PharmaFocus Today – Page 339 – media

AstraZeneca decries low kidney disease diagnosis rates, finds ‘urgent need’ for better screening

Chronic kidney disease (CKD) affects around 37 million Americans, but this disease, which does not get the attention other conditions often do, can go undetected for years, boosting the risks of organ failure and even death.AstraZeneca, maker of blockbuster diabetes drug Farxiga that recently nabbed an expanded label in CKD, wants more to be done to find those who have this disease. The pharma cited new, real-world evidence that shows the prevalence of undiagnosed stage 3—moderate—CKD is 85% to 97% across Australia, Brazil, Canada and Spain. The study was shared this month at the European Renal Association 2023 Congress in Milan, Italy. This is a “staggeringly low rate” of diagnosis in CKD, according to an accompanying release from AstraZeneca, with these data showing “that an urgent need exists for improved screening.” Improved screening can lead to earlier diagnosis and thus potentially better outcomes, given that once kidney damage sets in ...
- Source: drugdu
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- June 28, 2023
Generics to Novartis’ leukemia drug Tasigna to reach poor countries under 4 MPP licenses

More than a year ago, eight pharma giants partnered to provide cancer medicines to many of the world’s most needy nations where oncology treatments often are non-existent.On Thursday, the effort took a major step toward fruition as the United Nations-backed Medicines Patent Pool (MPP) signed up four generic drugmakers to produce copycat versions of Novartis’ myeloid leukemia blockbuster Tasigna (nilotinib). The agreement allows BrightGene of Indonesia and three Indian manufacturers—Dr. Reddy’s, Eugia and Hetero—to produce generic nilotinib, even though it remains on patent in the U.S. The generic companies plan to make their copycats in six countries—Egypt, Guatamala, Morocco, Pakistan, the Philippines and Tunisia—and supply it to 44 territories. “We have seen great gains in cancer survival in the richest countries over the last decade, however, the benefit of our innovation is not reaching everyone,” Lutz Hagemann, Novartis’ president of global health and sustainability, said in a release. “Through public-private ...
- Source: drugdu
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- June 28, 2023
Jazz brings the noise to the FDA with lawsuit over approval of Avadel’s narcolepsy drug Lumryz

After years of using the patent system to delay competition from a rival company and then exhausting that ploy early this year, Jazz Pharmaceuticals is taking a new route—suing the FDA.Jazz is challenging the regulator for approving Avadel Pharmaceuticals’ narcolepsy drug Lumryz, which poses a major threat to Jazz’s blockbuster Xyrem/Xywav franchise. In U.S. district court in Washington, D.C., Jazz claimed that the green light for Lumryz—which was awarded on May 1—was “unlawful.” The Dublin company says that the approval violated the orphan drug exclusivity (ODE) the agency granted to Xywav in 2021. In awarding Lumryz its own ODE, the FDA ruled that Lumryz is superior to Jazz’s offerings, citing its ability to make a major contribution to patient care based on its convenience and additional clinical benefit. While Lumryz is taken once a night, Xywav requires two doses. Both are oral suspension drugs. Jazz maintains that the FDA acted ...
- Source: drugdu
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- June 28, 2023
Patients affected by depression more likely to stop taking their heart medications

Patients who feel low when having a cardiac device implanted are more likely to stop taking their heart medications than those without depression, according to research presented today at ACNAP 2023, a scientific congress of the European Society of Cardiology (ESC). Study author Mr. Ole Skov, a psychologist and PhD student in cardiac psychology at the University of Southern Denmark, Odense, Denmark said: “Medications help to control symptoms and prevent further heart problems so adherence is important. Patients with an implantable cardioverter defibrillator (ICD) who feel depressed or anxious should be encouraged to express their concerns, thoughts, and feelings and contact a health care professional who can screen them for distress to explore the best course of action. This could be referral to a psychologist or other measures.” An ICD implantation is recommended for people at high risk of a life-threatening arrhythmia and for those who have had a sudden ...
- Source: drugdu
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- June 27, 2023
Using deep learning algorithm for automated detection of occlusal caries

A diagnostic study on the detection of occlusal caries from a clinical photograph using a deep learning algorithm will be presented at the 101st General Session of the IADR, which will be held in conjunction with the 9th Meeting of the Latin American Region and the 12th World Congress on Preventive Dentistry on June 21-24, 2023, in Bogotá, Colombia. The Interactive Talk presentation, “Automated Detection of Occlusal Caries Using Deep Learning Algorithm,” will take place on Saturday, June 24 at 4:25 p.m. Colombia Time (UTC-05:00) during the “Prevalence of Health Conditions and Risk Factors” session. The study by Chukwuebuka Elozona Ogwo of Temple University, Philadelphia, PA, USA sought to determine the accuracy, precision, and sensitivity of the YOLOv7 object detection algorithm in occlusal caries detection from clinical photographs and (2) develop software for occlusal caries detection. Only consenting adults (>=18 years old) with permanent dentition receiving care at the Temple ...
- Source: drugdu
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- June 27, 2023
New Orleans infection preventionists adapt adult protocols to reduce infections in babies

