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Moderna Mounts 2 New Patent Lawsuits Against mRNA Rivals Pfizer, BioNTech

Caught in a litigation crossfire, Moderna has reportedly opened two new fronts in its COVID-19 vaccine patent war with Pfizer and BioNTech.Seeking damages from Pfizer and BioNTech for alleged infringement, Moderna has lodged new lawsuits at the High Court in Dublin, Ireland, and the Brussels Commercial Court in Belgium, European intellectual property outlet Juve Patent reported Tuesday. The Irish court, where Moderna is claiming infringement by Pfizer-BioNTech on a pair of Spikevax patents, is set to hear the case in early 2024, according to the publication. Less is known about the status of Moderna’s Belgian lawsuit, Juve points out. A spokesperson for Moderna didn’t immediately respond to a request for comment. The new lawsuits add to a complex web of ongoing mRNA patent litigation. The legal melee began last August when Moderna filed patent infringement lawsuits in the U.S. and Germany. Separately, Moderna has also sued Pfizer and its German partner BioNTech in the Netherlands, plus ...
- Source: drugdu
- 131
- July 13, 2023
UAE, Saudi Arabia Serve as Gateway to International Markets for Biopharma

Biopharma companies, including Sanofi, AbbVie and Virax Biolabs, are finding significant business opportunities in the Middle East, particularly in the United Arab Emirates and Saudi Arabia. These countries have emerged as attractive markets for novel therapies, driven by growing populations with increasing incidences of chronic diseases such as diabetes and cardiovascular diseases. The Middle East is emerging as a key healthcare market, with an increasing demand for innovative healthcare solutions, particularly after the region struggled to meet the challenges brought on by the pandemic, said Cameron Shaw, chief operating officer for Virax Biolabs, which recently made a deal to set up a regional headquarters in the Dubai Science Park in the UAE. “The UAE was hit very hard by the COVID pandemic, similarly to how everyone in the world was affected,” Shaw told BioSpace. This is partly due to the high prevalence of diabetes and obesity in Dubai and Saudi Arabia, he ...
- Source: drugdu
- 151
- July 13, 2023
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
- 138
- 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
- 138
- 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
- 142
- 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
- 120
- 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
- 134
- 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
- 148
- 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
- 140
- July 12, 2023

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