HIV

FDA Approves Biktarvy® Label Update With Data for Pregnant Adults With HIV

Retrieved on: 
Friday, April 26, 2024

This update makes Biktarvy the only second-generation integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) with in-label clinical trial data and FDA approval in virologically suppressed adults who are pregnant.

Key Points: 
  • This update makes Biktarvy the only second-generation integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) with in-label clinical trial data and FDA approval in virologically suppressed adults who are pregnant.
  • Additionally, guidelines recommend continuing Biktarvy for PWH already on treatment who are virologically suppressed and tolerating treatment well who may become pregnant.
  • “This label update marks an important milestone for Biktarvy, reinforcing its efficacy profile for pregnant PWH, an often understudied and most vulnerable community in clinical research,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences.
  • “Not only is Biktarvy an alternative regimen for use in pregnancy, but people of childbearing potential can also remain on Biktarvy if they become pregnant.

Gilead Sciences Announces First Quarter 2024 Financial Results

Retrieved on: 
Thursday, April 25, 2024

Gilead Sciences, Inc. (Nasdaq: GILD) announced today its first quarter 2024 results of operations.

Key Points: 
  • Gilead Sciences, Inc. (Nasdaq: GILD) announced today its first quarter 2024 results of operations.
  • Diluted (loss) earnings per share (“EPS”) was $(3.34) in the first quarter 2024, compared to $0.80 in the same period in 2023.
  • Non-GAAP diluted (loss) EPS was $(1.32) in the first quarter 2024, compared to $1.37 in the same period in 2023.
  • During the first quarter 2024, Gilead paid dividends of $990 million and repurchased $400 million of common stock.

AHF Praises Colombia for Putting Lives Before Pharma Greed

Retrieved on: 
Friday, April 26, 2024

Thousands of lives and valuable health resources will be saved,” said AHF Director of Global Advocacy and Policy Guillermina Alaniz.

Key Points: 
  • Thousands of lives and valuable health resources will be saved,” said AHF Director of Global Advocacy and Policy Guillermina Alaniz.
  • “We salute the government of Colombia for putting the lives of people living with HIV ahead of pharma greed.
  • AHF has provided HIV screening services to more than 195,000 people in Colombia and HIV treatment to nearly 5,000 patients.
  • AHF Colombia currently serves 2,755 patients and operates clinics in Bogotá, Bucaramanga, Riohacha, Valledupar, Cartagena, and Cúcuta.

Owlstone Medical Secures $6.5 Million to Support Development of Breath-based Diagnostics for Infectious Disease

Retrieved on: 
Thursday, April 25, 2024

The funding is comprised of a $5 million equity investment to advance Owlstone’s Breath Biopsy platform and $1.5 million in grant funding to develop breath-based diagnostics and identify breath biomarkers for tuberculosis (TB) and HIV.

Key Points: 
  • The funding is comprised of a $5 million equity investment to advance Owlstone’s Breath Biopsy platform and $1.5 million in grant funding to develop breath-based diagnostics and identify breath biomarkers for tuberculosis (TB) and HIV.
  • Owlstone, with support from the foundation, is interested in developing new cost-effective detection technologies for volatile organic compounds (VOCs) that could serve as markers of diseases that disproportionately affect the developing world.
  • Billy Boyle, co-founder and CEO at Owlstone Medical, said: “Early diagnosis is a critical determinant of health outcomes.
  • This investment by the Gates Foundation is testament to how Owlstone is uniquely positioned to transform infectious disease diagnosis through our Breath Biopsy platform.

The Antera Brand Back at the Summit of Light Alloy-wheel Producers

Retrieved on: 
Wednesday, April 24, 2024

The Antera brand makes its comeback on the world stage during the 2024 Milan Design Week with a new collection of light alloy wheels.

Key Points: 
  • The Antera brand makes its comeback on the world stage during the 2024 Milan Design Week with a new collection of light alloy wheels.
  • A premium made-in-Italy brand, Antera combines timeless design, cutting-edge technology, and the determination to overcome any obstacle.
  • The new Antera collection features five different models of various dimensions, from 19 inches to 24 inches, and seven finishes.
  • Today, on the occasion of the 2024 Milan Design Week, the prestigious Antera brand makes its comeback on the global scene with a new collection of light alloy wheels for the automotive industry.

Innoviva Specialty Therapeutics’ Positive Phase 3 Oral Zoliflodacin Data for the Treatment of Uncomplicated Gonorrhea Announced at ESCMID Global 2024

Retrieved on: 
Wednesday, April 24, 2024

Zoliflodacin is a first-in-class spiropyrimidinetrione, single dose, oral antibiotic that is being developed in partnership with GARDP for the treatment of uncomplicated gonorrhea.

Key Points: 
  • Zoliflodacin is a first-in-class spiropyrimidinetrione, single dose, oral antibiotic that is being developed in partnership with GARDP for the treatment of uncomplicated gonorrhea.
  • GARDP and Innoviva Specialty Therapeutics plan to submit the Phase 3 zoliflodacin data for future publication in a medical journal.
  • Oral zoliflodacin 3g was generally well tolerated and emergent adverse events were comparable between treatment arms (46.2% vs 46.4%).
  • Details for the ESCMID Global 2024 presentations are as follows:
    Title: Oral zoliflodacin is non-inferior to a combination of ceftriaxone and azithromycin for treatment of uncomplicated urogenital gonorrhoea: results of a large global Phase 3 randomized controlled trial
    Session: 05.

