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 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 ...

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 ...

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 ...

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 ...

Basel, 22 May 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Tina-quant® lipoprotein Lp(a) RxDx assay has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) to identify patients who may benefit from innovative Lp(a)-lowering therapy currently in development. Lp(a) is emerging as an important, yet under-recognised, potential risk factor for cardiovascular disease, a major public health issue. "While modern lifestyles are a major driver, as much as 30 ...

The FDA granted this designation to inavolisib in combination with Ibrance (palbociclib) and Faslodex (fulvestrant) to treat adult patients with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER)-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. HR-positive breast cancer is the most prevalent type of breast cancer and roughly accounts for approximately 70% of cases. The d ...

Basel, 21 May 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for inavolisib, an investigational oral therapy, in combination with palbociclib (Ibrance®) and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completin ...

cagkansayin/iStock via Getty Images And from Carmot's 4-week data release last year, we know that 4-week efficacy was in the ballpark of Viking's VK2735 – absolute weight loss of 8.4% for CT-388 at its highest dose versus 7.8% for the highest VK2735 dose in its 4-week trial. Roche Holding (OTCQX:RHHBY) announced positive topline results from the phase 1b trial of its obesity candidate CT-388 this week and its share price received a 4% boost on the day of the announcement. The results look strong with 18.8% ...

Company Insights - Roche announced positive results from an early-stage study of its obesity drug candidate CT-388, showing a mean placebo-adjusted weight loss of 18.8% over 24 weeks [1] - Management described the results as 'clinically meaningful and statistically significant', with all patients achieving more than 5% weight loss and approximately 45% losing over 20% of their body weight [2] - The side effects of CT-388 were reported to be similar to those of currently marketed incretin-based medicines like Novo Nordisk's Wegovy and Eli Lilly's Zepbound [3] - CT-388 also demonstrated benefits for type 2 diabetes patients, with all pre-diabetic participants achieving normalized glycemia after 24 weeks [4] - Roche's shares have decreased by 13.3% year-to-date, contrasting with the industry's growth of 14.5% [5] - Roche entered the obesity market by acquiring Carmot Therapeutics for $2.7 billion, adding CT-388 and other incretin-based drug candidates to its pipeline [6] Industry Insights - The obesity market has gained significant attention, particularly after Novo Nordisk's FDA approval for Wegovy in 2021, which has seen consistent sales growth [7] - Eli Lilly recently launched Zepbound, following its FDA approval in December, contributing to the competitive landscape dominated by Novo Nordisk and Eli Lilly [8] - Research by Goldman Sachs predicts the U.S. obesity market will grow to $100 billion by 2030, prompting major pharmaceutical companies like Amgen and AstraZeneca to develop their own obesity drugs [9] - Amgen has completed an interim analysis of its phase II study for its GLP-1 receptor candidate MariTide, with top-line data expected in late 2024 [11] - AstraZeneca has entered an exclusive deal with Eccogene to develop an oral drug for obesity and related conditions, securing global rights outside of China [12]