INT

MVE + Partners Announces the Opening of Its First Latin America Office in Guadalajara

Retrieved on: 
Monday, March 18, 2024

GUADALAJARA, Mexico, March 18, 2024 (GLOBE NEWSWIRE) -- MVE + Partners (MVE), a leading architecture, planning, interior design and urban design firm, today announced the opening of MVE Architects Mexico, its first Latin-America-based office in Guadalajara, Mexico.

Key Points: 
  • GUADALAJARA, Mexico, March 18, 2024 (GLOBE NEWSWIRE) -- MVE + Partners (MVE), a leading architecture, planning, interior design and urban design firm, today announced the opening of MVE Architects Mexico, its first Latin-America-based office in Guadalajara, Mexico.
  • Bernardis’ notable projects include Guadalajara International Airport’s Terminal 2 , Acuarela master plan , and Luna Luxury Residential Tower in San Pedro, Monterrey, as well as diverse projects in Latin America.
  • “I’m inspired by MVE’s body of work and honored to support the establishment of the first hub in Latin America.
  • Opening a Guadalajara location just felt like the natural next step,” said Matthew McLarand, AIA, NCARB, president, MVE.

NRx Pharmaceuticals to Report Fourth Quarter and Full Year 2023 Financial Results and Provide a Corporate Update on March 28, 2024

Retrieved on: 
Thursday, March 21, 2024

RADNOR, Pa., March 21, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that it will release its fourth quarter and full year 2023 financial results after the market closes on Thursday, March 28, 2024, via press release, which will be available on the Company's website at https://ir.nrxpharma.com/press-releases .

Key Points: 
  • RADNOR, Pa., March 21, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that it will release its fourth quarter and full year 2023 financial results after the market closes on Thursday, March 28, 2024, via press release, which will be available on the Company's website at https://ir.nrxpharma.com/press-releases .
  • The Company will host a conference call to discuss the financial results as well as provide a corporate update at 4:30 p.m.
  • A live webcast of the conference call will be available on the Company's website at https://ir.nrxpharma.com/events .
  • Participants that are unable to join the webcast can access the conference call via telephone by dialing domestically 1-877-704-4453, Int'l Investors Dial 1-201-389-0920.

Cepheid Receives FDA Clearance for Xpert® Xpress GBS

Retrieved on: 
Monday, March 11, 2024

SUNNYVALE, Calif., March 11, 2024 /PRNewswire/ -- Cepheid announced today that it has received clearance from the U.S. Food and Drug Administration for Xpert® Xpress GBS, a dual-target molecular diagnostic test for the qualitative intrapartum detection of Group B Streptococcus (GBS). This next-generation test incorporates new dual targets in highly-conserved regions of the GBS genome to improve sensitivity and bacterial strain coverage. The test is designed for use on Cepheid's GeneXpert® systems.

Key Points: 
  • SUNNYVALE, Calif., March 11, 2024 /PRNewswire/ -- Cepheid announced today that it has received clearance from the U.S. Food and Drug Administration for Xpert® Xpress GBS, a dual-target molecular diagnostic test for the qualitative intrapartum detection of Group B Streptococcus (GBS).
  • Xpert Xpress GBS allows for the use of intrapartum direct PCR testing for women with unknown or unavailable antepartum GBS status.
  • With the capability of returning positive results as early as 30 minutes,2 Xpert Xpress GBS can provide real-time GBS status and inform decisions about empiric antibiotic prophylaxis if appropriate, to prevent GBS transmission during birth.
  • With Xpert Xpress GBS, Cepheid continues to provide fast, accurate, and reliable PCR solutions to facilitate evidence-based treatment and improved clinical care.

Moving Testimony of Apostle V.T. Williams Can Encourage Readers to Leave an Imprint on the World

Retrieved on: 
Monday, March 11, 2024

SAN ANTONIO, Texas, March 11, 2024 /PRNewswire-PRWeb/ -- FL—Author Bishop Charles E. Flowers tells the compelling story of Apostle V.T. Williams in The Footprints of a Prophet: Living Out Your Purpose & Destiny ($15.49, paperback, 9781662891632; $6.99, e-book, 9781662891649).

