PVR

Gossamer Bio Announces Publication of TORREY Phase 2 Results in the Lancet Respiratory Medicine

Retrieved on: 
星期五, 五月 3, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Cardiology, Pulmonary hypertension, Safety, GOSS, Randomness, The Lancet, PAH, Heart, Disease, Patient, The, PVR, Manuscript, Quality of life, Orthostatic hypertension, Pharmaceutical industry

Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), today announced the publication of its TORREY Phase 2 study manuscript in the Lancet Respiratory Medicine journal.

Key Points: 
  • Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), today announced the publication of its TORREY Phase 2 study manuscript in the Lancet Respiratory Medicine journal.
  • The paper, titled "Seralutinib in Adults with Pulmonary Arterial Hypertension (TORREY): A Randomized, Double-blind, Placebo-controlled Phase 2 Trial," details the study's significant findings in advancing the treatment of PAH.
  • 86 patients were randomized to receive either seralutinib or placebo by dry powder inhaler twice daily for 24 weeks.
  • Details about PROSERA can be found here: https://clinicaltrials.gov/ct2/show/NCT05934526
    "The publication of the TORREY results in Lancet Respiratory Medicine represents a significant milestone in our ongoing commitment to addressing unmet medical needs for patients with pulmonary hypertension,” said Faheem Hasnain, CEO, Co-founder, and Chairman of Gossamer Bio.

EFG Companies Expands Powerhouse Leadership Roster

Retrieved on: 
星期二, 四月 30, 2024
Other Professional Services, Insurance, Other Retail, Automotive, Other Automotive, Professional Services, General Automotive, Retail, Dominion, Motivation, Region, Business development, Group 1, Audi, Digital, Environment, GMC, PVR, EFG, Multimedia, Sales, Strategic planning, Management

EFG Companies, recently named as a USA Today National Standard Top Employer, has added three senior executives with a combined 70+ years of experience in retail automotive sales and finance and insurance (F&I) management.

Key Points: 
  • EFG Companies, recently named as a USA Today National Standard Top Employer, has added three senior executives with a combined 70+ years of experience in retail automotive sales and finance and insurance (F&I) management.
  • (Graphic: Business Wire)
    “While retail automotive remains healthy in relation to profit potential, our clients face a new variety of complex issues that can be distracting and dilutive to the bottom line,” said Jennifer Rappaport, President and CEO of EFG Companies.
  • Prior to joining EFG, Gabe served as Vice President of Sales in the Dealership Division of Vehlo.
  • Prior to joining EFG, Brittany served in finance management and sales management roles for Ken Garff Porsche Audi, Young Automotive Group, and Jerry Seiner Buick GMC.

Asbury Automotive Group Reports Record $4.2 Billion in Revenue

Retrieved on: 
星期四, 四月 25, 2024
General Automotive, Other Automotive, Aftermarket, Automotive, Share repurchase, Webcast, Internet, Asbury Automotive Group, Insurance, GAAP, Reconciliation, PVR

“We delivered a strong first quarter, crossing over $4 billion in revenue for the first time in our company’s history,” said David Hult, Asbury’s President and Chief Executive Officer.

Key Points: 
  • “We delivered a strong first quarter, crossing over $4 billion in revenue for the first time in our company’s history,” said David Hult, Asbury’s President and Chief Executive Officer.
  • Our results demonstrate how our strategic investments have enabled us to deliver strong results despite challenging market conditions.
  • Please see “Non-GAAP Financial Disclosure and Reconciliation, Same Store Data and Other Data” and the reconciliations for non-GAAP metrics used herein.
  • Participants may enter the conference call five to ten minutes prior to the scheduled start of the call by dialing:

U.S. FDA Approves OPSYNVI® (macitentan and tadalafil) as the First and Only Once-Daily Single-Tablet Combination Therapy for Patients with Pulmonary Arterial Hypertension (PAH)

Retrieved on: 
星期五, 三月 22, 2024
Diagnosis, ESC, Toxicity, ERA, Tadalafil, Internal medicine, European Respiratory Society, Disease, Risk, Pulmonary hypertension, Patient, PVR, Mitigation, Female, Nitric oxide, Connective tissue disease, Orthostatic hypertension, World Health Organization, PDE5, Johnson & Johnson, REMS, WHO, Pulmonary circulation, PAH, FDA, Constriction, ERS, Food, Pharmaceutical industry

RARITAN, N.J., March 22, 2024  /PRNewswire/ -- Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved OPSYNVI® – a single-tablet combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor – for the chronic treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group I) and WHO functional class (FC) II-III.1 OPSYNVI® may be used in patients with PAH who are treatment-naïve or who are already on an ERA, PDE5 inhibitor or both. OPSYNVI® may be used in patients who are currently treated concomitantly with stable doses of macitentan 10 mg and tadalafil 40 mg (20 mg x 2) as separate tablets.1

