Search Results for “FDA” – Page 154 – media

Bayer’s blockbuster hopeful Nubeqa, AstraZeneca’s Forxiga pick up nods from England’s NICE

Bayer has blockbuster hopes for prostate cancer med Nubeqa, and a new endorsement from the U.K.’s National Institute for Health and Care Excellence (NICE) provides another milestone toward that goal. After an approval last November to treat patients with metastatic hormone-sensitive prostate cancer (mHSPC), Bayer inked a deal with officials in England to make the drug available to certain patients under an early access program. Now, thanks to NICE’s endorsement in combination with androgen deprivation therapy and the chemotherapy docetaxel, the drug will be available to more patients in England and Wales, Bayer said in a release. Already, a “few hundred” patients with mHSPC have received the drug, according to Bayer. The drug scored its mHSPC approval in England last November thanks to late-stage data showing that the combination cut the risk of death by 32.5% compared with placebo. Previously, the drug had carried a NICE endorsement to treat patients ...
- Source: drugdu
- 115
- May 24, 2023
WHO launches global network to detect infectious disease threat

The World Health Organization on Saturday launched a global network to help swiftly detect the threat from infectious diseases, like COVID-19, and share the information to prevent their spread. The International Pathogen Surveillance Network (IPSN) will provide a platform for connecting countries and regions, improving systems for collecting and analyzing samples, the agency said. The network aims to help ensure infectious disease threats are swiftly identified and tracked and the information shared and acted on to prevent catastrophes like the COVID pandemic. The network will rely on pathogen genomics to analyze the genetic code of viruses, bacteria and other disease-causing organisms to understand how infectious and deadly they are and how they spread. The data gathered will feed into a broader disease surveillance system used to identify and track diseases, in a bid to contain outbreaks and to develop treatments and vaccines. ‘Ambitious’ goals WHO chief Tedros Adhanom Ghebreyesus hailed ...
- Source: drugdu
- 133
- May 23, 2023
NICE recommends Cara’s Kapruvia to treat CKD-associated pruritus

Cara Therapeutics and Vifor Fresenius Medical Care Renal Pharma (VFMCRP) have announced that the US’s National Institute for Health and Care Excellence (NICE) has recommended Kapruvia (difelikefalin) to treat chronic kidney disease (CKD)-associated pruritus. Kapruvia has been recommenced to treat moderate-to-severe CKD-associated pruritus in adult patients who are undergoing haemodialysis. This will allow patients in Northern Ireland, England, and Wales to get access to Kapruvia. The recommendation from NICE follows the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) authorisation of Kapruvia for the same indication in April last year. Cara Therapeutics president and CEO Christopher Posner said: “We are pleased that Kapruvia will be available to CKD patients in England, Wales and Northern Ireland who are undergoing haemodialysis and suffering from moderate-to-severe CKD-associated pruritus. “Together with VFMCRP, we are committed to bringing our first-of-its kind therapy to providers and patients around the world to help change the way pruritus ...
- Source: drugdu
- 216
- May 23, 2023
CDC

As early signs point to a potential resurgence of mpox cases in the U.S. this summer, the Centers for Disease Control and Prevention (CDC) is rolling out real-world data for Bavarian Nordic’s vaccine and urging at-risk people to take two shots.Bavarian Nordic’s Jynneos, given in two doses, is estimated to be 85.9% effective against mpox, a real-world case-match study conducted in 12 U.S. jurisdictions showed. At one dose, the vaccine was found to be 75.2% effective. The CDC released the results in its new Morbidity and Mortality Weekly Report (MMWR). The report comes as a cluster of 21 mpox cases was reported in Chicago, with several diagnoses among those who were vaccinated raising concerns over Jynneos’ efficacy. Although Jynneos’ efficacy may look similar between the partial and full doses in this study of about 900 people, the CDC is still calling for at-risk people to take two doses because the ...
- Source: drugdu
- 115
- May 22, 2023
In a new look at Novo’s Wegovy data, researchers spell out weight loss for teens

Kyle LaHucik May Associate Editor A few months after the FDA approved the weight loss drug Wegovy for adolescents, researchers are out with a post-hoc look at the late-stage data, this time finding that 45% of the teens taking Novo Nordisk’s drug dipped below the clinical cutoff for obesity. The analysis, presented by University of Minnesota pediatrics professor Aaron Kelly at this week’s European Congress on Obesity in Dublin, gives new insight into the popular drug, which is part of the ballooning obesity R&D field that has Novo and Eli Lilly in the lead and biopharmas like Amgen and Boehringer Ingelheim racing to catch up. The results from the same study, the STEP TEENS trial, were published in the New England Journal of Medicine last December, shortly before the FDA expanded the original 2021 label for adults to include teens 12 years old and older. Almost three-quarters (74%) of teens ...
- Source: drugdu
- 103
- May 21, 2023
Pfizer puts kibosh on 4 antibiotics in India after contractor’s manufacturing issues