Key Points: 
  • SAN ANTONIO, Texas, March 11, 2024 /PRNewswire-PRWeb/ -- FL—Author Bishop Charles E. Flowers tells the compelling story of Apostle V.T.
  • Williams in The Footprints of a Prophet: Living Out Your Purpose & Destiny ($15.49, paperback, 9781662891632; $6.99, e-book, 9781662891649).
  • As their friendship culminated, it was evident to Bishop Flowers that Apostle V.T.
  • Williams is a sign and a wonder, a jewel and great treasure, tucked away in a remote village of the Caribbean.

Reflection paper on investigation of pharmacokinetics in the obese population - Scientific guideline

Retrieved on: 
Wednesday, February 14, 2024

Reflection paper on investigations of pharmacokinetics in

Key Points: 
    • Reflection paper on investigations of pharmacokinetics in
      the obese population
      Table of contents
      1.
    • References .............................................................................................. 9

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 2/12

      1.

    • This is considered
      a shortcoming that is potentially compounded by obese patients often being poorly represented in
      clinical studies.
    • The specific aims of this reflection paper are to:
      ?

      describe how the effects of obesity can be investigated during clinical medicinal product
      development.

    • ?

      provide recommendations on when investigations of the effect of obesity on the PK of a
      medicinal product should be particularly considered.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 3/12

      ?

      discuss how to reflect PK (and/or PK/PD) findings in weight/weight-based dosing
      recommendations.

    • Absorption
      Reduced rate of absorption linked to locally reduced blood flow (8) is reported for the subcutaneous
      and transdermal routes in obese subjects.
    • Distribution
      The distribution of medicinal products is driven by body composition, regional blood flow and binding to
      tissue and plasma proteins.
    • Obese subjects have a larger absolute lean body weight (LBW) as well as fat mass.
    • The physicochemical properties of a medicinal product (lipophilicity, polarity, molecular size, and
      degree of ionization) influence its distribution in the body.
    • In BMI class III obese
      subjects, the blood flow per gram of fat is significantly lower than that observed in class I obese or
      lean subjects (4).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 4/12

      An increased amount of alpha-1-acid-glycoprotein (AAG), linked to a chronic inflammatory state, is
      reported in obese individuals.

    • Fatty infiltrations are present in the liver for 90% of obese subjects, with the extent of the infiltrations
      being proportional to the degree of obesity.
    • In some cases, in particular for CYP3A4 metabolized medicinal products,
      bodyweight normalized clearance can be lower in obese patients (23).
    • Based on presently available data, it has been suggested that uptake transporters

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 5/12

      are downregulated while efflux transporters may be upregulated (31).

    • Platelet hyper-reactivity is also observed,
      which can impair the response to anti-platelet medicinal products in obese patients (42, 43).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 6/12

      3.

      the medicinal product properties and scientific literature indicate that obesity may lead to a
      marked effect on elimination and/or distribution or on the PK/PD relationship.

    • These
      models may aid in extrapolating the known efficacy and safety in the non-obese population to the
      obese population.
    • The Pharmacokinetics of the CYP3A Substrate Midazolam in Morbidly Obese Patients
      Before and One Year After Bariatric Surgery.
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 11/12

      41.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 12/12

A Response to Unfounded Claims Questioning the Qualifications of Black Commercial Pilots

Retrieved on: 
Monday, February 12, 2024

Recent comments questioning the qualifications of Black commercial pilots have compelled us to address these baseless claims with a resolute commitment to truth, merit, and the principles that underpin our profession.

Key Points: 
  • Recent comments questioning the qualifications of Black commercial pilots have compelled us to address these baseless claims with a resolute commitment to truth, merit, and the principles that underpin our profession.
  • We also acknowledge the landmark Supreme Court case of 1963, which outlawed discriminatory hiring practices and mandated commercial airlines hire qualified Black pilots based on merit.
  • The recent unfounded claims regarding the qualifications of Black commercial pilots not only perpetuate harmful stereotypes but also undermine the hard-earned achievements of countless professionals within our community.
  • Captain Jason Ambrosi, President - Air Line Pilots Association, Int'l
    Clovis Jones, President - United States Army Black Aviation Association, Inc.

