Search Results for “ oncology” – Page 48 – media

Perrigo’s OTC birth control pill aces FDA expert meeting

The jury has spoken, giving a unanimous “yes” to push Perrigo’s birth control tablet Opill over the counter. Wednesday, experts from a joint FDA meeting of outside experts voted 17 to 0 in favor of Opill’s over-the-counter approval pivot. If approved later this year by the FDA, Opill would become the first OTC daily hormonal birth control pill cleared in the U.S. The unanimous vote came despite a number of big questions from the FDA about the potential for Opill’s responsible over-the-counter use in the real world. The FDA does not have to follow the advice of its advisory committees when making an approval vote, though it often does. Panelists had one main question to consider. Namely: Was there “adequate information to conclude that consumers will be likely to use [Opill] properly, such that the benefits of making this available for nonprescription use … exceed the risks.” Overall, panelists concluded ...
- Source: drugdu
- 127
- May 12, 2023
First Of Its Kind Urine Biomarker Methylation Test Predicts Bladder Cancer Recurrence

By LabMedica International staff writers Bladder EpiCheck is the first urine biomarker methylation test of its kind to be FDA cleared for NMIBC surveillance (Photo courtesy of Nucleix) Bladder cancer ranks as the sixth most common cancer in the U.S., with around 700,000 individuals living with the disease and over 80,000 new cases detected each year. The majority of these cases are classified as non-muscle invasive bladder cancer (NMIBC). Although NMIBC can be treated surgically and therapeutically, it has a high recurrence rate (up to 70% over five years), necessitating frequent monitoring to detect high-grade recurrence and treat it promptly. The standard of care involves regular and invasive cystoscopies, which patients undergo up to four times annually for a minimum of five years or, in some cases, for their entire lives. Now, a simple, objective urine test for recurrent bladder cancer is set to become commercially available in the ...
- Source: drugdu
- 119
- May 11, 2023
As COVID vaccine sales plummet, BioNTech looks for new growth opportunities

After raking in billions with its Pfizer-partnered vaccine, BioNTech is turning to new ventures as its revenues plummet. BioNTech reported first-quarter revenues of €1.27 billion (1.4 billion), a far cry from 2022’s first-quarter haul of €6.37 billion ($7.03 billion). Despite the downturn, the quarter went “fully to our expectations,” CFO Jens Holstein said on a conference call. Sales-wise, the current quarter should be the weakest of 2023, Holstein said. The company’s COVID-19 vaccine revenue guidance for 2023 stands at €5 billion ($5.4 billion), which is “something we can live with,” the CFO added. Meanwhile, BioNTech believes the United States’ transition to a commercial COVID-19 vaccine market could provide new growth opportunities. But as its pandemic-related business struggles, BioNTech is busy advancing its pipeline as it looks for its next big growth driver. The company’s pipeline includes multiple oncology ventures, including an HER2-targeted antibody-drug conjugate (ADC) that it’s working on with ...
- Source: drugdu
- 133
- May 10, 2023
AI model shows promise in detecting lung cancer earlier

Lung cancer accounts for more than 20% of cancer deaths in the UK A new UK study has revealed the potential of using artificial intelligence (AI) to help doctors diagnose lung cancer earlier. LIBRA, which was led by researchers from the Royal Marsden NHS Foundation Trust, the Institute of Cancer Research, London, and Imperial College London, used data from the CT scans of nearly 500 patients with large lung nodules – abnormal growths – to develop an AI model. The Royal Marsden Cancer Charity, the National Institute for Health and Care Research, RM Partners and Cancer Research UK also supported the study. To assess how effective the new model was at predicting cancer, the team used a measure called the area under the curve (AUC). An AUC of one would indicate a perfect model, while 0.5 would be expected if the model was randomly guessing. The results, which have ...
- Source: drugdu
- 136
- May 9, 2023
Researchers use skull-implantable ultrasound to help deliver chemotherapy to the brain

By Sean Whooley Leave a Comment [Screenshot from video provided by Nortwestern Medicine] Northwestern Medicine shared results from a first-in-human clinical trial for a skull-implantable ultrasound device that supports chemotherapy delivery. The device opened the blood-brain barrier to repeatedly permeate large, critical regions of the human brain. This enabled the delivery of chemotherapy injected intravenously. With the patient awake, a four-minute procedure opens the blood-brain barrier and patients go home after a few hours. Results from the Northwestern study demonstrated both a safe and well-tolerated treatment. Some patients even reached up to six cycles of chemotherapy treatment. The paper published on May 2 in The Lancet Oncology. More about the chemotherapy study The researchers say this marks the first study to successfully quantify the effect of ultrasound-based blood-brain barrier opening on the concentrations of chemotherapy in the human brain. Opening the blood-brain barrier led to approximately a four-to-six-fold increase in drug concentrations ...
- Source: drugdu
- 117
- May 7, 2023
FDA issues new draft guidance on decentralised clinical trials

