PharmaFocus Today – Page 327 – media

EMA Flags Potential Suicide Risk Tied to Novo’s Ozempic, Saxenda

The European Medicines Agency has identified risks of self-harm and suicidal ideation that could potentially be linked to Novo Nordisk’s medications containing the active ingredients semaglutide and liraglutide. The potential risks were first identified by the Icelandic Medicines Agency, according to a CNN report, citing the EMA. Iceland’s regulator documented one case of suicidal ideation in a patient who had taken the diabetes drug Ozempic (semaglutide) and another after using the weight-loss medicine Saxenda (liraglutide). A third incident involving thoughts of self-harm was also detected in a patient who was receiving Saxenda. The Pharmacovigilance Risk Assessment Committee (PRAC), the EMA’s main group responsible for assessing and monitoring the safety of drug products, has put both treatments under review. The committee is also evaluating whether it will need to extend the review to other products in this drug class, according to CNN. This class, called GLP-1 receptor agonists, include Novo’s Wegovy, Victoza, and Rybelsus, as well as ...
- Source: drugdu
- 140
- July 13, 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
- 144
- July 13, 2023
Medtronic Secures Medicare Coverage for MiniMed 780G Insulin Pump

Dive Brief Medtronic has received Medicare and Medicare Advantage coverage for its recently approved MiniMed 780G insulin pump. The company said on Thursday that it has begun processing orders and will start shipping devices to patients with Type 1 diabetes who meet the eligibility criteria over “the next few weeks.” The coverage clears a barrier to patient access for a pump that is central to Medtronic’s plans to kickstart growth at its diabetes business after a tough period defined by regulatory problems. Dive Insight The U.S. Food and Drug Administration approved the 780G pump in April. Medtronic had aimed to bring the device to the U.S. market sooner, but its plans were delayed by a warning letter, hindering its ability to compete with Insulet and Tandem Diabetes Care in the insulin pump market. With the device now approved for use, Medtronic is working to ensure patients ...
- Source: drugdu
- 151
- July 13, 2023
Bacteria in Kitchen May Not Be as Harmful as You Think

Relative abundance (%) of the 10 most abundant genera/families in the different sample types and countries. The values are based on the average of similar sample types within each country. The number of samples (N) representing each bar is written in parentheses after the sample type. There were no sponges or cloths from Hungary (marked NA in the figure). Bacteria found in 74 kitchens spread among five European countries were mostly harmless according to new research published in Applied and Environmental Microbiology. “We have previously found considerable variations in kitchen standards, food preparation practices, and cleaning regimes between France, Norway, Portugal, Romania and Hungary,” said Birgitte Moen, Ph.D., Scientist—Department of Food Safety and Quality, Nofima—Norwegian Institute of Food, Fisheries and Aquaculture Research, Ås, Norway. In the study, the researchers sampled bacteria populations from sinks, cutting boards, countertops, handles and cleaning utensils—sponges and cloths—used in kitchens. Despite large numbers of species and considerable differences ...
- Source: drugdu
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- July 13, 2023
Unhealthy Drink Consumption Highest Among Economically-Vulnerable Households on Multiple Food Assistance Programs

A long-standing and contentiously debated question is the extent to which US federal food assistance programs contribute to or deter healthy beverage intake. Findings of a new study in the Journal of Nutrition Education and Behavior show that while beverage intake patterns rarely differed between mothers and young children who participated only in the Supplementation Nutrition Program for Women, Infants, and Children (WIC), only the Supplemental Nutrition Assistance Program (SNAP), or neither program, those whose households participated in both programs consumed high amounts of sugar-sweetened beverages (SSBs). Bottled water intake, which is common among communities with high distrust of tap water and can be an economic burden for low-income families, was also common among mothers participating in WIC and SNAP. While both WIC and SNAP aim to improve families’ food security, the programs operate quite differently. WIC benefits allow the purchase of specific foods and beverages and are only available to pregnant and breast-feeding women ...
- Source: drugdu
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- July 13, 2023
Doer Biologics Announces License Agreement with BioNTech

