By Kate Goodwin Pictured: Novartis Building/iStock, JHVE Photo With Xolair’s patents set to expire over the next year, Novartis has been looking to strengthen its grip on the chronic spontaneous urticaria market. Thursday, the Swiss pharma shared positive Phase III results for chronic hives with its BTK inhibitor and announced plans to submit for regulatory approval next year. In two late-stage studies, remibrutinib met the primary endpoint of change from baseline in a weekly urticaria activity score at week 12. While studies will continue for a full year, the BTK inhibitor demonstrated a rapid onset, improving patients’ symptoms in as little as two weeks. Patients with chronic spontaneous urticaria (CSU) deal with chronic hives that can last for six weeks or longer. The trigger is internal, as opposed to allergen exposure. While antihistamines are the first line of treatment, around 60% of patients’ symptoms are inadequately controlled with antihistamines alone. ...
GSK’s Cabenuva made history in 2020 as the world’s first complete, long-acting HIV regimen. But the injectable drug is approved in various countries only as a switch therapy for patients who already have undetectable HIV levels in the blood. Trying to reach tough-to-treat patients who have difficulty controlling the virus with existing daily oral therapies, GSK’s ViiV Healthcare is getting creative. To seek an approval for Cabenuva in patients who aren’t virologically suppressed while on oral drugs, GSK’s ViiV is exploring running a clinical trial using a historical control group. This would replace the standard practice of randomizing some patients in the study to receive standard-of-care oral meds, ViiV’s R&D head Kimberly Smith, M.D., said during a recent interview. The FDA in February unveiled draft guidance laying out the considerations for the use of external control groups in clinical trials to prove a drug’s safety and efficacy. The gist is, ...
Right before opening arguments were set to begin in Gilead Sciences and Teva’s HIV antitrust trial, the two came to a last-minute settlement with some of the plaintiff groups. Both companies settled with the pharmacy plaintiffs, a group that includes CVS Pharmacy, Rite Aid and Walgreens, while Gilead made a deal with the direct purchasers. Now, indirect purchasers and others involved in the suit can take their claims to a California federal jury. Gilead and Teva confirmed the settlements, and Gilead noted that the lawsuit with the other parties is ongoing. “The claims against Gilead in this lawsuit lack merit, do not accurately reflect antitrust laws, and ignore Gilead’s history of innovation and scientific advancements to help address the pressing challenges of the HIV epidemic,” a Gilead spokesperson said over email. The deals mark an eleventh hour end to a sprawling case that dates back to 2019, when plaintiffs including ...
Some HIV patients are naturally able to keep the virus fully in check without any medicinal help, a phenomenon that has intrigued scientists for decades. New research appears to identify at least one reason why: an abnormally powerful version of an infection-fighting white blood cell called CD8+ T cell. CD8+ T cell’s are a type of T cell, a normal feature in everyone’s immune system. T cells typically amass in the lymph nodes of an HIV-infected patient. But among “spontaneous controllers”—those with the rare ability to automatically corral HIV and prevent it from triggering illness—investigators found that CD8+ T cells appear significantly more adept at identifying and stopping HIV. “About one in 300 people are able to control HIV without the need for medications,” noted study author Dr. Bruce Walker, director of the Ragon Institute of MGH, MIT and Harvard, an immune system research center in Cambridge, Mass. It appears ...
Genetic alterations that give rise to a rare, fatal disorder known as MOGS-CDG paradoxically also protect cells against infection by viruses. Now, scientists at the Lewis Katz School of Medicine at Temple University have harnessed this unusual protective ability in a novel gene-editing strategy aimed at eliminating HIV-1 infection with no adverse effects on cell mortality. The new approach, described online April 28 in the journal Molecular Therapy—Nucleic Acids, is based on a combination of two gene-editing constructs, one that targets HIV-1 DNA and one that targets a gene called MOGS—defects in which cause MOGS-CDG. In cells from persons infected with HIV-1, the Temple researchers show that disrupting the virus’s DNA while also deliberately altering MOGS blocks the production of infectious HIV-1 particles. The discovery opens up new avenues in the development of a cure for HIV/AIDS. Proper MOGS function is essential for glycosylation, a process by which some cellular ...
It’s extremely unusual for the U.S. government to go after a pharmaceutical company for alleged patent infringement, much less take the case to trial. But in the government’s case against Gilead Sciences, the California drugmaker has come out on top.After years of litigation, Gilead prevailed following the trial in a Delaware federal court. The jury found the patents at issue were invalid, The New York Times reports.With that, the company doesn’t have to pay the more than $1 billion that the government sought with its patent infringement case. The company is “pleased” with the decision, Gilead’s executive vice president of corporate affairs and general counsel Deb Telman said in an emailed statement. “Today’s decision confirms our longstanding belief that we have always had the rights to make Truvada and Descovy for PrEP available to all who need it,” Telman said. “Gilead will continue to champion collaborations, including our efforts with the ...
A U.K. man may be cured of HIV comes the announcement that a man in Germany may also be HIV-free thanks to a similar treatment
The skin rejuvenation procedures like ‘Vampire facial’ are conducted by cosmetologists in order to regenerate the damaged part of the patient’s skin, which will make you look younger. In many regions, even a spa offers this service. But is it really safe? Is there any risk behind it? In Vampire facial, the platelets are extracted from the client’s blood and re-injected back into the face via micro-needling method. Though this procedure seems to be effective, no research study claims that it has a long-lasting effect. The risk is found especially in handling the blood. When a client reported that she got affected by an unspecified disease following the Vampire facial procedure, the health officials from the New Mexico Department of Health, along with representatives of the New Mexico Regulation and Licensing Department and the Barbers and Cosmetologists Board, visited the spa located in Albuquerque, from where she had gone through ...
Findings from data pertaining to 16,864 gonorrhea and Chlamydia tests done on individuals visiting three HIV Research Network locations spanning 2011-2014, suggested that females and males who indulge in sexual intercourse only with women (MSW) should be screened based on age and not universally, as reported by Susan A. Tuddenham, MD, an assistant professor of medicine at Johns Hopkins University, Baltimore. “Detection and treatment of gonorrhea and chlamydia in HIV-positive patients in the United States is a priority both because of patient morbidity and because of the potential for these infections to enhance transmission of HIV,” said Dr. Tuddenham. Their findings were showcased at a Center for Disease Control and Prevention (CDC) conference on STD prevention. Dr. Tuddenham and her colleagues calculated the number needed to screen (NNS) by dividing the number of individuals tested by number of individuals who tested positive for three risk sections including age and ...
Pre-exposure prophylaxis (PrEP) by U.S. residents against HIV infection has resulted in positive outcomes. Incidence of new HIV infections among those 13 years old and above fell during 2012 - 2016, and this plunge presented a statistically noteworthy association with an increase in drug prophylaxis among U.S. residents in the same duration.
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