Search Results for “Janssen” – Page 5 – media

Nanobiotix shares promising results for radiotherapy enhancer in advanced pancreatic cancer

Nanobiotix has shared positive new data from an early-stage study evaluating a drug designed to enhance the efficacy of radiotherapy in patients with locally advanced pancreatic cancer. Results from the phase 1 study of NBTXR3, which is being conducted as part of an ongoing collaboration between Nanobiotix and the University of Texas MD Anderson Cancer Center, were presented at this year’s American Association for Cancer Research Special Conference on Pancreatic Cancer. Pancreatic ductal adenocarcinoma (PDAC) is associated with a poor prognosis and remains one of the leading causes of cancer-related death worldwide. For more than 90% of patients with locally advanced disease who are not eligible for surgery, there are few treatment options with curative intent, and the five-year overall survival rate for patients with unresectable PDAC remains less than 5%. Radiotherapy is one of the most common treatment modalities for cancer, with approximately 50% of patients undergoing it at ...
- Source: drugdu
- 100
- October 9, 2023
FDA to start review of subcutaneous Entyvio for Crohn’s disease

The US Food and Drug Administration (FDA) has accepted Takeda’s biologics license application (BLA) for the company’s investigational subcutaneous administration of Entyvio (vedolizumab) for the treatment of Crohn’s disease. The BLA, which is for maintenance therapy of moderate to severe active forms of the disease after induction therapy with IV vedolizumab, will now be reviewed by the FDA alongside a separate BLA submitted by Takeda for the same formulation indicated for ulcerative colitis treatment. Dr Vijay Yajnik, vice president and head of US Medical for Gastroenterology at Takeda said in a statement: “With two applications for a subcutaneous option of Entyvio now under FDA review, we remain firm in our commitment to the inflammatory bowel disease community—adults with ulcerative colitis or Crohn’s disease—and the healthcare professionals actively managing their care.” Takeda submitted the most recent BLA with data from a Phase III clinical trial demonstrating that Entyvio led to a ...
- Source: drugdu
- 129
- September 15, 2023
Sandoz partners with Samsung Bioepis to license Stelara biosimilar

Sandoz has partnered with Samsung Bioepis to develop and market a Stelara (ustekinumab) biosimilar in the US, Canada, and Europe. Stelara is an interleukin (IL)-12/IL-23 inhibitor monoclonal antibody developed by Janssen Pharmaceutical Companies of Johnson and Johnson (J&J). It was first approved by the US Food and Drug Administration (FDA) for treating moderate to severe plaque psoriasis in adults in 2009. Its approval was later expanded to include Crohn’s disease, active psoriatic arthritis, and ulcerative colitis. With Stelara being a high-grossing drug for J&J, generating $3.2bn in sales in H1 2023, as per the company’s Q2 financial report, multiple companies are developing biosimilars. J&J has already settled three lawsuits with multiple companies, including Amgen, to push the launch of the Stelara biosimilar’s release date to 2025. Samsung Bioepis is expected to present Phase III trial data with the Stelara biosimilar, SB17, by the end of 2023. The Phase I trial ...
- Source: drugdu
- 102
- September 13, 2023
J&J dumps high-dose Opsumit trial upon failure in rare type of pulmonary hypertension

Johnson & Johnson’s plan to expand decade-old pulmonary hypertension med Opsumit has hit a snag.J&J’s Janssen has decided to stop a phase 3 trial for a 75-mg dose of macitentan in patients with chronic thromboembolic pulmonary hypertension (CTEPH). The company pulled the plug after an independent data monitoring committee performed an interim analysis and figured the trial wouldn’t succeed. Macitentan, given at 10 mg daily, won approval in 2013 under the brand name Opsumit for treating pulmonary arterial hypertension (PAH). PAH and CTEPH are slightly different diseases, but both feature abnormally high blood pressure in the arteries of the lungs. The results from the high-dose trial, dubbed MACiTEPH, won’t affect the marketed product, J&J said. Separately, J&J is trying to show that the higher dose works better than the FDA-approved 10-mg version in PAH. That study, coded UNISUS, remains ongoing with an estimated primary completion date next month, according to ...
- Source: drugdu
- 101
- September 9, 2023
J&J’s patient assistance program suffers data breach, IBM says