HANGZHOU, China, July 10, 2023 /PRNewswire/ — Zhejiang Doer Biologics Co., Ltd. (“Doer Bio”), a clinical stage biopharmaceutical company developing innovative biotherapeutics for metabolic diseases and cancers, today announced that it has entered into a license agreement with BioNTech SE (Nasdaq: BNTX, “BioNTech”). Under the terms of the agreement, Doer Bio will grant BioNTech a worldwide license to utilize one of Doer Bio’s innovative discoveries to research, develop, manufacture, and commercialize innovative biotherapeutics against an undisclosed target. Doer Bio will receive an upfront payment and will be eligible for potential development, regulatory, and commercial milestone payments. “This license agreement with BioNTech is a great demonstration of the enormous potential of Doer Bio’s platform technologies, which has been well validated by extensive preclinical research and ongoing clinical studies,” said Yanshan Huang, Ph.D., founder and Chief Executive Officer of Doer Bio. “We are thrilled to work with BioNTech, a globally leading biopharmaceutical company, to translate our ...
- Source: drugdu
- 144
- July 12, 2023
FDA Puts Clinical Hold on Hemogenyx’s CAR-T AML Therapy

The FDA has placed a clinical hold on Hemogenyx Pharmaceuticals’ investigational HEMO-CAR-T, which is being trialed for the treatment of acute myeloid leukemia (AML), the UK-based biotech announced Monday. In its full review letter, the FDA pointed to manufacturing problems as the reason for the regulatory pause. In particular, the regulator flagged a “splicing deficiency” that arises during the production of the lentivirus that is used to create the CAR-T cells for Hemogenyx’s candidate, according to the company’s press release. Hemogenyx has already found the source of the splicing issue and has come up with a method to solve it. CEO Vladislav Sandler said in a statement that the company is “confident” that it will “be able to address the FDA’s questions and concerns” regarding HEMO-CAR-T’s Investigational New Drug (IND) application. The company submitted its IND seeking to launch a Phase I trial for HEMO-CAR-T in May 2023. In its letter to Hemogenyx, the ...
- Source: drugdu
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- July 12, 2023
Coloplast to Pay $1.2B Upfront to Buy Fish Skin Wound Care Business Kerecis

Dive Brief Danish medical device maker Coloplast has agreed to buy Iceland-based wound care company Kerecis for $1.2 billion upfront, giving it control of a business that is expected to grow sales by 50% this year, the companies announced Friday. Kerecis sells a wound care product based on fish skin. Launched in 2016, the product drove sales at Kerecis to 510 million Danish kroner ($74.5 million) last year, and more growth is forecast for this year. Coloplast, which will run Kerecis as a standalone business unit, increased its long-term organic growth guidance by one percentage point, bumping the target up to the 8% to 10% range. Dive Insight Coloplast is already a player in the wound care segment. With a portfolio that features the Biatain foam dressing, the Danish medtech company grew wound care sales by 12% in its second quarter. Backorders limited growth in the quarter, ...
- Source: drugdu
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- July 12, 2023
Acute Kidney Injury Does Not Predict Worsening Kidney Function Trajectory in CKD Patients

A study of hospitalized persons with chronic kidney disease (CKD) fournd that acute kidney injury (AKI) did not predict worsening of kidney function trajectory once difference in pre-hospitalization characteristically were fully accounted for. Instead, the authors suggest that much of determinants of faster kidney disease decline observed after AKI may already be present before AKI. The findings are published in Annals of Internal Medicine. Many now believe that AKI is an independent risk factor for accelerated loss of kidney function. This has led to changes in research focus, practice patterns, and public health targets. However, prior studies associating AKI with more rapid subsequent loss of kidney function had methodological limitations, including inadequate control for differences between patients who had AKI and those who did not. Researchers from the University of California, San Francisco and colleagues in the Chronic Renal Insufficiency Cohort (CRIC study) analyzed data from 3,150 persons ...
- Source: drugdu
- 138
- July 12, 2023
Novartis Plans Appeal to Ward Off Entresto Generics

Swiss-based Novartis announced that the US District Court for the District of Delaware has invalidated the patent covering its cardiac drug Entresto, which expires on 15 July 2025 with the associated paediatric exclusivity. The company said it will now appeal to the US Court of Appeals for the Federal Circuit (CAFC) to further pursue the efforts to validate the combination patent around Entresto. A combination of sacubitril and valsartan, Entresto was first approved by the US Food and Drug Administration (FDA) to treat heart failure with reduced ejection fraction in July 2015. It is also approved to treat symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients. Apart from the patent which was adjudicated by the District Court, additional patents for the combinations of sacubitril and valsartan, including the drug forms and dosages, are listed to expire from November 2026 to May 2036. ...
- Source: drugdu
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- July 12, 2023

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