Key Points: 
  • Historically, this required patients to take multiple pills because no single-tablet combination therapy targeting two or more pathways was available," said Kelly Chin, M.D., Professor of Internal Medicine and Director of the Pulmonary Hypertension Program at UT Southwestern Medical Center, and an investigator in the A DUE study.
  • The FDA's approval of OPSYNVI® is based on the results from the pivotal Phase 3 A DUE study , in which OPSYNVI® demonstrated greater reduction in Pulmonary Vascular Resistance (PVR) after 16 weeks versus tadalafil or macitentan monotherapy.
  • "People with PAH often live with the burden of taking many pills each day, which can pose challenges," said James F. List, M.D., Ph.D., Global Therapeutic Area Head, whose team oversees a portfolio of programs including Pulmonary Hypertension at Johnson & Johnson.
  • "We're thrilled to bring this single-tablet combination therapy to patients, as it has the potential to optimize disease management and fulfill a significant unmet need in supporting recently updated treatment guidelines that call for initial or early combination treatment."

Asbury Automotive Group Reports Fourth Quarter Financial Results

Retrieved on: 
星期四, 二月 8, 2024
Fleet Management, Retail, General Automotive, Automotive, Specialty, Internet, EPS, TCA, GAAP, PVR, Asbury Automotive Group, Investment, Acquisition, Webcast, Reconciliation, Insurance, Share repurchase

Asbury Automotive Group, Inc. (NYSE: ABG) (the “Company”), one of the largest automotive retail and service companies in the U.S., reported fourth quarter 2023 net income of $56 million ($2.70 per diluted share), a decrease of 89% from $353 million ($15.95 per diluted share) in fourth quarter 2022.

Key Points: 
  • Asbury Automotive Group, Inc. (NYSE: ABG) (the “Company”), one of the largest automotive retail and service companies in the U.S., reported fourth quarter 2023 net income of $56 million ($2.70 per diluted share), a decrease of 89% from $353 million ($15.95 per diluted share) in fourth quarter 2022.
  • Fourth quarter 2023 results include non-cash asset impairments of $117.2 million or $4.29 per diluted share.
  • Fourth quarter 2022 results include gains on dealership divestitures of $203 million or $6.92 per diluted share.
  • Four of the divestitures closed in the first quarter, three in the second quarter, and nine in the fourth quarter of 2022.

AutoFi's Platform Expansion Delivers Overwhelming Results With Deal Time Reduced by 70%

Retrieved on: 
星期一, 一月 8, 2024
Automotive, General Automotive, Technology, Other Automotive, Software, Electronic Commerce, Friction, Partnership, YES, Multimedia, Running, PVR, Service, CRM, Enterprise, DMS

Capabilities including deal estimation, desking, lender routing and F&I menu, are now all included in one powerful platform effectively bridging the existing sales technology gap between the in-store CRM and DMS systems.

Key Points: 
  • Capabilities including deal estimation, desking, lender routing and F&I menu, are now all included in one powerful platform effectively bridging the existing sales technology gap between the in-store CRM and DMS systems.
  • AutoFi’s expanded platform solves everyday problems with the flexibility to enhance existing dealership processes, not force change on them.
  • With rapid product iteration across a diverse dealer base, we have brought to life a product that delivers results we never could have imagined.
  • The AutoFi platform includes digital retailing, deal estimation, desking, lender routing and F&I menu - all in one powerful platform that helps dealers sell smarter, not harder.

Discover the Enchanting Paradise of Costalegre on Mexico's Pacific Coast

Retrieved on: 
星期四, 十二月 28, 2023
Travel, Bread, Partnership, Carretera, Restaurant, Season, Paradise, PVR, Tranquillity, Swimming, Privacy, Sport, Alchemy, Transport, Tourism, Tree, Immersion, Relaxation, ZLO, Pacific coast, Hotel

New York, Dec. 28, 2023 /PRNewswire-PRWeb/ --

Key Points: 
  • Picture-perfect oceanside towns, enchanting coves, and breathtaking views of the endless horizon await visitors along this 238-mile stretch of tropical paradise that runs along the Pacific Coast south of Puerto Vallarta to Manzanillo.
  • Costalegre is easily accessible through Licenciado Gustavo Díaz Ordaz International Airport in Puerto Vallarta (PVR) and the Manzanillo-Costalegre International Airport (ZLO).
  • The aim is to keep operations modest, ensuring swift customs clearance for arriving passengers, allowing them to unwind shortly after landing in Costalegre.
  • Renowned for its exclusive luxury retreats, Costalegre offers discerning travelers refined indulgence that perfectly captures the essence of the region.

