PharmaFocus Today – Page 343 – media

77.4% ORR! Abbisko to present the updated clinical phase Ib data of Pimicotinib (ABSK021) at the 2023 ASCO Annual Meeting

SHANGHAI, May 28, 2023 /PRNewswire/ — Abbisko Therapeutics Co., Ltd. (“Abbisko Therapeutics” hereafter) today announced that the updated results of Phase Ib study of its CSF-1R inhibitor Pimicotinib (ABSK021) in treating patients with advanced tenosynovial giant cell tumor (“TGCT”), will be released at the 2023 American Society of Clinical Oncology (“ASCO”) annual meeting to be held in Chicago, USA from June 2 to June 6, 2023. The data demonstrates the excellent antitumor efficacy and the safety profile of Pimicotinib in the treatment of patients with advanced TGCT and will be presented with the title of “EFFICACY AND SAFETY PROFILE OF PIMICOTINIB (ABSK021) IN TENOSYNOVIAL GIANT CELL TUMOR (TGCT): PHASE 1B UPDATE” in a poster presentation with the poster Bd# of “493”. Among the data released by Abbisko, the most remarkable result is the objective response rate (ORR) of the 50 mg QD dose group of Pimicotinib (ABSK021), which reached 77.4% ...
- Source: drugdu
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- May 31, 2023
US and Mexico sound alarm over cosmetic surgery-linked fungal outbreak

IMAGE SOURCE,ABRAHAM PINEDA Image caption, Mexican authorities shut one of two clinics linked to the fungal outbreak By Laura Gozzi BBC News US and Mexican authorities are urging the World Health Organization (WHO) to declare a public health emergency over a fungal outbreak linked to cosmetic operations in Mexico. The Centers for Disease Control and Prevention (CDC) said two people who got surgeries involving epidural anaesthesia have died of meningitis. Almost 400 people in the US and Mexico are being monitored. Two cosmetic clinics in the Mexican city of Matamoros have been shut. Authorities in both the US and Mexico have urged people who had surgeries involving epidural anaesthesia at either the River Side Surgical Center or Clinica K-3 since January to get evaluated, even if they are currently asymptomatic. The CDC said it had already identified 25 people in the US with “suspected” or “probable” cases of fungal meningitis. ...
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- May 31, 2023
Marinus Pharmaceuticals gets positive opinion for ZTALMY from CHMP

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of Marinus Pharmaceuticals’ ZTALMY (ganaxolone) oral suspension. This recommendation is for ZTALMY to serve as the adjunctive treatment of epileptic seizures related with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients two to 17 years of age. ZTALMY may be continued in those patients who are aged 18 years and more. A serious and rare genetic disorder, CDKL5 deficiency disorder (CDD) is characterised by early‑onset, difficult‑to‑control seizures besides severe neuro‑developmental impairment. Marinus chairman and CEO Scott Braunstein said: “The CHMP’s positive opinion reinforces the safety and efficacy profile of ZTALMY and is a testament to the tireless efforts and dedication of our team and the CDD community. “This recommendation brings us one step closer to addressing a significant unmet need for CDD patients with treatment-resistant seizures ...
- Source: drugdu
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- May 31, 2023
While Pfizer, BioNTech agree to cut COVID vaccine supply to Europe, Moderna sets up shop in China

With demand plummeting for COVID-19 vaccinations, the EU has cut a deal with Pfizer and BioNTech to alter their contract, reducing purchases of the companies’ Comirnaty vaccine by roughly 35%, EU sources told Bloomberg. The companies provided little information on the adjusted contract, calling it a “rephrasing of delivery doses annually through 2026,” in a release. “The agreement includes an aggregate volume reduction, providing additional flexibility for EU Member States,” the companies wrote. “The EC [European Commission] will maintain access to future adapted COVID-19 vaccines and the ability to donate doses.” Some member states opted out of the deal, according to a statement from the EU. Meanwhile, the world’s other premier producer of COVID-19 vaccines, Moderna, is looking to advance sales of its mRNA shot in China, as it has established a unit called Moderna Biotech Ltd. in Shanghai, Reuters reports. Moderna CEO Stephane Bancel visited Shanghai last month, according ...
- Source: drugdu
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- May 31, 2023
Gilead, Teva reach 11th-hour settlements with some groups in HIV antitrust case

Right before opening arguments were set to begin in Gilead Sciences and Teva’s HIV antitrust trial, the two came to a last-minute settlement with some of the plaintiff groups. Both companies settled with the pharmacy plaintiffs, a group that includes CVS Pharmacy, Rite Aid and Walgreens, while Gilead made a deal with the direct purchasers. Now, indirect purchasers and others involved in the suit can take their claims to a California federal jury. Gilead and Teva confirmed the settlements, and Gilead noted that the lawsuit with the other parties is ongoing. “The claims against Gilead in this lawsuit lack merit, do not accurately reflect antitrust laws, and ignore Gilead’s history of innovation and scientific advancements to help address the pressing challenges of the HIV epidemic,” a Gilead spokesperson said over email. The deals mark an eleventh hour end to a sprawling case that dates back to 2019, when plaintiffs including ...
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Type 2 diabetes patients who were physically active in the afternoon have greater reductions in blood sugar

