Advisory Committee

ARS Reports Second Quarter 2023 Financial Results and Provides Business Updates

Retrieved on: 
Thursday, August 10, 2023

SAN DIEGO, Aug. 10, 2023 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis, today reported business updates and financial results for the second quarter of 2023.

Key Points: 
  • Topline data from the company’s ongoing Phase 2 randomized, placebo-controlled study of neffy in urticaria patients are expected by the fourth quarter of 2023.
  • R&D Expenses: Research and development (R&D) expenses were $7.3 million for the quarter ended June 30, 2023.
  • G&A Expenses: General and administrative (G&A) expenses were $13.3 million for the quarter ended June 30, 2023.
  • Net Loss: Net loss was $17.4 million for the quarter ended June 30, 2023.

Parent Project Muscular Dystrophy's RUSP Nomination Package for Duchenne Muscular Dystrophy Passes First Hurdle in Federal Committee Vote

Retrieved on: 
Thursday, August 10, 2023

WASHINGTON, Aug. 10, 2023 /PRNewswire/ -- Parent Project Muscular Dystrophy (PPMD), a nonprofit organization leading the fight to end Duchenne muscular dystrophy (Duchenne), announced that the nomination package to add Duchenne to the Recommended Uniform Screening Panel (RUSP) passed the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) Nomination and Prioritization vote today. This decision marks another exciting step towards the organization's goal of having Duchenne added to newborn screening (NBS) programs across the country, as the ACHDNC voted to move the package forward to more extensive review.

Key Points: 
  • WASHINGTON, Aug. 10, 2023 /PRNewswire/ -- Parent Project Muscular Dystrophy (PPMD), a nonprofit organization leading the fight to end Duchenne muscular dystrophy (Duchenne), announced that the nomination package to add Duchenne to the Recommended Uniform Screening Panel (RUSP) passed the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) Nomination and Prioritization vote today.
  • Niki Armstrong, PPMD's Newborn Screening Program Manager, explains that Duchenne has passed the first hurdle toward being on the RUSP.
  • Ms. Armstrong says, "This vote in favor means that the Committee feels that additional investigation into Duchenne newborn screening is warranted.
  • As the Committee continues to review Duchenne for the RUSP, state specific efforts towards NBS for Duchenne are underway in selected states.

Vaxcyte Reports Second Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, August 8, 2023

SAN CARLOS, Calif., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced financial results for the second quarter ended June 30, 2023 and provided a business update.

Key Points: 
  • “Our strong balance sheet provides a solid foundation as we advance our PCV franchise and pipeline programs.
  • The six-month safety data from both studies showed safety and tolerability results for VAX-24 similar to PCV20 at all doses studied.
  • Clearance of the adult IND application by the FDA in the fourth quarter of 2023 following submission.
  • The June 30, 2023 amount includes the $545.3 million in net proceeds from the follow-on offering completed in April 2023.

Sarepta Therapeutics Announces Second Quarter 2023 Financial Results and Recent Corporate Developments

Retrieved on: 
Wednesday, August 2, 2023

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported financial results for the second quarter 2023.

Key Points: 
  • Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported financial results for the second quarter 2023.
  • Sarepta was awarded the PRV following U.S. Food and Drug Administration (FDA) accelerated approval of ELEVIDYS (delandistrogene moxeparvovec-rokl).
  • These non-GAAP measures are not intended to be considered in isolation or to replace the presentation of the Company’s financial results in accordance with GAAP.
  • All relevant non-GAAP measures are reconciled from their respective GAAP measures in the attached table “Reconciliation of GAAP Financial Measures to Non-GAAP Financial Measures.”

South Africa's new Marriage Bill raises many thorny issues - a balancing act is needed

Retrieved on: 
Wednesday, August 2, 2023

The Department of Home Affairs has invited public comment on the Draft Marriage Bill 2022.

Key Points: 
  • The Department of Home Affairs has invited public comment on the Draft Marriage Bill 2022.
  • The bill amends some marriage laws, and prescribes what’s required for marriages to be considered valid, forms of registration, and the property consequences of marriage.
  • While it is innovative for bringing all forms of intimate partnerships under one piece of legislation, the bill raises thorny questions.

The thorny issues

    • A couple could live together for reasons such as exorbitant rent, distance to workplaces, and prohibitively high bridewealth (ilobolo).
    • The bill doesn’t recognise such intimate partnerships, which the Constitutional Court has accorded the same legal status as formal marriages.
    • As the court has acknowledged, unmarried partnerships have serious implications for finances, human dignity, property ownership and child custody.
    • This could affect inheritance, property and child custody because legal systems may govern these issues differently.
    • If the thorny issues in the bill are not addressed, the eventual legislation could be challenged as discriminatory.

A balancing act

    • The advisory committee that worked on the Single Marriage Statute (Project 144) proposed two options for regulating life partnerships in its discussion paper.
    • These are a Protected Relationships Bill and a Recognition and Registration of Marriages and Life Partnerships Bill.
    • Read more:
      LGBTQ+ rights: African Union watchdog goes back on its own word

      Ultimately, new forms of relationships demand legislative recognition.