Aerovate Therapeutics Announces Simultaneous Completion of Enrollment in Phase 2b Portion and Enrollment of First Patient into Phase 3 in the IMPAHCT Trial Evaluating AV-101 for the Treatment of Pulmonary Arterial Hypertension

Retrieved on: 
星期一, 十一月 20, 2023
Inhalation, PAH, Apoptosis, PVR, Therapy, Pharmacokinetics, Patient, Safety, Orthostatic hypertension, Pharmaceutical industry

WALTHAM, Mass., Nov. 20, 2023 (GLOBE NEWSWIRE) -- Aerovate Therapeutics, Inc. (Nasdaq: AVTE), a clinical stage biopharmaceutical company focused on developing drugs that meaningfully improve the lives of patients with rare cardiopulmonary disease, today announced the Phase 2b portion of the Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial (IMPAHCT) Phase 2b/Phase 3 study evaluating AV-101, a novel dry powder inhaled formulation of imatinib for the treatment of pulmonary arterial hypertension (PAH), has completed enrollment at 202 adult patients. Aerovate expects to report topline data from the Phase 2b portion of the trial in June 2024. In addition, the first patient has been enrolled in the Phase 3 portion of IMPAHCT.

Key Points: 
  • Aerovate expects to report topline data from the Phase 2b portion of the trial in June 2024.
  • In addition, the first patient has been enrolled in the Phase 3 portion of IMPAHCT.
  • “The completion of enrollment in the Phase 2b portion of the trial marks an exciting milestone for Aerovate and for people living with PAH,” said Tim Noyes, Chief Executive Officer at Aerovate Therapeutics.
  • The Phase 2b primary endpoint of IMPAHCT is the placebo corrected change from baseline in pulmonary vascular resistance (PVR).

Jalisco Anticipates New Airport, Updates and Flight Routes in 2024

Retrieved on: 
星期二, 十二月 19, 2023
Biophysical environment, Travel, Delta Air Lines, VIP, DTW, PVR, Environment, GDL, Certification, Disability, ATL, USD, LEED, Gold Award, Ministry, LAX, JetBlue, Carbon, Tourism minister, Tree, Flair, Tourism

The alluring coastline of the Costalegre region, famously dubbed Mexico's "Happy Coast," has become a hotspot for the jet-set drawn to its 238--mile stretch of unspoiled beaches, enchanting capes and bays, and luxury resorts. Situated south of Puerto Vallarta, where the jungle meets the beach, the region is currently accessible through commercial flights to PVR typically requiring several hours of driving post flight to reach key resorts and hotels. Anticipated to open in late 2024, the upcoming Chalacatepec International Airport will offer direct access to this sought-after destination. The aim is to keep operations modest, ensuring swift customs clearance for arriving passengers, allowing them to unwind on the serene beaches in no time. The airport will play a pivotal role in meeting the growing demand for the area, complemented by the launch of the highly awaited Xala. This visionary $1 billion development, spanning 3,000 acres, is set to become one of Mexico's premier destinations. The ambitious project encompasses luxury hotels, estate-style vacation homes, and a lavish 51-villa Six Senses hotel, scheduled to open its doors in 2026.

Key Points: 
  • The upswing in tourism is, in part, a result of collaborative initiatives between Jalisco's Ministry of Tourism and a variety of airlines.
  • Anticipated to open in late 2024, the upcoming Chalacatepec International Airport will offer direct access to this sought-after destination.
  • Beginning May 31, 2024, Canadian low-cost carrier Flair will revive a route last operated in 2004, providing direct service between Vancouver (YVR) and GDL.
  • This expansion not only strengthens air connectivity between Jalisco and key U.S. destinations but also marks a substantial step towards providing passengers with increased travel options and convenience.

Updated Data from the BRUIN Phase 1/2 Study of Pirtobrutinib in Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma Presented at the 2023 ASH Annual Meeting

Retrieved on: 
星期二, 十二月 12, 2023
Medicine, Drug, Safety, NYSE, Arrhythmia, BTK, CTCAE, MCL, Lymphoid leukemia, Progression-free survival, ASH, Cytopenia, Dana–Farber Cancer Institute, Lymphocytosis, Bleeding, Clinical trial, Fatigue, Non-Hodgkin lymphoma, Rituximab, Patient, Abstract, Mantle cell lymphoma, PFS, SLL, Lymphoma, Infection, FDA, DOR, LLY, Exposition, Neutropenia, PVR, ORR, Lilly, Eli Lilly and Company, Chronic lymphocytic leukemia, Nausea, Diarrhea, Pulmonary toxicity, IRC, Chills, Society, OS, NHL, PV, HIV disease progression rates, Venetoclax, Pharmaceutical industry, Dietary supplement, CLL

These data, which were presented in oral and poster presentations at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition, continue to support the role of pirtobrutinib in the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) and mantle cell lymphoma (MCL).

Key Points: 
  • These data, which were presented in oral and poster presentations at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition, continue to support the role of pirtobrutinib in the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) and mantle cell lymphoma (MCL).
  • The labeling for pirtobrutinib contains warnings and precautions for infections, hemorrhage, cytopenias, cardiac arrhythmias, second primary malignancies, and embryo-fetal toxicity.
  • The BRUIN Phase 1/2 clinical trial is evaluating pirtobrutinib in patients previously treated for MCL, CLL/SLL, or other non-Hodgkin lymphomas (NHL).
  • All presentations of safety and efficacy data from the BRUIN Phase 1/2 trial utilized a cutoff date of May 5, 2023.