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 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 ...

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, 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, 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, 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 ...