Search Results for “HIV” – Page 21 – media

MSF, trying to secure supplies of ViiV’s Apretude, calls out new clauses in purchasing contract

As GSK’s ViiV Healthcare looks to widen the reach of its HIV franchise, Médecins Sans Frontières (MSF) has been working to secure access to the company’s long-acting HIV prevention drug, Apretude, for more than a year. Now, the organization is airing grievances about the negotiation process with an open letter to ViiV’s executive team. MSF is calling on the company to take out what it says are problematic new amendments to the proposed purchase agreement. Since last June, MSF has been stuck in contract negotiations with ViiV for Apretude, according the letter from Sidney Wong, executive co-director of MSF’s access campaign, and Philip Aruna, team leader for MSF’s southern Africa region. The sides almost reached a deal in December, but ViiV subsequently changed the terms because of supply limitations, Wong and Aruna wrote. Thanks to last-minute edits that deviate from standard MSF purchase agreements, the new contract more closely resembles ...
- Source: drugdu
- 133
- August 19, 2023
Study Shows 82% of Child Deaths in Low-Income Countries Could Be Prevented

Eighty-two percent of child deaths in low-income countries could be prevented, according to a study from the international CHAMPS network published in JAMA Network Open. The study, which used the minimally invasive autopsy technique developed by the Barcelona Institute for Global Health (ISGlobal), found an infectious agent in 87% of cases and identified malnutrition as the most common underlying cause of death. Ninety-nine percent of deaths in children under five years of age occur in low- and middle-income countries. “If we want to prevent these deaths, we need to know the causes, but the problem is that we lack reliable data,” says Quique Bassat, ICREA researcher at ISGlobal, an institution supported by the “la Caixa” Foundation. Clinical data and family or caregiver testimonies (verbal autopsies) are often used to determine the causes in low-resource areas, but they are not detailed enough. In addition, it is important to ...
- Source: drugdu
- 144
- July 28, 2023
GSK Tamps Down Short-Term Expectations for RSV Shot Arexvy, but Still Boosts 2023 Guidance

Expectations are sky high for GSK’s entry this fall into the new respiratory syncytial virus (RSV) vaccine market. The company forecasts peak sales of £3 billion ($3.9 billion) for its shot Arexvy, while Global Data sees the vaccine as the market leader through 2029. But with Arexvy set to launch in the United States later this year, GSK is tamping down the anticipation. On Wednesday, CEO Emma Walmsley said that Arexvy will not hit the ground running as quickly as GSK’s shingles shot Shingrix, which generated £784 million ($1.05 billion) in its first full year on the market (2018). “It won’t be the same rate of build as Shingrix was,” Walmsley said as GSK presented its second-quarter earnings (PDF). “But we do think it is a really key pillar.” The competitive landscape was more favorable for Shingrix to thrive early on, Walmely said. She also noted that the newly established market for ...
- Source: drugdu
- 115
- July 28, 2023
J&J’s Darzalex Stays on its Upward Trajectory as Company Adds $1B to Annual Sales Projection

In 2017, when Genmab CEO Jan van de Winkel declared its multiple myeloma drug Darzalex—which is marketed by Johnson & Johnson—had the potential for peak sales of $13 billion, he relented that it was a best-case scenario.Six years later, that best-case scenario appears possible. On Thursday, J&J reported another quarter of strong sales for the monoclonal antibody. Darzalex generated $2.43 billion in the period, a 22% increase from the second quarter of last year. After realizing sales of $6 billion in 2021 and $8 billion last year, Darzalex is on track to approach revenue of $10 billion in 2023. The drug, which was approved in 2015, was boosted in 2020 with the development of Darzalex Faspro, a subcutaneous version of the treatment which allows patients to receive doses in minutes compared to hours for the previous intravenous administration. A year ago, J&J reported that 85% of patients receiving Darzalex were using Faspro. ...
- Source: drugdu
- 116
- July 24, 2023
J&J Exceeds Q2 Expectations, Oncology and Immunology Top Pharma Drivers

Pictured: Johnson & Johnson Sign in Silicon Valley/Shutterstock, Michael Vi Johnson & Johnson exceeded Wall Street expectations in its second quarter performance. The healthcare products giant posted sales of $25.5 billion in its earnings report on Thursday. Worldwide sales numbers reflected a 6.3% growth for J&J with revenue close to $1 billion higher than analysts expected, thanks in particular to a nearly 10% increase in its medtech sales. Medtech has been on the rebound since patients have returned to non-emergent surgeries like knee and hip replacements, which saw a significant drop during the pandemic. Operational sales for the company’s pharma arm, suffering growth points due to dwindling COVID-19 vaccine sales, was up 3.9%. The second quarter posted no U.S. sales of J&J’s COVID vaccine, with no domestic revenue expected beyond the $747 million from outside the U.S. reported last quarter. Its government contracts are now complete. Primary growth drivers were J&J’s oncology and immunology ...
- Source: drugdu
- 111
- July 24, 2023
Citius Seeks Approval for I/ONTAK Ahead of Spin-Off Plans

