Search Results for “mental health” – Page 36 – media

Novartis Scores Phase III Chronic Hives Wins as Sanofi Challenges

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. ...
- Source: drugdu
- 215
- August 11, 2023
As COVID revenues disappoint, once-high-flying Pfizer looks at possible cost cuts

As COVID-19 revenues ebb and flow—but mostly ebb—Pfizer is eyeing the cost-cutting shears. “Clearly, there is a higher level of uncertainty regarding the demand projections for our COVID-19 products than for the rest of our business,” Pfizer chief Albert Bourla, Ph.D., admitted on a conference call Tuesday. While the shift to a traditional commercial market for Paxlovid and Comirnaty could help, a veil of uncertainty persists. In turn, “we are also preparing to have the ability to adjust our 2024 total cost base” to align with future COVID needs, the CEO added. “In fact, we have already identified specific areas where we can make adjustments primarily within our COVID-19 cost base,” he said. Paxlovid generated just $143 million in worldwide sales for the second quarter, down 98% from the $8.1 billion it pulled down over the same stretch in 2022. MRNA vaccine Comirnaty, for its part, brought home $1.4 billion, ...
- Source: drugdu
- 170
- August 3, 2023
FDA Adopts New Sterilization Standard to Support Switch From Ethylene Oxide

Dive Brief The U.S. Food and Drug Administration has adopted an international sterilization standard to give medical device manufacturers another alternative to ethylene oxide (EtO). Manufacturers can now make declarations of conformity to the International Organization for Standardization’s recommendations on low-temperature vaporized hydrogen peroxide in submissions to the FDA. The FDA framed the addition of the ISO test to its Recognized Consensus Standards database as a response to pressure to reduce EtO use and the need to support supply chain resiliency. Dive Insight In April, the U.S. Environmental Protection Agency proposed limiting EtO emissions from sterilization facilities by 80% to minimize the risk of people developing cancer from exposure to the gas. AdvaMed has warned the limit could halve capacity at commercial sterilizing plants, and the FDA has cautioned that there is a lack of viable alternatives to EtO for many devices. The ...
- Source: drugdu
- 145
- July 28, 2023
BD Gains FDA Clearance to Relaunch Alaris Infusion Pump After Recalls

Dive Brief The Food and Drug Administration has granted Becton Dickinson 510(k) clearance for its updated Alaris infusion pump, paving the way for the company to begin distributing the system again and to remediate or replace all older versions of the device in the field, BD said Friday. The FDA’s green light comes two years after the company filed a new submission for modifications to the pump, which delivers medications and other fluids intravenously to patients, following a series of recalls due to system malfunctions. A large installed base of Alaris systems remains in hospitals. BD said it will address all recall requirements still open to bring those devices into compliance with the FDA clearance, including hardware, software and cybersecurity updates. Dive Insight Widely used in healthcare, infusion pumps from a number of manufacturers have been among the devices that frequently appear on the ...
- Source: drugdu
- 252
- July 27, 2023
Roche Expands Into RNAi Through Alnylam Alliance on Hypertension Drug

Photo: Giuseppe Aresu/Bloomberg, via Getty Images Alnylam pioneered RNA interference drugs for rare disease. The biotech aims to bring RNAI to prevalent disorders and its alliance with Roche on the drug zilebesiran for hypertension better positions the company to achieve this goal. Cardiometabolic disease isn’t a big part of Roche’s drug portfolio or pipeline, but the pharmaceutical giant is trying to change that with a deal to share in the development of an experimental Alnylam Pharmaceuticals hypertension drug that could offer patients efficacy and dosing advantages. According to deal terms announced Monday, Roche is paying $310 million for outside-of-the-U.S. rights to the drug, zilebesiran. The companies will share in the development of the RNA therapy for hypertension. Roche has the opportunity to lead future development of the drug for other indications. Cambridge, Massachusetts-based Alnylam is a pioneer among companies developing therapies that leverage RNA interference, a pathway in ...
- Source: drugdu
- 114
- July 26, 2023
Majority of Cosmetic Practitioners in the UK are not Qualified Medical Doctors, Study Finds

