Search Results for “FDA” – Page 135 – media

CancerVAX joins forces with UCLA to develop a universal CAR-T cell therapy

CancerVAX has announced the development of a universal chimeric antigen receptor (CAR) T-cell platform in partnership with a research team from the University of California, Los Angeles (UCLA). The company plans to adapt the nanoparticle technology developed by the UCLA team, which is currently being used for a universal cancer vaccine project to target T cells. The nanoparticle technology is inspired by the lipid nanoparticle and messenger RNA (mRNA) technology used to develop Covid-19 vaccines. Conventional CAR-T therapies rely on gene editing performed in the laboratory to transform the allogeneic T cells to induce CAR protein expression before reinfusion of these calls back into the patient. The universal CAR-T cell therapy would use injectable smart nanoparticles, which would be loaded with genetic information for specific cancer cell targeting. These nanoparticles would attach to the patient’s T cells and reprogram them to target specific cancer cells. CancerVAX has reported that preliminary ...
- Source: drugdu
- 148
- September 14, 2023
2seventy bio fires 40% of staff after reduced Abecma sales forecasts

2seventy bio will be reducing its workforce by 40% and firing 176 employees in an effort to cut costs. One of the main reasons cited for restructuring was the decreased 2023 sales forecasts of Abecma (idecabtagene vicleucel), the company’s only approved therapy. The chimeric antigen receptor (CAR) T-cell therapy, developed in partnership with Bristol Myers Squibb, is expected to generate $470m-$570m less in sales than previously projected, as per 2seventy bio. Still, the company was quick to note that it remains hopeful Abecma sales may improve, considering the expected label expansion for a third indication. The therapy is currently under review with the US Food and Drug Administration (FDA) for the treatment of triple-class exposed relapsed and/or refractory multiple myeloma, with the Prescription Drug User Fee Act (PDUFA) date set for 16 December. Multiple pharma companies have announced staff layoffs this year following FDA rejections and as a general cash ...
- Source: drugdu
- 91
- September 14, 2023
Gilead’s Trodelvy Shows Potential as First-Line Treatment in NSCLC

By Tristan Manalac Pictured: Gilead’s corporate headquarters in California/iStock, Sundry Photography Early data from the Phase II EVOKE-02 study showed that Gilead’s Trodelvy (sacituzumab govitecan-hziy), combined with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab), demonstrates promising efficacy in patients with metastatic non-small cell lung cancer, the company reported Sunday. However, the trial also detected worrying safety signals, with 18% of participants dropping out due to side effects. One patient died due to treatment-related sepsis. Nevertheless, the overall safety profile of Trodelvy in EVOKE-02 was generally consistent with what had previously been established. The most common treatment-emergent adverse events were diarrhea, anemia and asthenia. EVOKE-02 is an open-label, multi-cohort Phase II study with 224 patients enrolled. The trial assessed the combination of Trodelvy and Keytruda, with or without additional chemotherapeutic agents such as carboplatin or cisplatin. Advanced or metastatic non-small cell lung cancer (NSCLC) patients were enrolled regardless of PD-L1 expression status. The ...
- Source: drugdu
- 247
- September 13, 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
- 94
- September 13, 2023
Click Expands to Substance Use Disorder With Indivior Digital Therapeutics Pact

Click Therapeutics, a developer of prescription digital therapeutic products, is adding substance use disorder to its pipeline through a new partnership with addiction medicines maker Indivior. Like other products in the Click pipeline, the new substance use disorder treatment, codenamed CT-102, will be a mobile software app. This app will be designed to work alongside drugs used to treat addiction. The Indivior portfolio includes the opioid addiction products Sublocade and Suboxone. Click said the partnered app will combine evidence-based behavioral therapy with tailored interventions intended to have an effect on the brain. Privately held Click is part of a cohort of companies developing software as treatments for various medical conditions. The company has mapped the entire brain to discover faulty brain circuits that are implicated across a variety of diseases. To treat these diseases, the company designs apps that present users with tasks that have the effect of retraining and ...
- Source: drugdu
- 175
- September 12, 2023
Danco takes mifepristone restrictions lawsuit to the Supreme Court