Vir Biotechnology Announces Nomination of Norbert Bischofberger, Ph.D. and Ramy Farid, Ph.D. to its Board of Directors

Retrieved on: 
Thursday, April 18, 2024

Vir Biotechnology, Inc. (“Vir” or “the Company”, Nasdaq: VIR) today announced the nomination of Norbert Bischofberger, Ph.D. and Ramy Farid, Ph.D. to its Board of Directors (the “Board”) at its upcoming annual meeting of stockholders on May 29, 2024 (the “Annual Meeting”).

Key Points: 
  • Vir Biotechnology, Inc. (“Vir” or “the Company”, Nasdaq: VIR) today announced the nomination of Norbert Bischofberger, Ph.D. and Ramy Farid, Ph.D. to its Board of Directors (the “Board”) at its upcoming annual meeting of stockholders on May 29, 2024 (the “Annual Meeting”).
  • The nomination of the two new independent directors demonstrates Vir’s commitment to ongoing Board refreshment.
  • Marianne De Backer, M.Sc., Ph.D., MBA, Vir’s Chief Executive Officer, said: “We are incredibly excited about the prospect of adding such highly talented directors in Norbert and Ramy to the Board.
  • Previously, he served on the board of directors of Nimbus Therapeutics, a biotechnology company he helped found in 2009.

MISTR, Known for its Free Online PrEP and Long-Term HIV Care, is Now Prescribing DoxyPEP

Retrieved on: 
Tuesday, April 16, 2024

MISTR, the largest telemedicine provider offering free online PrEP and long-term HIV care in all 50 states, D.C., and Puerto Rico, is now prescribing Doxycycline Post-Exposure Prophylaxis (DoxyPEP), an antibiotic that reduces bacterial STIs, including gonorrhea, chlamydia, and syphilis.

Key Points: 
  • MISTR, the largest telemedicine provider offering free online PrEP and long-term HIV care in all 50 states, D.C., and Puerto Rico, is now prescribing Doxycycline Post-Exposure Prophylaxis (DoxyPEP), an antibiotic that reduces bacterial STIs, including gonorrhea, chlamydia, and syphilis.
  • Beginning today, patients can now use MISTR’s seamless telehealth platform to receive DoxyPEP online for free.
  • “I’m proud that MISTR is democratizing access to PrEP, HIV Care, and now DoxyPEP.”
    DoxyPEP has already shown promising results in reducing the rates of certain STIs.
  • Now MISTR patients can receive DoxyPEP, in addition to their PrEP or HIV care medications.

Nodexus Adds Flow Cytometry Leaders to Scientific Advisory Board

Retrieved on: 
Wednesday, April 10, 2024

Nodexus Inc., a leader in automated benchtop single-cell characterization and microfluidic isolation technologies, today announced that three leading experts in cytometry sciences, pathology, and cancer biology have joined its Scientific Advisory Board (SAB).

Key Points: 
  • Nodexus Inc., a leader in automated benchtop single-cell characterization and microfluidic isolation technologies, today announced that three leading experts in cytometry sciences, pathology, and cancer biology have joined its Scientific Advisory Board (SAB).
  • The Nodexus SAB is chaired by Professor Jonni Moore, PhD, one of the world’s leading experts in flow cytometry, laboratory medicine, and cellular immunology.
  • He is a founding member of the Southern California Flow Cytometry Association (SoCal Flow) and the American Association of Pharmaceutical Scientists (AAPS) PharmaFlow Working Group.
  • “I’m extremely pleased to serve as the Chairperson of Nodexus’ Scientific Advisory Board,” said Dr. Moore.

ZERO Prostate Cancer Taps Community Healthcare Leader as First-Ever Chief Mission Officer

Retrieved on: 
Tuesday, April 23, 2024

WASHINGTON, April 23, 2024 /PRNewswire/ -- ZERO Prostate Cancer, the nation's leading prostate cancer organization, is pleased to announce the appointment of Brian Bragg as its first-ever Chief Mission Officer. Bragg, a distinguished expert in the healthcare and community health space, will lead the organization's bold mission-first strategy to reduce late-stage diagnoses, improve patient quality and quantity of life, and decrease mortality. He will also spearhead continued efforts to center health equity solutions into all of ZERO Prostate Cancer's education, support, and advocacy work. Bragg begins his role on May 6.

Key Points: 
  • WASHINGTON, April 23, 2024 /PRNewswire/ -- ZERO Prostate Cancer , the nation's leading prostate cancer organization, is pleased to announce the appointment of Brian Bragg as its first-ever Chief Mission Officer.
  • He will also spearhead continued efforts to center health equity solutions into all of ZERO Prostate Cancer's education, support, and advocacy work.
  • In his new role, Bragg will lead a comprehensive approach working both in-community and virtually to accelerate and expand mission delivery.
  • "ZERO Prostate Cancer is making an unprecedented expansion in mission, and Brian's vast experience and vision will drive our outreach, community health, patient programs, and advocacy efforts to new heights," said Courtney Bugler, President & CEO of ZERO Prostate Cancer.