Search Results for “antibody” – Page 49 – media

Janssen’s patient programme becomes latest victim of data breach

IBM has announced a data breach of Janssen’s CarePath platform and has started informing affected customers. The Janssen CarePath portal provides patients and healthcare professionals in the US with information regarding insurance coverage, out-of-pocket costs, and prescribing information at no cost to the users. The number of highest grossing Janssen drugs are included in the platform such as Darzalex (daratumumab) and Stelara (ustekinumab) which generated $2.5bn and $3.2bn in US sales in H1 2023, respectively, as per the company’s Q2 2023 financial report. Data breaches at the top pharma companies are nothing new, as companies such as Merck & Co (MSD), Roche, and AstraZeneca have all been hacked in the past. Data breaches cost the companies an average of $5m to remediate, as per IBM’s 2020 data breach report. The Janssen CarePath systems provider, IBM, indicated that the stolen data may have contained information provided as part of the Janssen ...
- Source: drugdu
- 105
- September 11, 2023
Roche hits FDA delay with subcutaneous version of Tecentriq amid manufacturing process changes

It’s looking like Roche may not receive an on-time FDA decision for the subcutaneous version of its cancer immunotherapy Tecentriq.The FDA was supposed to dole out a verdict on subcutaneous Tecentriq by next week. But Roche now needs to update the therapy’s manufacturing processes, the Swiss pharma’s drug delivery technology partner Halozyme Therapeutics said in a securities filing Thursday. “These updates are expected to be completed in 2023 and are expected to support a potential launch of Tecentriq SC in the U.S. in 2024,” Halozyme said. Roche is making the changes in response to the FDA’s evolving requirements, a spokesperson with the company’s Genentech unit told Fierce Pharma. The spokesperson confirmed that the company now expects to receive an FDA approval in 2024. Roche filed the under-the-skin formulation to both the FDA and the European Medicines Agency in November. It’s targeting all existing indications of the original intravenous Tecentriq. Last ...
- Source: drugdu
- 167
- September 9, 2023
BioNTech, DualityBio Move ADC into Phase III for HER2-Low Breast Cancer

By Kate Goodwin Pictured: 3D rendering of antibody-drug conjugate/iStock, Love Employee BioNTech’s licensed antibody-drug conjugate is moving on to Phase III testing in a potential effort to challenge AstraZeneca and Daiichi Sankyo’s blockbuster Enherto in a heavily treated breast cancer subpopulation. DualityBio, BioNTech’s partner and the ADC’s creator, posted the trial plans Wednesday. BioNTech added the ADC, DB-1303, to its portfolio in April 2023 when it paid China’s DualityBio $170 million upfront for rights to it plus a second preclinical asset. Another $1.5 billion is on the line in milestone payments, plus tiered royalties. DB-1303 will be pitted against chemotherapy in the open-label Phase III for patients with HER2-low, HR+ metastatic breast cancer patients whose disease has progressed despite endocrine therapy. ADC therapy is like a targeted missile for cancer, with an antibody targeted to deliver the cancer killing payload. DB-1303 is a topoisomerase-1 inhibitor. Phase I/II trial results showed ...
- Source: drugdu
- 110
- September 5, 2023
Novo Bolsters Obesity Pipeline with Potential $500M Embark Biotech Buy

By Kate Goodwin Novo Nordisk has again bought a weight-loss focused biotech, as the obesity market heats up. Announced Wednesday, the Danish pharma plans to buy Embark Biotech for $16.3 million up front with close to $500 million on the line in milestone payments—Novo’s second obesity-focused acquisition in three weeks. Novo participated in the seed round for Embark in 2017 when the biotech spun out from Novo Nordisk Foundation Center for Basic Metabolic Research at the University of Copenhagen. The company said it was founded on the discovery of a “novel target that suppresses appetite increases energy expenditure and enhances insulin sensitivity.” The acquisition announced Wednesday gives Novo full rights to develop and commercialize Embark Biotech’s lead metabolic program, currently in preclinical stages. Included is a three-year R&D collaboration with Embark Laboratories, a new company being formed by the biotech’s team to develop therapies for obesity and related conditions, with ...
- Source: drugdu
- 210
- September 1, 2023
Pfizer’s RSV vaccine granted EC approval to protect infants and older adults

Pfizer’s respiratory syncytial virus (RSV) vaccine has been approved by the European Commission (EC) to protect both infants and older adults against RSV-caused lower respiratory tract disease (LRTD). The EC’s decision allows Abrysvo to be given as a single dose to adults aged 60 years and older, and those who are 24 to 36 weeks into their pregnancy to protect their babies from birth until they are six months old. RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people recover within a week or two, the virus can cause severe illness in young infants and older adults. In the EU, about 245,000 yearly hospital admissions have been associated with RSV in children aged under five years, while the virus is estimated to cause more than 270,000 hospitalisations in older adults each year. The EC’s decision, which follows a recent recommendation from the European Medicines ...
- Source: drugdu
- 127
- August 30, 2023
Merck, Eisai Drop Phase III Keytruda-Lenvima Trial for Head and Neck Cancer