The legal kerfuffle over the FDA’s 2000 approval of Danco Laboratories’ abortion pill mifepristone, also known as Mifeprex, is heading to the Supreme Court. Friday, Danco asked the Supreme Court to overturn a recent U.S. Court of Appeals for the Fifth Circuit ruling that would severely limit access to the abortion pill mifepristone. “The risks and confusion that result from the Fifth Circuit’s decision are not ones that women, teenage girls, and the public health system should be forced to bear without this Court’s review,” Danco’s lawyers wrote in a legal filing. “Denying review of the Fifth Circuit’s opinion would eviscerate the sovereign authority of states that have chosen to expand and protect access to medication abortion in their jurisdictions,” Danco’s legal team continued, adding that the case is of “indisputable importance.” Mifepristone remains unrestricted until the Supreme Court weighs in on the case. Medication abortion makes up the majority ...
- Source: drugdu
- 98
- September 12, 2023
ICR study finds way to determine efficacy of experimental breast cancer drugs

Researchers at The Institute of Cancer Research (ICR), London, have discovered a way to use a simple, non-invasive MRI scan to determine whether an experimental approach to enhance treatment for breast cancer is effective. New research from the study, funded by Cancer Research UK, could help doctors visualise tumours and speed up the development of targeted therapies for breast cancer. If successful, these drugs could enhance the effectiveness of other drugs administered in combination. Common features of breast cancer include excessive connective tissue, which consists of cells and fibres that provide a scaffold, known as the extracellular matrix (ECM), where tumours can grow. Hyaluronic acid, which works by absorbing water, is naturally present inside the tumour ECM and causes cancer tumours to swell, making it challenging for drugs to penetrate, reach and destroy cancer cells. Researchers are able to use experimental drugs that target and degrade a chemical called hyaluronic ...
- Source: drugdu
- 98
- September 12, 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
- 97
- September 9, 2023
BMS Accused by HMO of Patent Fraud to Allegedly Sustain Pomalyst Monopoly

By Tristan Manalac Pictured: BMS office in California/iStock, hapabapaBlue Cross and Blue Shield of Louisiana on Tuesday filed a class action lawsuit against Bristol Myers Squibb, accusing the pharma giant of unlawfully extending the market exclusivity for its multiple myeloma drug Pomalyst (pomalidomide), according to Reuters. The Baton Rouge-based health maintenance organization is being joined by HMO Louisiana, a subsidiary of Blue Cross and Blue Shield of Louisiana. The plaintiffs are representing a proposed class of entities in the U.S. and its territories that paid for or reimbursed Pomalyst from October 2020. In the 151-page complaint, the not-for-profit health insurance company alleged that BMS and its subsidiary Celgene committed patent fraud by misrepresenting and concealing data regarding Pomalyst’s properties, formulations and uses that had already been publicly available. The pharma companies also “abused the federal judicial system” by launching a barrage of “sham lawsuits” against generics companies that were trying ...
- Source: drugdu
- 172
- September 9, 2023
Idorsia reacquires aprocitentan rights from Janssen for $343m

Idorsia has decided to reacquire the global rights for the oral endothelin receptor antagonist aprocitentan almost six years after they were sold to Janssen. The news comes after Idorsia announced potential layoffs, and cost-reduction initiatives, including the sale of its Asia Pacific operations, in July due to “lower than anticipated” sales in H1 2023. The reacquisition of aprocitentan is expected to provide a much-needed boost to Idorsia’s profits. GlobalData forecasts aprocitentan to generate $241m in sales in 2029. Idorsia CEO Jean-Paul Clozel said: “Aprocitentan has demonstrated significant and clinically meaningful sustained blood pressure lowering benefits with a good safety profile, particularly suited to the high-risk patient population with resistant hypertension.” Aprocitentan is currently under review with the US Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) set for 19 December. An EU approval application was filled with the European Medicines Agency (EMA) in January. Idorsia ...
- Source: drugdu
- 110
- September 8, 2023

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