According to an analysis of the UK’s cosmetic injectables industry by UCL researchers, 68% of cosmetic practitioners who are administering injections such as Botox are not qualified medical doctors. The study, published in the Journal of Plastic, Reconstructive & Aesthetic Surgery, is the first survey of who is providing cosmetic injectable services, such as Botulinum Toxin (Botox) and Dermal Fillers, in the UK. Currently, little is known about the background qualifications, training and experience levels of those who are administering treatments. To fill this knowledge gap, researchers from UCL evaluated 3,000 websites to identify 1,224 independent clinics and 3,667 practitioners who were delivering cosmetic injections such as Botox. Of the professions represented, 32% were doctors, 13% were nurses, 24% were dentists and 8% were dental nurses. Of the 1,163 doctors identified, 41% were on the specialist register and 19% were on the GP register. Among the ...
- Source: drugdu
- 136
- July 25, 2023
Researchers Identify Genes that Directly Influence What We Eat

In one of the first large-scale studies of genes related to diet, researchers have uncovered almost 500 genes that appear to directly influence the foods we eat. The findings represent an important step toward using a person’s genetics to develop precision nutrition strategies that help improve health or prevent disease. “Some genes we identified are related to sensory pathways—including those for taste, smell, and texture—and may also increase the reward response in the brain,” said research team leader Joanne Cole, Ph.D., assistant professor in the Department of Biomedical Informatics at the University of Colorado School of Medicine. “Because some of these genes may have clear paths toward influencing whether someone likes a food or not, they could potentially be used to create sensory genetic profiles for fine-tuning a person’s dietary recommendations based on foods they like to eat.” For the study, the researchers used the UK ...
- Source: drugdu
- 105
- July 24, 2023
WHO director-general calls out critics of planned pandemic accords

At the World Health Organization’s (WHO) sixth meeting of the Intergovernmental Negotiating Body in Geneva, the WHO director-general Dr Tedros Adhanom Ghebreyesus has called out critics of the organisation’s planned pandemic accords at the opening remarks of Intergovernmental Negotiating Body’s sixth meeting. “20 years ago, the tobacco industry tried to undermine negotiations on the WHO Framework Convention on Tobacco Control. The same thing is happening now. Groups with vested interests are claiming falsely that the accord is a power grab by WHO, and that it will stymie innovation and research,” he said in his opening remarks on 19 July. The “Pandemic prevention, preparedness and response accord” is an agreement between the WHO member states to “draft and negotiate a convention, agreement or other international instrument under the Constitution of the World Health Organization to strengthen pandemic prevention, preparedness and response”. Member states began developing the pandemic accords in February 2022 ...
- Source: drugdu
- 110
- July 22, 2023
Pfizer Group B Strep Vaccine for Infants Returns Encouraging Mid-Stage Trial Results

Pfizer on Wednesday said its experimental vaccine targeting the potentially deadly bacterial disease Group B Streptococcus returned strong mid-stage clinical trial results, a promising step as the drug inches toward potential approval. Pfizer is among several drugmakers racing to develop the world’s first shot targeting Group B strep disease, which is linked to nearly 150,000 infant deaths worldwide each year, especially in lower-income countries. The Food and Drug Administration in September granted breakthrough therapy designation to Pfizer’s vaccine, which is intended to expedite the development and review of the shot. Pfizer’s single-dose shot generated antibodies that may provide infants with meaningful protection against the disease, according to the data released Wednesday from a phase two clinical trial. The jab is administered to expectant mothers, who pass vaccine-induced antibodies to their fetuses. One of the company’s vaccines targeting respiratory syncytial virus also uses that maternal vaccination method. ...
- Source: drugdu
- 110
- July 21, 2023
Prevalence of atopic diseases increased in sexually diverse individuals

The prevalence of atopic diseases, including atopic dermatitis, is increased in sexually diverse people, including those who identify as lesbian, gay, or bisexual, according to a research letter published online July 12 in JAMA Dermatology. Katelyn J. Rypka, from the University of Minnesota Medical School in Minneapolis, and colleagues calculated crude and multivariable-adjusted odd ratios for prevalence of atopic dermatitis, asthma, and allergic rhinitis comparing heterosexual and sexually diverse individuals. Data were included for 27,012 respondents to the 2021 National Health Interview Survey, of whom 25,701 were heterosexual and 1,311 were sexually diverse. The researchers found that sexually diverse individuals were more likely to report atopic dermatitis (11.1 versus 7.2 percent), asthma (12.0 versus 7.8 percent), and allergic rhinitis (33.7 versus 25.6 percent) compared with heterosexual individuals (adjusted odds ratios, 1.49, 1.39, and 1.30, respectively). In sex-stratified analyses, results were similar. “This study found higher rates of atopic disease among sexually diverse ...
- Source: drugdu
- 128
- July 15, 2023

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