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LIXTE Biotechnology Holdings to Collaborate with Roche and Netherlands Cancer Institute in New Colon Cancer Clinical Trial
GlobeNewswire News Room· 2024-06-14 13:30
Clinical trial to test recent findings that show LIXTE's lead clinical compound, LB-100, increases recognition of colon cancer cells by the immune system PASADENA, CA, June 14, 2024 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. ("LIXTE" or the "Company") (Nasdaq: LIXT and LIXTW), a clinical stage pharmaceutical company, today announced a collaboration with Roche and the Netherlands Cancer Institute (NKI) to conduct a new clinical trial in immune therapy unresponsive (MSI Low) metastatic colon cance ...
Roche (RHHBY) NSCLC Drug Alecensa Gets EC Nod for Label Expansion
ZACKS· 2024-06-10 17:01
In April 2024, the FDA also approved Alecensa as adjuvant treatment following tumour resection for patients with ALK-positive NSCLC (tumours ≥ 4 cm or node positive), as detected by an FDA-approved test. Sales of the Alecensa came in at CHF 355 million in the first quarter of 2024. Approval in the adjuvant treatment setting should boost demand for Alecensa for treating ALK-positive resectable NSCLC where there is a significant need for treatments. Roche's shares have lost 7.8% year to date against the indus ...
Roche Diagnostics Company Profile 2024, Featuring a Detailed Product Pipeline Analysis and Ongoing Clinical Trials Insights
GlobeNewswire News Room· 2024-06-10 11:44
This report is a source for data, analysis, and actionable intelligence on the company's portfolio of pipeline products. The report provides key information about the company, its major products and brands. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. 291. HER2 (Human Epidermal Growth Factor Receptor 2) Expression/ Gene Amplification CDx Test - Pertuzumab Product Overview 292. HER2 Expression/ Gene Amplification T-DM1 Diagnos ...
Roche four-in-one molecular test for SARS-CoV-2, Influenza A/B viruses and RSV receives U.S. FDA Emergency Use Authorization
GlobeNewswire News Room· 2024-06-10 05:05
A, influenza B and RSV RNA are generally detectable in nasal swab and nasopharyngeal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2, influenza A, influenza B and/or RSV RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other pathogens not detected by the test. The agent detected may not b ...
European Commission approves Roche's Alecensa as the first and only targeted adjuvant treatment for people with ALK-positive early-stage lung cancer
GlobeNewswire News Room· 2024-06-10 05:00
European Commission approves Roche's Alecensa as the first and only targeted adjuvant treatment for people with ALK-positive early-stage lung cancer Alecensa reduced the risk of disease recurrence or death by an unprecedented 76% in people with ALK-positive resected non-small cell lung cancer, as demonstrated in the Phase III ALINA study1 Alecensa's approval addresses an urgent unmet need in the early-stage setting where about half of all people experience disease recurrence following surgery, despite adjuv ...
Five-year data for Roche's Evrysdi show the majority of treated children with a severe form of spinal muscular atrophy (SMA) achieved or maintained the ability to sit, stand or walk
GlobeNewswire News Room· 2024-06-07 14:40
Basel, 07 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new five-year data confirming the sustained efficacy and safety profile of Evrysdi® (risdiplam) in children with Type 1 spinal muscular atrophy (SMA) from the open-label extension of the pivotal FIREFISH study. By the end of Year 5, 91% of children treated with Evrysdi were alive, 81% were alive without permanent ventilation and the majority were able to sit without support for at least 30 seconds (59%). At the end of year 5, seven chi ...
Roche's (RHHBY) Inavolisib NDA Gets FDA Priority Review Tag
zacks.com· 2024-05-29 16:30
Roche Holding AG (RHHBY) announced that the FDA has accepted its new drug application (NDA) seeking approval for its investigational oral therapy inavolisib for treating adult patients with breast cancer. The NDA is seeking approval for inavolisib in combination with Pfizer's (PFE) Ibrance (palbociclib) and AstraZeneca's (AZN) Faslodex (fulvestrant) to treat adult patients with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER)-negative, locally advanced/metastati ...
FDA grants Priority Review to Roche's inavolisib for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation
globenewswire.com· 2024-05-29 05:00
Roche recently announced the inavolisib-based regimen has been granted FDA Breakthrough Therapy Designation based on INAVO120, the 29th for Roche's oncology portfolio.7 Additional analyses from INAVO120 will be presented in an oral abstract session at the 2024 American Society of Clinical Oncology Annual Meeting, taking place 31 May - 04 June. Inavolisib is currently being investigated in three company-sponsored Phase III clinical studies (INAVO120, INAVO121, INAVO122) in PIK3CA-mutated locally advanced or ...
Roche and Hitachi High-Tech extend their 46-year partnership, paving the way for further breakthroughs in diagnostic testing
prnewswire.com· 2024-05-27 05:00
BASEL, Switzerland, May 27, 2024 /PRNewswire/ -- Roche announced today that Hitachi High-Tech and Roche have extended their partnership, committing to at least 10 years of additional collaboration. Bringing together the companies' expertise and track record in diagnostics innovation, engineering and manufacturing, the renewed contract further strengthens the two companies' long lasting partnership. Together, the companies have delivered significant innovations that paved the way for industry-leading in-vitr ...
Changes to the Roche Enlarged Corporate Executive Committee
globenewswire.com· 2024-05-27 05:00
Basel, 27 May 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that James Sabry (1958), Head of Roche Pharma Partnering, will be retiring after fourteen years with the company. James Sabry joined Genentech in 2010 as Head of Genentech Partnering. In 2018, he became the Head of Pharma Partnering and a member of the enlarged Corporate Executive Committee, based in Basel, Switzerland. James Sabry completed an MD at Queen's University in Canada and his residency at Harvard Medical School, and then comp ...