CHESAPEAKE ENERGY CORPORATION PROVIDES 2023 FOURTH QUARTER AND FULL YEAR EARNINGS CONFERENCE CALL INFORMATION

Retrieved on: 
Tuesday, February 6, 2024

OKLAHOMA CITY, Feb. 6, 2024 /PRNewswire/ -- Chesapeake Energy Corporation (NASDAQ: CHK) today announced that it will release its 2023 fourth quarter and full year operational and financial results after market close on Tuesday, February 20, 2024.

Key Points: 
  • OKLAHOMA CITY, Feb. 6, 2024 /PRNewswire/ -- Chesapeake Energy Corporation (NASDAQ: CHK) today announced that it will release its 2023 fourth quarter and full year operational and financial results after market close on Tuesday, February 20, 2024.
  • A conference call to discuss the results has been scheduled on Wednesday, February 21, 2024 at 9:00 am EST.
  • The telephone number to access the conference call is 1-888-317-6003 / INT TOLL: 1-412-317-6061, passcode 8453967.
  • Headquartered in Oklahoma City, Chesapeake Energy Corporation is powered by dedicated and innovative employees who are focused on discovering and responsibly developing leading positions in top U.S. oil and gas plays.

Comprehensive Review Highlights Importance of Leukine® in Combination with Anti-GD2 Immunotherapy for Treatment of High-Risk Pediatric Neuroblastoma

Retrieved on: 
Wednesday, January 17, 2024

LEXINGTON, Mass., Jan. 17, 2024 /PRNewswire/ -- Partner Therapeutics, Inc. (PTx) announced today the publication of a comprehensive review by Mora et al.

Key Points: 
  • LEXINGTON, Mass., Jan. 17, 2024 /PRNewswire/ -- Partner Therapeutics, Inc. (PTx) announced today the publication of a comprehensive review by Mora et al.
  • It also describes why the authors believe it is suboptimal to replace with Leukine with G-CSF in this regimen for mechanistic reasons.
  • Leukine has been studied extensively in combination with dinutuximab and naxitamab leading to improved patient outcomes.
  • As a result, all clinical trials supporting the FDA-approval of dinutuximab and naxitamab included Leukine and both products are labeled for use in combination with GM-CSF.

Philochem and Blue Earth Diagnostics Announce First Three Patients Imaged in Phase 1 Clinical Trial of 68Ga-OncoFAP (68Ga-OncoFAP-DOTAGA) for Diagnostic Imaging in Solid Tumors

Retrieved on: 
Monday, December 4, 2023

Under the agreement, the Philogen Group is conducting a Phase 1 clinical study to evaluate the safety and dosimetry of 68Ga-OncoFAP (68Ga-OncoFAP-DOTAGA) in patients with solid tumors.

Key Points: 
  • Under the agreement, the Philogen Group is conducting a Phase 1 clinical study to evaluate the safety and dosimetry of 68Ga-OncoFAP (68Ga-OncoFAP-DOTAGA) in patients with solid tumors.
  • The agreement provides Blue Earth Diagnostics rights to develop and commercialize 68Ga-OncoFAP worldwide.
  • The Philogen Group has a Phase I clinical trial (called FAPrimo) underway in Europe to evaluate the safety and dosimetry of 68Ga-OncoFAP in patients with solid tumors.
  • The first three enrolled patients in the trial were imaged in November 2023 at the National Cancer Institute of Milan (INT).

Merck and Moderna Initiate INTerpath-002, a Phase 3 Study Evaluating V940 (mRNA-4157) in Combination with KEYTRUDA® (pembrolizumab) for Adjuvant Treatment of Patients with Certain Types of Resected Non-Small Cell Lung Cancer

Retrieved on: 
Monday, December 11, 2023

Global recruitment of the INTerpath-002 has begun, and the first patients enrolled in Australia.

Key Points: 
  • Global recruitment of the INTerpath-002 has begun, and the first patients enrolled in Australia.
  • “By combining KEYTRUDA with V940 (mRNA-4157), a promising new modality, we are researching innovative new approaches for earlier stage non-small cell lung cancer.”
    “Addressing lung cancer reflects the constant struggle between medical innovation and biological complexity.
  • “We believe an individualized neoantigen therapy can be this catalyst for innovation and drive us forward towards the next frontier of cancer care.
  • The companies plan to continue expansion of the comprehensive clinical development program for V940 (mRNA-4157) to additional tumor types.