The US Food and Drug Administration (FDA) has issued new draft guidance on the implementation of decentralised clinical trials (DCTs), in which some or all trial-related activities occur at locations other than traditional investigation sites. This could include carrying out clinical tests at a local facility rather than a research medical centre, or conducting follow-up visits in the participants’ homes using telemedicine. The 16-page document provides recommendations for sponsors, investigators and other stakeholders on the use of these trials, which the agency expects’ will play an important role in addressing public health needs’. ‘By reducing barriers to participation, we expect that DCTs will increase the breadth and diversity of participants in clinical trials and improve accessibility for those with rare diseases or mobility challenges,’ the FDA said in a statement. The guidance covers recommendations on topics such as DCT design, the use of digital health technologies for remote patient monitoring, ...
- Source: drugdu
- 125
- May 6, 2023
Quest to Reach Another Segment in Liquid Biopsy with New M&A

Omar Ford Quest Diagnostics is diving into a quickly growing segment of liquid biopsy with its latest M&A prospect. The Secaucus, NJ-based company announced a definitive agreement to acquire Haystack Oncology in an all-cash equity transaction. Quest will pay $300 million in cash at closing and Haystack has the potential to obtain up to an additional $150 million in performance milestones. If the deal were to close, then Quest would inherit Baltimore, MD – based Haystack’s minimal residual disease testing technology. MRD testing is a specific category of liquid biopsy that identifies circulating tumor DNA (ctDNA) in the bloodstream of patients following surgery and treatment for cancer. In a prospective, multi-institution study published in the New England Journal of Medicine in June 2022, an earlier version of the Haystack technology demonstrated the ability to better identify patients with residual disease for adjuvant chemotherapy after surgery for stage II colon cancer, thereby reducing ...
- Source: drugdu
- 141
- May 1, 2023
Immunotherapy strongly improves prognosis of babies with leukemia

Immunotherapy with blinatumomab leads to a strongly improved survival rate—from 66% to 93%—for children with an aggressive form of acute lymphoblastic leukemia (ALL). They also had fewer side effects from the treatment. Based on the results, blinatumomab will now become standard treatment worldwide for babies with this aggressive form of leukemia. Three quarters of babies with acute lymphoblastic leukemia (ALL)—three babies a year in the Netherlands—have a particular fault in the DNA of their leukemia cells. This so-called KMT2A rearrangement leads to an aggressive form of ALL with a poor prognosis. Despite intensifying chemotherapy, the prognosis for these babies has not improved in recent decades. Intensive chemotherapy works very well for half of the babies. But in the other half of the children, the disease returned within two years, or children died from the disease or sometimes from the side effects of the therapy. 90% of recurrences—when the cancer comes ...
- Source: drugdu
- 138
- April 28, 2023
Novartis trims 10% of drug pipeline in research cutback

The company discontinued about 20 early-stage projects after reviewing their strategic fit and commercial potential. Novartis said Tuesday it will discontinue or license out 10% of its clinical development projects after reviewing their strategic fit and sales potential. The Swiss drugmaker has trimmed its drug pipeline to 136 projects, down by 16 from the 152 disclosed in its fourth quarter earnings report, according to a presentation Tuesday. The biggest cutbacks came to its early-stage projects, with 19 programs cut. Half of those were early-stage programs testing drugs for solid tumors. The move comes one year after Novartis resized its business and narrowed its research focus to five core therapeutic areas — cardiovascular, immunology, neuroscience, solid tumors and hematology. It expects to save at least $1 billion annually by 2024 as a result. “We systematically looked at the pipeline, identified projects that were outside the scope ...
- Source: drugdu
- 224
- April 27, 2023
ICR in research partnership with NeoPhore

Collaboration will further boost its promising pipeline of cancer treating therapies NeoPhore – a company focused on small molecule neoantigen immuno-oncology – has announced that it is collaborating with Professor Chris Lord’s lab at The Institute of Cancer Research (ICR) in London. Under the terms of the agreement, the lab will use NeoPhore’s proprietary small molecule inhibitors of DNA mismatch repair (MMR) to explore single agent activity amid tumours with defined genetic backgrounds. Meanwhile, its promising MMR modulators have the ability to induce neoantigen expression and increase immunogenicity in solid tumours that become sensitive to immunotherapy. The collaboration will further develop NeoPhore’s discoveries and ongoing research, while boosting its pipeline of cancer treating therapies. It also becomes the fourth partnership established by NeoPhore during the past six years, having also made reached agreements with St George’s University of London, Memorial Sloan Kettering Cancer Center and ...
- Source: drugdu
- 121
- April 20, 2023

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