: NSCLC Biomarker Study
ARS Pharmaceuticals announces neffy® meets primary endpoints and shows rapid symptom control in Phase 2 ...
New data presented at AAD showcase continued commitment to advance treatments for inflammatory dermatologic diseases
New Data from Incyte’s Growing Dermatology Portfolio to be Presented at the 2024 American Academy of Dermatology (AA
New England Journal of Medicine Publishes Phase III Data Showing Xolair Significantly Reduced Allergic Reactions Across Mul
Gossamer Bio Announces Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update
Press Release: Phase 2 results demonstrate rilzabrutinib rapidly reduced itch severity and significantly improved ...
[Trial Change] Oral N-acetylcysteine for Retinitis Pigmentosa
Incyte Reports 2024 First Quarter Financial Results and Provides Updates on Key Clinical Programs
Sanofi’s $3.7B Principia Buy Starts to Pay Off with Phase III Rilzabrutinib Win
HUTCHMED Reports 2023 Full Year Results and Provides Business Updates
Head-to-head, it's AbbVie's Rinvoq over Regeneron's Dupixent
Sanofi pulls off phase 3 LUNA landing, sparking race to regulators for BTK inhibitor
CHMP Issues Positive Opinions For Both Bempedoic Acid And The Bempedoic Acid / Ezetimibe Fixed-Dose Combination Table
Incyte Announces New Data from Phase 2 Study Evaluating Ruxolitinib Cream (Opzelura®) in Patients with Mild-to-Moderate
A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequ
[Trial Change] Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Syste
New Positive Data Presented on Briquilimab Conditioning in Patients with Fanconi Anemia
Dupixent® (dupilumab) Late-Breaking Data from NOTUS Confirmatory Phase 3 COPD Trial Presented at ATS and Published i
Promising Anti-tumor Activity of Novel Costimulatory Bispecific Antibody REGN7075 (EGFRxCD28) in Combination with Libt
Media Update: Dupixent® continues scientific leadership with late-breaking results showing reduced airway ...
Blueprint Medicines Reports Fourth Quarter and Full Year 2023 Results
Gossamer Bio Announces First Quarter 2024 Financial Results and Provides Business Update
AstraZeneca caps patient out-of-pocket costs at $35 per month for its US inhaled respiratory portfolio
Blueprint Medicines Reports Strong First Quarter 2024 Results and Raises AYVAKIT®/AYVAKYT® (avapritinib) Full ...
[Trial Change] Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythe
Sanofi leans on COPD as 'next major growth pillar' for its immunology star Dupixent: CEO
Media Update: New results from rilzabrutinib phase 2 study show potential to be first advanced oral treatment for moderate-to-sev
Jasper Therapeutics Reports Fiscal 2023 Financial Results and Recent Corporate Developments
Dupixent® sBLA accepted for FDA Priority Review for treatment of COPD with type 2 inflammation
Incyte Presents New Late-Breaking Data from Phase 2 Study Evaluating Povorcitinib in Patients with Prurigo Nodularis
Evommune Announces Expanded Strategic Collaboration with Maruho to Develop and Commercialize MRGPRX2 antagonist EV
Pre-clinical result of LP-005, a novel bi-functional complement antibody-fusion protein was unveiled by LongBio at WCN2024
AstraZeneca Full year and Q4 2023 Financial Results
AstraZeneca announces initiation of THARROS – a Phase III clinical trial investigating the potential of BREZTRI to improve ca
Novartis Q4 2023 Earnings Call
[Trial Change] A Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo and W
Celldex Reports Fourth Quarter and Year End 2023 Financial Results and Provides Corporate Update
A Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo and With Omalizuma
Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Ery
Treatment of Iron Overload With Deferasirox (Exjade) in Hereditary Hemochromatosis and Myelodysplastic Syndrome
Incyte Announces Acquisition of Escient Pharmaceuticals and its Pipeline of First-in-Class Oral MRGPR Antagonists
TipRanks 'Perfect 10' List: These 2 Top-Scoring Stocks Could Double (or More), According to Analysts
[Trial Change] A Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo and W
Dupixent® (dupilumab) sBLA Accepted for FDA Priority Review for Treatment of Adolescents with Chronic Rhinosinusitis wit
Incyte Inks $750M Deal to Buy Escient and Skin Disease Drug Candidates
Dupixent® (dupilumab) Late-Breaking Data from NOTUS Confirmatory Phase 3 COPD Trial Presented at ATS and Published i
24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <
GEMINI-NSCLC: NSCLC Biomarker Study
NEW DATA PRESENTED AT ATS 2024 SHOW THE POTENTIAL OF TEZSPIRE® TO HELP PATIENTS LIVING WITH C
Sanofi pulls off phase 3 LUNA landing, sparking race to regulators for BTK inhibitor
[Trial Change] A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With C
[Trial Change] A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With C
Celldex Announces First Patient Dosed in Phase 2 Study of Barzolvolimab in Prurigo Nodularis
[Trial Change] Preclinical Studies of Omalizumab in Chronic Rhinosinusitis With Nasal Polyposis
[Trial Change] A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With C
[Trial Change] A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With C
Enanta Pharmaceuticals Reports Financial Results for its Fiscal Second Quarter with Webcast and Conference Call ...