Citius Pharmaceuticals is planning to spin out its immune asset I/ONTAK into a separate publicly-traded entity, pending the FDA’s verdict on the candidate, due July 28. I/ONTAK, which Citius is proposing as a treatment for T-cell lymphoma, is a reformulation of Eisai’s Ontak (denileukin diftitox), which won initial approval in 1999 for the same indication. Citius’ candidate is a recombinant fusion protein that combines a diphtheria toxin with the interleukin-2 protein. It works by specifically binding to IL-2 receptors to precisely deliver its toxic payload, thereby preventing protein synthesis in malignant T cells. I/ONTAK also targets the immunosuppressive regulatory T cells, which in turn allows the body to produce a stronger immune response against the cancer. The therapeutic fusion protein is approved in Japan, where it is marketed under the brand name Lymphir. The FDA accepted Citius’ Biologics License Application for I/ONTAK in December 2022 and initially gave it a target action ...
- Source: drugdu
- 100
- July 19, 2023
Prevalence of atopic diseases increased in sexually diverse individuals

The prevalence of atopic diseases, including atopic dermatitis, is increased in sexually diverse people, including those who identify as lesbian, gay, or bisexual, according to a research letter published online July 12 in JAMA Dermatology. Katelyn J. Rypka, from the University of Minnesota Medical School in Minneapolis, and colleagues calculated crude and multivariable-adjusted odd ratios for prevalence of atopic dermatitis, asthma, and allergic rhinitis comparing heterosexual and sexually diverse individuals. Data were included for 27,012 respondents to the 2021 National Health Interview Survey, of whom 25,701 were heterosexual and 1,311 were sexually diverse. The researchers found that sexually diverse individuals were more likely to report atopic dermatitis (11.1 versus 7.2 percent), asthma (12.0 versus 7.8 percent), and allergic rhinitis (33.7 versus 25.6 percent) compared with heterosexual individuals (adjusted odds ratios, 1.49, 1.39, and 1.30, respectively). In sex-stratified analyses, results were similar. “This study found higher rates of atopic disease among sexually diverse ...
- Source: drugdu
- 127
- July 15, 2023
Bruker Launches Portable MOBILE-IR II Spectrometer to Bring Laboratory-Grade FT-IR Analysis to the Field

Bruker Optics announces the launch of the MOBILE-IR II – a portable, battery-powered Fourier Transform Infrared (FT-IR) spectrometer that delivers the high spectral performance of a laboratory benchtop system. This powerful mobile spectrometer will enable users worldwide to bring routine and advanced FT-IR applications to the field. The MOBILE-IR II is intended to “mobilize” established use-cases of FT-IR spectroscopy, and also to enable new applications that demand mobility, flexibility, and spectral performance. Key application examples include the identification of illegal substances during police or border control operations, the characterization of recycled goods for sorting, the use in warehouses for mobile incoming goods inspection, or in mobile laboratories for the exploration of natural resources. Its IP65-class protection makes the MOBILE-IR II waterproof, dustproof and stable for field applications. A built-in battery powers the device during off-grid operations and safeguards it against power blackouts. The additional IP67 carry-case makes it ...
- Source: drugdu
- 136
- July 13, 2023
Cipla Pulls 6 Batches of Asthma Med Albuterol After Inhaler Leak Complaint

Cipla, which was recently hit with a 23-page Form 483 filing from the FDA, is adding to the albuterol supply strain with a U.S. recall of six batches of the asthma med.The company’s voluntary recall of albuterol sulfate inhalation aerosol is a result of a container defect, Cipla said in a filing with the Bombay Stock Exchange. Specifically, a market complaint flagged leakage in one inhaler, the company said. The leak was spotted in the inhaler valve, leading Cipla to pull all of the lots of the drug that used that same batch of valves from U.S. shelves. The company made the move “out of an abundance of caution,” it noted in the release. The lots were manufactured in November of 2021 and expire this November. “Cipla maintains stringent quality processes to assess quality defects and safety issues,” the company said in the filing. “Cipla conducts regular investigation and assessment by committees consisting ...
- Source: drugdu
- 141
- July 11, 2023
Global efforts to reduce infectious diseases must include older children and adolescents

Global efforts to reduce infectious disease rates must have a greater focus on older children and adolescents after a shift in disease burden onto this demographic, according to a new study. The research, led by Murdoch Children’s Research Institute and the Institute for Health Metrics and Evaluation, has found that infectious disease control has largely focused on children aged under five, with scarce attention on young people between five and 24 years old. Published in The Lancet, the study found three million children and adolescents die from infectious diseases every year, equivalent to one death every 10 seconds. It looked at data across 204 countries between 1990 and 2019 from birth to 24 years of age. Diarrhea, pneumonia and malaria account for two-thirds of infectious diseases and death among children and adolescents. HIV and tuberculosis were the leading causes among older adolescents. The shift in infectious disease burden from young ...
- Source: drugdu
- 101
- July 6, 2023

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