PharmaFocus Today – Page 312 – media

GSK’s Jemperli Beats Merck’s Keytruda for Frontline Endometrial Cancer Approval

By Tristan Manalac The FDA has approved GSK’s Jemperli (dostarlimab-gxly) for the treatment of primary advanced or recurrent endometrial cancer, the company announced Monday. The label expansion covers a combination regimen of Jemperli, carboplatin and paclitaxel, followed by Jemperli as a single agent. Monday’s approval also only applies to patients who are mismatch repair deficient (dMMR), as confirmed by an FDA-approved test, or who have high microsatellite instability (MSI-H). Jemperli is the first immuno-oncology treatment and PD-1 inhibitor to be authorized for frontline use in this patient population, according to GSK. The expanded approval “redefines the treatment landscape for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer,” for whom chemotherapy alone has been the standard of care, though many patients still see disease progression, Hesham Abdullah, GSK’s senior vice president and global head of oncology development, said in a statement. Jemperli is an anti-PD-1 antibody that was first approved ...
- Source: drugdu
- 135
- August 3, 2023
New study finds vaccines could avert 500,000 antimicrobial resistance deaths each year

A new study published in BMJ Global Health has revealed that over 500,000 deaths associated with antimicrobial resistance (AMR) could be averted each year with the effective use of existing vaccines and continued development of new vaccines to tackle priority pathogens. The modelling study, Global and regional burden of attributable and associated bacterial antimicrobial resistance avertable by vaccination, was carried out by the World Health Organization (WHO), the International Vaccine Institute, Korea (IVI) and the London School of Hygiene and Tropical Medicine. AMR occurs when bacteria, viruses, fungi and parasites change over time and become resistant to medicines. The condition has been declared by WHO as one of the top ten global threats to global public health, associated with around 4.95 million deaths globally per year. Science has been playing catch-up to mitigate AMR due to the strain that was faced by health systems worldwide throughout the COVID-19 pandemic. Using ...
- Source: drugdu
- 130
- August 3, 2023
As COVID revenues disappoint, once-high-flying Pfizer looks at possible cost cuts

As COVID-19 revenues ebb and flow—but mostly ebb—Pfizer is eyeing the cost-cutting shears. “Clearly, there is a higher level of uncertainty regarding the demand projections for our COVID-19 products than for the rest of our business,” Pfizer chief Albert Bourla, Ph.D., admitted on a conference call Tuesday. While the shift to a traditional commercial market for Paxlovid and Comirnaty could help, a veil of uncertainty persists. In turn, “we are also preparing to have the ability to adjust our 2024 total cost base” to align with future COVID needs, the CEO added. “In fact, we have already identified specific areas where we can make adjustments primarily within our COVID-19 cost base,” he said. Paxlovid generated just $143 million in worldwide sales for the second quarter, down 98% from the $8.1 billion it pulled down over the same stretch in 2022. MRNA vaccine Comirnaty, for its part, brought home $1.4 billion, ...
- Source: drugdu
- 177
- August 3, 2023
US DoD backs potential treatment for Fragile X-linked neurodegenerative disorder

The US Department of Defense (DoD) has awarded PureTech Health $11.4m to help target Fragile X-associated tremor/ataxia syndrome (FXTAS), a late-onset neurological condition that is difficult to diagnose and currently has no effective treatments. Based in Massachusetts, US, Puretech Health will use the funds to advance LYT-300 in a Phase II trial. LYT-300 is an oral prodrug of allopregnanolone, which is known to regulate mood via its positive allosteric modulation of gamma-aminobutyric-acid type A (GABAA) receptors. It is already approved by the US Food and Drug Administration (FDA) as an infusion treatment for postpartum depression. PureTech Health said administration limitations have previously restricted the wider use of the neurosteroid. Developed using the company’s Glyph platform that harnesses natural lipid absorption and transport processes, LYT-300 can be orally administered. FXTAS occurs in premutation carriers of Fragile X Syndrome. Estimates suggest that 30%-40% of male carriers, and 8%-16% of premutation carriers will ...
- Source: drugdu
- 108
- August 3, 2023
Neuraxpham gears up to market TG’s relapsing MS treatment Briumvi in Europe

TG Therapeutics has signed an ex-US commercialisation agreement with Neuraxpham Group to launch its multiple sclerosis treatment Briumvi (ublituximab) in Europe. Briumvi is an anti-CD20 monoclonal antibody that has been approved in the US and European Union (EU) for relapsing forms of multiple sclerosis (RMS). Following the agreement, Neuraxpharm will also seek approvals in the UK and Switzerland. As per the agreement, TG will receive a $140m upfront payment followed by an additional $12.5m after the launch of Briumvi in the first EU country. Additional milestone-based payments of up to $492.5m are based on certain launch and commercial milestones. The deal news came on the same day as the company’s Q2 financial results. Following both announcements, there was a 42.5% decline in TG’s stock price at market open today, compared to the market close yesterday. In the Q2 earnings, TG Therapeutics reported he a loss of $86.8m and $47.6m for ...
- Source: drugdu
- 206
- August 3, 2023
Integra warns impact of plant closure will continue into 2024, with delays possible