Exterro Announces Ariana Tadler as the 2023 Honorable Shira Scheindlin Lifetime Achievement Award Honoree

Retrieved on: 
Tuesday, August 1, 2023

PORTLAND, Ore., Aug. 01, 2023 (GLOBE NEWSWIRE) -- Exterro today announced that Ariana Tadler, the founding partner of Tadler Law LLP, a WBENC-certified, women-owned boutique law firm that offers an array of litigation and legal counseling services, as the 2023 Honorable Shira Scheindlin Lifetime Achievement Award Honoree.

Key Points: 
  • PORTLAND, Ore., Aug. 01, 2023 (GLOBE NEWSWIRE) -- Exterro today announced that Ariana Tadler, the founding partner of Tadler Law LLP, a WBENC-certified, women-owned boutique law firm that offers an array of litigation and legal counseling services, as the 2023 Honorable Shira Scheindlin Lifetime Achievement Award Honoree.
  • Ms. Tadler will be given the award at The Hero Awards, taking place in New Orleans as part of Exterro’s XChange Conference on September 20th.
  • The evening will see Ms. Tadler recognized as one of the leading women litigators in the country.
  • “Ariana Tadler has been a thought leader in the e-discovery world for more than two decades,” said Judge Scheindlin regarding the selection.

National Minority Quality Forum Urges Policymakers to Ensure Equitable Access to New Respiratory Syncytial Virus Immunizations

Retrieved on: 
Monday, July 24, 2023

Health Equity Action Report shows low-income children of color are at high risk of severe RSV

Key Points: 
  • It is a highly contagious respiratory virus that can result in severe illness, hospitalizations, and in some cases, even death.
  • "RSV is a growing concern for families of young children across the country and like so many other diseases and illnesses, it disproportionately affects minoritized communities," said Dr. Gary Puckrein, President and CEO of National Minority Quality Forum.
  • We feel very strongly that our policymakers should ensure that any future immunizations should be available for free to all families to help reduce disparities."
  • The disparities are a culmination of inadequate health insurance coverage, access to primary care, and lack of culturally competent care.

NFID Names Robert H. Hopkins, Jr., MD, as Medical Director

Retrieved on: 
Thursday, July 20, 2023

BETHESDA, Md., July 20, 2023 /PRNewswire/ -- The National Foundation for Infectious Diseases (NFID) has announced the appointment of Robert H. Hopkins, Jr., MD, as its new medical director.

Key Points: 
  • BETHESDA, Md., July 20, 2023 /PRNewswire/ -- The National Foundation for Infectious Diseases (NFID) has announced the appointment of Robert H. Hopkins, Jr., MD, as its new medical director.
  • Hopkins succeeds William Schaffner, MD, who served NFID for many years and will continue to serve as an NFID spokesperson, lending his expertise to NFID initiatives.
  • As medical director, Hopkins will focus on the growth of NFID programs, including efforts to build vaccine confidence, address health equity issues, increase awareness of disease prevention and treatment, and strengthen NFID partner collaborations.
  • In his role as NFID medical director, Hopkins will also serve as an ex-officio member of the NFID Board of Directors and all Board-level committees.

CSL Seqirus Begins Shipping Portfolio of Innovative Influenza Vaccines for the 2023/24 U.S. Season

Retrieved on: 
Monday, July 17, 2023

CSL Seqirus is the only influenza vaccine manufacturer that offers differentiated vaccine options for individuals six months of age and older.

Key Points: 
  • CSL Seqirus is the only influenza vaccine manufacturer that offers differentiated vaccine options for individuals six months of age and older.
  • CSL Seqirus is the only manufacturer to offer differentiated influenza vaccine options approved for use in individuals six months of age and older.
  • This year's 2023/24 U.S. influenza season portfolio includes:
    There were two real world evidence (RWE) studies conducted by the Marshfield Clinic Research Institute during the 2022/23 Northern Hemisphere season, in which a large majority (84%) of vaccinated participants received FLUCELVAX QUADRIVALENT.
  • For additional information on influenza vaccine options for the upcoming flu season, visit flu360.com.

Quebec’s Heidi Yetman begins her term as President of the Canadian Teachers’ Federation

Retrieved on: 
Friday, July 14, 2023

OTTAWA, July 14, 2023 (GLOBE NEWSWIRE) -- Heidi Yetman, former President of the Quebec Provincial Association of Teachers (QPAT), began her two-year term as President of the Canadian Teachers’ Federation (CTF/FCE ) following the Annual General Meeting in Ottawa.

Key Points: 
  • OTTAWA, July 14, 2023 (GLOBE NEWSWIRE) -- Heidi Yetman, former President of the Quebec Provincial Association of Teachers (QPAT), began her two-year term as President of the Canadian Teachers’ Federation (CTF/FCE ) following the Annual General Meeting in Ottawa.
  • Yetman succeeds outgoing President Sam Hammond.
  • “I am truly humbled to be stepping into Sam Hammond’s shoes as President of the CTF/FCE,” says Heidi.
  • “Sam has been an extraordinary leader and a strong voice for the Federation, and I am honoured and excited to be able to continue the incredible work.