Facing persistent cases of hospital-onset Methicillin-resistant Staphylococcus aureus (MRSA) during the pandemic, the infection prevention and control (IPC) team at Children’s Hospital New Orleans developed an inexpensive nasal decolonization regimen previously used only in their adult patients that decreased rates of MRSA by 50 percent. Their results are being presented at the Association for Professionals in Infection Control and Epidemiology’s (APIC’s) Annual Conference in Orlando Florida, June 26-28. Without a lot of scientific literature on nasal decolonization in the pediatric population to guide them, Infection Preventionist Jennifer Schroeder, MPH, CIC, and colleagues designed two nasal decolonization protocols to fit their patient population—one for children younger than two, and the other for children older than two. The intervention took place in the hospital’s critical care units because most of the MRSA was occurring there. The team swabbed the nostrils of patients admitted to their cardiac intensive care unit, neonatal intensive care ...
- Source: drugdu
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Initiative helps neurosurgical infections drop more than 80% in two years at Pittsburgh hospital

When excess surgical site infections (SSIs) were detected among neurosurgery patients at University of Pittsburgh Medical Center (UPMC) Mercy in 2019, infection preventionist Katie Palladino, MPH, CPH, CIC, partnered with a hospital neurosurgeon on a multidisciplinary quality and process improvement initiative that led to a steep drop in infection rates over a two-year period. Their successful initiative is being presented at the Association for Professionals in Infection Control and Epidemiology’s (APIC’s) Annual Conference in Orlando Florida, June 26-28. Palladino and the surgeon began the initiative by reviewing the path of a surgical patient—from the first pre-op meeting to the surgery, to the patient’s discharge from the hospital—observing practices and looking for opportunities where infections could arise. They also reviewed pre-surgical instructions for patients and found ways to improve information about chlorhexidine gluconate (CHG) bathing, nasal decolonization, and other important infection prevention practices. The next step was a literature review of ...
- Source: drugdu
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- June 27, 2023
Biotech AltPep scores around $53m in Series B funding round

US-based amyloid diseases treatment solutions developer AltPep has raised $52.9m in its Series B investment round led by Senator Investment Group. Former investors such as Matrix Capital Management Company and Alexandria Venture Investments, who took part in the firm’s Series A round, joined the latest fundraise along with new backers. The new investors in Series B include Eli Lilly and Company, Partners Investment, and Section 32. As part of the deal, Senator Investment Group’s Rohit Vanjani will join the AltPep board. Besides, Lilly’s senior vice president and chief scientific officer for Neurobiologicals Ronald DeMattos will become a member of the Scientific Advisory Board at AltPep. Vanjani noted: “We believe AltPep is in an excellent position to optimise the value of its unique technology. “With scientific application for both therapeutics and diagnostics in a wide range of amyloid diseases, the potential for the company’s pipeline is vast and extremely promising.” The ...
- Source: drugdu
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- June 27, 2023
Intercept restructures as Ocaliva’s NASH hopes dashed again with FDA rejection

Even after a second application attempt, Intercept’s Ocaliva wasn’t the fatty liver disease breakthrough that the company had hoped it would be. Three years after an initial rejection, the FDA once again turned down Ocaliva, or obeticholic acid, for nonalcoholic steatohepatitis (NASH) patients with stage 2 or 3 liver fibrosis, Intercept said Thursday. The denial means patients with NASH will have to wait longer for the first FDA-approved therapy and that a market estimated to be worth multiple billions of dollars still awaits a winner. For Intercept, it also means it’s time for a new direction. Intercept has decided to discontinue all NASH-related investment and restructure its operations, with the goal to save about $140 million in operating costs, the company said Friday. Measures it’s taking include winding down a long-term patient outcomes follow-up of the phase 3 REGENERATE study for Ocaliva in NASH. All R&D, commercial, medical affairs and ...
- Source: drugdu
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- June 27, 2023
Amgen’s supplemental Biologics License Application for Blincyto approved by FDA

Amgen has announced the full approval by the US Food and Drug Administration (FDA) of the supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab). Blincyto is used to treat adults and children with CD19-positive B-cell precursor acute lymphoblastic leukaemia (B-ALL), who are in their first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. Approved after additional data was submitted from two phase 3 studies, Blincyto’s accelerated approval is now a full approval. David Reese, executive vice president of research and development at Amgen commented that the treatment was “the first FDA-approved CD19-directed CD3 T-cell engager BiTE immunotherapy, and the first to be FDA-approved for MRD in 2018″. He added that the “full approval underscores the clinical benefit of Blincyto for people living with B-ALL”. Blincyto is a bispecific T-cell engager (BiTE) immune-oncology therapy that targets CD19 surface antigens on B cells. Helping the ...
- Source: drugdu
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- June 27, 2023

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