By Connor Lynch Pictured: Merck logo on building/iStock, Sundry Photography Merck and Eisai have dropped another joint drug trial after disappointing Phase III results. The companies announced Friday that they would be ending their combination treatment of Keytruda and Lenvima, respectively, after a second interim analysis found no improvement in overall survival. The LEAP-010 trial was evaluating the safety and effectiveness of Merck’s anti-PD-1 therapy in combination with Eisai’s multiple receptor tyrosine kinase inhibitor for metastatic or unresectable head and neck squamous cell carcinoma (HNSCC). An independent monitoring committee conducted two interim analyses over the course of 11 months. Initial results from the first analysis were promising: the therapy combo met two of the trial’s three primary endpoints of progression-free survival and objective response (OS) rate. However, the treatment failed to show evidence of meeting the third endpoint, overall survival, in the second analysis. The companies in Friday’s announcement said ...
- Source: drugdu
- 109
- August 29, 2023
Regeneron wins FDA approval for rare immune disease med Veopoz, expects high-dose Eylea decision in the coming weeks

Along with resolving site inspection issues that cost Regeneron a high-dose Eylea launch in June, the company has scored an FDA nod for Veopoz as the first treatment for the ultra-rare inherited immune condition Chaple disease. The disease, which is also known as CD55-deficient protein-losing enteropathy, has a global patient population of fewer than 100 people. In just the U.S., fewer than 10 patients have been diagnosed, Regeneron said in its Friday release. Chaple disease is caused by mutations of the complement regulator CD55 gene, which can lead the compliment system to attack the body’s own cells. Enter Veopoz, a fully human monoclonal antibody that targets a protein involved in complement system activation called compliment factor C5. It’s approved for patients 1 year of age and older and comes with a $34,615 price tag per single-use vial, a Regeneron spokesperson said in an emailed statement. The injection was tested in ...
- Source: drugdu
- 122
- August 22, 2023
AbbVie achieves win for migraine prevention drug Aquipta in Europe

The European Commission has approved AbbVie’s Aquipta as migraine prophylaxis for adult patients, making it the first daily oral treatment of its class to be approved in the EU for the prevention of both chronic and episodic migraines. Several calcitonin gene-related peptide (CGRP) antibodies are administered subcutaneously or via intravenous infusions. But there is a preference among patients for oral therapies, says Dawn Carlson, vice president, Neuroscience Development at AbbVie, in an interview with Pharmaceutical Technology. Lundbeck’s CGRP antibody Vyepti (eptinezumab), is administered through intravenous infusions, while Amgen’s Aimovig (erenumab) is injected subcutaneously. The approval of Aquipta is based on the results of the two Phase III studies—ADVANCE (NCT03777059) and PROGRESS (NCT03855137), which both met their primary endpoint of a statistically significant reduction in mean monthly migraine days versus placebo, per the 17 August announcement. In the PROGRESS trial, patients in the 60mg Aquipta cohort reported a 6.8-day reduction in ...
- Source: drugdu
- 120
- August 22, 2023
Severe COVID-19 may cause long-term changes to innate immune system

Severe COVID-19 may cause long-lasting alterations to the innate immune system, the first line of defense against pathogens, according to a small study funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. These changes may help explain why the disease can damage so many different organs and why some people with long COVID have high levels of inflammation throughout the body. The findings were published online today in the journal Cell. Researchers led by Steven Z. Josefowicz, Ph.D., of Weill Cornell Medicine in New York City examined immune cells and molecules in blood samples from 38 people recovering from severe COVID-19 and other severe illnesses, as well as from 19 healthy people. Notably, the researchers established a new technique for collecting, concentrating and characterizing very rare blood-forming stem cells that circulate in the blood, eliminating the need to extract such cells from ...
- Source: drugdu
- 183
- August 21, 2023
FDA approves Talvey for heavily pre-treated multiple myeloma

US Food and Drug Administration (FDA) has approved Talvey (talquetamab-tgvs) for the treatment of refractory or relapsed multiple myeloma in adult patients who have received at least four prior lines of therapy. Talvey is a bispecific antibody targeting T-cell CD-3 receptors and G protein-coupled receptor class C group 5 member D (GPRC5D) developed by Janssen. It received accelerated approval as a weekly or biweekly subcutaneous therapy. University of California multiple myeloma programme director Ajai Chari noted in a press release: “Patients at this stage of the disease have a poor prognosis. Talquetamab as a first-in-class therapy is a new option for patients with this difficult-to-treat blood cancer.” The approval was based on meaningful overall response rates (ORR) demonstrated in the Phase II clinical trial data. However, continued approval for Talvey is contingent upon further confirmatory trials showing clinical benefit. To that end, Talvey is only available for use via a ...
- Source: drugdu
- 126
- August 21, 2023

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