Global drug giant Pfizer is warning physicians and clinicians in India to immediately stop using four of its antibiotics due to manufacturing issues at a contract producer.The warning covers Magnex, Zosyn, Magnamycin and Magnex Forte. All four products treat infections, with Zosyn used to target various infections caused by bacteria including stomach infections, skin infections, pneumonia, and severe uterine infections. Magnamycin injections and Magnex Forte are also used to treat bacterial infections. The company issued the warning because of “deviations” at a manufacturing facility operated by Astral Steritech Private Limited, according to a letter shared on Twitter by Dr. Sudhir Kumar, M.D., of Apollo Hospitals in Hyderabad. “Whilst the manufacturer is currently investigating the matter, they have requested Pfizer, as an abundant precautionary measure and as per best practices, to temporarily suspend the sale/distribution/supply and use of the aforementioned products, pending the investigation by the manufacturer,” the company said in ...
- Source: drugdu
- 117
- May 20, 2023
Roche’s fenebrutinib shows promise in relapsing forms of MS

Roche has announced positive new data from a mid-stage study of fenebrutinib in adults with relapsing forms of multiple sclerosis (MS). The phase 2 FENopta study met its primary and secondary endpoints, the company said, with oral fenebrutinib significantly reducing MRI markers of MS disease activity in the brain compared to placebo. MS is a disabling, neurological disease in which the immune system attacks the protective myelin sheath that covers the nerves and disrupts communication between the brain and the rest of the body. The disease affects approximately 2.8 million people worldwide. Relapsing forms of MS are characterised by clearly defined, but unpredictable, attacks of worsening neurologic function, followed by partial or complete recovery periods. Approximately 85% of patients are initially diagnosed with relapsing forms of MS, compared to 15% with progressive forms of the disease. Roche and Genentech’s fenebrutinib belongs to a class of drugs known as Bruton’s tyrosine ...
- Source: drugdu
- 115
- May 19, 2023
After Hemgenix approvals, uniQure cashes out some of its royalty rights for $375M-plus

Months after the U.S. and European approvals of its CSL-partnered hemophilia A gene therapy Hemgenix, uniQure is selling some royalty rights for up to $400 million. In a deal with HealthCare Royalty (HCRx) and Sagard Healthcare, uniQure agreed to part ways with a portion of its Hemgenix royalty rights. The company previously licensed the drug to Australia’s CSL Behring, and it’s entitled to milestone and royalty payments as the launch progresses. Now, though, it’s trading some of those royalty rights for a quick payday. Under the new deal with HCRx and Sagard Healthcare, uniQure will get $375 million upfront and another $25 million if an undisclosed sales threshold is achieved. The cash lets uniQure “continue to invest” in its adeno-associated virus vector gene therapy pipeline, CEO Matt Kapusta said a statement. The pipeline includes a Huntington’s disease prospect, a refractory temporal lobe epilepsy candidate and an SOD-1 amyotrophic lateral sclerosis ...
- Source: drugdu
- 120
- May 17, 2023
Cervical Cancer Screenings Double With Mailed DIY Kits

WebMD Health News Mailing do-it-yourself sampling kits to test for cervical cancer doubled the rate of screening in a population of low-income and under-screened women, researchers say. The self-sampling kits, which detect human papilloma virus (HPV), are available only for use in clinical trials, but the researchers hope that eventually these kits will be approved for use by the general public. The researchers, from the University of North Carolina, explored use of these kits in the My Body, My Test-3 study, which was published online Thursday in the journal Lancet Public Health. Experts writing in a commentary published with the study said it “provides the required evidence that … self-collected samples can be an effective strategy for hard-to-reach populations.” The study involved 665 women (aged 25-64) in North Carolina who were either uninsured or enrolled in Medicaid or Medicare. The patients had low-income backgrounds and lived in urban areas. More ...
- Source: drugdu
- 117
- May 17, 2023
Ahead of high-stakes California trial, GSK notches Zantac win in Canada

As GSK’s July court date nears for a key Zantac trial in California, the company can wipe its hands of at least one Canadian class action suit. The company said in a Friday statement that it “welcomes the decision” of the British Columbia Supreme Court to dismiss a proposed class action suit on behalf of Canadian Zantac users. A Vancouver man filed the lawsuit in 2020, alleging that his use of the heartburn med from 2018 to 2019 caused him to develop cancer. His complaint named more than a dozen companies as defendants, including Sandoz Canada and GSK. But the court dismissed the case due to “the uncontroverted evidence that neither ranitidine nor NDMA are reliably associated with increased cancer risk,” GSK said in its statement. Zantac is ranitidine’s brand name and much of the Zantac cases revolve around reports of N-nitrosodimethylamine (NDMA) contamination in the products. Health Canada started investigating the potential impurity in ...
- Source: drugdu
- 120
- May 16, 2023

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