[Trial Change] A Multicenter, Open-label Phase 3 Study: Ambulatory Blood Pressure Monitoring in Adult Patients With Chronic
Incyte Reports 2024 First Quarter Financial Results and Provides Updates on Key Clinical Programs
[Trial Change] An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urtica
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kit_id name
1 Filing for Reimbursement - US
2 Filing for Reimbursement - EU
3 Launch of new DTC Campaign - US
4 New KOL/ Analyst Opinion Reports
5 Change in Drug Positioning
6 New Co-marketing Activities
7 Sales Performance Update
8 Field Force Changes
9 M&A Related News
10 Manufacturing Updates for Competitors
11 Product Approval/ Filing/ Delay/ Rejection
12 Major Change in Approved Label
13 Regulatory Warning or Safety Concerns
14 Planned Adcom and Results - FDA
15 Regulatory Submission and Approval Dates
16 Approval in Key Markets
17 Regulatory Feedback or Planned Results
18 Regular Trial Update
19 Phase 4 Trial Update
20 Phase 3 Trial Update
21 Phase 2 Trial Update
22 Phase 1 Trial Update - Scoped Indication
23 Phase 1 Trial Update - Biosimilars/Generic
24 New Phase 3 Trial Initiation
25 Head-to-Head Study Update
26 Trial with New Formulation/Device
27 Clinical Trial Outcomes - Outside Scoped Indication
28 Impact on Scoped Indication
29 Biomarker Updates in Scoped Indication
30 Diagnostics Updates in Scoped Indication
31 Litigation and Class Actions
32 Legal Developments Impacting Drug Supply
description
Filing for Reimbursement or payer decision negative or positive update - US.
Filing for Reimbursement or payer decision negative or positive update - EU.
Launch of new DTC Campaign or significant change in promotional campaign - US.
New KOL/ Analyst opinion reports on customer or competition products.
Change in drug positioning or target customers or messages.
New Co-marketing or Co-promotion activities in scoped markets.
Sales performance update.
Field force changes.
Merger/Acquisition/spin-off/Collaboration related news.
Manufacturing updates impacting supply or quality of competition drugs - for direct competitors.
Product Approval/ filing/delay/ rejection for new indication or formulation.
Major Change in approved label (US and EU) - Safety/Efficacy/Formulation.
Regulatory warning or other safety concerns.
Planned Adcom and results - FDA.
Regulatory planned submission date and expected approval date (PDUFA).
Product Approval in key markets (US, EU, Japan
Regulatory feedback or planned results concerning CHMP or EMA evaluations and decisions.
Updates on pre-defined/scoped trials including start, completion, major changes in timelines, patient population/numbers, trial
Initiation, completion, or results of Phase 4 trials for scoped indication. Includes company-sponsored safety studies and PMCs
Any trial initiation, completion, or results for Phase 3 trials scoped indication.
Any trial initiation, completion, or results for Phase 2 trials scoped indication.
Any trial initiation, completion, or results for Phase 1 trials scoped indication.
Any trial initiation, completion, or results for Phase 1 trials for other indications including biosimilars and generics.
Initiation of new Phase 3 trials other than scoped indication.
Updates on head-to-head (H2H) studies with relevant competitors, irrespective of indication.
Trials involving new formulations or new devices.
Outcomes from clinical trials outside of scoped indication, especially if there are safety issues.
Updates and revisions in major guidelines that directly impact treatment protocols, drug usage, or clinical practices within the
Inclusion of new biomarkers or updates to existing biomarkers that have implications for diagnosis, treatment, or monitoring w
Inclusion of new diagnostic tools or updates to existing diagnostics protocols that impact the detection, monitoring, or manage
Updates on any litigation or class actions including their initiation, progress, or resolution that may affect the pharmaceutical i
Updates on any legal developments that could potentially impact the supply of competition drugs in key markets.