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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
- 116
- 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
- 131
- 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
- 130
- 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
- 138
- 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
- 130
- 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
- 258
- July 12, 2023
Novavax’s COVID-19 Vaccine Granted Full Marketing Authorisation in EU

Novavax has announced that its COVID-19 vaccine, Nuvaxovid, has been granted full marketing authorisation in the EU. The vaccine is now fully authorised for use as a primary series in individuals aged 12 and older for COVID-19 prevention and as a booster dose in adults aged 18 and older, the company said. Novavax’s protein-based vaccine, which was originally granted a conditional marketing authorisation in the EU for these indications, contains the SARS-CoV-2 spike protein and Matrix-M adjuvant to enhance immune response and stimulate high levels of neutralising antibodies. The European Commission’s latest decision follows a recommendation by the European Medicines Agency’s human medicines committee earlier this year and is supported by positive results from the phase 3 PREVENT trial that evaluated the safety, immunogenicity, and efficacy of Nuvaxovid. John Jacobs, president and chief executive officer of Novavax, said: “This marketing authorisation establishes the foundation for all ...
- Source: drugdu
- 194
- July 12, 2023
Novartis Pledges to Appeal After Delaware Court Nixes Patent on Big-Selling Entresto

After a Delaware federal court ruled a Novartis combination patent on big-selling cardiovascular drug Entresto is invalid, the company pledged to continue its efforts to block generics with an appeal. The combination patent, which includes an extension thanks to a pediatric exclusivity award, is set to expire in July of 2025. Other patents on the drug run until 2026, 2027 and 2036. Now, Novartis will head to the U.S. Court of Appeals for the Federal Circuit (CAFC) in an effort to reverse the decision, the company said in a recent statement. The company will “continue to defend” its Entresto patents “vigorously” and warned that any generics that launch before the outcome of the appeal “may be at risk” of litigation. Currently, there are no Entresto copycats with tentative or official FDA approvals, the company noted. Just last week, the company chalked up a win against Mylan when a West Virginia court ruled that the ...
- Source: drugdu
- 132
- July 12, 2023
Samsung Biologics, After Expanding Pfizer Collab, Inks Novartis Production Deal Worth $391M

Just days after sewing up a pair of $897 million deals with Pfizer, Samsung Biologics has added a few hundred million dollars more to its partnership cash pile—this time courtesy of an expanded pact with Novartis. Monday, Samsung Bio said in a regulatory filing that it’s inked a $390.9 million deal to help crank out Novartis drugs. The latest production pact builds on an earlier Samsung-Novartis tie-up worth $81 million in June 2022. Last week, meanwhile, Samsung Bio said Pfizer had added $486 million to two biosimilar production accords the companies made in early 2023. In June, the partners signed a contract for the Korean CDMO to produce biosimilar drugs in the fields of immunology, oncology and inflammation. And in March, the companies linked up on a deal worth $193 million, according to a regulatory filing. Samsung’s Novartis deal comes in below that Pfizer deal from June. Still, the Novartis tie-up now represents ...
- Source: drugdu
- 135
- July 12, 2023
CMS Expands Medicare Coverage for Leqembi After FDA Traditional Approval

Pictured: Sign of U.S. Department of Health & Human Services at its headquarters in Washington/iStock, JHVEPhoto The Centers for Medicare and Medicaid Services will now provide broader coverage for Eisai and Biogen’s Alzheimer’s disease therapy Leqembi (lecanemab), the federal agency announced Thursday. The Medicare coverage expansion comes after Leqembi won the FDA’s traditional approval, making it the first anti-amyloid and disease-altering treatment to do so. Eisai and Biogen were granted accelerated approval for Leqembi in January and soon commenced their bid for full approval with data from the Phase III Clarity-AD study. According to CMS, only patients enrolled in Medicare and with physicians participating in a qualified registry will be eligible for reimbursement—provided their doctors collect their data as real-world evidence for Leqembi and submit it to a registry. Coverage is restricted to those who are diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia, with evidence of beta-amyloid deposits in the brain. “With FDA’s decision, CMS will ...
- Source: drugdu
- 129
- July 11, 2023

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