A technical flaw has resulted in “unauthorized access” to personal information at Johnson & Johnson’s Janssen CarePath patient assistance program, IBM reported on Wednesday. After an internal investigation, IBM was unable to determine how many accounts were affected, or the exact information that may have been compromised. The company is reaching out to all Janssen CarePath customers “out of an abundance of caution,” the tech giant said in a statement. The Janssen program helped more than 1.16 million U.S. patients access medications in 2022 alone, according to the drugmaker’s website. The free initiative facilitates access by helping patients navigate health insurance, plus provides information to get patients started on and stay on treatment. The program also provides options to manage out-of-pocket costs. By IBM’s account of events, J&J first became aware of a technical loophole in the Janssen CarePath system. Once informed, IBM, which manages the service, “promptly remediated the ...
- Source: drugdu
- 113
- September 8, 2023
US announces first ten drugs up for Medicare price negotiation

Medicare will soon be able to negotiate the prescription drug prices for the first time, under US President Joe Biden’s Inflation Reduction Act (IRA), which was enacted last year. Earlier today, the US Department of Health and Human Services (HHS) released a list of ten drugs that will be up for price negotiations. Aimed at driving down healthcare costs and increasing patient power, the IRA allows the Centers for Medicare and Medicaid Services (CMS), the US Government’s national insurance programme, to provide drugs at reduced prices. The price negotiation process will consider elements like the drug’s clinical benefit, the unmet clinical need, and the costs associated with the drug’s production. The negotiations with manufacturing companies will occur in 2023 and 2024, with any price changes rolling in by 2026. Blockbuster drugs are aplenty on the list. Bristol-Myers Squibb (BMS) and Pfizer’s co-developed drug Eliquis (apixaban) and Amgen’s Enbrel (etanercept) are ...
- Source: drugdu
- 102
- August 31, 2023
AstraZeneca Latest to Sue Biden Administration Over IRA’s Drug Price Negotiations

By Nadia Bey Pictured: AstraZeneca’s San Francisco office/iStock, hapabapa AstraZeneca has joined a growing list of drugmakers suing the Biden administration over a provision in the Inflation Reduction Act that allows the federal government to negotiate Medicare drug prices, the company announced Friday. The British drugmaker is the latest pharma company to file a legal complaint. Boehringer Ingelheim filed a lawsuit Aug. 18, arguing that Medicare price negotiations under the IRA violate the company’s constitutional rights to due process, protection against excessive fines and free speech. Other companies—including Merck, Bristol Myers Squibb, Johnson & Johnson and Astellas—that have sued the U.S. government over the IRA have focused on constitutional arguments. Similarly, the lobbying group Pharmaceutical Research and Manufacturers of America filed a suit challenging the constitutionality of the law. However, AstraZeneca has taken a different approach in its legal complaint filed Aug. 25 in the U.S. District Court for the ...
- Source: drugdu
- 106
- August 30, 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
- 124
- August 21, 2023
Pfizer Bispecific Drug Wins FDA Accelerated Approval for Multiple Myeloma

By Tristan Manalac Pictured: Pfizer office at its South San Francisco campus/iStock, hapabapa The FDA on Monday granted accelerated approval to Pfizer’s bispecific antibody elranatamab, to be marketed as Elrexfio, for the treatment of relapsed or refractory multiple myeloma. Elrexfio’s label covers patients who had been treated with at least four prior lines of therapy, including an anti-CD38 antibody, an immunodulatory agent and a proteasome inhibitor. According to Pfizer’s announcement, Monday’s approval makes Elrexfio the first off-the-shelf, ready-to-use fixed-dose subcutaneous therapeutic that targets the BCMA protein. “With significant responses in a patient population with highly refractory disease, we believe Elrexfio is poised to potentially become the new standard of care for multiple myeloma,” Pfizer Chief Commercial Officer Angela Hwang said in a statement, adding that the company will continue the treatment’s clinical development through its broad MagnetisMM program. The FDA’s approval was supported by data from the Phase II MagnetisMM-3 ...
- Source: drugdu
- 216
- August 17, 2023
Researchers publish early results with new interleukin-targeting antibody

An academic group has published preclinical results with a new antibody that has greater activity and fewer side effects than existing biological therapies for inflammatory conditions. This could translate into a clinical benefit for patients living with rheumatoid arthritis (RA), psoriasis, or inflammatory bowel disease (IBD). Researchers from the University of Birmingham in the UK and the University of Naples Federico II in Italy revealed promising results after designing an antibody that targets a 20-long amino acid sequence in interleukin-17 (IL-17) – a protein important in inflammatory pathways. According to the team, they demonstrated for the first time that this sequence activates the release of cyto-chemokines. The antibody, which has been called Ab-IPL-IL-17, targets this sequence in both IL-17A and IL-17F. In cell studies, it demonstrated an ability to reduce the production of cyto-chemokines and white blood cell migration to inflammation-primed tissue. When the researchers compared it to existing therapies ...
- Source: drugdu
- 228
- August 17, 2023

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