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. TUCSO ...

VYLOY is the first and only CLDN18.2-targeted treatment approved in the U.S. for adults with advanced gastric and gastroesophageal junction cancer whose tumors are CLDN18.2 positive TOKYO, Oct. 18, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has approved VYLOY™ (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of ad ...

Roche (RHHBY) announced that the FDA has approved pipeline candidate, inavolisib, for the treatment of breast cancer, under the brand name Itovebi. The drug is approved in combination with Pfizer's Ibrance (palbociclib) and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDAapproved test, following recurrence on or after c ...

Positive data confirm Evrysdi efficacy and safety in children first treated pre-symptomatically before six weeks of age, with most achieving motor milestones similar to children without SMA All children were able to swallow and feed orally, with none requiring permanent ventilation Evrysdi is the only non-invasive SMA therapy and is approved in over 100 countries, with more than 16,000 people with SMA treated globally Basel, 14 October 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) presented positive two-year da ...

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 ...

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