Over 37 million Americans have diabetes, and 90-95% of that population are diagnosed with type 2 diabetes. Lifestyle interventions, such as a healthy diet and a regular physical activity program, are methods to manage diabetes. A new study from a collaboration of investigators at Brigham and Women’s Hospital, a founding member of the Mass General Brigham healthcare system, and Joslin Diabetes Center, part of Beth Israel Lahey Health, uses data from the Look AHEAD (Action for Health in Diabetes) study, a randomized controlled trial that compared an intensive lifestyle intervention with diabetes support and education in patients diagnosed with type 2 diabetes and overweight or obesity to track the development of cardiovascular disease over time. In the current study, the research team assessed whether physical activity at certain times of day was associated with greater improvement in blood glucose control. Their findings suggest patients with type 2 diabetes who were ...
- Source: drugdu
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- May 30, 2023
Restoring thought-controlled movement after spinal cord injury using a brain-computer interface

ONWARD Medical N.V., the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announces a publication in Nature showing that a wireless brain-computer interface (BCI) can use thought to modulate ARC Therapy. Researchers reported that when paired with ARC Therapy, an implanted BCI allowed an individual to gain augmented control over when and how he moved his paralyzed legs. Dave Marver (CEO of ONWARD) said, “This publication shows the remarkable potential of ARC Therapy to be enhanced with the introduction of a BCI, facilitating more natural movement based on the thoughts of a person living with paralysis. We have positioned ONWARD as a leader in the BCI field with our unique understanding of spinal cord stimulation for people with SCI.” As a neuroscientist and professor, EPFL, and Co-author of the Nature Paper, Grégoire Courtine said, “The ...
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Social vulnerability tied to higher assault-related firearm death rates for youth

States with restrictive gun laws have lower rates of assault-related firearm deaths among youths, but youths from socially vulnerable communities are disproportionately impacted across the spectrum of state gun laws, according to a study published online May 24 in JAMA Network Open. Eustina G. Kwon, M.D., M.P.H., from Seattle Children’s Hospital, and colleagues assessed the rate of death due to assault-related firearm injury by community-level social vulnerability and state-level gun laws. The Gun Violence Archive was used to identify all 5,813 assault-related firearm deaths among U.S. youths (aged 10 to 19 years) between Jan. 1, 2020, and June 30, 2022. The researchers found that the death rate in the low social vulnerability index (SVI) cohort was 1.2 per 100,000 person-years versus 2.5 in the moderate SVI cohort, 5.2 in the high SVI cohort, and 13.3 in the very high SVI cohort. Comparing the very high to the low SVI cohort, ...
- Source: drugdu
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- May 30, 2023
European Commission to receive fewer Pfizer-BioNTech vaccine doses under amended contract

Nicole DeFeudis Editor The European Commission has made a few changes to its vaccine contract with Pfizer and BioNTech, reducing the dose volume while extending the delivery timeline to cope with “evolving public health needs.” The Commission previously struck a contract in May 2021 for 900 million doses, with the option to purchase another 900 million. Of those, 450 million were expected to be delivered in 2023, though an amendment now calls for fewer doses. While neither the Commission nor Pfizer and BioNTech have revealed an exact amount, an unnamed source told Reuters that the amendment reduces the remaining expected doses by about a third. Some member states have opted out of the amendment, and “will continue to be bound by current contractual obligations,” the Commission said. The news comes weeks after the World Health Organization ended its three-year global health emergency for Covid-19, while warning that “the virus is ...
- Source: drugdu
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- May 30, 2023
VarmX raises funds to seek IND approval for VMX-C001

Biotechnology company VarmX has raised an additional €30m in a Series B2 financing round to obtain investigational new drug (IND) approval for its lead compound VMX-C001. VMX-C001 is a modified recombinant human blood clotting factor X that enables patients taking direct oral anticoagulant blood thinners to undergo emergency surgery without the risk of bleeding. It also enables blood to clot normally in the presence of factor Xa blood clotting inhibitors. VarmX also intends to use the financing to complete preparations for the pivotal clinical trial including large scale manufacturing. The company’s first-in-human study will demonstrate the safety of VMX-C001 and provide clinical proof of concept. Enrolment for this study is completed. Full study results are expected to be announced later this year. Led by Sound Bioventures, the Series B2 financing round has also seen participation from another new investor, the European Innovation Council (EIC) Fund. Existing investors include EQT Life ...
- Source: drugdu
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- May 30, 2023

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