PharmaFocus Today – Page 293 – media

Bavarian Nordic’s chikungunya vaccine candidate shows promise in late-stage trial

Bavarian Nordic has shared positive top-line results from a late-stage study of its chikungunya virus vaccine candidate in adults and adolescents. Chikungunya is a mosquito-borne viral disease for which there is currently no approved vaccine or effective treatment. Infection leads to symptomatic disease after four to eight days following the bite of an infected mosquito, with clinical symptoms including acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. More than 3,200 people aged 12 to 64 years were enrolled and randomised to receive either a single intramuscular injection of Bavarian Nordic’s virus-like particle-based vaccine candidate, CHIKV VLP (PXVX0317), or placebo. Results showed that the vaccine was highly immunogenic in healthy adolescents and adults at up to 22 days post-vaccination, as demonstrated by the strong induction of chikungunya neutralising antibodies in 98% of those in the active group. CHIKV VLP induced significant neutralising antibodies in ...
- Source: drugdu
- 106
- August 9, 2023
Iveric Gets FDA Approval in Geographic Atrophy After Being Acquired by Astellas

By Tristan Manalac Pictured: Astellas’ American headquarters in Illinois/iStock, JHVEPhoto The FDA on Friday approved Iveric Bio’s intravitreal avacincaptad pegol, now to be marketed as Izervay, for the treatment of geographic atrophy secondary to age-related macular degeneration. The regulatory win comes three months after the New Jersey biotech was bought by Astellas Pharma for $5.9 billion. The companies completed the acquisition last month. Friday’s approval makes Izervay the first authorized geographic atrophy (GA) treatment that has significantly slowed down GA progression at 12 months across two Phase III studies, according to Astellas’ announcement. The eye injection also offers a new treatment option to physicians and patients across the U.S., Iveric Bio President Pravin Dugel said in a statement. Discovered and developed by Iveric, Izervay is an intravitreally administered inhibitor of the complement C5 protein. By blocking the cleavage of C5, the eye injection also disrupts more downstream processes, including the formation ...
- Source: drugdu
- 212
- August 9, 2023
unrNektar Flags Lilly’s Miscalculations in Rezpeg Atopic Dermatitis Trials

By Tristan Manalac Pictured: Nektar signage at its headquarters in California/iStock, Sundry Photography Nektar Therapeutics on Monday revealed that former partner Eli Lilly had incorrectly calculated efficacy data for its investigational regulatory T-cell stimulator rezpegaldesleukin (rezpeg), which the company is developing as a treatment for atopic dermatitis. At the 31st Congress of the European Academy of Dermatology and Venereology (EADV), held in September 2022, Lilly presented data from a Phase Ib study of rezpeg, showing that while the candidate elicited positive and dose-dependent improvements in key efficacy measures, these effects ultimately fell short of statistical significance. At 12 weeks, Lilly erroneously reported the 12-µg/kg and 24-µg/kg doses of rezpeg were associated with a 53% and 66% improvement in Eczema Area and Severity Index (EASI) scores, respectively, whereas placebo induced a 49% improvement relative to baseline, Nektar reported. Neither dose was significantly superior to placebo, according to the company. However, Nektar’s ...
- Source: drugdu
- 109
- August 9, 2023
A review of treatment strategies

A new editorial paper was published in Oncoscience (Volume 10) on June 28, 2023, entitled, “Adenoid cystic carcinoma of the head and neck – treatment strategies of a highly malignant tumor with variable localizations.” In this new editorial, researchers Florian Dudde, Kai-Olaf Henkel and Filip Barbarewicz from the Army Hospital Hamburg discuss head and neck tumors, which are among the most common malignancies. In this anatomical region, squamous cell carcinoma (SCC) is the most common malignant entity. However, there are also other malignant tumors that, unlike SCC, originate in the salivary glands of the head and neck region, such as mucoepidermoid carcinoma or adenoid cystic carcinoma (ACC). In general, tumors originating from the minor salivary glands often show a higher degree of malignancy than tumors of the major salivary glands (parotid gland, submandibular gland, sublingual gland). Consequently, the ACC in particular is often localized in the area of the hard ...
- Source: drugdu
- 129
- August 8, 2023
Study helps understand how RNA modification promotes pancreatic cancer

Chemical modifications of RNA molecules, such as m6A, can critically impact gene expression, influencing various aspects of cancer development and progression. However, while studies into m6A modification of messenger RNA (mRNA) have been extensive, exploration of its impact on lncRNAs, especially within the context of PDAC, has been relatively limited. In an innovative study published in the Genes & Diseases journal, a team from The Children’s Hospital, Zhejiang University School of Medicine, People’s Hospital of Hangzhou Medical College and University of Mississippi Medical Center employed a methylated RNA immunoprecipitation (MeRIP) strategy to uncover the role of LINC00901, an m6A-modified long noncoding RNA (lncRNA), in promoting the proliferation, survival, and invasiveness of pancreatic ductal adenocarcinoma (PDAC) cells, thus leading to tumor growth. Intriguingly, the study suggests that the m6A reader protein YTHDF1 negatively regulates LINC00901 expression. The team identified two m6A sites on LINC00901 essential for its interaction with YTHDF1. Their ...
- Source: drugdu
- 208
- August 8, 2023
Two people caught swine flu after visiting pig exhibits at agricultural fairs, CDC reports