Dive Brief Integra LifeSciences is aiming to restart manufacturing at its Boston tissue product plant in the fourth quarter and resume commercial sales in the second quarter of next year, CEO Jan De Witte said in a Thursday earnings call. The forecast, which follows the recall of all devices made at the plant over the past five years, confirms that the problem will continue to drag on Integra’s results into next year. Further delays are possible. Integra expects the quality situation to wipe $60 million from its revenues this year, and predicts that it will take another $50 million sales hit next year. Dive Insight Integra disclosed the problems at its Boston plant in May. After discovering endotoxin testing deviations, the company recalled SurgiMend collagen matrix and other tissue devices made over a five-year period. Integra lowered its second quarter revenue forecast by $24 million and told ...
- Source: drugdu
- 152
- August 2, 2023
Non-profit receives FDA approval to supply cheaper OTC naloxone

The US Food and Drug Administration (FDA) approved the second over-the-counter (OTC) naloxone nasal spray product, RiVive (3mg) by non-profit pharmaceutical company Harm Reduction Therapeutics, for the emergency treatment of known or suspected opioid overdose. This approval follows the agency’s approval of Emergent BioSolutions’ Narcan in March 2023, as the agency has recently increased efforts to address the opioid crisis. The FDA also approved the first generic non-prescription naloxone drug in July 2023. Naloxone reverses opioid overdoses by blocking opioid receptors, thus preventing the drugs’ addictive effects. Harm Reduction Therapeutics has announced that the drug will be available by early 2024 and be primarily supplied to state governments and US harm organisations at “costs lower than other opioid antagonist nasal sprays”. The US-based non-profit organisation has said that the first 200,000 doses (10% of projected initial annual product production) of RiVive will be available free of charge. ...
- Source: drugdu
- 138
- August 2, 2023
Searchlight licenses Mithra’s menopause drug Donesta for Canadian market

Mithra Pharmaceuticals and Searchlight Pharma have entered a licensing agreement for Donesta, an investigational drug for treating menopausal symptoms. The agreement grants Searchlight exclusive sales and marketing rights in Canada. As per the agreement, Searchlight is responsible for regulatory approval of Donesta in Canada while Mithra would be entitled to licensing fees, Canadian sales royalties, and milestone-based payments totalling up to €17.05m ($18.8m). Donesta is an orally administered estetrol (E4) hormone therapy that targets nuclear estrogen receptor alpha (ERα) and can potentially avoid the common side effects associated with hormonal therapies. Mithra’s first estertrol (E4) therapy was a combination therapy Estelle (15mg estetrol and 3mg drospirenone), which is currently marketed in the US, Canada, and Europe. The data from the two multicentre, randomised Phase III trials (C301 – NCT04209543, and C302 – NCT04090957) evaluating Donesta, demonstrated a reduction in vasomotor symptoms from baseline and compared ...
- Source: drugdu
- 251
- August 2, 2023
GSK beats Merck to first PD-1 approval in newly diagnosed endometrial cancer

GSK has won the first FDA approval for an immunotherapy to treat certain patients with newly diagnosed endometrial cancer. But the industry-first go-ahead is tempered with a label limitation. The FDA has cleared Jemperli as an add-on to chemotherapy for patients with primary advanced or recurrent endometrial cancer, GSK said Monday. To be eligible for the therapy, the patient’s tumor must be mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H), both terms that describe a type of genetic abormality. The approval comes nearly two months ahead of schedule and puts Jemperli ahead of Merck & Co.’s rival PD-1 inhibitor Keytruda, which is also gunning for the first-line endometrial cancer use. But the dMMR/MSI-H restriction comes as a bit of a disappointment for the GSK drug. By GSK’s estimate, about 15% to 20% of the roughly 60,000 new cases of endometrial cancer each year in the U.S. will be diagnosed at an advanced ...
- Source: drugdu
- 116
- August 2, 2023
Human senescent fibroblasts trigger fibrogenic reaction in the lungs of immunodeficient mice

A new research paper was published on the cover of Aging (listed by MEDLINE/PubMed as “Aging (Albany NY)” and “Aging-US” by Web of Science) Volume 15, Issue 14, entitled, “Human senescent fibroblasts trigger progressive lung fibrosis in mice.” Cell senescence has recently emerged as a potentially relevant pathogenic mechanism in fibrosing interstitial lung diseases (f-ILDs), particularly in idiopathic pulmonary fibrosis. In a new study, researchers Fernanda Hernandez-Gonzalez, Neus Prats, Valentina Ramponi, José Alberto López-Domínguez, Kathleen Meyer, Mònica Aguilera, María Isabel Muñoz Martín, Daniel Martínez, Alvar Agusti, Rosa Faner, Jacobo Sellarés, Federico Pietrocola, and Manuel Serrano from Hospital Clinic Barcelona, The Barcelona Institute of Science and Technology (BIST), Instituto de Investigaciones Biomédicas August Pi i Sunyer (IDIBAPS), Centro de Investigación Biomédica en Red Enfermedades Respiratorias (CIBERES), University of Barcelona, Karolinska Institute, Catalan Institution for Research and Advanced Studies (ICREA), and Altos Labs hypothesized that senescent human fibroblasts may suffice to ...
- Source: drugdu
- 168
- August 2, 2023

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