Approval is based on Phase III INAVO120 results, showing the Itovebi™ (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting1 This approval helps address an urgent unmet need in breast cancer for people with a PIK3CA mutation, one of the most commonly mutated genes in HR-positive disease, associated with poor prognosis2,3 Itovebi is Roche's first targeted therapy approved for people with HR-positive disease, the most p ...

BRISBANE, Calif., Oct. 10, 2024 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, today announced an agreement with Roche to advance the evaluation of amezalpat (TPST-1120) in combination with atezolizumab (Tecentriq®) and bevacizumab, the current standard of care for unresectable or metastatic hepatocellular carcinoma (HCC), into a pivotal Phase 3 trial for the first-lin ...

The new VENTANA CLDN18 (43-14A) RxDx Assay helps fulfil an unmet medical need by enabling clinicians to identify patients with gastric or gastroesophageal junction (GEJ) cancer who may benefit from a targeted treatment option. CLDN18.2 is an emerging biomarker in gastric and GEJ cancers and helps predict the likelihood of response to targeted therapy. As the leader in companion diagnostics, Roche continues to build on its commitment to improve personalised healthcare to enable better patient outcomes. Basel ...

Survey findings from over 8,700 people in 12 countries show that half of those polled have inadequate understanding of HPV, with nearly one-third being unsure or unaware of it altogether.1 Findings also show that significant barriers continue to exist that are preventing women from seeking screening.1 However, more than 70% of the respondents indicated they would be interested in the option of collecting their own sample for screening if available. TUCSON, Ariz., Oct. 8, 2024 /PRNewswire/ -- GWI research co ...

Positive phase III results for Roche's Gazyva/Gazyvaro show superiority to standard therapy alone in people with lupus nephritis The REGENCY study met its primary endpoint, demonstrating statistically significant and clinically meaningful treatment benefits in people with active lupus nephritis Gazyva/Gazyvaro is designed to target an underlying cause of lupus nephritis, aiming to prevent or delay progression to end-stage kidney disease1,2 Lupus nephritis is a potentially life-threatening manifestation of a ...

I publish my best ideas and top coverage on the Growth Stock Forum . If you're interested in finding great growth stocks, with a focus on biotech, consider signing up. We focus on attractive risk/reward situations and track each of our portfolio and watchlist stocks closely. To receive e-mail notifications for my public articles and blogs, please click the follow button . And to go deeper, sign up for a free trial to Growth Stock Forum. Shares of Roche Holding AG ( OTCQX:RHHBY ) pulled back this month after ...

New TAGS (Temperature-Activated Generation of Signal) technology enables up to 15 targets to be detected simultaneously in a single patient sample on the high throughput molecular diagnostic analysers cobas 5800, 6800 and 8800. TAGS has the potential to revolutionise testing for other infectious diseases in the future, by bringing high throughput customised syndromic panel testing to the routine clinical laboratory. The first TAGS-based test to be made available, the cobas Respiratory flex, offers fast, eff ...

Roche's CINtec PLUS Cytology is the only FDA-approved and CE-marked dual-stain test to triage human papillomavirus (HPV)-positive cervical cancer screening test results Dual-stain biomarkers aid in detection of cervical precancer and may reduce the number of women who undergo unnecessary colposcopy procedures while allowing earlier intervention for those who are at higher risk of developing cervical cancer. This recognition follows the American Society for Colposcopy and Cervical Pathology (ASCCP)'s recent ...

I publish my best ideas and top coverage on the Growth Stock Forum . If you're interested in finding great growth stocks, with a focus on biotech, consider signing up. We focus on attractive risk/reward situations and track each of our portfolio and watchlist stocks closely. To receive e-mail notifications for my public articles and blogs, please click the follow button . And to go deeper, sign up for a free trial to Growth Stock Forum. Shares of TG Therapeutics (NASDAQ: TGTX ) made new 52-week highs this w ...

Data from the CENTERSTONE study shows single-dose Xofluza reduces transmission of influenza from an infected person to household members This is the first time that any antiviral used in the treatment of a respiratory viral illness has demonstrated a transmission reduction benefit in a global phase III study Reducing the spread of infection in the household could help limit transmission within communities and societies, easing the burden of both seasonal and pandemic influenza on healthcare systems Basel, 1 ...