By Brenda Goodman, CNN The CDC reported that two people in Michigan caught flu strains, such as the virus particles shown in green, that typically circulate in pigs. NIAD/NIH/Universal Images Group/Getty Images CNN — Two people have caught flu strains that normally circulate in pigs, the US Centers for Disease Control and Prevention said on Friday, and pig exhibits at agricultural fairs appear to be to blame. Each patient became ill with flu-like symptoms about 10 days after visiting pig exhibits at two different agricultural fairs in early and late July. Neither was hospitalized, and their infections do not appear to have spread to other people, the CDC said. Both cases were identified by the Michigan Department of Health. There are a few such cases in the U.S. each year, usually linked to swine exhibits at fairs. Still, the illnesses highlight the possibility that flu viruses have the ability jump ...
- Source: drugdu
- 106
- August 8, 2023
FDA Approves Biogen, Sage’s Zurzuvae as First Pill for Postpartum Depression

By Heather McKenzie Pictured: FDA Headquarters/iStock, Grandbrothers In a bittersweet decision for Biogen and Sage Therapeutics, the FDA approved the fast-acting therapy zuranolone Friday as the first pill for postpartum depression—but rejected the treatment for major depressive disorder. Zuranolone—to be marketed as Zurzuvae in postpartum depression (PPD) —is only the second treatment for this indication and the first pill that can be taken at home. Prior to Zurzuvae, there was only one FDA-approved treatment for PPD—Sage’s Zulresso (brexanolone)—but as it must be administered intravenously at a hospital, it is out of reach for many women, Fortune Well reported. Zurzuvae also marks a significant change from the current treatment paradigm, which consists of drugs that are longer acting, showing efficacy typically within six to eight weeks, Sage Chief Business Officer Chris Benecchi, told BioSpace in a previous interview. However, the fast-acting pill—jointly developed by Biogen and Sage—can improve symptoms in as ...
- Source: drugdu
- 106
- August 8, 2023
Artificial sweeteners linked to increased body fat, study finds

Published in the International Journal of Obesity, University of Minnesota Medical School and School of Public Health researchers led a study on the relationship between dietary intake and cardiovascular disease risk factors. Over 20 years, the research team examined people’s regular dietary intake, paying particular attention to non-nutritive sweeteners commonly found in artificial sweeteners. They found that long-term consumption of aspartame, saccharin, and diet beverages were linked to increased fat stores in the abdomen and fat within muscle. However, the study found no significant association between the artificial sweetener sucralose and these measures of fat volume. Brian Steffen (PhD, MSCR, Professor, Department of Surgery, University of Minnesota Medical School) said, “This study showed that habitual, long-term intake of total and individual artificial sweetener intakes are related to greater volumes of adipose tissue, commonly known as body fat. This was found even after accounting for other factors, including how much a ...
- Source: drugdu
- 263
- August 7, 2023
New technique enables high-resolution analysis of DNA

Function and form are deeply intertwined in biology. Knowing how organisms grow, adapt and reproduce requires understanding their physical structures. Hence the transformative power of the microscope across the past four centuries of science. Microscopy, or the field of microscope use, can now reveal the tiniest of structures through techniques such as microcrystal electron diffraction, or MicroED. Instead of passing light through a cell like an optical microscope, MicroED bombards crystalline samples with a stream of electrons to produce detailed information about their atomic configuration. Brent Nannenga (Associate Professor, Chemical Engineering, Arizona State University) said, “The method was developed to reveal or ‘solve’ the structure of proteins. Then researchers started applying it to compounds for pharmaceuticals and small organic molecules. However, it had not been demonstrated for nucleic acids, and the scientific community was asking whether it would work for DNA.” Nannenga and colleagues just answered that question. A research ...
- Source: drugdu
- 111
- August 7, 2023
Bavarian Nordic locks up $120M BARDA deal to replenish US stock of smallpox, mpox vaccine

After coming to the rescue during the mpox outbreak in 2022, vaccine maker Bavarian Nordic has agreed to help replenish U.S. stores of its smallpox/mpox shot. The U.S. Biomedical Advanced Research and Development Authority (BARDA) is handing Bavarian Nordic a new $120 million contract, primarily to cover the production of new bulk vaccine product, the company said in a press release Thursday. The bulk product order represents $96 million of the contract value. That portion will be manufactured and invoiced in 2023 and will “only partly restore the inventory,” Bavarian Nordic said. Bavarian Nordic will also manufacture and supply an additional $3 million worth of liquid-frozen doses in 2023. The rest of the contract will cover “additional services” totaling $21 million, with Bavarian Nordic getting its hands on most of that sum over the next two years. Throughout 2022 and 2023, Bavarian Nordic says it’s manufactured around 5.5 million smallpox/mpox ...
- Source: drugdu
- 213
- August 7, 2023

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